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BioSig Technologies, Inc. Appoints Medical Device Industry Leader to its Board of Directors

James J. Barry, Ph.D. will join as an Independent Director as Company expands clinical footprint with its signal processing technology for arrhythmia care

 

Westport, CT – September 21, 2021  — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced the appointment of James J. Barry, Ph.D. as an Independent Director to its Board of Directors.

 

Dr. Barry has more than 30 years of experience in the medical device industry as an executive and corporate board director.  He is currently the Principal Owner at Convergent Biomedical Group LLC., a company providing advisory services to the life sciences industry.  Prior to Convergent, Dr. Barry was President and CEO at InspireMD, Inc. (Nasdaq: NSPR) and platform technology company, Arsenal Medical.  Dr. Barry spent the majority of his career at Boston Scientific (NYSE: BSX) with increasing roles of responsibility culminating as Sr. Vice President of Corporate Technology. While at Boston Scientific, Dr. Barry led the development and launch of the TAXUS drug-eluting coronary stent that achieved annual sales exceeding $3 billion.

 

Dr. Barry is the author of multiple peer-reviewed publications and holds more than 40 U.S. and international patents. He holds a Ph.D. in Biochemistry from the University of Massachusetts-Lowell and a B.A. in Chemistry from St. Anselm College.

 

“I have always viewed the electrophysiology field as a tremendous opportunity given the burden heart rhythm disorders have on the healthcare system.  It is a space that can benefit greatly from innovation, and I am impressed with the PURE EP™ system which appears to be a meaningful advance in signal detection and should have a positive impact on procedure time and cost.  I look forward to working with the BioSig Board and the management team to leverage my experience and executive leadership to deliver on the strategic expansion of the PURE EP™  system and the company’s many pipeline opportunities,” commented Dr. Barry.

 

“Jim’s accomplishments in the medical device sector are second-to-none, and we are thrilled that he can join us as our new Independent Director. Our mission is to empower physicians to make better procedural decisions through more advanced technological solutions, and Jim’s industry expertise is perfectly aligned with our passion for innovation. We look forward to learning from Jim as we continue to expand our commercial roll-out,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

 

The PURE EP™ is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, over 60 physicians have completed over 1300 patient cases with the PURE EP™ System across twelve clinical sites.

 

The Company recently completed its first multi-centered, prospective clinical trial and presented preliminary clinical data during the annual Heart Rhythm 2021 convention in July in Boston, MA.

 

The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida and is in regular use in some of the country’s leading centers of excellence, including the Mayo Clinic in Rochester, MN, and St. David’s Medical Center in Austin, TX.

 

About BioSig Technologies

 

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

Forward-looking Statements

 

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:

Andrew Ballou

BioSig Technologies, Inc.

Vice President, Investor Relations

55 Green Farms Road

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

 

SOURCE:  BioSig Technologies, Inc.

BioSig Completes 1000 Patient Cases with its Signal Processing System for Electrophysiology

The Company recently increased its procedural volume targets due to accelerated technology usage

 

BioSig expands its commercial team to target technology adoption across three strategic regions

 

Westport, CT – June 30, 2021 — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that physicians have completed 1000 patient cases with its technology across nine installation sites.

 

BioSig’s non-invasive computerized technology, the PURE EP™ System, aims to drive procedural efficiency and efficacy in electrophysiology. The system provides essential diagnostic signals with high clinical value in all cardiac ablations that treat irregular heartbeats or arrhythmias.

 

Previously the Company increased the patient case goal from 1000 to at least 1500 procedures by the end of 2021, having delivered 425 procedures at the end of 2020. The Company is currently conducting patient cases in nine medical centers across the country. Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, TX, Mayo Clinic Florida Campus, the Company’s first commercial customers, and the University of Pennsylvania count among the most prominent technology users with over 600 patient cases conducted to date[1].

 

“We are thrilled to cross the 1000-case milestone, a figure that was our initial target for the entire 2021. Most importantly, this case growth allows us to collect vast amounts of clinical data daily, providing us with immense intelligence that is vital for our clinical and commercial strategy. Increased technology usage in elective procedures is a much-awaited sign of the steady pandemic recovery in our country, and we are looking forward to a strong second half of 2021,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

 

The Company is in the targeted commercial launch phase, focusing on expanding its clinical footprint across the Northeast, Texas, and Florida, the three regions that account for the largest electrophysiology programs in the country. The Company recently expanded its commercial team by appointing Mr. Walt Quinn to lead regional sales in Florida. Mr. Quinn brings to the Company over 25 years of medical device and capital equipment sales experience in some of the leading companies in the field, including Ethicon (a Johnson&Johnson company), Medtronic, Topera (an Abbott company), and CardioFocus.

 

The Company will be exhibiting at the annual Heart Rhythm 2021 convention on July 28-31, 2021, at the Boston Convention and Exhibition Center in Boston, MA. BioSig’s executive leadership, clinical, commercial, and engineering teams will host a series of presentations that will showcase the latest clinical data and demonstrate the newest software features of its PURE EP™ System.

 

One in 18 Americans suffers from cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050.[2] According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually[3].

 

About BioSig Technologies

 

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, the PURE EP™ System, is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

Forward-looking Statements

 

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations

54 Wilton Road, 2nd floor

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x119

 

[1] Data as of June 24, 2021.

[2] Top 10 Things You should Know About Heart Rhythm; Scripps Health.

[3] Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue

 

SOURCE:  BioSig Technologies, Inc.

Major Medical Centers Enter into Installation Agreements for Evaluation of BioSig PURE EP™ Systems

New 90-day evaluation cycles enable hospitals to more rapidly assess the platform technology while also accelerating BioSig’s commercial activities

 

Westport, CT – February 11, 2021 – BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it has entered into three new evaluation agreements for the PURE EP™ System, its novel electrophysiology (EP) signal acquisition and analysis technology.

 

New installations of the PURE EP™ System will now follow a shorter assessment cycle of 90 days based on favorable data from installation evaluations in 2020. As part of its evaluation agreements, the Company’s clinical team provides on-site training and assists with data collection and interpretation, and workflow customization to optimize the user experience for every physician and EP lab staff member.

 

“Since initiating our first clinical study in November 2019, our team has acquired a wealth of knowledge about the capabilities of the PURE EP™ System in a broad range of clinical cases,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc. “Our experience in 2020 has provided the Company meaningful strategic information that gives us confidence in accelerating our rollout and reducing the clinical evaluation period to 90 days or less, beginning with these three major hospitals. With the recent decline of COVID-19 cases reported and the resulting decline in hospitalization rates in the past several weeks, our Company is poised to expand near-term activity on our targeted commercial plans for 2021.”

 

New clinical sites due to receive BioSig’s PURE EP™ System include New York-Presbyterian/Weill Cornell Medical Center, Michigan Medicine–University Hospital (two centers that account for two of the largest EP programs in the country), and Houston Methodist Hospital.

 

More than 500 patient cases have been conducted using the PURE EP™ System by 34 physicians in seven clinical sites to date.

 

About BioSig Technologies BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

Forward-looking Statements

 

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

 

Source: BioSig Technologies, Inc.

BioSig and Mayo Clinic Collaborate on New R&D Program to Develop Transformative AI and Machine Learning Technologies for its PURE EP™ System

Global market for AI in healthcare is estimated to reach $45.2 billion by 2026

 

Westport, CT – February 2, 2021 —  BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced a strategic collaboration with the Mayo Foundation for Medical Education and Research to develop a next generation AI- and machine learning-powered software for its PURE EP™ system.

 

The new collaboration will include an R&D program that will expand the clinical value of the Company’s propriertary hardware and software with advanced signal processing capabilities and aim to develop novel technological solutions by combining the electrophysiological signals delivered by the PURE EPÔ and other data sources. The development program will be conducted under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic’s Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory, and Alexander D. Wissner-Gross, Ph.D., Managing Director of Reified LLC.

 

The global market for AI in healthcare is expected to grow from $4.9 billion in 2020 to $45.2 billion by 2026 at an estimated compound annual growth rate (CAGR) of 44.9%[1]. According to Accenture, key clinical health AI applications, when combined, can potentially create $150 billion in annual savings for the United States healthcare economy by 2026[2].

