BioSig Technologies looking to unlock the future of bioelectronic medicine

BioSig Technologies looking to unlock the future of bioelectronic medicine

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Using targeted electrical signals to harness the body’s natural mechanisms to diagnose and treat a range of diseases Has commercialized its first product, a biomedical signal processing platform called PURE EP To date more than 680 patient cases have been conducted with the PURE EP System across eight clinical sites.  What BioSig Technologies does: BioSig Technologies Inc (NASDAQ:BSGM) is working to develop and deliver advanced signal processing solutions that will unlock the future of bioelectronic medicine. Bioelectronic medicine is a rapidly growing field of healthcare that explores how targeted electrical signals can harness the body’s natural mechanisms to diagnose and treat a range of diseases. The field represents not just a narrow category of medical devices, but an entire approach to detecting and treating disease – using electrical pulses and the body’s own mechanisms as an adjunct or alternative to drugs and medical procedures. Founded in 2009, the Westport, Connecticut-based company has already built an impressive scientific and business track record. It has developed a first-of-its-kind technology, attracted significant investment, conducted pre-clinical studies with centers of excellence, signed a 10-year strategic agreement with Mayo Clinic, and developed a robust IP strategy. The company has commercialized its first product, a biomedical signal processing platform called PURE EP, which is designed to improve signal fidelity and uncover the full range of electrocardiogram (ECG) and intracardiac signals. PURE EP elevates the standard of care in electrophysiology through enhanced signal acquisition, digital signal processing, and analysis. The $4.6 billion electrophysiology (EP) market is growing at more than 10% annually and expected to exceed $8.5 billion by 2024, according to a 2018 report on ‘Opportunities in Global Medical Devices and Diagnostics’. BioSig hopes to expand the applications of its technology to new disease areas and markets - helping to bring the promise of bioelectronic medicine to millions of patients worldwide. BioSig’s founder and CEO, Ken Londoner, has a proven track record as a business entrepreneur, a biomedical executive, and an investment expert. How is it doing: BioSig has been very busy in the first quarter of 2021, with significant progress in the commercialization of its PURE EP systems. On April 6, the company announced that another unnamed top-rated leading hospital system had purchased PURE EP systems for multiple campuses in its national network. BioSig pointed out that more than 680 patient cases have been conducted with the PURE EP System to date across eight clinical sites.  The company said it continues to accumulate significant amounts of data to be utilized in the development of its AI platform. At the end of March, BioSig had announced the first commercial sale of three PURE EP units to St. David’s HealthCare in Austin, Texas, an HCA Healthcare-owned hospital. The group also said then that at least three more clinical sites were scheduled to kick off evaluation of the PURE EP system in coming months. In February, the group said it had entered into three new evaluation agreements for the PURE EP System with New York-Presbyterian/Weill Cornell Medical Center, Michigan Medicine–University Hospital - two centers that account for two of the largest EP programs in the country - and with Houston Methodist Hospital. It also revealed then that new installations of the PURE EP System would follow a shorter assessment cycle of 90 days based on favorable data from installation evaluations in 2020. And the company started the year with news that it had installed and conducted the first patient cases using the PURE EP system at Memorial Hospital of South Bend, part of Beacon Health System in South Bend, Indiana.  At the start of February, BioSig also announced a strategic collaboration with the Mayo Foundation for Medical Education and Research to develop next-generation Artificial Intelligence (AI) and machine learning-powered software for the PURE EP system. The collaboration will include a research and development program that will expand the clinical value of the company’s proprietary hardware and software with advanced signal processing capabilities and aim to develop novel technological solutions by combining the electrophysiological signals delivered by the PURE EP with other data sources.  On another front, at the start of January, BioSig announced a partnership with Vuzix Corporation, which will deploy its M400 Smart Glasses for remote servicing of the PURE EP System. The deployment will support the planned nationwide rollout of the system, with remote servicing support offering an ideal solution for compliance with coronavirus (COVID-19) travel restrictions, it added. On the patent front, at the end of March, BioSig said the US Patent Office had allowed it a utility patent covering its PURE EP noise-filtering technology. The firm said the patent describes and claims systems and methods for filtering noise during a quiet period. In particular, the patent involves filtering out harmonics and noise from an input cardiac signal, it added. The company said the patent complemented its expanding patent portfolio which now includes 34 issued or allowed worldwide patents as well as exclusive licenses to 16 additional worldwide utility patent applications from the Mayo Foundation for Medical Education and Research, three of which have been issued and/or have been allowed to date. And at the start of March, BioSig said the US Patent Office had allowed a utility patent that its majority-owned subsidiary NeuroClear Technologies, Inc. had exclusively licensed from the Mayo Foundation for Medical Education and Research. The patent describes and claims methods and materials for improving the treatment of hypertension via electroporation of nerves in the renal area. Electroporation is an emerging technique that has demonstrated efficacy in treatments for several critical conditions and is currently being evaluated for the treatments of autonomic nervous disorders, including hyper and hypotension/syncope, it noted. In December 2020, BioSig revealed that NeuroClear Technologies had signed a new research agreement with the University of Minnesota. Under the terms of the agreement, BioSig said it intends to launch a program to develop novel therapies to treat sympathetic nervous system disease. In the boardroom, on February 16, BioSig revealed that it had appointed Brenda Castrodad to lead its Human Resources department. The company noted that Castrodad has a wealth of experience in leading organizational development in start-ups and Fortune 500 companies within the life sciences sector.  Most recently, she led the HR department at TissueTech, Inc., a Miami, Florida-based biotech leader in regenerative amniotic tissue-based products, where she was responsible for transformation and automation of the company’s HR practices, talent planning, and team building. Prior to TissueTech, Inc., Castrodad spent six years at HeartWare, Inc., a heart failure medtech company acquired by Medtronic in 2016 for $1.1 billion. And on the financial front, BioSig recently highlighted that its balance sheet remains robust, with $28.3 million in cash, cash equivalent, and short-term investments. Inflection points: More news on commercial sales of PURE EP units Further details of strategic collaboration with the Mayo Foundation for Medical Education and Research for AIn and machine learning software NeuroClear Technologies novel therapy program launch news What the broker says: In a note on September 15, 2020, Laidlaw & Company repeated a ‘Buy’ rating and a 12-month price target of $17 on BioSig shares. The analysts said they viewed the data readout from the first clinical study as “very encouraging given the positive trend (based on identifying more signals) of applying the PURE EP system vs. the conventional method in facilitating AFib ablation procedures”. They added: “We are also encouraged by the recent rapid opening up of cardiac surgical procedures in hospitals that could accelerate the adoption of testing and potential later purchasing of PURE EP system.” The Laidlaw analysts concluded: “With the PURE EP system at an initial stage of commercialization, potential addition of Vicromax value and a positive outlook for its revenue stream, we believe BSGM shares remain undervalued.” What the boss says: In the company's statement on April 6, 2021, BioSig chairman and CEO Kenneth L. Londoner said: “We are pleased to expand our commercial installations across this most important healthcare system in multiple states. We expect to see further commercial sales in coming weeks and months.” “We are excited to see leading electrophysiologists and institutions commercially adopt the PURE EP system which we believe demonstrates acceptance of the unique benefits of our system platform, software, and data,” he added. Contact the author at jon.hopkins@proactiveinvestors.com

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