(FinancialPress) — December 27, 2017 / It hasn’t even been 20 years since France’s Michelle Haissaguerre first described using catheter ablation in patients with atrial fibrillation (AF), a common type of heart arrhythmia linked to strokes. Science has come a long way since then in mapping the triggers of AF, with catheter ablation now a staple in AF management strategies. In fact, it is routine enough today that some studies suggest ablating AF should be the front-line treatment ahead of heart-rhythm drugs, instead of vice-versa, as is typical protocol.
As ablation technology gets even better, there is more support for the ablation-first thesis and companies like BioSig Technologies (BSGM) are shepherding in the next evolution of technology known as bioelectronic medicine. A burgeoning space, the bioelectric market is forecast to rise from $17.2 billion in 2016 to $25.2 billion in 2021. Los Angeles-based BioSig is entrenched in the emerging field, aimed first at improving outcomes for the more than 14.4 million Americans affected by arrhythmias, with the most common being AF and ventricular tachycardia (VT).
An increasing number of diagnoses and a more proactive approach towards ablation underscores estimates that the number of ablation procedures will climb from 865,000 in 2015 to more than 1.3 million annually by 2020. That’s 1.3 million Americans that could benefit from the next generation technology of BioSig’s PURE EP™ System that provides electrophysiologists performing the procedures clearer signals of the heart tissue to ablate that is at the root of AF and VT. Broadly speaking, the BioSig system filters out noise of conventional systems and accurately covers a broader range of electrical signals. As a novel software/hardware package, PURE EP effectively addresses technical and procedural challenges unlike anything else in ablation procedures today.
The Los Angeles-based company is expecting the FDA to approve the medical device for use in the near term and for commercialization to begin in mid-2018. As human data is added to the body of pre-clinical information collected, BioSig believes its system will gain momentum in the medical community, just like mapping did in the early days.
BioSig Founder, CEO, and Executive Chairman, Ken Londoner, thinks the market is even bigger than at first blush. As he explained to Medgaget.com in June, “There is an estimated up to 6.1 million people in the United States that are atrial fibrillation patients, and only 6-7% of these patients elect to have the ablation procedure performed.”
The company is also looking outside the U.S., with plans to have international sales in about three years.
In a regulatory filing on Wednesday, Londoner reflected upon a successful 2017 that included a number of highlights, including positioning for a global footprint by opening an office in Geneva, Switzerland. Also on the international front, the BioSig shareholder base was expanded to include investors from Switzerland, U.K., Ireland, France, Spain, Israel, Qatar, Iceland, United Arab Emirates, and more this year. On the corporate level, BioSig raised $5.5 million at a premium-to-market, hired key staff, and added tech and medical device IP expert Andrew Filler to its Board of Directors. The company also solidified a 10-year collaboration deal with the Mayo Clinic and completed a two-year market development project with Health Research International. As is stares down commercialization of PURE EP, BioSig penned a partnership with Prisma Geneva, a Swiss-based influential advisor, to help with business development in Europe and retained Sherpa Technology Group, a leading IP strategy firm, to strengthen its asset portfolio.
While 2017 may one day be looked at as an inflection point for BioSig, 2018 is aligned be the breakout year. After years of laying the groundwork, clearance from the FDA to sell the PURE EP System would be the biggest accomplishment to date and a true game changer for BioSig.
An FDA green light unlocks value and should provide tailwinds for BioSig, as it paves the way for the first in-man data ever for PURE EP and aligns BioSig to enter the revenue stage by commercializing the system across leading medical centers in the U.S. The company also intends to uplist its stock to the NASDAQ exchange in the future, a move that attracts institutional investors that are forbidden to invest in OTC-listed companies and should help bolster the balance sheet. According to the SEC filing, these are amongst some of the anticipated milestones BioSig is striving for, along with seeking strategic partnerships and building out the pipeline and protecting it with assistance from Sherpa.
To the credit of scientists and for the benefit of patients, multiple advances have been made in ablation procedures in recent years. More developments are on the horizon that essentially keep making the proverbial window clearer that physicians look through during ablation procedures. With better technology comes better outcomes and that could translate to a company maker if the PURE EP System works in humans the way lab studies indicate. For BioSig, that horizon is no longer off in the distance, it’s right in front of them.
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