 

“AI-powered algorithms that are developed on superior data from multiple biomarkers could drastically improve the way we deliver therapies, and therefore may help address the rising global demand for healthcare,” commented Kenneth L Londoner, Chairman and CEO of BioSig Technologies, Inc. “We believe that combining the clinical science of Mayo Clinic with the best-in-class domain expertise of Dr. Wissner-Gross and the technical leadership of our engineering team will enable us to develop powerful applications and help pave the way toward improved patient outcomes in cardiology and beyond.”

 

“Artificial intelligence presents a variety of novel opportunities for extracting clinically actionable information from existing electrophysiological signals that might otherwise be inaccessible. We are excited to contribute to the advancement of this field,” said Dr. Wissner-Gross.

 

BioSig announced its partnership with Reified LLC, a provider of advanced artificial intelligence-focused technical advisory services to the private sector in late 2019. The new research program builds upon the progress achieved by this collaboration in 2020, which included an abstract for ‘Computational Reconstruction of Electrocardiogram Lead Placement’ presented during the 2020 Computing in Cardiology Conference in Rimini, Italy, and the development of an initial suite of electrophysiological analytics for the PURE EPÔ System.

 

BioSig signed a 10-year collaboration agreement with Mayo Clinic in March 2017.  In November 2019, the Company announced that it signed three new patent and know-how license agreements with the Mayo Foundation for Medical Education and Research.

 

About BioSig Technologies

 

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EPä System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

Forward-looking Statements

 

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations

54 Wilton Road, 2nd floor

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x119

 

SOURCE:  BioSig Technologies, Inc.

 

[1] Artificial Intelligence in Healthcare Market with COVID-19 Impact Analysis by Offering, Technology, End-Use Application, End User and Region – Global Forecast to 2026; Markets and Markets

 

[2] Artificial Intelligence (AI): Healthcare’s New Nervous System https://www.accenture.com/us-en/insight-artificial-intelligence-healthcare%C2%A0

ViralClear adds St. David's HealthCare in Austin, Texas, to its Planned Phase II trial for its Broad-Spectrum Oral Anti-Viral Candidate for COVID-19

Randomized, double-blind, placebo-controlled Phase II trial of merimepodib to be conducted in adults with COVID-19 who are hospitalized and require supplemental oxygen or are on non-invasive ventilation or high-flow oxygen devices

 

Westport, CT – June 5, 2020 — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it has expanded its patient enrollment centers to include St. David’s South Austin Medical Center in Austin. The hospital is part of St. David’s HealthCare, one of the largest healthcare systems in Texas. The Company intends to commence its Phase II clinical trial for merimepodib, its broad-spectrum oral anti-viral candidate for the treatment of COVID-19 in adult patients in the coming weeks.

 

The clinical trial team consists of Brian Metzger, M.D., MPH, Medical Director of Infectious Diseases at St. David’s Medical Center, who is is the principal investigator,  as well as Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., Cardiac Electrophysiologist and Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, and Matthew Robinson, M.D., Medical Director of Infectious Diseases at St. David’s South Austin Medical Center, who are co-investigators for the study.

 

“The safety and quality of treatment for our patients is our top priority, and we take numerous measures to ensure the highest level of care. As such, we remain steadfast in the pursuit against the coronavirus, and we look forward to working with ViralClear on the Phase II trial of its antiviral candidate as a potential solution against this virus,” commented Dr. Metzger.

 

“Adding St. David’s South Austin Medical Center as an investigating center in the ViralClear clinical trial with merimepodib has the potential to allow the Company to accelerate clinical development and generate results from a more diverse population of patients,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. and Director at ViralClear Pharmaceuticals, Inc. “We have been innovating with Dr. Andrea Natale since we started BioSig over eleven years ago. His guidance has been vital to us through all stages of product development and in the early commercialization of our PURE EP(tm) System. We are thankful for Dr. Natale’s leadership during these unprecedented times and look forward to collaborating with the whole St. David’s team on this important mission.”

 

The Phase II randomized, double-blind, placebo-controlled study is designed to enroll adult patients with advanced Coronavirus Disease 2019 (COVID-19). A description of this clinical trial can be accessed via www.clinicaltrials.gov.

 

Preclinical in vitro laboratory studies performed by the Galveston National Laboratory at The University of Texas Medical Branch demonstrated that merimepodib, provided in combination with remdesivir, showed reduction in SARS-CoV-2 replication to undetectable levels. Peer reviewed publication of these findings can be found at F1000 Research: https://f1000research.com/articles/9-361

 

About St. David’s HealthCare

St. David’s HealthCare includes seven of the area’s leading hospitals and is one of the largest health systems in Texas. The organization has been recognized with a Malcolm Baldrige National Quality Award—the nation’s highest presidential honor for performance excellence. St. David’s HealthCare is the third-largest private employer in the Austin area, with more than 10,600 colleagues across 132 sites of care.

 

St. David’s HealthCare is a unique partnership between hospital management company HCA Healthcare and two local non-profits—St. David’s Foundation and Georgetown Health Foundation. The proceeds from the operations of the hospitals fund the foundations, which, in turn, invest those dollars back into the community. Since the inception of St. David’s HealthCare in 1996, more than $535 million has been given back to the community to improve the health and healthcare of Central Texans.

 

About BioSig Technologies

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

About Merimepodib (MMPD)

Merimepodib, a broad-spectrum anti-viral candidate, has demonstrated strong activity against COVID-19 in cell cultures in laboratory testing.  Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials conducted (including 315 chronic hepatitis C patients, 24 psoriasis patients, and 98 healthy volunteers) and an extensive preclinical safety package completed.

 

A manuscript titled, “The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro”, was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch.

 

About ViralClear

BioSig’s subsidiary, ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical to treat COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against COVID-19 in cell cultures. Merimepodib has been previously studied in 12 clinical trials, including 5 in patients with hepatitis C (1 Phase 1b, 1 Phase 2, 2 Phase 2a, and 1 Phase 2b), 1 in patients with psoriasis (Phase 2), and six in healthy volunteers (Phase I).

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations

54 Wilton Road, 2nd floor

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

 

Source: BioSig Technologies, Inc.

ViralClear Publishes Comparative In Vitro Data on Merimepodib and Remdesivir Activity Against the COVID-19 Novel Coronavirus in F1000 Research

Merimepodib is shown to decrease viral production of COVID-19 coronavirus more than remdesivir at clinically meaningful drug concentrations in pre-clinical testing.

 

Article highlights recent work done in laboratory studies of COVID-19 with merimepodib at the Galveston National Laboratory at The University of Texas Medical Branch

 

 

Westport, CT – April 23, 2020 – BioSig Technologies, Inc. (Nasdaq: BSGM) today announced that an article titled, The IMPDH inhibitor merimepodib has similar antiviral activity against SARS-CoV-2 replication in vitro to the adenosine analogue remdesivir” was accepted by F1000 Research, an  online peer-reviewed life sciences journal publishing program in biology and medicine.

 

This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. (“ViralClear”) as a corresponding author.

 

The article highlights emerging pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. The work was started with Trek Therapeutics and after merimepodib was acquired by ViralClear has been continued by ViralClear.

 

“The concentrations of merimepodib used in the cell culture studies described in this article are achievable in humans by our oral solution formulation,” said Dr. Zeldis, Executive Chair and Founder of ViralClear Pharmaceuticals, Inc. “We are now exploring whether remdesivir and merimepodib are synergistic in this in vitro model.  We look forward to starting our first clinical trial in COVID-19 patients upon receiving FDA clearance to commence with the proposed phase 2 trial.”

 

Vero cells in tissue culture were pre-treated with two concentrations (2.5 and 5 µM) of either merimepodib or remdesivir for 4 hours before the SARS-CoV-2 coronavirus was added.  The amount of virus released to the media was measured at baseline and 16 hours and 24 hours after infection.  At 16 hours, a significant reduction in viral production was observed for both concentrations of merimepodib (1.9 log decrease in titer, p = 0.003 and 2.1 log decrease in titer, p = 0.001) but only at the higher concentration of remdesivir (1 log decrease in titer, p = 0.103 and 2.1-log decrease in titer, p = 0.001).  At 24 hours both concentrations of both drugs significantly reduced viral production; however, 2.5 µM remdesivir reduced viral titer by 1.5 logs (p = 0.002) as compared to a decrease of 3.9 logs for 5 µM remdesivir (p < 0.001), whereas 2.5 and 2.7 log reductions (p = 0.001 and p < 0.001, respectively) were observed for the 2.5 and 5 µM concentrations of merimepodib.

