The first site initiation visit took place last week at the University of Florida at Gainesville, under the leadership of R. David Anderson, MD. The tiers, starting with the most serious events, would be (1) all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), excluding those deemed procedure-related occurring within the first seven days post-procedure (heart failure hospitalization, stroke or myocardial infarction), ordered by time to event, and (3) change from baseline in Six Minute Walk Distance at 12 months.
Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. 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. 333-236404) previously filed with the Securities and Exchange Commission (“SEC”) and declared effective on June 16, 2020. BioCardia CEO Peter Altman, PhD, said, “The only major modification to our previous endpoint is that patients who experience a MACCE event and recover will not be factored into the benefit seen in the third-tier measure of Six Minute Walk Distance at one-year follow-up. 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. By introducing patient screening and highly-efficient delivery to stem cell therapy, the company seeks to increase the likelihood of treatment success, enabling more patients to return to the things they love.BioCardia Announces Activation of Pivotal Trial Studying CardiAMP Cell Therapy Trial to Treat Chronic Myocardial IschemiaBioCardia Announces CardiAMP Heart Failure Pivotal Trial Continues with First Patient Randomized in COVID-19 EraBioCardia Announces Pricing of $10.0 Million Public OfferingBioCardia Reports First Quarter 2020 Financial Results and Business HighlightsBioCardia Announces Positive Preclinical Results Supporting Investigational New Drug Application for Anti-Inflammatory Cell Therapy in Heart FailureBioCardia Announces FDA-Recommended Modifications to Primary Endpoint for CardiAMP Cell Therapy Heart Failure Trial to Support Marketing Approval
Ongoing trial assessing novel assay to determine response to cardiac regenerative therapyInvestigational Therapy Exploring Treatment of Heart Failure Seeks to Stimulate Body’s Natural Healing ResponseBiocardia wins IDE for cell therapy as treatment for anginaBiocardia presses on with Cardiamp pivotal trial to treat patients with heart failureBioCardia® Helix Results in Higher Stem Cell Retention in MyocardiumUW Health trial involves injecting stem cells into patients with heart failure © 2007-2018 BIOCARDIA, INC. | 125 SHOREWAY ROAD, SUITE B, SAN CARLOS, CA 94070 | (800) 624-1179 | (650) 226-0120CAUTION. This press release contains forward-looking statements that are subject to many risks and uncertainties. BioCardia’s Phase III trial aims to enrol up to 260 patients across 24 trial locations in the US and is the first multicenter clinical trial of autologous cell therapy to pre-assess the validity of cell potency in order to ensure the patients selected for treatment are … Forward-looking statements include references to progress in enrollment in our ongoing pivotal clinical trial, the efficacy of our products and therapies, and statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. K Cheng et al, Management of Refractory Angina Pectoris, Eur.Cardiol 2016. The primary endpoint going forward will be an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis, an established outcomes design that has been used in other leading heart failure programs. CardiAMP Therapy, CardiALLO Therapy, and Helix device are investigational. BioCardia (NSDQ:BCDA) said ... and expect it to favorably impact revenues in the second half of 2019,” BioCardia CEO Peter Altman said in a press release. Published: April 14, 2020 at 9:08 a.m. 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. 3. For additional resources and to learn more about the CardiAMP Heart Failure Trial, visit This press release contains forward-looking statements that are subject to many risks and uncertainties. BioCardia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. The national co-principal investigators are Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville.