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BSGM: PURE EP Poised For Strong U.S. Launch

09/25/2018


NASDAQ:BSGM

Following receipt of FDA 510(k) clearance in early August and uplisting their shares to Nasdaq, BioSig Technologies Inc. (NASDAQ:BSGM) is readying for launch of their flagship product, the PURE EP System, and simultaneously ramping up investor outreach efforts. These initiatives will be supported by an aggregate of $12.5M in new financing raised during 2018 (including $4.3M in August).

BioSig is a medical device company engaged in the development and commercialization of a proprietary signal processing platform designed to significantly improve real-time information and clinical decision-making in the ~$4B - $5B electrophysiology (EP) market. Their PURE (Precise Uninterrupted Real-time evaluation of Electrograms) EP System is a signal acquisition and processing system used by electrophysiologists during cardiac ablation procedures to help identify areas of tissue that create an abnormal heart rhythm (arrhythmia).


View Exhibit I

When drug therapy fails to control certain complex heart conditions such as atrial fibrillation and ventricular tachycardia, cardiologists often turn to catheter ablation. A catheter ablation procedure includes an electrophysiology (EP) study, which provides information about the cause and location of the arrythmia, followed by ablation (i.e. destruction) of the tissue that is causing the abnormal heart rhythm.

A catheter ablation procedure involves inserting one or more flexible catheters into large veins in the groin or neck and threading them towards the heart. Information gathered during the EP phase of the procedure involves recording of the heart’s electrical signals, ‘pacing’ (speeding/slowing) of the heart and arrythmia induction. When the problem areas have been identified and located, heating (or extreme cold) is then employed to ablate the tissue that is believed to be the cause of the arrythmia.

Unfortunately, the quality of information from electrophysiology studies can be compromised by interference, or ‘noise’, from proximal electrical equipment during recording. And while noise-reduction filters are currently available to mitigate electronic interference, they can alter signal quality. Success of catheter ablation often relies on the information obtained during the EP study and signal noise is a contributor to low atrial fibrillation procedural success rates. Risk of recurrence of atrial fibrillation 18 months following catheter ablation has shown to be as high as 40% - 50% (Verma A., et al. Approaches to Catheter Ablation for Persistent Atrial Fibrillation. May 7, 2015 N Engl J Med 2015; 372:1812-1822 DOI: 10.1056/NEJMoa1408288). Given that recurrence often requires the catheter ablation procedure be repeated, the importance of eliminating noise and otherwise improving the quality and accuracy of information from the EP study can be of significant value (to the clinician, patient and cost of healthcare).

Improving signal quality is important to electrophysiologists and is exactly what PURE EP aims to do. PURE EP, which functions alongside existing recording and mapping systems, utilizes surface electrocardiogram and intracardiac multichannel recording to provide electrophysiologists with real-time information during catheter ablation procedures. It has been designed to provide precise and unique recording functionality that is not currently available in the marketplace. By improving signal clarity and reducing signal ‘noise’, PURE EP has demonstrated the potential to increase an electrophysiologist’s efficiency and accuracy and, therefore, reduce rates of repeat procedures – thereby reducing associated costs and improving patient outcomes.

These benefits are of significant value-add, according to a BioSig-sponsored market study of U.S. electrophysiologists conducted by Healthcare Research International. The survey respondents rated all six features listed of the PURE EP System as being ‘Very Helpful’ for ablation procedures, particularly those related to overall noise reduction and improvement in signal clarity.


View Exhibit II

PURE EP Validation

Human (clinical) studies are expected to be an integral component of BSGM’s commercial strategy and complement PURE EP’s preclinical experience. Validation to-date of the PURE EP technology includes multiple publications and a collaborative effort between BioSig and some of the most highly respected cardiology centers in the United States.

- Texas Cardiac Arrythmia Institute: since 2011 BSGM collaborated with the Texas Cardiac Arrythmia Institute at St. David’s Medical Center in Austin, TX which aided in initial validation of the technology

- UCLA: in 2013 the PURE EP proof-of-concept unit was evaluated using an electrocardiogram/intracardiac simulator at BSGM’s lab and then with pre-clinical recordings from the lab at UCLA.