 

Merimepodib, a broad-spectrum anti-viral candidate, demonstrated strong activity against COVID-19 in cell cultures in laboratory testing and additional antiviral studies are underway.  Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with a 12 clinical trials conducted (including 315 chronic hepatitis C patients, 24 psoriasis patients, and 98 healthy volunteers) and an extensive preclinical safety package completed . ViralClear intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials in Q2 2020.

 

About BioSig Technologies

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

About ViralClear

 

BioSig’s subsidiary ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical to treat advanced COVID-19. Merimepodib is a broad-spectrum anti-viral agent that has demonstrated strong activity against the COVID-19 virus in cell cultures in laboratory testing. ViralClear plans to initiate a multi-center, phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of merimepodib administered orally every eight hours for 10 days in adult patients with advanced COVID-19 upon FDA clearance to proceed. Merimepodib has been studied in twelve clinical trials prior to this study, including five trials in patients with hepatitis C (one phase 1b, one phase 2, two phase 2a, and one phase 2b), one trial in patients with psoriasis (phase 2), and six trials in healthy volunteers (all phase 1).

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations

54 Wilton Road, 2nd floor

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

 

Source:  BioSig Technologies, Inc.

Positive Data Generated by Biosig Subsidiary ViralClear on Covid-19 Coronavirus Published in bioRxiv

>> Vicromax shown to decrease viral production of Covid -19 coronavirus by over 98%

>> Article highlights recent work done in laboratory studies of Covid -19 with Vicromax(tm) at the Galveston Lational Laboratory at The University of Texas Medical Branch

 

Westport, CT – April 14, 2020 – BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing a proprietary biomedical signal processing platform, today announced that an article titled “The IMPDH inhibitor merimepodib suppresses SARS-COV-2 replications” to bioRxiv, an online archive and distribution service for reprints in the life sciences. This manuscript is authored by Natalya Bukeryeva, Emily Mantlo, Rachel Sattler, Chen Huang, Slododan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear.

 

The article is the first public disclosure of pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. The work was started with Trek Therapeutics and after Vicromax was acquired by ViralClear, the work continues under contract with ViralClear.

 

“Oftentimes if an antiviral agent such as Vicromax decreases viral production by over 90% as is presented in this article, it will have meaningful activity in the clinic,” said Dr. Zeldis, ViralClear’s Executive Chair and founder. “More data will be submitted to peer review journals over the coming weeks and we are looking forward to submission of our IND to the FDA and advancing to human trails with this potential therapeutic .”

 

Vicromax(tm), a broad-spectrum anti-viral candidate, demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. The pharmaceutical is currently undergoing extensive pre-clinical testing. The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials in Q2 2020.

 

To view the the article in its entirety, please use this link:

https://www.biorxiv.org/content/10.1101/2020.04.07.028589v1

 

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: – BioSig Technologies, Inc.

BioSig to Host Telebriefing on Development Updates Regarding Vicromax(tm), a Novel Broad-Spectrum Anti-Viral Candidate That May Treat COVID-19

>> Introduction to ViralClear management and scientific team
>> Strategy for rapid FDA advancement of Vicromax(tm)
>> Update on BioSig core business developments and commercialization plans

 

Westport, CT, April 03, 2020 – BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing a proprietary biomedical signal processing platform, today announced that it intends to provide a public business update via teleconference regarding its recently acquired anti-viral pharmaceutical candidate, Vicromax(tm). The briefing is being held on Tuesday, April 7, 2020 at 11am ET.

 

ViralClear Pharmaceuticals, Inc. will be represented by Nick Spring, CEO, Steven King, COO and Jerome Zeldis, M.D., Ph.D, Executive Chair. BioSig will be represented by Kenneth L. Londoner, MBA, Chairman and CEO of BioSig Technologies, Inc.

 

Conference Call Details:
Date: Tuesday, April 7, 2020
Time: 11:00 A.M. Eastern Time (ET)
Dial in Number for U.S. Callers: 1- 877-407-8293
Dial in Number for International Callers: 1- 201-689-8349

 

A replay will be available for two weeks starting on April 7, 2020 at approximately 2:00 P.M. ET. To access the replay, please dial 1- 877-660-6853 in the U.S. and 1- 201-612-7415 for international callers. The conference ID# is 13701652.

 

In a preliminary internal review, the orally administered, broad-spectrum anti-viral agent Vicromax(tm) demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. In this analysis, Vicromax(tm) was added to a tissue culture assay for SARS-CO-2 coronavirus (the causative agent for COVID-19) and an anti-viral effect was observed, which led to a reduction of over 90% of infectious viruses. The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials.

 

The product candidate already completed Phase I and three Phase II clinical trials involving over 134 subjects for indications other than COVID-19, and underwent extensive animal testing and human clinical experience. The Company expects that Vicromax(tm) might be used alone or in a combination with other anti-viral agents or immune modulators.

 

About BioSig Technologies

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

 

SOURCE:  BioSig Technologies, Inc.

Jerome Zeldis, M.D., Ph.D, Appointed as Executive Chair of ViralClear Pharmaceuticals, Inc.

Former Chief Medical Officer of Celgene to lead development of Vicromax(tm), a novel broad-spectrum anti-viral agent that may treat COVID-19

 

Westport, CT – March 31, 2020 – BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing a proprietary biomedical signal processing platform, today announced that it appointed Jerome Zeldis, M.D., Ph.D as Executive Chair of ViralClear Pharmaceuticals, Inc., a new division within its majority-owned subsidiary NeuroClear Technologies, Inc., which recently acquired the rights to develop a novel pharmaceutical to treat Coronavirus Disease 2019 (COVID-19).

 

Jerome (“Jerry”) Zeldis, M.D., Ph.D brings extensive life sciences experience gained primarily through his career at Celgene, Inc. He previously served as Chief Executive Officer of Celgene Global Health and Chief Medical Officer of Celgene Corporation, a publicly traded, fully integrated biopharmaceutical company, where he was employed for nearly 20 years, starting in 1997. Celgene Corporation was recently acquired by Bristol Myers-Squibb (NYSE:BMY]. Dr. Zeldis currently serves as a Director of BioSig.

 

“From the moment we learned that we may have a possible solution to help address this global pandemic, we have been working tirelessly to bring this pharmaceutical to patients,” commented Dr. Zeldis. “I look forward to pursuing development of Vicromax(tm) and contributing my knowledge and expertise to this important initiative.”

 

From 2016 to recently, Dr. Zeldis served as Chief Medical Officer and President of Clinical Research, Medical Affairs Drug Safety, Quality, and Regulatory at Sorrento Therapeutics, Inc. He attended Brown University for an AB, MS, followed by Yale University for an M Phil, MD, PhD in Molecular Biophysics and Biochemistry. Dr. Zeldis trained in Internal Medicine at the UCLA Center for the Health Sciences and in Gastroenterology at the Massachusetts General Hospital and Harvard Medical School. He was Assistant Professor of Medicine at the Harvard Medical School, Associate Professor of Medicine at University of California, Davis, Clinical Associate Professor of Medicine at Cornell Medical School and Professor of Clinical Medicine at the Robert Wood Johnson Medical School in New Brunswick, New Jersey. Dr. Zeldis is a named inventor on 43 US patents, has published 122 peer reviewed articles and 24 reviews, book chapters and editorials.

 

In a preliminary internal review, the orally administered, broad-spectrum anti-viral agent Vicromax(tm) demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. In this analysis, Vicromax(tm) was added to a tissue culture assay for SARS-CO-2 coronavirus (the causative agent for COVID-19) and an anti-viral effect was observed, which led to a reduction of over 90% of infectious viruses. The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials. The product candidate already completed Phase I and three Phase II clinical trials involving over 134 subjects for indications other than COVID-19, and underwent extensive animal testing and human clinical experience. The Company expects that Vicromax(tm) might be used alone or in a combination with other anti-viral agents or immune modulators.

