NEW YORK, NY / ACCESSWIRE / June 18, 2018 / SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced it has issued an update note on BioSig Technologies, Inc. (OTCQB: BSGM).
The note is available here: BSGM June 2018 Note.
BioSig Technologies, Inc. (OTCQB: BSGM, "BioSig") is an innovative medical device company based in Minneapolis, MN. Led by its flagship product line, the PURE EP™ System (Precise Uninterrupted Real-time evaluation of Electrograms), BioSig is developing products with the potential to improve outcomes for patients with complex cardiac arrhythmias (heart rhythm disturbances). BioSig is focused on commercializing products for the $4 billion global market for electrophysiology (EP), a growing market which analyzes electrical activity in the heart to identify the cause and nature of arrhythmias. BioSig continues to make significant progress on financing as it seeks regulatory clearance for its PURE EP device; as of May 1, the company had has raised $6.3mn in capital thus far in 2018.
Highlights from the note include:
BioSig announces FDA 510(k) submission for PURE EP™
BioSig took a major step towards the potential commercialization of PURE EP with the submission of its 510(k) application to the US Food and Drug Administration (FDA) for its flagship PURE EP™ System as a class 2 device. The PURE EP™ System is a non-invasive, surface electrocardiogram and intracardiac multichannel recording system, which acquires, processes and displays high fidelity cardiac recordings required during electrophysiology studies and catheter ablation procedures. While application processing times can vary, and there is always risk that the device may not be cleared by the FDA, we view the submission as a significant accomplishment by management, completed in line with its prior outlook and our thinking. While it is difficult to predict the timing of a 510(k) application, or the chances of clearance, the FDA website states that the agency aims to process 510(k) applications within 100 days. This would suggest that information on the company's application is likely to occur this summer. If the PURE EP is cleared, BioSig could be in a position to begin commercial activities by the end of the year with 2019 representing the first full year of commercialization.
Recent acquisition of EPD Solutions highlights value in space
As noted in our prior coverage of BioSig, we have always felt that there was potential for strategic value from BioSig's PURE EP™ System due to the significant merger activity and relatively high valuations that have taken place in the space. Last week this trend resumed when industry behemoth Koninklijke Philips NV ("Philips") announced that it would purchase Israel-based EPD Solutions for a provider of heart-imaging technology for the medical sector. Interestingly, the deal carries a sizeable valuation, comprising 250mn euros upfront, plus up to 210mn euros in additional payments if certain milestones are met. While it is difficult to ascertain the precise motivations behind the valuation of the EPD deal, given its focus on cardiac imaging and navigation for improved outcomes for cardiac arrhythmias, we would view EPD as an intriguing comparable when considering a potential "bluebird" situation for BioSig. We believe EPD devices have been cleared for sale in Europe by a CE Marking, however, they have not yet received FDA clearance for sale in the US.
Target increases to $4.50 for BioSig
We are encouraged by the progress made by BioSig and look forward to what could be a pivotal year for the company in 2018, with a decision from the FDA on clearance for PURE EP™ expected this summer and continued interest in the EP space by large device makers, as evidenced by the recent announcement that Philips plans to acquire EPD.
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About BioSig Technologies, Inc.
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System. The technology has been developed to address an unmet need in a large and growing market.
The Company's first product, PURE EP(TM) System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig's main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.
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