- CardiAMP cell therapy-treated patients had 37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and 9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) at mean 20-month follow-up compared to control patients on guideline-directed heart medications alone
- Large sub-set of treated patients with elevated NTproBNP – a marker of heart distress – showed greater reductions, with 86% relative risk reduction in heart death equivalents and 24% relative risk reduction in non-fatal MACCE
- FDA-approved follow-on Phase III trial of high-responding patient population with elevated NTproBNP (CardiAMP HF II) has launched to validate positive interim results
Over a mean 20 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial dose of autologous CardiAMP cell therapy while on maximal medical therapy had a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in non-fatal incidence of heart attacks, strokes, and hospitalization due to heart failure (MACCE). Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (8.3% vs. 13.2%, respectively). CardiAMP cell therapy was also associated with trends toward reduced ventricular tachyarrhythmias, enhanced heart function as measured by left ventricular ejection fraction, and improved NTproBNP.
In a subgroup analysis of patients with elevated NTproBNP at baseline – encompassing 59% of total enrolled randomized patients – patients treated with CardiAMP cell therapy experienced an 86.2% relative risk reduction in heart death equivalents and a 23.9% relative risk reduction in MACCE. These patients saw more than a 17% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (2.9% vs. 21.1%, respectively).
“These positive results for CardiAMP cell therapy are very encouraging, especially for patients with elevated NTproBNP, who encompass the majority of heart failure patients that we see in our daily practice,” said trial co-principal investigator
“We thank the FDA for its speedy review and approval of the important follow-on Phase III trial. We are encouraged by the totality of today’s results and anticipate that both the final 24-month data analysis and follow-on trial outcomes would be consistent with this highly positive data,” said
Also at the THT scientific meeting, first enrollment for the dose escalation safety phase of BioCardia’s Phase I/II study of the CardiALLO™ allogeneic mesenchymal stem cell (MSC) therapy in heart failure patients was reported. The cohort receiving the lowest dose of 20 million cells has been initiated with no treatment-emergent adverse events, arrhythmias, rejection, or allergic response. The first author of the study is
About BioCardia’s CardiAMP Autologous Cell Therapy Program*
Designated by the FDA as a Breakthrough Therapy, CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP HF trial is supported by the
About BioCardia’s CardiALLO Allogeneic Cell Therapy Program*
CardiALLO allogeneic cell therapy provides an “off the shelf” mesenchymal stem cell therapy typically derived from younger donors. These cells are immunomodulatory, with the potential to impact inflammatory processes in heart failure and have been shown to release multiple critical angiogenic factors that can enhance microvascular function and capillary networks in ischemic tissue. CardiALLO therapy for heart failure uses BioCardia’s new MSC manufacturing process, which builds on the experience of three completed co-sponsored MSC clinical trials encompassing 84 treated patients in the same indication with the same delivery platform.
*CardiAMP and CardiALLO therapies are considered investigational and limited by
About
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, whether the final 24-month analysis and follow-on trial outcomes would be consistent with the interim results presented here as expected, whether CardiAMP HF II receives CMS reimbursement as expected, whether CardiAMP HF II validates the results of the interim data from CardiAMP HF, and statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, and overall market conditions. These forward-looking statements are made as of the date of this press release, and
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the
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