 

“We know Dr. Zeldis as an accomplished medical scientist and a talented Board member, and we are honored that he accepted this important role. I have personally worked closely with Jerry for years and highly value his unique talents. As we battle the biggest healthcare crisis in a generation, we need world-class scientific and business leadership to find a solution which would take the pressure off our healthcare resources. BioSig remains fully committed to expanding clinical footprint in electrophysiology, and we look forward to working with Dr. Zeldis and his team in this new capacity,” stated Kenneth L. Londoner, Founder, Chairman and CEO of BioSig Technologies, Inc.

 

About BioSig Technologies

 

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

About NeuroClear Technologies

 

NeuroClear Technologies, a majority-owned BioSig subsidiary, is a medical technology company focused on electroneurogram recordings. The Company aims to address some of the biggest challenges of bioelectronic medicine devices through targeted stimulation and feedback loops for optimal therapy delivery.

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that
may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Shareholder contact: Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road,
2nd floor Westport, CT 06880
aballou@biosigtech.com 203-409-5444, x133

Media contact: High Lantern Group
Drew Holzapfel (US)
dholzapfel@highlanterngroup.com
215-515-2353
Mario Ottiglio (International)
mottiglio@highlanterngroup.com
+41 79 538 8624

 

Source:  BioSig Technologies, Inc.

BioSig subsidiary NeuroClear acquires license for a broad-spectrum anti-viral agent that may treat COVID-19. Laboratory results demonstrate high level of activity against COVID-19 in cell culture

Novel pharmaceutical Vicromax(tm)* has already undergone extensive animal testing and human clinical experience in other indications

 

Westport, CT – March 25, 2020 – BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing a proprietary biomedical signal processing platform, today announced that its majority-owned subsidiary NeuroClear Technologies, Inc. acquired the rights to develop a novel pharmaceutical to treat Coronavirus Disease 2019 (COVID-19).

 

In a preliminary internal review, the orally administered, broad-spectrum anti-viral agent Vicromax(tm) demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. In this analysis, Vicromax(tm) was added to a tissue culture assay for SARS-CO-2 coronavirus (the causative agent for COVID-19) and an anti-viral effect was observed, which led to a reduction of over 90% of infectious viruses. The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials.

 

The product candidate already completed Phase I and three Phase II trials in other indications, and underwent extensive animal testing and human clinical experience. The Company expects that Vicromax(tm) could be used alone or in a combination with other anti-viral agents or immune modulators.

 

“Stopping the COVID-19 pandemic and preventing similar viral threats in the future must be the number-one priority of all of us in the healthcare community,” said Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “This very promising anti-viral is the result of tireless efforts by an accomplished group of pharmaceutical industry veterans, and we are doing everything in our power to ensure it gets tested and brought to market as soon as possible.”

 

The Company intends to develop Vicromax(tm) and take it through clinical trials under a new NeuroClear subsidiary, ViralClear Pharmaceuticals, Inc. The Company appointed Mr. Nick Spring as Chief Executive Officer of ViralClear and Mr. Steve King as Chief Operating Officer.

 

Mr. Spring is a seasoned global executive and entrepreneur with experience spanning both human and animal health. During his extensive career at Merck & Co., he led the worldwide franchise for live viral human vaccines as well as the strategic team that crafted the US launch plan for the HPV vaccine, Gardasil®, which became a billion-dollar franchise. Most recently, Mr. Spring was Founder and CEO of Humanitas, a biotechnology and life sciences consulting firm that advises blue-chip global companies. Previously, he served as President and CEO of a medical device company, Reliefband Technologies, and as Founder and CEO of Topaz Pharmaceuticals Inc, where he raised $35 million in private investment and took the company from concept to FDA approval to exit, selling the company for over $200 million to Sanofi. Earlier in his Merck career, Mr. Spring helped build the Ivermectin family of endectocides into a billion-dollar global franchise and manage the start-up of Merial, a Merck/Sanofi animal health joint venture. While at Merial, Mr. Spring was part of the strategic leadership planning team that laid the foundations for Heartgard® and the blockbuster Frontline® brand.

 

Mr. King is an experienced pharmaceutical executive with proven skills in business development, licensing, and small-molecule drug development and commercialization.  Most recently, he served as President at 21159 Pharma, a strategic consulting and business development company. Previously he was Senior Vice President at Pii (Pharmaceutics International Inc), building the contract development and manufacturing organization (CDMO) in the US and the UK.  Earlier in his career, Mr. King worked for Janssen Pharmaceuticals and managed international business development for UK-based R.P. Scherer Corporation (Catalent), which specializes in the development and supply of pharmaceutical products including  softgel products. He earned his Pharmacy degree from the London School of Pharmacy.

 

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

About NeuroClear Technologies

NeuroClear Technologies, a majority-owned BioSig subsidiary, is a medical technology company focused on electroneurogram recordings. The Company aims to address some of the biggest challenges of bioelectronic medicine devices through targeted stimulation and feedback loops for optimal therapy delivery.

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

 

Shareholder contact:

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations

54 Wilton Road, 2nd floor

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

 

Media contact:

Mario Ottiglio

High Lantern Group
mottiglio@highlanterngroup.com

+41 79 538 8624

 

Source:  BioSig Technologies, Inc.

BioSig Completes 100th Patient Case with PURE EP(tm) System

Commercialization and install plan ahead of schedule

– Installations at new centers are driving patient enrollments and clinical data collection

 

Westport, CT –  February 19, 2020 — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company successfully completed 100 patient cases with its PURE EP(tm) System.

 

The Company initiated its first clinical trial in November 2019, and is currently enrolling patients at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center and Mayo Clinic’s Florida campus. Earlier in 2019 the Company conducted patient cases at Indiana University School of Medicine, Greenville Memorial Hospital, Santa Barbara Cottage Hospital and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. The Company’s PURE EP(tm) System was used during the procedures on patients with persistent atrial fibrillation, ischemic ventricular tachycardias, PVC, atypical flutters and other types of complex arrhythmias.

 

Clinical observations collected with PURE EP(tm) System were recently presented by Andrea Natale, M.D., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center during the 25th Annual International AF Symposium. Management is encouraged by the level of interest in commercial deployments from over 40 leading U.S. based medical centers generated at this event.

 

“We are responding to the requests in a methodical fashion in order to assess and meet the needs of these centers. We are running ahead of our plans stated in our November 2019 shareholder letter,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. The Company’s most recent Shareholder Letter stated the intentions to install PURE EP(tm) System at up to nine new centers leading up to the Heart Rhythm Society’s annual convention in May 2020.

 

The PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The PURE EP(tm) System aims to minimize noise and artifacts and acquire high-fidelity cardiac signals. Improving fidelity of acquired cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures.

 

About BioSig Technologies BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com).

 

Forward-looking Statements  This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact: Andrew Ballou BioSig Technologies, Inc.  Vice President, Investor Relations  54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x119

 

Source:  BioSig Technologies, Inc.

BioSig Technologies Signs a New Licensing Agreement with Mayo Clinic

New Agreement to Support Development of Advanced Features of PURE EP(tm) System

 

Westport, CT – September 12, 2019 — BioSig Technologies, Inc. (NASDAQ: BSGM), a medical technology company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, today announced that it signed a new licensing agreement with Mayo Clinic.

 

The new agreement aims to develop a new product pipeline to support some of the more advanced features of BioSig’s first product, PURE EP(tm) System. The development program will be run under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic’s Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory.

 

“We are very pleased to expand our relationship with the outstanding physician team at Mayo Clinic. Their commitment to improving patient care resonates deeply with our Company’s mission to bring innovative technological solutions to medicine, and we are looking forward to this next chapter in our collaboration. The new product that we intend to develop under the latest licensing  will seek to significantly advance the current arrhythmia treatments. It will be an exciting journey, and we look forward to reporting on our progress,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

 

BioSig was recently added to the Russell 3000 Index and allowed 33 patent claims covering its PURE EP(tm) System. In the first half of 2019 BioSig successfully conducted first patient cases using its PURE EP(tm) System at the Texas Cardiac Arrhythmia Institute in Austin, TX, Greenville Memorial Hospital in Greenville, SC and Indiana University School of Medicine. The Company signed a 10-year collaboration agreement with Mayo Clinic in March 2017.

