PORTLAND, Ore., June 17, 2021 /PRNewswire/ — VisCardia Inc., a privately held medical device developer, announced today it has been selected to participate in MedTech Innovator’s Annual Showcase and Accelerator Program. The selection process reduced 1,100 applicants from over 50 countries to 195 candidate companies that presented their technology to teams of senior industry leaders. From these 195 presentations, 50 companies (25 early-stage and 25 mid-stage) were selected to compete in the MedTech Conference powered by the Advanced Medical Technology Association (AdvaMed) in September.
VisCardia’s advancement is based on its VisONE SDS® technology, which is an innovative approach to the treatment of advanced chronic heart failure. VisONE SDS has completed a European First-in-Human study with very encouraging results which led to the granting of Breakthrough Device Designation by the U.S. FDA. The therapy utilizes a diaphragmatic stimulator to modulate the pressure in the chest cavity and make it easier for a weakened heart to fill and pump. The European study demonstrated that patients’ hearts improved in performance, patients improved their exercise tolerance and the patients felt better (improved Quality of Life) over a one-year trial.
Gregg Harris, VP of Clinical & Regulatory Affairs, stated, “Through the Breakthrough Device program, we have begun a collaborative relationship with the FDA to start clinical studies in the U.S. with the goal to make our technology available to U.S. patients in the most timely manner possible.” VisCardia plans to begin the study in early 2022 after the recruitment of top medical centers in the country. The Scientific Advisory Board is comprised of leading cardiologists from three of the top 40 hospitals for heart failure as ranked by U.S. News & World Reports for 2020-2021.
Peter Bauer, Ph.D., CEO of VisCardia, said, “We are proud to see our presentations at international meetings, such as MedTech Conference powered by AdvaMed (Sept. 27-29, 2021) and the Heart Failure Society of America (Sept. 10-13, 2021), gain recognition and attention of both the scientific communities as well as industry leaders. We believe our technology has an important role in the treatment of heart failure.”
About VisONE® SDS® Therapy
The VisONE implantable system delivers VisCardia’s proprietary Synchronized Diaphragmatic Stimulation (SDS) therapy for improving cardiac function in heart failure patients. By electrically stimulating the diaphragm in an imperceptible manner, transient intrathoracic pressures synchronized to cardiac activity are modulated, improving both cardiac filling and output. The therapy is non-invasively adjusted and programmed using an external programmer to improve hemodynamic benefit and optimize stimulation parameters.
SOURCE VisCardia Inc.