BioSig Technologies Inc. (BSGM) 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).
Following receipt of FDA 510(k) clearance in early August and subsequently uplisting their shares to Nasdaq, BioSig is readying for launch of the PURE EP System while simultaneously ramping up investor outreach efforts. In late August they hired Amy Scott, a seasoned medical device professional with more than two decades’ experience in the electrophysiology space, to lead the launch. Then, in September, they brought on the Gilmartin Group to handle the investor relations side of the business. These initiatives will be supported by an aggregate of $12.5M in new financing raised during 2018 (including $4.3M in August).
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. This evidence-based strategy is expected to blossom further going into 2019, with plans to create a clinical trial registry and develop the initial clinical trial protocol. BSGM’s existing relationships with the Mayo Clinic and other prominent cardiac centers could be of significant value as they move into clinical studies.
As we noted in an article on BSGM in September, PURE EP looks to be poised to enjoy a warm reception as it appears that inbound commercial interest has already begun. Management noted that following receipt of FDA clearance that they “started seeing significant interest from solid med-tech professional, financial corporations and global institutions.” Fortunately, the launch timing aligns well with market fundamentals and accelerating demand for new catheter ablation technologies.
Market fundamentals have never been better…
It appears that the market fundamentals may never have been better for products targeting the catheter ablation segment and, perhaps, particularly so for complementary products such as PURE EP. 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 electrophysiology 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.
Particularly compelling as it relates to the market for PURE EP is that it was designed as a complement to, as opposed to a replacement for, existing catheter ablation technologies. This means that demand for PURE EP should benefit from overall market growth (‘rising tide lifts all boats’) and, fortunately, market growth should further benefit from the long list of recent and anticipated regulatory approvals of new catheter ablation products. Many of the recent catheter ablation FDA approvals relate to products from the titans in med-tech, including Abbott, Johnson & Johnson and Medtronic, which can wield significant market influence including bolstering push-through demand.
European launch anticipated in 2019…
Entry into Europe represents another potential near-term growth catalyst. CE Mark and launch of PURE EP in Europe, which is anticipated sometime next year, would significantly expand the size of its addressable market. We estimate the aggregate European developed markets are approximately similar in size to that of the U.S.
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