BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy for treating chronic myocardial ischemia and refractory angina as it seeks a second indication.
The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate the body’s natural healing response.
“This therapeutic approach of focused implantation of the right combination of bone marrow-derived cells delivered intramyocardially for the treatment of refractory angina is supported by significant existing data. CardiAMP has pre-procedure selection criteria for patients that enhances the probability that patients receive the same effective dose of CD34+ cells that has shown efficacy in other large, recent trials,” chief medical officer Dr. Eric Duckers said in a prepared statement.
BioCardia said it is pursuing the indiciation after having already received FDA approvla for a Phase III trial of the CardiAMP in treating ischemic heart failure, which has already begun to enroll patients.
“The CardiAMP Chronic Myocardial Ischemia Trial is expected to benefit greatly from the experience and capabilities BioCardia has established in the CardiAMP Heart Failure Trial. Should the FDA approve the IDE and CMS grant a category B designation, as they have for the CardiAMP Heart Failure Trial, we anticipate that the first patients could be enrolled in the second half of 2018,” BioCardia CEO Peter Altman said in a press release.