 

About BioSig Technologies

BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP(tm) System. The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. This novel cardiac signal acquisition and display system is engineered to assist electrophysiologists in clinical decision-making during electrophysiology procedures in patients with abnormal heart rates and rhythms. BioSig’s ultimate goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and received FDA 510(k) clearance for the PURE EP(tm) System in August 2018.

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:
Natasha Drapeau
BioSig Technologies, Inc.
Executive Vice President

54 Wilton Road, 2nd floor

Westport, CT 06880

ndrapeau@biosigtech.com

203-409-5444, x119

 

Source:  BioSig Technologies, Inc.

Dr. Jerome Zeldis, M.D., Ph.D, Former Chief Medical Officer of Celgene, to Join BioSig Board of Directors

Santa Monica, CA – May 20, 2019 – BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, today announced that Dr. Jerome B. Zeldis agreed to re-join the Company as an Independent Director, effective immediately.

 

Dr. Jerome (“Jerry”) Zeldis, M.D., Ph.D brings extensive life sciences experience gained primarily through his career at Celgene, Inc. He previously served as Chief Executive Officer of Celgene Global Health and Chief Medical Officer of Celgene Corporation (NASDAQ:CELG), a publicly traded, fully integrated biopharmaceutical company, where he has been employed for nearly 20 years, starting in 1997.. Celgene Corporation has been recently acquired by Bristol Myers-Squibb (NYSE:BMY) in a cash and stock deal valued at $74 billion.

 

Since 2016, Dr. Zeldis serves as Chief Medical Officer and President of Clinical Research, Medical Affairs Drug Safety, Quality, and Regulatory. He attended Brown University for an AB, MS, followed by Yale University for an M Phil, MD, PhD in Molecular Biophysics and Biochemistry. Dr. Zeldis trained in Internal Medicine at the UCLA Center for the Health Sciences and in Gastroenterology at the Massachusetts General Hospital and Harvard Medical School. He was Assistant Professor of Medicine at the Harvard Medical School, Associate Professor of Medicine at University of California, Davis, Clinical Associate Professor of Medicine at Cornell Medical School and Professor of Clinical Medicine at the Robert Wood Johnson Medical School in New Brunswick, New Jersey. Dr. Zeldis is a named inventor on 43 US patents, has published 122 peer reviewed articles and 24 reviews, book chapters and editorials.

 

“Dr. Zeldis is one of our earliest investors and has watched our company grow from the beginning.  He continues to invest in the Company.  We are eager to work with him to capitalize on his extensive experience in clinical development, regulatory strategy, shareholder wealth creation, and platform development.  We are especially excited regarding Jerry’s understanding of bioelectronics medicine and how our PURE EP ™ system can contribute to this rapidly emerging field”, stated Kenneth L. Londoner BioSig Technologies, Inc. Founder, Chairman, and CEO.

 

“I am very pleased with the progress that has occurred from the time I left the Board until now.”  Stated Dr. Zeldis.  “I look forward to the realization of the clinical benefit that may occur by reducing noise in a variety of setting in which detection of small signals is critical for therapeutic interventions.”

 

BioSig recently exhibited at the Heart Rhythm Society’s 40th Annual Scientific Sessions on May 8-11, 2019 at Moscone Center in San Francisco, CA.

 

Previously, BioSig announced that it successfully conducted first patient cases using its PURE EP(tm) System at the Texas Cardiac Arrhythmia Institute in Austin, TX, Greenville Memorial Hospital in Greenville, SC and Indiana University School of Medicine. These initial experiences suggested improved cardiac signal detection and fidelity.

 

About BioSig Technologies

BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. This novel cardiac signal acquisition and display system is engineered to assist electrophysiologists in clinical decision-making during electrophysiology procedures in patients with abnormal heart rates and rhythms. BioSig’s ultimate goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and received FDA 510(k) clearance for the PURE EP™ System in August 2018.

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:
Natasha Drapeau
BioSig Technologies, Inc.
Executive Vice President

12424 Wilshire Blvd Ste 745

Los Angeles, CA 90025

ndrapeau@biosigtech.com

310-620-9320

 

Source:  BioSig Technologies, Inc.

BioSig Technologies Completes Patient Cases at Indiana University

Third Center to Use PURE EP(tm) System 

 

Santa Monica, CA – May 06, 2019 – BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, today announced that the Company conducted patient cases using the PURE EP(tm) System at Indiana University School of Medicine. The cases were conducted under the leadership of Prof. John M. Miller, M.D. and Dr. Mithilesh K. Das, MBBS.

 

“We found that the clarity of the signals made a great difference in the confidence with which we could continue applying ablation energy to an abnormal pathway that was in the region of the normal conduction system; BioSig technology allowed us to see a clear signal from the normal conduction pathway during ablation that was obscured by noise on our standard recordings. It was a jaw-dropper!” commented Prof. M. Miller, M.D

 

A recognized expert in catheter and intraoperative mapping and ablation of ventricular tachyarrhythmias, Dr. Miller initially received his training in cardiovascular and cardiac electrophysiology under the tutelage of Dr. Mark Josephson at the Hospital of the University of Pennsylvania. He joined the Indiana University School of Medicine as a full professor of medicine to lead its clinical cardiac electrophysiology group in 1998. Since then, he has continued to be an active clinician, educator, author and clinical investigator. Prof. Miller has authored more than 200 scientific publications and has served on many national committees. He oversees a nationally regarded, rigorous fellowship training program in cardiac electrophysiology at the IU School of Medicine.

 

The PURE EP(tm) System was used during procedures on patients with atypical flutter, atrioventricular nodal reentry tachycardia (AVNRT), atrial fibrillation, SVT, PVC and a rare case of dual septal pathway.

 

“We are honored to be able to work with Dr. Miller and Indiana University as one of the first centers of excellence to conduct patient cases with our PURE EP(tm) System. We have tremendous respect for Dr. Miller and his team at IU School of Medicine for their collective achievements in clinical electrophysiology and look forward to building upon their findings during this pivotal phase,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies.

 

Indiana University School of Medicine was the third center to receive the PURE EP(tm) System. Previously, BioSig announced that it successfully conducted first patient cases using the PURE EP(tm) System at the Texas Cardiac Arrhythmia Institute in Austin, TX in February 2019 and Greenville Memorial Hospital in Greenville, SC in April 2019. These initial experiences suggested improved cardiac signal detection and fidelity.

 

BioSig is exhibiting at the Heart Rhythm Society’s 40th Annual Scientific Sessions on May 8-11, 2019 at Moscone Center in San Francisco, CA. BioSig conducted seventeen pre-clinical studies using the  PURE EP(tm) System to date, the results of which have been published in a number of journals. BioSig’s latest manuscript on pre-clinical research entitled “Evaluation of Real Time Catheter Tissue Contact using Unipolar Intracardiac Signal Morphology” has been recently accepted to the 41st International Engineering in Medicine and Biology Conference.

 

The PURE EP(tm) System is indicated as a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.

 

About BioSig

 

Technologies BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market. The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. This novel cardiac signal acquisition and display system is engineered to assist electrophysiologists in clinical decision-making during electrophysiology procedures in patients with abnormal heart rates and rhythms. BioSig’s ultimate goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and received FDA 510(k) clearance for the PURE EP™ System in August 2018.

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Natasha Drapeau BioSig Technologies, Inc.  Executive Vice President  12424 Wilshire Blvd, Ste 745 Los Angeles, CA 90025 ndrapeau@biosigtech.com 310-620-9320

 

Source:  BioSig Technologies, Inc.

BioSig Completes Successful Patient Cases at Greenville Memorial Hospital

Second Center to Report Positive Clinical Experience with PURE EP(tm) System

 

Santa Monica, CA – April 16, 2019 — BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address unmet needs for the electrophysiology (EP) marketplace, today announced that the Company successfully conducted patient cases using PURE EP(tm) System at Greenville Memorial Hospital, part of Prisma Health System. PURE EP(tm) System is the Company’s FDA cleared proprietary electrocardiogram and intracardiac signal acquisition and amplification system. The patient procedures were conducted by Andrew Brenyo, M.D., FHRS.

