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BioSig Strengthens Relationship With Top Heart Doctor

The med-tech startup is testing a new platform for treating complex heart arrhythmia.

A Twin Cities-based medical device start-up hoping to enhance the ability of cardiologists to treat complex heart arrhythmias has deepened its research relationship with one of the nation’s top electrophysiologists – Dr. Samuel Asirvatham of the Mayo Clinic.

BioSig Technologies Inc. (OTCQB: BSGM), led by medtech start-up veteran Gregory Cash, announced it has tripled its funding for a research program with Asirvatham after a set of initial pre-clinical studies of BioSig’s PURE EP electrophysiology tech platform carried out last year proved encouraging.

In its partnership with Asirvatham, BioSig tapped into a level of credibility that could spark further investor interest in the seven-year-old, pre-revenue firm, which has spent $1.79 million on research activities since 2014. It is aiming for 510(k) marketing clearance from the FDA by the first half of 2017, followed by marketing and commercialization of the PURE EP System.

As one of the country’s top practitioners of catheter ablation therapy to treat complex heart arrhythmias, BioSig says Asirvatham 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.

The India-born doctor has also gained a certain level of visibility as a medical consultant for ABC News on the subject of heart health and arrhythmia.

“We are extremely pleased to continue our relationship with Dr. Asirvatham and his colleagues at the Mayo Clinic,” Cash said in a statement.  “The previous studies confirmed the potential of PURE EP to improve the clarity of cardiac signals while minimizing electrical noise in the cardiac electrophysiology laboratory.”

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.
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