- Mayo Clinic: since 2014 BSGM has worked with Dr. Samuel J. Asirvatham and other physicians of the Mayo Clinic in Rochester, Minnesota and Jacksonville, FL on further validation of PURE EP. That has included pre-clinical studies to validate the technology within the initial prototype and to determine clinical effectiveness for features within the PURE EP System. Since March 2016, BSGM has published seven manuscripts in collaboration with the physicians from Mayo Clinic evidencing their pre-clinical findings

- Mount Sinai: pre-clinical studies of the PURE EP System related to ventricular tachycardia were conducted in 2016 at Mount Sinai Hospital in NYC

In addition, PURE EP has been the subject of a plethora of manuscripts, presentations and publications. Among the most recent include;

- April 2017: the PURE EP System was featured in The Journal of Innovations in Cardiac Rhythm Management with the manuscript entitled, “Initial Experience with the BioSig PURE EP Signal Recording System: An Animal Laboratory Experience” co-authored by physicians from Mayo Clinic and Harvard Brigham & Women’s Hospital

- July 2018: research poster entitled “Unipolar Intracardiac Signal Morphology as a Parameter for Catheter Contact Evaluation” was presented during the 40th International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC 2018). The findings suggest that the morphology of a unipolar signal obtained by the PURE EP System can provide incremental information in proper contact evaluation

Large and rapidly growing target markets

The worldwide electrophysiology market is estimated to be worth between $4B and $5B and expected to grow in the low double-digit percentages over the next five to six years. Global annual revenue of EP mapping and recording systems, a subset of the atrial fibrillation market, is estimated at approximately $560M. Atrial fibrillation affects almost 34M people globally, including as many as 6M in the U.S. Catheter ablation procedure volume has exploded over the last two decades, rising 2.5-fold since the year 2000. Currently, approximately 950k catheter ablations are performed globally each year, with the U.S. accounting for about 30% (~285k) of the total.


View Exhibit III

With just 2.5% of the diagnosed symptomatic atrial fibrillation population currently undergoing catheter ablation and several catalysts (including an ageing population) poised to push procedural volume higher, there may not have been a more ideal time for BSGM’s impending launch of PURE EP. And, importantly, since PURE EP is essentially a new product category and designed work in parallel with and act as a complement to existing technology, BioSig is not directly competing with the likes of GE Healthcare (GE), Boston Scientific (BSX), St Jude Medical and other med-tech Goliaths which serve the same market.

Commercialization

PURE EP received FDA 510(k) clearance on August 8th. Per the 510(k) Summary, Indications for Use; “PURE EP™ is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.”

BioSig has been busy preparing for their strategic launch of PURE EP while at the same time ramping up their investor outreach efforts. Subsequent to receiving FDA 510(k) clearance of PURE EP on August 8th, BSGM raised an additional $4.3M of cash which, along with cash-on-hand ($3.7M as of June 30th), should provide a significant runway in funding their initial U.S. roll-out. They also hired Amy Scott, a seasoned medical device professional with more than two decades’ experience in the electrophysiology space, to lead the launch.

BSGM shares were uplisted to Nasdaq and began trading on the exchange late last week. With the shares now trading above $5 and the additional liquidity afforded by the Nasdaq listing, institutional investor interest is likely to grow. That likely is what prompted BSGM to bring on Gilmartin Group to handle investor relations (announced earlier this week).

While specifics of the commercialization strategy are still being worked out, BSGM has indicated that they expect an evidence-based approach will be integral to their overall gameplan. This includes collection of first-in-man data which they anticipate will happen by current year-end. BSGM’s existing relationships with the Mayo Clinic and other prominent cardiac centers could be of significant value as they move into clinical studies.

PURE EP looks to be poised to enjoy a warm reception as appears that inbound commercial interest has already begun. Management noted that following receipt of FDA clearance that they “started seeing significant interest from solid medtech professional, financial corporations and global institutions.”

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