BioSig Technologies looking to unlock the future of bioelectronic medicine

Using targeted electrical signals to harness the body’s natural mechanisms to diagnose and treat a range of diseases Commercializing its first product, a biomedical signal processing platform called PURE EP Has a 10-year strategic agreement with Mayo Clinic What BioSig Technologies does: BioSig Technologies Inc (NASDAQ:BSGM) is working to develop and deliver the 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 is commercializing 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. Since receiving US Food & Drug Administration FDA 510(k) market clearance for PURE EP in 2018, it has initiated first-in-human trials at three medical centers, started a first clinical trial and collected a vast amount of clinical data in 2019. 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: On October 29, BioSig revealed that it had completed the installation of its PURE EP System at the Deborah Heart and Lung Center in Browns Mills, New Jersey. The group said its PURE EP System is also undergoing an evaluation and clinical data collection at the center, under the leadership of Dr Raffaele Corbisiero. The company also added that it is currently conducting patient cases under the clinical trial titled “Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study)” at Texas Cardiac Arrhythmia Research Foundation in Austin, Texas and Mayo Clinic Florida Campus in Jacksonville. And said it recently added Massachusetts General Hospital and the Hospital of the University of Pennsylvania to its clinical sites, as well. On September 15, the company revealed that a scientific abstract had concluded that PURE EP is able to produce reliable and high-quality signals when compared to the available standard of care systems. The conclusions came in an abstract and poster, entitled 'A novel cardiac signal processing system for electrophysiology procedures: early insights from the PURE EP 2.0 study', which was presented electronically at the ESC Congress 2020 - The Digital Experience. The abstract was co-authored by Carola Gianni, M.D., Amin Al-Ahmad, M.D., Shane M. Bailey, M.D., G. Joseph Gallinghouse, M.D., Rodney P. Horton, M.D. and Andrea Natale, M.D. of the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center in Austin, TX. The independent, blinded reviewers were Bradley P. Knight, M.D. (Northwestern University), Wendy Tzou, M.D. (University of Colorado), and Pasquale Santangeli, M.D. (University of Pennsylvania). According to the abstract, identical electrocardiographic and intracardiac signal data were recorded during 15 atrial fibrillation ablation procedures from the PURE EP System, the signal recording system, and the 3D mapping system. The collected signals underwent blinded, controlled evaluation by three independent electrophysiologists to determine whether the PURE EP signals are a viable alternative to conventional sources and if it provides additional or clearer diagnostic information. The reviewers were asked to record the quality of each signal sample on a scale of 1-10 and select a rationale for their rating in a dropdown menu. Based on the ratings for each pair of signals, a cumulative total of 29 PURE EP signals out of 34 (85.3%) were rated as statistically equivalent or better for this dataset. In 35.5% of samples, the reviewers selected PURE EP data because "more signal components were visible." Earlier in the year, the company had received Institutional Review Board approvals to install its PURE EP System at several medical centers across the country for evaluation.  In July, the medtech group submitted its application to the federal government-owned Systems for Award Management (SAM) website. Both current and potential government vendors are required to register in SAM to be awarded contracts by the government. Upon completion of its registration with SAM, the company became eligible to conduct business with the federal government. On the financing front in 2020, BioSig raised $39 million and, as of September 30, 2020, the group had $32.8million in cash on its balance sheet, with shares issued and outstanding totalling 30.1mln, and no debt. Inflection points: Further progress on commercialization of PURE EP Additional product pipeline development Positive outlook for revenue stream What the broker says: In a note on September 15, 2020, highlighting the abstract presented at the ESC Congress 2020 showing superior and greater signals were observed by processing from the PURE EP recording and mapping system, analysts at 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: “We believe that BioSig is in a strong position to expand our business headed into 2021,” Kenneth L. Londoner, founder, chairman, and CEO of BioSig Technologies said in the group’s October Letter to Shareholders. “We entered the final stretch of 2020 with a healthy balance sheet with ample cash and no debt and notable corporate and clinical achievements, including new evaluative deployments of the PURE EP System at leading medical centers across the country. The strength of our sales and marketing team allows us to drive commercial adoption of the PURE EP System. "At the same time, we continue developing an additional product pipeline to complement our core technology further and strengthen its competitive positioning for years to come. Our company demonstrated strong operational progress in some of the most challenging economic and social conditions, delivering on multiple catalysts in 2020 and building a foundation for robust growth in 2021.” Contact the author at jon.hopkins@proactiveinvestors.com