Following receipt of FDA 510(k) clearance in early August and uplisting their shares to Nasdaq, BioSig Technologies Inc. (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).
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.
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