 

“Over the last two days I have been amazingly surprised at the fidelity and utility of the BioSig’s PURE EP(tm) System. I made sure to use it in cases of the highest complexity and found in more than one circumstance the behavior of the system such that I could visualize waveform signals that I could not on my usual recording system. This led me towards a better understanding of a tachycardia event. I would count myself lucky to have had this eye-opening experience highlighting the signals that I have been missing.” commented Dr. Brenyo.

 

The PURE EP(tm) System was used during the procedures on patients with ischemic ventricular tachycardias, atrial fibrillation, PVC and atypical flutters, and conducted in parallel with Abbott’s EnSite Precision(tm) and Biosense Webster’s  (Johnson & Johnson) CARTO(tm) 3 cardiac mapping systems.

 

“Dr. Brenyo’s use of the PURE EP(tm) System allowed us to see high frequency, low amplitude signals during more advanced arrhythmia cases and repeat procedures,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies. “Positive clinical experience with of our technology in the medical centers with diverse patient profiles is key to a strong market positioning. We believe that more clinical experience, delivered by the next set of centers scheduled to use PURE EP(tm) System in the coming months, will allow us to gain additional insight into our key value proposition and deliver on our strategic goals in the second half of the year.”

 

Greenville Memorial Hospital is the second installation site for PURE EP(tm) System. On February 20, 2019, BioSig announced that it successfully conducted first patient cases using PURE EP(tm) System at the Texas Cardiac Arrhythmia Institute in Austin, TX under the leadership of Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. This initial experience suggested improved cardiac signal detection and fidelity.

 

The Company released its Shareholder Letter earlier in February 2019, where it stated its intentions to present the results from the initial clinical cases and the early feedback from the use of the PURE EP(tm) System to a larger community of physicians during the Heart Rhythm Society event in May 2019.

 

The PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The PURE EP(tm) System aims to minimize noise and artifacts and acquire high-fidelity cardiac signals. Improving fidelity of acquired cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures. The results of pre-clinical studies have been published in a number of journals, including The Journal of Innovations in Cardiac Rhythm Management.

 

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first product, PURE EP™ System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and received FDA 510(k) clearance for the PURE EP™ System in August 2018.

 

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:
Natasha Drapeau
BioSig Technologies, Inc.
Executive Vice President

12424 Wilshire Blvd, Ste 745

Los Angeles, CA 90025

ndrapeau@biosigtech.com

310-620-9320, extension 119

 

SOURCE:  BioSig Technologies, Inc.

BioSig Appoints John Kowalski to Lead Commercialization of PURE EP

Electrophysiology Industry Veteran to Lead Sales Strategy For the Company’s Novel Cardiac Signal Acquisition and Processing Technology

 

Santa Monica, CA, February 4, 2019 — BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has appointed Mr. John Kowalski as Vice-President of Sales.

 

Mr. Kowalski brings to the Company over 30 years of experience in medical device sales, including over 20 years at Biosense Webster, a Johnson & Johnson company. Most recently, he served as Northeast Area Director, a role, in which he was responsible for leading six high-performing cardiac electrophysiology catheter and equipment market sales teams, consisting of 140 sales and clinical support employees. Mr. Kowalski was responsible for $175M disposables and system sales and has consistently exceeded area sales objectives. Having led U.S. strategic planning teams in his previous roles, Mr. Kowalski brings to BioSig proven track record in identifying key business growth opportunities within the cardiac electrophysiology market.

 

Mr. Kowalski is a holder of numerous Biosense Webster leadership awards, including a record 18-year Founders Club Award, and several “Area and Region of the Year” awards.

 

“John impressed us with his outstanding leadership skills and unparalleled knowledge of cardiac electrophysiology industry. Given John’s impressive accomplishments as a sales leader, we are confident that he is perfectly positioned to lead targeted market launch and grow our commercial capabilities for our innovative technology,” stated Mr. Kenneth Londoner, Chairman & CEO of BioSig Technologies, Inc.

 

“I am excited to lead the commercial launch of the PURE EP(tm) signal acquisition and processing system. I believe this innovative technology will enable improved diagnosis and treatment of cardiac arrhythmias and benefit millions of people who suffer from this debilitating illness,” commented Mr. Kowalski.

 

The Company announced that it received the 510(k) clearance for its PURE EP(tm) System on August 14, 2018. BioSig announced in November and December 2018 that it signed agreements to commence the first commercial use of the system at Texas Cardiac Arrhythmia Institute in Austin, Texas, and Mayo Clinic. BioSig signed a 10-year collaboration agreement with Mayo Clinic in March 2017 and announced a new research agreement focusing on development of additional advanced features and potential new applications of PURE EP(tm) System on November 13, 2018.

 

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first product, PURE EP™ System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510(k) clearance for the PURE EP™ System in August 2018.

 

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:
Natasha Drapeau
BioSig Technologies, Inc.
Executive Vice President

12600 Hill Country Blvd R-275

Austin, TX 78738

ndrapeau@biosigtech.com

512-329-2643

SOURCE: BioSig Technologies, Inc.

Former New Technology Education Manager to Assist with First Installations

Santa Monica, CA, Dec. 19, 2018 — BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has appointed Mrs. MaryAnn Edzards as Senior Director – Account Manager.Mrs. Edzards brings to the Company over 10 years of experience in electrophysiology (EP), including six years at Biosense Webster, a Johnson & Johnson company. Most recently, she served as New Technology Education Manager, a role, in which she was responsible for all internal and external marketing and training programs for two global product launches. Mrs. Edzards facilitated training of over 300 field and in-house employees and delivered impactful training modules for complex technologies through virtual and live classroom environments. She brings to BioSig extensive experience in converting Voice of Customer feedback into commercially valuable solutions. Mrs. Edzards is a holder of numerous Johnson & Johnson awards, including 2016 Standards of Leadership Award and 2017 Gold Encore Award from Commercial Marketing.

 

“A high-performing and motivated professional like MaryAnn is an invaluable addition to our commercial team. Her expertise in delivering highly impactful education and training of both in-house professionals and physicians will tremendously benefit our efforts during the vital First-in-Human patient data collection phase and subsequent market launch in 2019,” stated Mr. Kenneth Londoner, Chairman & CEO of BioSig Technologies, Inc.

 

The Company announced that it received the 510(k) clearance for its PURE EP™ System on August 14, 2018. BioSig announced on November 28, 2018 that it begins installations of the first systems at Texas Cardiac Arrhythmia Institute in Austin, Texas, followed by another announcement on December 6, 2018 about enrolling Mayo Clinic as the second center for the First-in-Human studies. BioSig signed a 10-year collaboration agreement with Mayo Clinic in March 2017 and announced a new research agreement focusing on development of additional advanced features and potential new applications of PURE EP™ System on November 13, 2018.

 

“I’m excited to join the BioSig team as the Company commences first installations of PURE EP™ System in some of the leading medical centers of excellence. There is a pressing need for better technological solutions in the space of arrhythmia treatments, and I look forward to contributing my knowledge and expertise to help the Company bring its novel platform onto the market,” commented Mrs. Edzards.

 

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first product, PURE EP™ System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510(k) clearance for the PURE EP™ System in August 2018.

 

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:
Natasha Drapeau
BioSig Technologies, Inc.
Executive Vice President
12600 Hill Country Blvd R-275
Austin, TX 78738
ndrapeau@biosigtech.com
512-329-2643

Source: BioSig Technologies, Inc.

BioSig Technologies Signs Agreement with Texas Cardiac Arrhythmia Institute for First–in-Human Studies

Santa Monica, CA, November 27 2018 — BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has signed an agreement with Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center in Austin, Texas to conduct First-in-Human studies using the PURE EP™ System.

 

These First-in-Human studies are aimed at validating the key value proposition elements of the PURE EP™ System that have already been established in pre-clinical studies and published to date in a number of journals, including The Journal of Innovations in Cardiac Rhythm Management. Collected data and physician experience arising from the First-in-Human studies will be documented and presented in the form of publications, clinical abstracts or late-breaking news.

 

Commencement of First-in-Human studies is the initial step in the Company’s targeted commercial launch of its first product, PURE EP™ System. The PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The PURE EP™ System aims to minimize noise and artifacts, and acquire high-fidelity cardiac signals. Improving fidelity of acquired cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures.  First-in-Human studies will be conducted at TCAI.

 

Andrea Natale M.D., F.A.C.C., F.H.R.S., F.E.S.C., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center will conduct the First-in-Human study.

