BioSig Deepens Ties With Mayo, Strikes Deal For Future Innovations

Heart signal-processing firm teams with clinic on a 10-year collaboration.

For the second time in two years, Twin Cities-based medical device startup BioSig Technologies has forged closer ties with a renowned Mayo Clinic team of electrophysiologists as well as with the clinic’s venture capital and licensing arm.

BioSig (OTCQB: BSGM), led by medtech startup veteran Gregory Cash, announced a year ago it had expanded its funding for a research program with Dr. Samuel Asirvatham of the Mayo Clinic after a set of initial pre-clinical studies of BioSig’s PURE EP electrophysiology tech platform carried out in 2015 proved encouraging.

This month, the company revealed it doubled down on that relationship, announcing it signed a 10-year collaboration with the Rochester institution and its licensing arm, Mayo Clinic Ventures. It says the new, expanded relationship builds on the work done through the March 2016 collaboration.

In an issued statement, BioSig said intends to work closely with Asirvatham and colleague K. L. Venkatachalam of Mayo’s Jacksonville, Florida campus, to further develop “advanced clinical features and applications” for its PURE EP System, which is aimed at improving the efficiency and safety of catheter ablation, an increasingly common invasive procedure to treat stubborn cases of complex heart arrhythmias.

Another feature of the expanded relationship is to come up with new kinds of know-how in the area of BioSig’s core competency—physiologic signal processing. As part of that deal, Mayo Clinic Ventures is “expected to contribute intellectual property and clinical support” to the partnership. The company and the clinic will jointly patent any new tech coming out of the relationship.

“Our experience working with Drs. Asirvatham and Venkatachalam has been outstanding and has resulted in three peer reviewed publications to-date,” Cash said. “Adding innovation and intellectual property to the equation should raise this collaboration to a whole new level, likely resulting in better diagnosis and treatment of complex arrhythmias in many patients.”

BioSig is aiming for 510(k) marketing clearance from the FDA by this year, followed by marketing and commercialization of the PURE EP System.

In its partnership with Asirvatham, it tapped into a level of credibility that could spark further investor interest in the eight-year-old, pre-revenue firm.  As one of the country’s top practitioners of catheter ablation therapy to treat complex heart arrhythmias, he is in a prime position to test the system, which it claims is capable of filtering out electromagnetic interference in the EP lab, thus producing much clearer real-time electrocardiogram signals needed for surgeons to accurately identify and target defective heart tissue for ablation procedures.

In addition to his roles as a professor in Mayo’s departments of internal medicine and pediatrics, Asirvatham is the program director of its Clinical Cardiac Electrophysiology Fellowship (electrophysiology is the study of the electric activity of the heart) and director of strategic collaboration for its Center for Innovation.

BioSig’s medical device play is aimed at improving the efficiency and safety of catheter ablation, an increasingly common invasive procedure to treat stubborn cases of complex heart arrhythmias, a condition in which the misfiring of electric signals through the heart can cause the upper chambers to beat abnormally fast or irregularly. If noninvasive methods such as drugs prove ineffective, doctors can opt for a catheter ablation therapy. In the procedure, cardiologists use radiofrequency waves to burn defective areas of tissues on the heart that are causing its electrical system to misfire.

But in order to be efficient and get it right on the first try, they need clean, detailed records of the heart delivered through an electrophysiology study (or EPS), which are obtained by sending specialized catheters through an incision in the thigh and into the heart, where they record tremendous amounts of information about the heart as it is induced to beat at different speeds.

A major problem in EPS, however, is that the signals are frequently marred by electromagnetic interference from all the different kinds of equipment in a typical EP lab. Because cardiologists can’t get clear enough images, they sometimes have trouble deciphering exactly where the trouble spots are in the heart, necessitating repeat ablations in order to completely cure patients from the most common forms of arrhythmia—atrial fibrillation and ventricular tachycardia.

BioSig says its technology—which can be added onto existing EP equipment—uses proprietary hardware, software and algorithms to make sure the original cardiac data is not distorted by interference. It’s also developing a library of software tools that can be configured to fit different arrhythmia treatments. The PURE EP System, the company asserts, will increase the workload ability and enhance the capabilities of the typical EP lab.

Electrophysiology, meanwhile, is growing market.  A steady stream of positive clinical data has been convincing clinicians that ablation is more effective in combatting atrial fibrillation compared to the traditional drug treatment. As a result, ablation is becoming the fastest growing procedure type in the EP market, increasing at an average annual rate of 16 percent from 2012 to 2016.