BioTuesdays

BioSig reports successful first-in-human use of PURE EP system

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BioSig Technologies (NASDAQ:BSGM) reported that it successfully conducted first patient cases using its PURE EP system at the Texas Cardiac Arrhythmia Institute in Austin, Tex.

PURE EP is an FDA-approved cardiac signal acquisition and display system that is designed to assist electrophysiologists during procedures to diagnose and treat patients with abnormal heart rates and rhythms.

“With the use of the PURE EP system, I was able to identify cardiac signals, which were previously undetectable to me,” Dr. Andrea Natale, executive medical director of the Texas institute, said in a statement.

“I believe that the PURE EP system could change diagnostic and treatment strategies of arrhythmias, leading to more successful outcomes,” he added.

The goal of the first commercial use of the technology is validating the system’s value proposition and reporting on the overall user experience during the procedure.

Kenneth Londoner, chairman and CEO of BioSig, said a “positive first-in-human experience is a major inflection point for our company and lays a strong foundation for our early commercialization efforts. We are well positioned to deliver on our strategic goals for 2019 and look forward to the expansion of our evaluation efforts in the coming months.”