FDA Approvals for Cardiac Electrophysiology Products Bright Spot in Healthcare Industry

Tuesday, August 14, 2018 Drug News
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PALM BEACH, Florida, August 14, 2018 /PRNewswire/ --

MarketNewsUpdates.com News Commentary 


rising prevalence of cardiac conditions such as flutter, atrial fibrillation and arrhythmia has driven the adoption of medical procedures such as ablation and electrophysiology (EP) study. Electrophysiology is one of the most rapidly-growing areas of
healthcare. Innovation within the field of electrophysiology continues to evolve toward improving our ability to visualize arrhythmias in much greater detail, and we are confident that patient outcomes will improve as a result. Electrophysiology Market Report, published by Allied Market Research, forecasts that the global market is expected to garner $8.2 Billion by 2022, registering a CAGR of 13.4% during the period of 2016-2022. Electrophysiology (EP) ablation catheters are expected to dominate the global electrophysiology market. Active healthcare stocks in news today include: BioSig Technologies, Inc. (OTC: BSGM), electroCore, Inc. (NASDAQ:ECOR), Boston Scientific Corporation (NYSE:BSX), Abbott Laboratories (NYSE:ABT), Johnson & Johnson (NYSE:JNJ).

BioSig Technologies, Inc. (OTCQB: BSGM) BREAKING NEWS - BioSig Technologies 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.  Read this and more news for BioSig Technologies at: http://www.marketnewsupdates.com/news/bsgm.html In other healthcare industry news of note:

electroCore, Inc. (NASDAQ:ECOR), a commercial-stage bioelectronic medicine company, recently announced a research collaboration with Massachusetts General Hospital (MGH) through the company's funding of a MGH program targeting neuroinflammation. Within this program, electroCore's non-invasive vagus nerve stimulation (nVNS) will be studied in preclinical settings, looking at the effects of this novel therapeutic approach on neuroinflammatory mechanisms which have been associated with conditions in the central nervous system (CNS) including pain, trauma and neurodegeneration. "We are proud to partner with a renowned research institution like Massachusetts General Hospital, whose core scientific mission aligns with our belief that it is through the deep understanding of the mechanisms of potential therapies that we learn to best help patients suffering from debilitating conditions," said J.P. Errico, Chief Science Officer at electroCore.

Boston Scientific Corporation (NYSE:BSX) last week announced it has signed an agreement to acquire VENITI, Inc., a privately-held company in Fremont, California which has developed and commercialized the VICI VENOUS STENTŪ System for treating venous obstructive disease. Boston Scientific has been an investor in VENITI since 2016 and currently owns 25 percent of the company. The transaction price for the remaining stake consists of $108 million up-front cash, as well as up to $52 million in payments contingent upon U.S. Food and Drug Administration (FDA) approval of the VICI stent system. Venous obstructive disease - instances of abnormal, blocked or damaged veins - affects more than 1.1 million people in the United States and Western Europe annually. Vein obstructions, often caused by conditions such as deep vein thrombosis, post thrombotic syndrome and May-Thurner syndrome, can prevent proper blood circulation and cause patients to experience pain, swelling, ulcers and a diminished quality of life.

Abbott Laboratories (NYSE:ABT) recently announced U.S. Food and Drug Administration (FDA) approval for an over-the-air software upgrade for all currently implanted Infinity DBS systems that delivers magnetic resonance (MR)-conditional labeling and innovative features. This life-changing technology from Abbott helps patients with progressive diseases live better. Prior to the latest Abbott approval, people new to deep brain stimulation (DBS) therapy or those living with older systems from other manufacturers may have experienced barriers in accessing the most advanced DBS therapy options because of the potential need for an MRI in the future. With its updated labeling, Abbott has addressed this challenge with the Infinity DBS system's improved therapy platform - the first and only FDA-approved MR-conditional directional DBS system.

Johnson & Johnson (NYSE:JNJ) announced recently the appointment of Chris DelOrefice to Vice President of Investor Relations for Johnson & Johnson, effective August 13, 2018. Mr. DelOrefice will report to Mr. Joseph Wolk, Executive Vice President and Chief Financial Officer of the Company. Mr. DelOrefice has been with Johnson & Johnson for 19 years and has most recently served as the CFO of the North America Hospital Medical Devices (MD) Business. In this role, he provided strategic financial leadership and counsel, which were integral in evolving the MD portfolio and commercial strategy to support our long-term growth. Previously, Mr. DelOrefice held various leadership positions across all three segments of Johnson & Johnson and many functions of the Company, and was instrumental in leading key mergers and acquisitions, negotiating critical licensing and managed care agreements and implementing major business restructurings.

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