 

A world recognized leader in the field of electrophysiology, Dr. Natale is known as a dedicated clinician, academician and researcher. He is an author of over 600 publications related to treatments of arrhythmia. Prior to joining TCAI, Dr. Natale was a member of the Cardiovascular Medicine Department at the Cleveland Clinic from 1999 to 2007, and served as Section Head for the Department of Cardiac Pacing and Electrophysiology and as Medical Director for the Cleveland Clinic’s Center for Atrial Fibrillation. In 2006, Dr. Natale was named to the Food and Drug Administration’s Task Force on Atrial Fibrillation.

 

“To better understand complex arrhythmia disease states, the ability to detect the smallest of electrical activity in various clinical situations has been a critical need for our industry. I am looking forward to the possibility that the PURE EP System will uncover these signals and advance treatment options so physicians can make more informed decisions for our patients,” commented Dr. Natale.

 

“BioSig reached another important milestone after achieving FDA clearance in August 2018 and uplisting to Nasdaq in September 2018. We opened an office in Austin, TX, earlier this year in anticipation of our present needs, and are now focused on providing TCAI full support during the First-in-Human use of our technology, which will preface our commercial launch in the U.S. in May 2019. Dr. Natale inspired the founding of our Company and has chaired our Scientific Advisory Board since 2011. We are proud to be working with Dr. Natale and his team during this important stage of our Company’s growth,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies.

 

About Texas Cardiac Arrhythmia Institute
Located at St. David’s Medical Center in Austin, Texas, the Texas Cardiac Arrhythmia Institute is a uniquely effective training, research and treatment facility dedicated solely to heart rhythm disorders. It is one of its kind in the world of electrophysiology.

 

St. David’s is a state-of-the-science medical center with a well-qualified medical support staff. Its robotics, magnetics and other advanced technologies complement the expertise of TCAI’s physicians. The Institute brings TCAI’s respected physicians and researchers together with St. David’s superior facilities to address even the most challenging arrhythmias.

 

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first product, PURE EP™ System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510(k) clearance for the PURE EP™ System in August 2018.

 

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:
Natasha Drapeau
BioSig Technologies, Inc.
Executive Vice President

12600 Hill Country Blvd R-275

Austin, TX 78738

ndrapeau@biosigtech.com

512-329-2643

 

SOURCE:  BioSig Technologies, Inc.

BioSig Technologies Announces New Research Program with Mayo Clinic

New Agreement to Focus on Enhanced Features of PURE EP System and Future Potential Clinical Applications

 

Santa Monica, CA, Nov. 13, 2018 — BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company entered into a new advanced research agreement with Mayo Clinic in Rochester, Minnesota.

 

The new program will be run under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic’s Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory. The program will consist of a number of two-to three-year projects, which will focus on development of additional advanced features of PURE EP(tm) System within the field of electrophysiology and potential clinical applications of BioSig’s technology in a new, previously unexplored, field.

 

“We are very pleased to continue our collaboration with Dr. Asirvatham and the outstanding team at Mayo Clinic. Our pre-clinical studies have shown the strong potential of PURE EP(tm) System to improve clarity of cardiac signals during the ablation procedures and related studies. We are confident that enhanced product development of our PURE EP(tm) System and testing of its advanced features at the number one hospital in the nation will lead to increased value proposition of our technology. We are fully committed to deliver outstanding value to our shareholders and our future clients,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

 

BioSig received FDA 510(k) clearance for its first product, PURE EP(tm) System on August 8, 2018. The Company began trading on the Nasdaq Capital Market on September 21, 2018 under the ticker symbol BSGM. The Company completed twelve pre-clinical studies at Mayo Clinic to date and has signed a 10-year collaboration agreement with the Clinic in March 2017.

 

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first product, PURE EP™ System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision- making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510 (k) clearance for the PURE EP™ System in August 2018.

 

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact: Natasha Drapeau

BioSig Technologies, Inc. Executive Vice President ndrapeau@biosigtech.com 512-329-2643

 

Source:   BioSig Technologies, Inc.

BioSig Technologies Opens Business Office in Norwalk, CT

New Location to Serve as the Company’s East Coast Business and Operations Hub

 

Santa Monica, CA, Oct. 31, 2018 – BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company opened a new office in Norwalk, Connecticut.

 

The new office will complement the Company’s headquarters in Los Angeles, CA and administration and finance office in Austin, TX. Norwalk office becomes the Company’s first location on the East Coast and will serve as the commercialization, sales support, investor relations and business development location.

 

Despite being the third smallest state, Connecticut has the highest per-capita income in the United States1. Due to the state’s historically attractive business climate and its close proximity to New York, NY and Boston, MA, Connecticut had 19 companies on Fortune 500 list in 2016, including Aetna and Xerox2. The state was also home to one of the most successful medical technology companies, US Surgical Corporation.

 

“Norwalk, CT offers us a strategic base on the East Coast, which will provide key support for both our capital formation and business and clinical development. Norwalk’s proximity to JFK and New York City is also a big plus for our global shareholder base. As we progress towards first installations of our PURE EP(tm) System in some of the busiest medical centers in the country, we are confident that our new business hub will deliver significant value in one of the key locations for medical technology,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

 

BioSig received FDA 510(k) clearance for its first product, PURE EP(tm) System on August 8, 2018. The Company began trading on the Nasdaq Capital Markets on September 21, 2018 under the ticker symbol BSGM.

 

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first product, PURE EP™ System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision- making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510(k) clearance for the PURE EP™ System in August 2018.

 

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

1 “Highest wages in East, lowest in South”, Stephen Ohlemacher, USA Today, November 18, 2010.

2 “Connecticut has 19 companies on Fortune 500 list”, Hartford Courant, June 9, 2016.

 

Contact:
Natasha Drapeau
BioSig Technologies, Inc.
Executive Vice President
12600 Hill Country Blvd R-275
Austin, TX 78738
ndrapeau@biosigtech.com
512-329-2643



Source: BioSig Technologies, Inc.

BioSig Technologies Begins Trading on Nasdaq

Santa Monica, CA, Sept. 21, 2018 – BioSig Technologies, Inc. (NASDAQ:BSGM) a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that shares of its common stock have begun officially trading on the Nasdaq Capital Market, under the ticker “BSGM”.

 

BioSig’s listing on the Nasdaq is the Company’s most recent operational achievement. In August 2018, the Company received 510(k) clearance from the FDA for their patented advanced signal acquisition and processing technology, PURE EP(tm) System. The non-invasive technology is a computerized system intended to enhance electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory for the treatments of arrhythmia, or irregular heartbeat. The Company completed 13 pre-clinical studies at Mayo Clinic and Mount Sinai to date and received first units from its contract manufacturer, Minnetronix, in September 2018. BioSig recently made an announcement about their ongoing progress with effective physician engagement and continues to add experienced industry hires to its clinical and commercial teams.

 

“The Nasdaq stock exchange is home to many of the world’s most innovative medical technology and healthcare companies and is a natural fit for BioSig,” stated Mr. Kenneth Londoner, Founder, Chairman and CEO of BioSig Technologies.  “Our listing on the Nasdaq exchange is a milestone and reflects the significant progress we have made in strengthening our corporate governance and expanding our industry footprint.”

 

Analysts forecast the global market for EP devices will grow at a 10.6 percent compound annual growth rate to more than $8.5 billion by 2024*, making it one of the fastest growing medical device segments. In the United Stated alone, the number of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) arrhythmia ablations is forecast to grow at 11 percent from 2015 to 2020**.

 

*EP device growth forecast from Electrophysiology Market by Devices Analysis, Market Research Engine, July 2017.
**Cardiac ablations growth forecast from Global Opportunities in Medical Devices & Diagnostics, Health Research International, 2016

 

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first product, PURE EP™ System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510(k) clearance for the PURE EP™ System in August 2018.

 

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contact:
Natasha Drapeau
BioSig Technologies, Inc. 
Executive Vice President 
12600 Hill Country Blvd R-275
Austin, TX 78738
nrusskina@biosigtech.com
512-329-2643

Source:  BioSig Technologies, Inc. 
BioSig Technologies Announces FDA 510(k) Clearance for PURE EP System

Santa Monica, CA, Aug. 14, 2018 – BioSig Technologies, Inc. (OTCQB: BSGM), announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the U.S. Food and Drug Administration (FDA).

