BCDAW BioCardia Inc

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.

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, Ph.D. “We are also delighted to announce the experienced and distinguished executive steering committee for the trial, which includes Dr. Timothy Henry of The Christ Hospital, Dr. Carl Pepine of the University of Florida, Dr. Amish Raval of the University of Wisconsin, and Dr. Bernard Gersh of the Mayo Graduate School of Medicine.”

“Based on our  experience with 75 patients randomized in the CardiAMP Heart Failure trial, the effective CD34+ cell dosage in the CardiAMP Chronic Myocardial Ischemia trial is likely to be greater than the effective CD34+ dosage advanced in previously published trials for selected CD34+ cells which demonstrated compelling clinical results,” said BioCardia Chief Medical Officer Eric Duckers, M.D. 3 “This is possible with patient selection, efficient delivery, and point of care cell processing, which are the pillars of the CardiAMP therapy.”  

For additional information, please visit www.clinicaltrials.gov. About BioCardia®: BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP autologous and NK1R+ allogenic cell therapies are the Company’s biotherapeutic platforms in clinical development.  The Company's products include the Helix biotherapeutic delivery system and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information, visit www.BioCardia.com.

Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include references to future enrollment and cell dosage in this second pivotal clinical trial and statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and obtaining regulatory approvals.  These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

1. K Cheng et al,  Management of Refractory Angina Pectoris, Eur.Cardiol 2016.
2. Povsic TJ, et. al.  JACC Cardiovascular Interventions, 2016.
3. Henry DT, et al. European Heart Journal, 2018.

INVESTOR CONTACT: David McClung, Chief Financial Officerinvestors@BioCardia.com, (650) 226-0120

MEDIA CONTACT:Michelle McAdam, Chronic Communications, Inc.michelle@chronic-comm.com, (310) 902-1274