The new company will keep the BioCardia name and the development program for its CardiAMP cell therapy for heart failure patient’s who’ve had a heart attack. Stem cells derived from the bone marrow of patients likely to respond to the therapy, as indicated by testing for BioCardia’s biomarker, are delivered at a high dose using the Helix catheter.
The $23 million in cash left after the merger will be used for a Phase III trial for CardiAMP, for which BioCardia said it already has an investigational device exemption from the FDA. The Centers for Medicare & Medicaid also approved the IDE for reimbursement, the company said.
The 250-patient, sham-controlled trial’s primary efficacy endpoint is change in 6-minute walking distance at 12 months. Safety outcomes include overall survival, freedom from major adverse cardiac events, time to 1st MACE and death from heart failure at 1 year. Other safety outcomes include survival at 2 years, serious adverse events at 30 days, plus heart failure hospitalization, all-cause hospitalization, days alive out of hospital, freedom from serious adverse events and New York Heart Assn. functional class, all at 12 months, according to ClinicalTrials.gov.
“Our CardiAMP cell therapy is seeking to address an enormous unmet need – a treatment for heart failure that develops after a patient has had a heart attack. The merger will provide resources necessary to continue our Phase III development of CardiAMP,” BioCardia CEO Peter Altman said in prepared remarks.
BioCardia said data from the trial are slated for review by the FDA’s Center for Biologics Evaluation & Research using the pre-market approval protocol.
Tiger X Medical shares were up 3.8% at 14¢ apiece today in mid-morning trading.