 

The non-invasive PURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.  The PURE EP System aims to minimize noise and artifacts, and acquire high-fidelity cardiac signals. Improving cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures.

 

To date, BioSig has performed twelve pre-clinical studies at Mayo Clinic in Rochester, MN, three at UCLA Medical Center in Los Angeles, CA, and one at Mount Sinai Hospital in New York, NY.  BioSig signed a 10-year collaboration agreement with Mayo Clinic in 2017 that will enable the Company to advance the platform and expand its capabilities into other areas of clinical importance.  The Journal of Innovations in Cardiac Rhythm Management published several years of pre-clinical data (https://www.biosigtech.com/technology/publications) conducted at Mayo Clinic.

 

Minnetronix, BioSig’s manufacturing partner in St. Paul, MN, has produced initial systems that will allow the Company to enter the market in the U.S. with selected sites.

 

“Our PURE EP System is the culmination of many years of scientific research and business development efforts. It is our goal to provide tangible benefits to electrophysiologists and improve the current standards of EP procedures in the clinical setting.  We are excited to bring the advanced platform to the U.S. market,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

 

One of the most common reasons for an EP procedure is the diagnosis and treatment of atrial fibrillation. Atrial fibrillation is the most common arrhythmia currently affecting 33.5 million people worldwide, with 6.1 million people in the U.S. Atrial fibrillation increases the risk of stroke by 4 to 5 times and contributes to ca. 750,000 hospitalizations per year. According to the 2016 HRI Global Opportunities in Medical Devices & Diagnostics report, the current market of EP is estimated at $4.6 billion and growing at 10.5% rate annually.

 

On August 1, 2018 the Company announced its intention to uplist to the Nasdaq exchange. The Company expects to be trading on Nasdaq in 2018.

 

The Company recently filed an omnibus patent with the leading patent law firm, Sterne Kessler Goldstein & Fox in Washington, DC that thoroughly protects the Company’s technology.

 

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System.  The technology has been developed to address an unmet need in a large and growing market.

 

The Company’s first FDA cleared product, PURE EP™ System, is a novel cardiac signal acquisition and display system that is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to ultimately deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward initial commercial distribution of the PURE EP™ System.

 

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contact: 
Natasha Russkina 
BioSig Technologies, Inc.  
VP Business Development & Corporate Finance 
12600 Hill Country Blvd R-275
Austin, TX 78738 
nrusskina@biosigtech.com 
512-329-2643


Source:  BioSig Technologies, Inc.

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About BioSig Technologies

A NEW ADVANCEMENT IN EP INFORMATION

The PURE EP™ System from BioSig Technologies™ was designed to improve the clinical information for electrophysiology (EP) studies and cardiac catheter ablation – procedures to test the electrical activity of the heart to find where an abnormal heartbeat originates, and then is destroyed.

Shortcomings for Existing Arrhythmia Treatments

 

Drug therapies often ineffective

 

Procedures for ablation need improvement

 

  • Anatomical for Paroxysmal Atrial Fibrillation (AFib) – not proven sufficient
  • Additional ablation targets needed for Chronic AFib
  • Insufficient signal quality for both AFib and Ventricular Tachycardia (VT) cases

 

Poor signal quality may lead to:

 

  • Long procedure times –
  • 2-8 hours depending on complexity, clinical experience

 

Uncertainty in ablation targets

 

  • Many undergo multiple procedures

 

 

Technology

 

GAIN A BETTER UNDERSTANDING OF THE SPACE AND PROBLEMS BIOSIG IS FOCUSING ON

 

Atrial Fibrillation (AFib) Background

 

  • On the left is a heart with a normal heartbeat.
  • Electrical signals travel from the hearts pacemaker called an SA node across and down the heart muscle.
  • On the right, you can see the path of rapid and irregular electrical signals in the upper chambers of the heart.
  • These cause abnormal contractions and poor blood flow.
  • This is called Atrial Fibrillation or AFib for short. Learn more about Atrial Fibrillation here.
  • Everyone over 40 has a 1 in 4-lifetime risk; Afib affects a population of approximately 6 million in the US.
  • This condition increases stroke risk more than 4 times, which is the 5th leading cause of death in the U.S.
  • Catheter ablation is now a recommended procedure; depending on the severity of the disease, multiple procedures are oftentimes necessary for effective results.
  • Current technology in the electrophysiology lab has limitations in precisely locating the tissue to ablate that is the source of the abnormality.
  • What is atrial fibrillation?

 

Current Diagnosis to Treatment

 

  • The current treatment process starts with an Electrocardiogram taken from the surface of the skin.
  • Doctors read the results and determine if medication and/or ablation is indicated.
  • If ablation is indicated, an EP study is performed.
  • A catheter is inserted into the heart via the patients’ neck or groin and the electrical activity of the heart is recorded.
  • Based on this EP study, ablation is done in the area(s) of the heart they suspect is causing the abnormal heart rhythms.

 

Ablation: One Current Solution for Atrial Fibrillation (AFib)

 

  • The current most recommended solution for AFib is ablation.
  • An ablation catheter is inserted in the patient’s blood vessel and guided to the site of the tissue that is causing the abnormal electrical current in the heart.
  • In the diagram on the left, you see the catheter entering from the bottom of the heart and winding into the left atrium.
  • In the diagram on the right, you see the catheter that is placed on the tissue that is triggering the abnormal electrical impulses.
  • The catheter will use either heat or cold to scar the tissue, reducing its ability to transmit abnormal electrical impulses which eliminate the abnormal heart rhythm.
  • Our goal is to give doctors the tools to solve the problem in fewer visits greatly reducing these costs and the discomfort to the patient.

 

Ventricular Tachycardia (VT)

 

  • We hope that our technology will be able to improve outcomes for the even more serious Ventricular Tachycardia or VT.
  • On the left, we see a diagram of a heart with a normal heartbeat.
  • Electrical signals travel from the heart’s pacemaker called an SA node across and down the heart muscle.
  • You can see the heartbeats are evenly spaced. On the right, we see that VT happens when the electrical signals in the ventricles, or lower chambers of the heart, get disorganized, overriding the heart’s normal rate and rhythm.
  • This is rapidly fatal if not reversed; there are approximately 450,000 sudden deaths a year in the US from ventricular arrhythmias.
  • Like AFib, VT is also treated by using ablation to scar the areas of tissue sending the abnormal electrical impulses.
  • In determining where to ablate, doctors rely on looking for tiny changes on these charts that are often filtered out or get lost in the noise with current technologies. This results in more treatments being required until the appropriate areas are found and ablated.
  • Understanding VT Ablation

 

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FN Media Group LLC (FNMG) owns and operates FinancialNewsMedia.com (FNM) which is a third party publisher that disseminates electronic information through multiple online media channels. FNMG’s intended purposes are to deliver market updates and news alerts issued from private and publicly trading companies as well as providing coverage and increased awareness for companies that issue press to the public via online newswires. FNMG and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNMG’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. The companies that are discussed in this release may or may not have approved the statements made in this release. Information in this release is derived from a variety of sources that may or may not include the referenced company’s publicly disseminated information. The accuracy or completeness of the information is not warranted and is only as reliable as the sources from which it was obtained. While this information is believed to be reliable, such reliability cannot be guaranteed. FNMG disclaims any and all liability as to the completeness or accuracy of the information contained and any omissions of material fact in this release. This release may contain technical inaccuracies or typographical errors. It is strongly recommended that any purchase or sale decision be discussed with a financial adviser, or a broker-dealer, or a member of any financial regulatory bodies. Investment in the securities of the companies discussed in this release is highly speculative and carries a high degree of risk. FNMG is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. This release is not without bias, and is considered a conflict of interest if compensation has been received by FNMG for its dissemination. To comply with Section 17(b) of the Securities Act of 1933, FNMG shall always disclose any compensation it has received, or expects to receive in the future, for the dissemination of the information found herein on behalf of one or more of the companies mentioned in this release. For current services performed FNMG has been compensated forty six hundred dollars for BioSig Technologies, Inc. current news coverage by a non-affiliated third party.  FNMG HOLDS NO SHARES OF BioSig Technologies, Inc.

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