BioSig Technologies (OTCQB: BSGM) said today that it inked a deal with Austin’s Texas Cardiac Arrhythmia Institute at St. David’s Medical Center to launch first-in-human studies using its Pure EP system.
The Santa Monica, Calif.-based company’s Pure EP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The device is intended to reduce noise and artifacts to produce high-fidelity cardiac signals, which the company claims could increase the diagnostic values of the signals.
BioSig Technologies said the first-in-human studies will be focused on validating “key value propositions” of the system and to reinforce results from pre-clinical studies that have already been released.
“To better understand complex arrhythmia disease states, the ability to detect the smallest of electrical activity in various clinical situations has been a critical need for our industry. I am looking forward to the possibility that the Pure EP System will uncover these signals and advance treatment options so physicians can make more informed decisions for our patients,” study lead Dr. Andrea Natale of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center said in a prepared statement.
The launch of the studies will act as the first step in BioSig’s targeted commercial launch of the Pure EP system, which won FDA 510(k) clearance in August, the company said.
“BioSig reached another important milestone after achieving FDA clearance in August 2018 and uplisting to Nasdaq in September 2018. We opened an office in Austin, Texas, earlier this year in anticipation of our present needs, and are now focused on providing TCAI full support during the first-in-human use of our technology, which will preface our commercial launch in the U.S. in May 2019. Dr. Natale inspired the founding of our company and has chaired our scientific advisory board since 2011. We are proud to be working with Dr. Natale and his team during this important stage of our company’s growth,” chair & CEO Kenneth Londoner said in a press release.
In September, BioSig Tech said that it uplisted onto the Nasdaq Capital Market.