BioSig recently completed first-in-human studies at the Rochester, Minn.-based clinic aimed at validating the safety and efficacy of its Pure EP system during mapping and ablation procedures in a cardiac EP lab. Patient studies were also conducted at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center and at Greenville Memorial in North Carolina, according to the Wayzata, Minn.-based company. Previously, BioSig conducted preclinical studies at Mayo.
Pure EP uses electricity to identify unhealthy cells that cause life-threatening heart arrhythmias., according to the company, which worked with Minnetronix Medical on technology development. The device received FDA 510(k) clearance in August 2018 and the company began trading on NASDAQ the following month. BioSig signed a 10-year collaboration agreement with Mayo Clinic in March 2017.
Earlier this month, the Mayo Foundation for Medical Education and Research bought 252,000 shares of BioSig common stock at $3.75 per share or $945,000, according to the company.
“Mayo Clinic has collaboration with hundreds of medtech, biotech and life-sciences companies, and BioSig is one of them,” a clinic spokeswoman wrote in an email to Medical Design & Outsourcing. “While we acknowledge financial interest in BioSig, we do not disclose the specificities of our investment or financial arrangements with a company.”