Arrhythmia, a condition that causes the heart to beat with an irregular or abnormal rhythm, is the fourth leading disease in the United States. Untreated or undiagnosed, arrhythmias can increase the risk of severe health complications—including stroke or even death.
Medtech company BioSig Technologies (NASDAQ: BSGM) has developed the PURE EP System, a technology that aims to improve the visuals of cardiac signals for surgeons that treat irregular heartbeats. The company hopes this will encourage more arrhythmia patients to elect for surgical treatment—a therapy option that is increasingly proving more effective than pharmaceutical alternatives.
With major players in the space like Johnson & Johnson (NYSE: JNJ), Medtronic (NYSE: MDT) and Abbott (NYSE: ABT) grabbing the attention of investors, let’s look at why and how BioSig is claiming a name for itself in the industry.
You Can’t Fix What You Can’t See: The Development of BioSig’s PURE EP System
One of the ways BioSig intends to profit from the EP market is with its first product, the PURE EP™ System: a novel real-time signal processing platform, engineered to reveal the full range of cardiac signals. This technology is intended to support physicians during surgical procedures by providing accurate visuals of high-frequency cardiac signals that carry important diagnostic value.
After receiving FDA 510(k) market clearance for PURE EP in 2018, BioSig initiated the first clinical trial in 2019 and began commercialization in 2020. The company has already seen increased technology usage across its installed base and anticipates at least 1500 cases by the end of 2021.
With 44 physicians having conducted over 800 arrhythmia patient cases to date, the company is currently conducting patient cases in 9 medical centers across the country. These sites include some of the leading hospitals such as Mayo Clinic in Jacksonville, Florida and Phoenix, Arizona, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas and University of Pennsylvania in Philadelphia, Pennsylvania.
The company is working diligently to further commercial sales. BioSig completed its first sale of three PURE EP Systems with St. David’s HealthCare of Austin, Texas, an HCA Healthcare-owned hospital in late 2020. More recently, the company announced the acquisition of PURE EP systems by Mayo Clinic across multiple states and locations.
Focusing on a Growth Market
In 2018, BioSig was named one of the “50 Innovative Companies to Watch” by The Silicon Review. The company has also been covered by EP Lab Digest, The Los Angeles Business Journal and Diagnostic and Interventional Cardiology, among others and was added to the LD Micro Index.
Since its founding in 2009, BioSig has developed a first-of-its-kind technology, attracted significant investment, conducted pre-clinical studies with centers of excellence, signed a 10-year strategic agreement with Mayo Clinic, and developed a robust IP strategy.
The company is currently penetrating the $4.6 billion electrophysiology (EP) market--a market expected to exceed $8.5 billion by 2024 and $12.2 billion by 2026. With room for substantial growth in the EP sector; BioSig is also exploring the potential for their proprietary signal processing capabilities within the emerging and cutting-edge field of bioelectronic medicine, starting with neurostimulation, a market that is projected to reach $12.2 billion by 20241. The company recently announced its newest patent claims for the development of a novel nerve sensing technology to improve the safety and efficacy of renal denervation procedures to treat hypertension.
The company recently reported $28 million in cash on the balance sheet and no debt from its 2020 annual review.
BioSig Technologies is dedicated to developing new ways to help patients and physicians. Find out more about the company at https://www.biosig.com/.
1Bioelectronic Medicine 2019 – 2029. IDTechEX report, Dr. Nadia Tsao
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