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 so far in 2021, with significant progress in the commercialization of its PURE EP systems. Most recently, on July 13, the compny announced the signing of a new agreement for the clinical evaluation of the company’s PURE EP technology for arrhythmia care at Medical City North Hills in North Richland Hills, Texas. As part of the evaluation agreement, Medical City North Hills clinical representatives will provide on-site training and assist with data collection and interpretation and workflow customization for every physician and all electrophysiology lab staff members to ensure optimal user experience. The company noted that Texas is one of the three strategic areas that BioSig is focused on in the targeted commercial launch phase, alongside the Northeast and Florida. A week earlier, on July 7, BioSig announced that it had installed its PURE EP ECG signal processing platform system at New York-Presbyterian/Weill Cornell Medical Center in New York. Weill Cornell Medical Center, which began conducting patient cases with the PURE EP System in June 2021, offers one of the most extensive electrophysiology programs in the country, the company said. The northeast is one of the three strategic areas that the BioSig is focused on in its targeted commercial launch phase.  And on July 1, BioSig announced that physicians have completed 1,000 patient cases with its technology across nine installation sites. Previously, on May 4, BioSig had increased the patient case goal from 1,000 to at least 1,500 procedures by the end of 2021, having delivered 425 procedures at the end of 2020.  The company said it is currently conducting patient cases in nine medical centers across the country. Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Mayo Clinic Florida Campus — BioSig’s first commercial customers — and the University of Pennsylvania count among the most prominent technology users with over 600 patient cases conducted to date. The company had announced on April 27 that Mayo Clinic’s campus in Phoenix, Arizona had started using the PURE EP System in patient cases treating cardiac arrhythmias. It said the 30-day clinical evaluation of the PURE EP System was being conducted by the cardiac electrophysiologists Win-Kuang Shen, Hichan El Masry, Arturo Valverde, and Luis Scott. And 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.  On April 13, BioSig said it had completed enrollment in the PURE EP 2.0 clinical trial. The multi-center, prospective clinical trial was conducted at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas, Mayo Clinic Florida Campus in Jacksonville, Florida, and Massachusetts General Hospital in Boston.  During the trial, BioSig said the PURE EP System was used in all types of arrhythmia cases, including atrial fibrillation, ventricular tachycardia, and atrial flutter. Atrial fibrillation, the most common arrhythmia type affecting over 6 million people in the US, accounted for more than 40% of enrollments. The company said it continues to accumulate significant amounts of data to be utilized in the development of its AI platform. Earlier in the same month, BioSig had announced the release of the PURE EP Software Version 4. The company said the latest version builds on the main system capabilities of the PURE EP while improving the overall user experience. The software upgrade will be rolled out to all new and existing customers, it added. On the collaboration front, 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.  And 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. On the financing front, on July 2 BioSig announced the pricing of an underwritten public offering to raise about $10 million. The company said it could gain roughly an additional $1.5 million in gross proceeds if the underwriter buys an additional 15% in shares. Under the financing scheme, BioSig was offering 2.5 million shares of its common stock, with a $0.001 par value per share, at $4 apiece.  BioSig said it intends to use the net proceeds from the offering for the continuation of full commercialization activities related to the company’s biomedical signal processing platform PURE EP, which is designed to improve signal fidelity and uncover the full range of electrocardiogram (ECG) and intracardiac signals. The money will also go towards additional support for organizational development, the continuation of the company’s ongoing research and development activities for new products, and general corporate purposes and other capital expenditures. On the personnel front, on April 15, BioSig announced the addition of two experienced electrophysiology regional directors to lead its commercial expansion across the southeast and central regions of the US. The company said Robert Sandler, who will lead regional sales across Texas, brings more than 25 years of sales experience in medical devices. Before joining BioSig, Sandler led regional sales at CardioFocus Inc and Cardiva Medical Inc. In addition, BioSig said Timothy Jones, who was appointed to head regional sales across Florida, has over 20 years of medical equipment sales and sales management experience. Most recently, he was employed by Boston Scientific Corp, where he led regional sales for its Augmenix division. 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. 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 July 27, 2021, Laidlaw & Company repeated a ‘Buy’ rating and 12-month price target of $13 on BioSig shares based on forward P/E analysis. The Laidlaw analysts noted that BioSig had reported a highly robust topline of PURE EP 2.0 clinical study (n=51 with a total of 218 procedures) as 93% (204/218) of PURE EP processed signals are equivalent or superior to that from the conventional method. They said: "We view the data readout a home-run given the study outcome exhibited: 1) substantially superior PURE EP facilitated signal reading of multiple signal categories; 2) also across multiple types of ablation procedures; 3) a much larger sample size and with consistent positive readout as to that of the interim readout (n=15, 34 procedures); and 4) multiple, not single center study. "There will be four presentations later this week that expected to gain substantial electrophysiologist attention during HRS 2021 meeting. Further, we anticipate the positive PURE EP 2.0 clinical study data not only could gain more physician buyin, but also provide hospital administrators more tangible evidence for making purchase decisions. "We believe clinical benefits of PURE EP system could shorten procedure time and improve surgical outcomes. As such, in our opinion, PURE EP system has the potential becoming a standard of signal processing." The Laidlaw analysts concluded: "With the PURE EP system at an early stage of commercialization and a positive outlook for its revenue stream, we believe BSGM shares remain undervalued." What the boss says: In the company's statement on July 1, 2021, BioSig chairman and CEO Kenneth L. Londoner said: “We are thrilled to cross the 1000-case milestone, a figure that was our initial target for the entire 2021. “Most importantly, this case growth allows us to collect vast amounts of clinical data daily, providing us with immense intelligence that is vital for our clinical and commercial strategy. Increased technology usage in elective procedures is a much-awaited sign of the steady pandemic recovery in our country, and we are looking forward to a strong second half of 2021,”  Contact the author at jon.hopkins@proactiveinvestors.com

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