A couple years ago, BioSig Technologies, Inc. was poised to apply for FDA clearance to market its technology to improve treatment of atrial fibrillation and ventricular tachycardia. Then its scientific advisors advised the Minneapolis company to put more work into that technology, a hardware-software combination designed to present clearer signals during electrophysiology studies and catheter ablation.
The technology, Pure EP, is designed to cut through the background noise of the lab and its equipment during cardiac recordings, enabling physicians to target and neutralize the areas of the heart that are causing atrial fibrillation (Afib), and ventricular tachycardia (VT), according to BioSig. More accurate targeting of the offending tissue may reduce the number of repeat catheter ablation procedures, which can last up to eight hours.
AFib is the most common human arrhythmia, affecting about 33 million patients worldwide. Often asymptomatic, it is associated with one-third of all ischemic strokes a well as a risk of heart failure and death. VT can also lead to sudden death.
BioSig’s system is designed to remove baseline wander, noise and artifacts, which make it difficult for physicians to see true cardiac signals. Baseline wander causes cardiac signals to shift from the isoelectric line. Signals that come from the patient’s body and the recording environment can produce noise that masks fine cardiac signal. And artifacts can intrude on those signals from a patient’s body movements, equipment, bad electrode connections to the skin or cardiac tissue, recording environment and other sources.
“Our invention is showing them information that they’ve not been able to see before,” BioSig CEO and co-founder Kenneth Londoner said in an interview. “We have the ability to see tiny little signals. We reduce the noise in our system to one microvolt.”
BioSig was founded in 2009 and went public in over-the-counter trading in 2014. It has raised nearly $26 million to date and is working on meeting the requirements to join NASDAQ. Londoner said he replaced Gregg Cash as CEO in June when Cash’s contract ran out. He declined to elaborate.
BioSig expects to file with FDA for 510(k) clearance by the end of 2017 and anticipates having that clearance in the first half of 2018, Londoner said, which would open the door to human trials. Bioelectrical researchers at Mayo Clinic began preclinical testing Pure EP in 2015.
A paper published in April in The Journal of Innovations in Cardiac Rhythm Management, describes the results of experiments comparing PURE EP with conventional EP signal processing equipment in dogs. BioSig also plans to conduct a pre-clinical VT study at the Cardiac Arrhythmia Center at the UCLA, end-user preference studies and research studies, according to a SEC filing.
BioSig is up against some medtech heavy hitters in its quest to treat Afib. In December 2016, FDA approved St. Jude Medical’s EnSite Precision cardiac mapping system and the Advisor FL Circular Mapping Catheter, Sensor Enabled. EnSite Precision is based on St. Jude’s EnSite Velocity cardiac mapping system, which is used in more than 2,000 electrophysiology labs around the world, according to St. Jude, now part of Abbott.
Abbott has integrated the EnSite system into its TactiCath contact force ablation catheter. Abbott also inherited St. Jude’s sensor-enabled FlexAbility ablation catheter in the $25 billion acquisition.
In March, BioSig signed a 10-year licensing agreement with Mayo Clinic Ventures, the nonprofit’s commercialization arm. The company has contracted with medtech design and manufacturing firm Minnetronix, to produce the PURE EP system for sale.
“It’s been going extremely well, very exciting stuff,” Londoner said. “The founders have been at this for nine-and-a-half years and we feel like we’re just getting started.