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 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 May 4, BioSig revealed that it had increased its patient case goal for PURE EP to at least 1,500 procedures by the end of 2021. Previously, the company had announced its target to complete 1,000 patient cases in 2021, having delivered 425 procedures by the end of 2020.  The company noted that 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, Texas, its first commercial customer, continues to be the biggest user of the technology with over 300 patient cases conducted to date.  Mayo Clinic Florida Campus and the University of Pennsylvania are the second and third largest patient case drivers with 130 and 112 cases, respectively. And more than 800 procedures have been conducted with the PURE EP System in the last 18 months, 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. 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. 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. 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. And in the Any-Other-Business category, on April 9, BioSig said it had accepted an invitation to join the Alliance for Artificial Intelligence in Healthcare (AAIH). The AAIH invite came after the company was awarded US patents for its artificial intelligence-based platform. BioSig noted that the AAIH is the global advocacy organization for the advancement and use of AI in healthcare to improve patients’ lives and create more efficient, sustainable, and accessible healthcare systems. 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 May 4, 2021, BioSig chairman and CEO Kenneth L. Londoner said: “Patient case volume is one of the leading indications of physician utilization of our technology." “We see steady procedural growth in almost all of our centers, which we believe will turn into commercial revenues. This case growth, combined with the consistently positive customer feedback, positions us well to deliver on our target of 20 installation sites by the end of 2021," he added. Contact the author at jon.hopkins@proactiveinvestors.com