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Positive results from Phase 1/2 stem cell trial reported

San Carlos, CA; November 6, 2012 BioCardia, Inc., focused on regenerative biologic therapies for cardiovascular disease, today announced positive results from a Phase 1/2 heart failure trial using the Company's Helical Infusion System, comprising the Helical Infusion System Catheter and Morph Vascular Access Catheter, to deliver allogeneic, or "off-the-shelf," and autologous, or from the treated patient, mesenchymal (adult) stem cells (MSCs) via transendocardial injection. According to the results, both the allogeneic and autologous MSCs were safe and well-tolerated at all doses and demonstrated similarly positive effects on cardiac structure and function, patient functional capacity and quality of life. Results from the POSEIDON (Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis) study were reported in a late breaker presentation titled, "Randomized Comparison of Allogeneic vs Autologous Mesenchymal Stem Cells in Patients with Ischemic Cardiomyopathy," at the American Heart Association's 2012 Scientific Sessions and have been published in an article in the November 6 edition of the Journal of the American Medical Association. The POSEIDON study was cosponsored by the NIH Specialized Center for Cell Therapy, the University of Miami, and BioCardia.

Joshua Hare, M.D., Director of the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine, and the POSEIDON study lead principal investigator, stated, "The combination of Allogenic MSCs with the BioCardia Helix catheter has enormous potential as a combination product for treating heart failure. The strong safety results and ease of the catheter delivery procedure in skilled hands, coupled with the potential for the use of allogeneic stem cells, suggest that this procedure may one day be as easy to perform as coronary angioplasty."

Peter Altman, Ph.D., President and CEO of BioCardia, commented, "The Helical Infusion System is intended to be the safest and easiest to use catheter for multiple clinical applications in cell- and gene-based therapy. We believe its performance and our track record of experience are second to none, and we are very optimistic about the delivery mesenchymal stem cells for the treatment of ischemic heart failure. Trial results such as POSEIDON require the talent and hard work of a dedicated team of experts, and we have been privileged to work with the clinical teams at the University of Miami and Johns Hopkins University."

Interventional cardiologist co-authors who performed the procedures in the study included Alan W. Heldman, M.D., and Juan Pablo Zambrano, M.D., at the University of Miami Miller School of Medicine, and Jeffrey A Brinker, M.D., and Peter VanDoren Johnston, M.D., at the Johns Hopkins University School of Medicine.

The Phase 1/2 POSEIDON study enrolled 31 patients with chronic ischemic left ventricular (LV) dysfunction due to ischemic cardiomyopathy (ICM). Patients were randomized to receive one of three different dose levels (20, 100, or 200 million cells) of either allogeneic MSCs or autologous MSCs. The stem cells were delivered to 10 LV sites in the myocardium by BioCardia's transendocardial stem cell injection (TESI) during retrograde left heart catheterization using BioCardia's Helical Infusion Catheter. The two catheter system fixates to the heart wall via a corkscrew needle, allowing for stable and controlled delivery of biologic therapies to the heart.

Following BioCardia's TESI, patients were hospitalized for a minimum of four days and were seen two weeks post-catheterization. Thereafter, safety and efficacy assessments using cardiac imaging studies, exercise peak VO2, a 6-minute walk test, New York Heart Association (NYHA) Class and the Minnesota Living with Heart Failure (MLHF) questionnaire were performed on a monthly basis for six months and then again at 12 months. After 13 months, all patients received follow-up CT scans of the heart, chest, abdomen and pelvis.

The primary objective of the study was to demonstrate the safety of allogeneic MSCs administered by BioCardia's TESI, determined by the incidence of any treatment-emergent serious adverse events (TE-SAEs) one month after stem cell injection. Data showed that within 30 days, one patient in each cohort was hospitalized for heart failure, a TE-SAE rate of 6.7%, substantially less than the pre-specified stopping rate of 25%. The secondary objectives were to compare the long-term safety of allogeneic MSCs to autologous MSCs and to demonstrate the efficacy of allogeneic MSCs and autologous MSCs administered by TESI in these patients. The one-year incidence of serious adverse events was not different between cell types, except for fewer ventricular arrhythmias in allogeneic recipients. Relative to baseline, allogeneic and autologous MSC therapy similarly improved the 6-minute walk and the MLHF questionnaire score, but not the exercise VO2 max. Finally, MSCs reduced infarct size (33.2%; P<0.0001), left ventricular (LV) volumes and sphericity index similarly in allogeneic and autologous groups. Importantly, allogeneic MSCs did not stimulate significant donor-specific alloimmune reactions.

A parallel Phase 1/2 study the Transendocardial Autologous Cells in Heart Failure Trial (TAC-HFT) also enabled by the BioCardia Helical Infusion System. The trial, co-sponsored by the University of Miami, is comparing autologous (bone marrow or mesenchymal) cell delivery to placebo in up to 68 cardiomyopathy patients randomized under a protocol similar to that of the POSEIDON trial. Early results in a first cohort of patients (N=8) were reported in 2011 to show that the autologous cells effected remodeling of LV shape and restoration of normal LV proportions.


Contact: Miranda Peto
BioCardia, Inc.

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