Growing Adoption of Electrophysiology Ablation Devices Dominating Unmet Technology Industry

Palm Beach, FL – (November 13, 2018) – The U.S. remains the largest medical device market in the world, with a market size of around $156 billion as well as representing about 40 percent of the global medical device market last year alone.  As a result, Biomedical companies are rightly focused on developing novel treatments to meet society’s unmet medical needs, working nimbly to bring those treatments from molecule to market.  In the electrophysiology sector, high technological adoption in the U.S. coupled with increasing research activities pertaining to development of new ablation techniques has positively impacted market growth. The latest technological advancements pertaining to advancing mapping, navigational and ablation techniques used in electrophysiology is expected to accelerate unment, EP devices adoption rate heading into the future shining a positive light on industry for diagnosing arrhythmias by locating areas of heart tissue that interrupt the normal functioning of the heart’s electrical system.  The Global Electrophysiology Market is expected to exceed more than $8.5 Billion by 2024 at a CAGR of 10.6%.  Active healthcare stocks in news today include:  BioSig Technologies, Inc. (NASDAQ:BSGM), Medtronic plc (NYSE:MDT), Koninklijke Philips N.V. (NYSE:PHG), Abbott Laboratories (NYSE:ABT), Johnson & Johnson (NYSE:JNJ).


BioSig Technologies, Inc. (NASDAQ:BSGM) BREAKING NEWS – BioSig Technologies, 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 Markets 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.         Read this and more news for BSGM at:


In other cardiac/heart health industry news of note:


Johnson & Johnson (NYSE: JNJ) recently announced that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has received approval from the U.S. Food and Drug Administration (FDA) for its VISITAG SURPOINT External Processing Unit and enrollment has begun in its post-market approval study. The VISITAG SURPOINT Module calculates a Tag Index, a single value combining parameters of power, contact force and duration during a catheter ablation procedure. The index was developed to simplify and standardize the workflow for ablating patients with paroxysmal atrial fibrillation (PAF) and to support electrophysiologists using the CARTO SMARTTOUCH Technology, to achieve Pulmonary Vein Isolation (PVI). Dr. Jose Osorio** at Grandview Medical Center in Birmingham, AL recently enrolled and treated the first patients in a post-market approval study that is assessing Tag Index-guided ablation using the VISITAG SURPOINT Module.


Medtronic plc (NYSE:MDT) recently announced U.S. Food and Drug Administration (FDA) approval to begin a clinical trial to evaluate the Symplicity Spyral(TM) renal denervation system in patients with high blood pressure (hypertension) who are already prescribed anti-hypertension medications. The SPYRAL HTN-ON MED Trial is the latest prospectively powered, randomized, sham-controlled study within the broader Medtronic SPYRAL HTN Global Clinical Program, and will evaluate a patient population comparable to what physicians typically encounter in daily practice – patients with uncontrolled blood pressure taking multiple anti-hypertensive medications. “A broad range of patients suffer with hypertension today, many of whom remain uncontrolled despite being prescribed a variety of medications; the consequences of uncontrolled hypertension represent both a substantial impact to public health and a large unmet need in medicine for new approaches,” said David Kandzari, M.D., director of interventional cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta, Ga., principal investigator and member of the SPYRAL HTN Global Clinical Program Executive Committee.


Koninklijke Philips N.V. (NYSE:PHG) recently announced the EPIQ CVx cardiovascular ultrasound system. Built on the powerful EPIQ ultrasound platform, EPIQ CVx is specifically designed to increase diagnostic confidence and simplify workflow for clinicians, giving them more time to interact with their patients and reducing the need for repeat scans. The initial response to the new system has been overwhelmingly positive: 95% of a group of clinicians who were shown the new EPIQ CVx believed it offered improved image quality: sharper and clearer images [1]. Philips is also introducing the EPIQ CVxi, specifically tailored for use in the interventional lab. EPIQ CVx and EPIQ CVxi are CE marked and have received 510(k) clearance from the U.S. Food and Drug Administration (FDA). “The EPIQ CVx brings together advanced image quality, quantification and intelligence specifically for the cardiologist,” said Roberto Lang, MD, Professor of Medicine, Director, Noninvasive Cardiac Imaging Laboratory at the University of Chicago Medicine. “I was impressed with the TrueVue feature, which elevates 3D ultrasound imaging to a totally new level and could impact diagnostic ability of echocardiography in different clinical scenarios, like better understanding of the anatomy of mitral valves.”


Abbott Laboratories (NYSE:ABT) recently announced that the HeartMate 3™ Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for a transplant who will live with their device for the rest of their lives. More than 5.7 million Americans suffer from heart failure, and there are approximately 915,000 new patients diagnosed with the disease annually. For advanced heart failure patients who can no longer rely on earlier stage treatment options, LVAD’s take the workload off a weakened heart by pumping blood through the body—providing crucial, life-saving support for patients awaiting a heart transplant or for those not able to receive one. “Approximately a quarter of a million people are living with advanced heart failure, and many of these people will need a heart transplant; however, only a few thousand will receive a new heart,” said Nir Uriel, M.D., director of Heart Failure, Transplant and Mechanical Circulatory Support at the University of Chicago Medicine.


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