FDA Nod for CardiAmp Cell Therapy IDE Trial in Chronic Myocardial Ischemia

The U.S. FDA has approved an Investigational Device Exemption for the CardiAMP Chronic Myocardial Ischemia (CMI) Trial to treat patients with refractory angina (RA).

Background

BioCardia® Inc., CardiAMP investigational cell therapy takes a personalized and minimally-invasive approach to the use of a patient’s own cells (autologous cells) in the treatment of cardiovascular disease. The investigational therapy is designed to stimulate the body’s natural healing response.

A leader in the development of comprehensive solutions for cardiovascular regenerative therapies, BioCardia says it has a green light from the FDA for its IDE study. The CardiAMP Chronic Myocardial Ischemia Trial will be a prospective, multi-center, randomized, sham-controlled, patient- and evaluator-blinded pivotal trial to validate the safety and efficacy of CardiAMP investigational cell therapy in the treatment of patients having CMI with RA.

The trial has been approved to enroll up to 343 subjects at up to 40 U.S. centers. This trial has the potential to support functional benefit claims sufficient for product registration without a second confirmatory trial.

This second clinical indication of CMI with RA for the CardiAMP investigational cell therapy follows the company’s FDA-approved pivotal clinical trial of CardiAMP cell therapy in ischemic heart failure­, which we covered on our pages. That trial is still currently enrolling patients.

Company comments

“FDA approval of the CardiAMP CMI Trial is another important milestone for the company,” said BioCardia CEO Peter Altman. “It is a step towards developing a new treatment strategy that could have tremendous benefit for patients with refractory angina. Approval of this second pivotal trial further demonstrates BioCardia’s leadership in the treatment of heart disease.”

Source: BioCardia®, Inc.

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