BioSig Technologies, Inc. (NASDAQ: BSGM)

Get Top Rated Stock Alerts Active Traders Depend On

Sign Up Today For FREE News Driven Alerts

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.

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

 

 

Management

 

 

Kenneth L. Londoner, MBA

Kenneth L. Londoner, MBA
Founder, Chief Executive Officer, Chairman, and Director

 

Mr. Londoner founded BioSig Technologies, Inc. in February 2009. Mr. Londoner is the Managing Partner of Endicott Management Partners, LLC, a firm dedicated to assisting emerging growth companies in their corporate development and investing needs since 2004. From April 2007 to October 2009, Mr. Londoner was the executive vice president of NewCardio, Inc., a silicon valley based cardiac software company. Mr. Londoner also served as a Director and the architect for the turnaround at Alliqua BioMedical, Inc. (Nasdaq: ALQA) from May 2012 to March 2014. Mr. Londoner is a co-founder of Safe Ports Holdings, LLC, in Charleston, South Carolina, a port security and logistics company. Started in July 2005, the company built and sold an inland port development project to Dubai Ports World. The sale, in the fall of 2007, was for almost six times what investors had invested. Mr. Londoner is a member of Safe Ports Board of Directors. Mr. Londoner was the founder and managing partner of Red Coat Capital Management in New York. Founded in late 1996, the hedge fund (long/short equity strategy) grew from its initial base of $ 2 million in assets to a peak of $ 1.1 billion. Mr. Londoner started his investment career at J. & W. Seligman & Co., Inc., a leading institutional money management firm where he rose from research analyst to managing $3.5 billion in mutual funds, pension funds, and international assets. He joined Seligman in 1991 and left in 1997. Mr. Londoner graduated from Lafayette College in 1989 with a degree in economics and finance and received his MBA from NYU’s Stern School of Business in 1994, with a dual major in finance and management. Mr. Londoner just celebrated his 25th wedding anniversary and has four children. Mr. Londoner has been working with Lafayette College to develop and expand a summer internship program designed to provide undergraduate students with high-value summer employment in leading growth industries in the U.S.

 

 

Steve Chaussy

Steve Chaussy
Chief Financial Officer

 

Mr. Chaussy has served as our chief financial officer on a full-time basis since January  2018.  Mr. Chaussy served as our chief financial officer on a part-time basis from May 2011 to January 2018. Since 2005, Mr. Chaussy has been the sole proprietor of Anna & Co., Inc., a consulting company that offers services to small publicly traded companies. Anna & Co., Inc. provides general financial and accounting services, with a special emphasis towards SEC reporting and compliance, to companies that lack sufficient resources to hire full-time employees to provide such services. From 2001 to 2005, Mr. Chaussy provided services as both a chief financial officer and as a consultant to small publicly traded companies. Prior to 2001, Mr. Chaussy served as chief financial officer for a large private distribution and wholesaling company, where he gained international experience. Mr. Chaussy is a graduate of Virginia Polytechnic Institute and State University and is a licensed certified public accountant in Virginia, California, and Florida.

 

 

Tiffini Wittwer

Tiffini Wittwer
Chief Regulatory and Compliance Officer

 

Mrs. Wittwer brings to BioSig over 15 years of experience in global regulatory affairs on behalf of public and private companies, most notably Trice Medical, Inc., Embrella Cardiovascular, Inc. (acquired by Edwards Lifesciences in 2011) and Cardica, Inc. (IPO in 2006). During her career, Mrs. Wittwer has successfully received FDA 510(k) clearance and CE Mark for numerous new technologies, including mi-eye(TM) and mi-eye 2(TM) visualization systems for Trice Medical and CE mark for Embrella Cardiovascular’s Embolic Deflector system for the use during transcatheter heart valve procedures.

 

 

 

Natasha Drapeau

Natasha Drapeau
Executive Vice President

 

Natasha Drapeau (formerly Russkina) has over 15 years of experience in international business development in the financial sector, including over 9 years at IG Group Plc, a British FTSE 250 company and a global leader in online trading. During this time, she was responsible for the Group’s global business development successfully delivering a number of high-level projects from opening new international branches to global rebranding, and providing all initial and ongoing business support to 16 international offices in Europe, South Africa, Singapore and Australia, a business sector, which accounted for 40% of the Group’s revenue. During her career, she had been appointed by the Board of Directors to open a new IT development office in Eastern Europe and was responsible for all parts of operations. During this assignment, the office grew from 14 inherited members of staff to over 135. Mrs. Drapeau is the founder and director of Augeous Consulting in Geneva, Switzerland, a firm that provides business development capabilities to companies in the life science sector. Mrs. Drapeau holds two MSc degrees with honors in Management and German from Samara Academy of Economics, and a certificate in Business, International Relations and The Political Economy from The London School Of Economics. Mrs. Drapeau is a member of the Institute of Directors in the United Kingdom.

 

 

Lora Mikolaitis

Lora Mikolaitis
Vice President, Administration

 

Ms. Mikolaitis helped co-found BioSig Technologies, Inc. in February 2009. As Vice President of Administration, her role encompasses a wide range of duties that began with co-writing the business plan to now co-writing marketing materials and SEC filings. She supports many of the departments of the Company including shareholder/investor/public relations, accounting/finance, legal, marketing, human resources, and research and development. Ms. Mikolaitis is also President of Miko Consulting Group, Inc., a firm that provides marketing research and administrative support to life science companies.

 

Amy Scott
Vice President, Physician Engagement

 

Mrs. Scott brings to the Company over 30 years of experience in medical devices, including over 20 years in electrophysiology (EP). Most recently, she served as Director of Strategic Partnerships for Biosense Webster (Johnson & Johnson), a role, in which she was responsible for primarily U.S. engagement of physicians and management of several Advisory Boards. Prior to that role, Mrs. Scott was managing a team responsible for driving customer engagement and education, including development of product demonstration and training sites, management of key accounts and liaison between internal clinical and field clinical trials teams. During her career with Biosense Webster, Mrs. Scott also served as Global Product Director for Atrial Fibrillation, the role in which she developed, executed and managed EP/Afib Centers of Excellence. She brings to BioSig extensive experience in defining customer needs and promoting key account relations and activities.

 

Source:  https://www.biosigtech.com/

Disclaimer

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.

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNMG undertakes no obligation to update such statements.

Sign Up & Get FREE News Alerts From FNM Today!