Helical Infusion System to treat Heart Failure
San Carlos, CA - March 14, 2012
BioCardia, a leading provider of cardiovascular catheter systems designed to deliver biologic therapies for cardiac regeneration and Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, announced today that they will continue to work together to execute Juventas’ Phase II trial of JVS-100 for the treatment of heart failure.
The Phase II safety and efficacy study has been allowed by the Food and Drug Administration and enrollment is targeted to start in Q2 2012. The previous Phase I trial enrolled 17 NYHA Class III heart failure patients and showed promising safety and signals of clinical benefit to the patients treated.
"JVS-100 provides the potential for an off the shelf regenerative medicine therapeutic, with the potential to significantly enhance patients lives,” states Peter Altman, Ph.D: “We are pleased to have the opportunity to continue to work with the Juventas team.”
“ Helical catheter performed well in our Phase I clinical trial and is an attractive delivery system for our targeted patient population”, states Rahul Aras, Juventas’s President and CEO. “It is a catheter system that is simple to use with a proven safety profile and we are excited to be working with it in our upcoming Phase II trial.