In July 2016, I wrote a brief article highlighting for investors what I believe is an important relationship between Minnesota-based medical device company, BioSig Technologies, Inc. (BSGM), and researchers at Mayo Clinic. BioSig and Mayo have been collaborating since late 2014, with researchers at Mayo performing preclinical and advanced research studies with PURE EP™ since that time. For those unfamiliar with the Rochester, Minnesota-based Mayo Clinic, it was recently ranked the No. 1 hospital in the U.S. by U.S. News & World Report (1)
Mayo Clinic's R&D budget for 2016 is over $650 million, putting it on par with some of the largest publicly traded medical device companies in the world (2). The hospital has a tremendous track record of helping start-up companies achieve success, often seeing a sizable return on a take-out or IPO (3). Mayo's efforts with BioSig are headed up by Samuel Asirvatham, M.D., Professor of Medicine & Vice Chair of Division of Cardiovascular Diseases at Mayo Clinic. Dr. Asivatham is also a member of BioSig's Scientific Advisory Board (4). I believe Mayo's involvement with BioSig is central to the development of PURE EP. In fact, the title of my article last month was, "For BioSig, The Mayo Clinic Partnership Provides Confidence, Credibility" (5).
No more is that importance exemplified than through the publication of data in peer-review medical journals. As such, BioSig achieved a significant milestone with Mayo last week when Ammar M. Killu, MBBS, and fellow colleagues at Mayo Clinic including Dr. Asirvatham, published findings from a preclinical study in the Journal of the American College of Cardiology: Clinical Electrophysiology. Below I provide a quick review of that publication.
The paper by Killu et al. is entitled, "Novel Electrophysiology Signal Recording System Enables Specific Visualization of the Purkinje Network and Other High-Frequency Signals." It is published in the June 2016 issue of JACC: Clinical Electrophysiology (6). The paper highlights key research discoveries with PURE EP, BioSig's novel hardware and software platform electrophysiology recording system.
As a reminder, PURE EP was designed to deliver precise and uninterrupted real-time electrocardiograms and electrograms to assist an electrophysiologist in evaluation during the electrophysiology studies (EPS) and ablation procedures. These are procedures done on patients with complex arrhythmias (irregular heartbeats), including atrial fibrillation (AF) and ventricular tachycardia (VT), when pharmaceutical intervention fails. The AF / VT market is about $4 billion in the U.S., but EPS equipment, about a $1 billion sub-set of the broader market, is one of the fastest-growing segments (7).
To evaluate BioSig's PURE EP System, researchers at Mayo Clinic performed unipolar and bipolar cardiac conduction system mapping using various catheters while simultaneously comparing PURE-EP with a standard recording system manufactured by GE Healthcare called CardioLab. For reference, GE Healthcare controls roughly 50% of this market, with competitors such as Boston Scientific and St. Jude Medical rounding out the top three (8).
- What They Found -
Researchers at Mayo found that "PURE-EP consistently demonstrated superior Purkinje potentials and other high-frequency signal visualization compared with the standard recorder in all sites of the cardiac conduction system." They also found that "The PURE EP system has the capability to display the same channel with different processing options to highlight specific features while still displaying the original electrogram signal."
As noted above, an important finding from the study was the ability to clearly visualize Purkinje potentials. Purkinje potentials are the electrical output of Purkinje fibers, which are specialized conducting fibers that can conduct cardiac action potentials in a rapid and efficient manner. Purkinje fibers allow the heart's conduction system to create synchronized contractions of its ventricles, and are, therefore, essential for maintaining a consistent heart rhythm (9). Errant Purkinje potentials may indicate certain types of ventricular tachycardias which can lead to ventricular fibrillation and death, if not treated. Analysis of Purkinje potentials is of high importance when analyzing and selecting target ablation sites for patients with AF or VT (10).
According to researchers at Mayo Clinic, the restricted dynamic range and sampling rate in modern electrophysiology recording systems, such as GE Healthcare's CardioLab, make it challenging to identify high-frequency, low-amplitude signals, especially those temporally situated near low-frequency, high-amplitude signals. This is because such systems have a limited dynamic range and sampling rate, and therefore lack the adjustability and fidelity to observe Purkinje signals.
By use of PURE EP, researchers were able to visualize high-frequency signals which correlated with Purkinje potentials (see Figure 1 below). Killu et al. believe that adjustability, along with enhanced filtering and processing provided by PURE EP improves the analysis of Purkinje potentials and other high-frequency signals such that it may help improve mapping / ablation outcomes in arrhythmia syndromes dependent on the Purkinje network.
Work with Mayo Clinic and other leading institutions such as UCLA, Case Medical Center, and Mt. Sinai has allowed BioSig to advance PURE EP such to the point that management anticipates filing the U.S. 510(k) application to the FDA during the first half of 2017. Importantly, PURE EP is classified as a Class II medical device, which commonly does not require human clinical trials for FDA clearance to market. Approval should allow BioSig to start generating revenue from PURE EP in 2018; and, with the data that Mayo Clinic has generated above, I expect the product to be a game-changer for electrophysiologists once commercialized.
Read about Mayo Clinics track record and history of success helping start-up biopharma and medical device companies >> LINK
Read about what I think BioSig's valuation should be today >> LINK
This article was written by Jason Napodano, CFA of BioNap, Inc.
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