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BioCardia Announces Activation of Pivotal Trial Studying CardiAMP Cell Therapy Trial to Treat Chronic Myocardial Ischemia
First Site Initiation Visit in Trial Completed and Executive Steering Committee Named SAN CARLOS, Calif., July 01, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc.
About this update from Biocardia, Inc.
[{"type":"text","content":"First Site Initiation Visit in Trial Completed and Executive Steering Committee Named\nSAN CARLOS, Calif., July 01, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced activation of a pivotal trial studying the Company’s investigational CardiAMP® cell therapy in the treatment of chronic myocardial ischemia (CMI), as well as completion of the first site initiation visit in the trial.\n The CardiAMP CMI Trial is studying CardiAMP cell therapy, an autologous cell therapy formulation designed to stimulate the body’s natural healing response for the treatment of refractory angina, estimated to impact between 600,000 and 1,800,000 patients in the United States.1 It has been reported that these patients suffer from poor perceived health status and psychological distress, have significant impairments in quality of life, and represent a burden to the health care system due to significant resource use.2 The study has been approved by the FDA to enroll up to 343 patients at up to 40 centers. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy in the treatment of patients with refractory angina pectoris and CMI. The FDA has said that the trial qualifies as a pivotal trial to produce the primary data to support market registration for the CardiAMP cell therapy for this significant unmet clinical need. The Center for Medicare and Medicaid Services (CMS) will reimburse investigational sites for patient screening, patient treatment, the investigational cell therapy product, and standard of care follow-up visits at a level similar to that being provided for the ongoing pivotal CardiAMP Heart Failure Trial. The first site initiation visit took place last week at the University of Florida at Gainesville, under the leadership of R. David Anderson, MD. Patient recruitment is expected to begin shortly. “We are pleased to be activating a second pivotal trial for the CardiAMP cell therapy and expanding our relationship with the clinical research team at the University of Florida under the guidance of Dr. Anderson, who is also the site principal investigator of the ongoing CardiAMP Heart Failure Trial and a world class interventional cardiologist,” said BioCardia Chief Executive Officer Peter Altman...