BioCardia Announces Successful Interim Safety Analysis In Its Phase III Clinical Trial Of Cardiamp Stem Cell Therapy For Heart Failure

SAN CARLOS, Calif.--(BUSINESS WIRE)--BioCardia (OTC: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed the pre-specified interim analysis of safety outcomes for the first 10 patients treated in the Phase 3 trial of its investigational CardiAMP cell therapy product. The DSMB indicated there were no significant safety concerns with the CardiAMP study results and recommended that the trial continue, as planned.

Amish Raval, MD, associate professor of cardiovascular medicine for the University of Wisconsin School of Medicine and Public Health, and co-national principal investigator for the ongoing CardiAMP Heart Failure Trial, stated, “The CardiAMP cell therapy program has hit another very important milestone. This minimally invasive, point of care approach has the potential to revolutionize the treatment of ischemic heart failure. We are now recruiting for the randomized, controlled pivotal trial, which is designed to test the hypothesis that transendocardial delivery of autologous bone marrow mononuclear cells to patients, who are pre-selected with high bone marrow potency markers, will improve Six Minute Walk distance and other clinically relevant endpoints.”

“This is a major achievement for BioCardia and our personalized CardiAMP cell therapy program,” said BioCardia CEO Peter Altman. “We are focused on addressing the growing problem of heart failure, which affects almost six million adults in the U.S.¹ and costs the healthcare system more than $30 billion each year.²”

This ongoing multi-center, double-blinded, randomized (3:2), sham-controlled Phase 3 trial is expected to enroll 260 patients at up to 40 centers nationwide. The trial is evaluating CardiAMP cell therapy in adult patients with heart failure that develops following a heart attack. The primary efficacy endpoint is a significant improvement in Six Minute Walk distance at 12 months’ post-treatment. It also incorporates the impact of major adverse cardiac events and other clinically meaningful events. Study subjects must be diagnosed with New York Heart Association (NYHA) Class II or III heart failure as a result of a previous heart attack. The national co-principal investigators are Dr. Raval and Carl Pepine, MD, of the University of Florida, Gainesville.

The company anticipates filing an investigational device exemption (IDE) supplement to add an interim efficacy readout in the fourth quarter of 2018 and expects top line data in the fourth quarter of 2019.

About the CardiAMP Therapy Program
The investigational CardiAMP therapy is designed to stimulate the body’s natural healing response. It takes a personalized and minimally-invasive approach to the use of a patient’s own bone marrow stem cells for treating heart failure resulting from a heart attack by screening for patients with bone marrow characteristics that may result in a higher likelihood of benefiting from the therapy. These patients then receive a high target dose of 200 million mononuclear cells directly to injured cardiac tissue using a proprietary delivery system.

Earlier CardiAMP studies – including the Phase II TAC-HFT-BMC trial – have shown a positive safety profile, with statistically significant improvements in patient quality of life^3,4 and functional capacity.⁴ Delivery of stem cell therapy to the heart using the Helix™ transendocardial delivery system, which is used in CardiAMP therapy, has been shown to result in superior cell delivery than either percutaneous intra-coronary infusion or direct injection in an open chest procedure.⁵

Patients interested in learning about the study can visit www.cardiamp.com or www.clinicaltrials.gov for more information.

About BioCardia®
BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP® and CardiALLO® cell therapies are the company’s biotherapeutic product candidates in clinical development. 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 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, 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 BioCardia assumes no obligation to update the forward-looking statements.

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, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation 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 Securities and Exchange Commission on March 30, 2017, including under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

1. Mozzafarian D, Benjamin EJ, GoAS, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics – 2016 update: a report from the American Heart Association. Circulation. 2016;133:e38-e360.
2. Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011;123(8):933-44.
3. Heldman AW, DiFede DL, Fishman JE, Zambrano JP, Trachtenberg BH, Karantalis V, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014;311(1):62-73.
4. Wong PFC. TAC-HFT BMC Phase II Data. October 23, 2015. Poster presented at World Congress of Regenerative Medicine.
5. Mitsutake Y, Pyun WB, Rouy D, Foo CWP, Stertzer SH, Altman P, Ikeno F. Improvement of local cell delivery using Helix transendocardial delivery catheter in a porcine heart. Int Heart J. 2017;58:1-6.