READY FOR COMMERCIALIZATION
Back in 2016 when we last talked with Kenneth L. Londoner, Chairman and CEO, BioSig Technologies, Inc., the proprietary tech company was starting to prepare to enter the electrophysiology (EP) marketplace with its first product, PURE EP™ System, an electrocardiogram and intracardiac multichannel signal acquisition and analysis system designed to help electrophysiologists make clinical decisions in real time.
BioSig was also laying the groundwork for FDA approval of PURE EP™ and had just opened an office in Minneapolis, which only added to the company’s challenges. Mr. Londoner explains how BioSig handled these challenges and is readying for the future.
Where are you currently in the commercialization process for PURE EP™?
We received FDA 510(k) clearance for PURE EP in August 2018 and that September we were listed on the NASDAQ stock exchange. In the third and fourth quarter of 2018, we started hiring industry-related professionals from Biosense Webster, Medtronic, Abbott, and Stryker to form the nucleus of our commercial team. We haven’t had trouble recruiting, which is encouraging.
BioSig has a number of locations. Where is the company headquartered?
We’ve been moving around. We started in Los Angeles, because our technology came from engineers at UCLA. We’ve grown our footprint there; that’s where all of our R&D, product development, project management and regulatory people are based. Our headquarters is in Westport, Conn. We did have a presence in Minneapolis for about three years and, based on the company’s needs, we decided to become bicoastal. But we are close to opening a clinical office in Rochester, Minn., which is where the Mayo Clinic is located.
One of the things we considered in changing our corporate headquarters from Los Angeles to Connecticut is that approximately 40 percent of the hospitals we’ll be selling to are on the East Coast.
What’s next for PURE EP™?
In the third and the fourth quarter, we’re going to the top hospitals in our field and they’ll be using our system in an evaluation phase for three months. Then we’ll be in a limited market release during which we’ll be looking for proof points in the market and testing our marketing materials. Over the next three to five years, our goal is to be in as many medical centers as we can in the United States, and then roll out to Europe and Japan.