BioCardia Announces Positive DSMB Recommendation to Continue Phase III Pivotal CardiAMP Heart Failure Study, As Planned
March 31, 2020
Company to Host Conference Call with National Co-Principal Investigators Today at 4:15 p.m. ET to Provide Study Updates
SAN CARLOS, Calif. – BioCardia (Nasdaq: 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 its prespecified data review for the Phase III pivotal CardiAMP™ Heart Failure Trial, based on a review of all available safety data for all patients randomized in the trial. The DSMB indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. To date, 74 patients have been enrolled in the trial.
The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide. The trial’s primary efficacy endpoint is a composite of death, major adverse cardiovascular and cerebrovascular events (MACCE), and six minute walk distance (a measure of a patient’s exercise capacity) at 12 months’ follow-up. Secondary efficacy endpoints include quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire, and superiority relative to MACCE and survival.
The national principal investigators are Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville.
BioCardia will host a conference call/webcast today at 4:15 p.m. ET featuring the principal investigators to provide updates on the CardiAMP Heart Failure Trial. To participate in the conference call, dial 1-877-270-2148. To access the live webcast of the call, please visit: www.biocardia.com/investors/events-presentations/id/1036. A replay of the webcast will be available for a limited time on the BioCardia website following the presentation
“We are pleased with the progress on the CardiAMP Heart Failure Trial that has led to a positive recommendation from the DSMB to continue the study. We are currently assessing the impact of COVID-19 on patient recruitment for the trial, as trial sites focus on patient care and delay elective procedures, in accordance with guidance from the Centers for Medicaid Services, as well as trial-related patient follow-up visits. We have seen an increase in informed patient consents to participate in the study, which is an indication that enrollment in the study will continue to accelerate after the COVID-19 situation resolves. We look forward to continuing to work closely with our clinical partners to build the high-quality evidence that will support CardiAMP Cell Therapy as an important option for heart failure patients in need,” said BioCardia Chief Medical Officer Eric Duckers, MD.
The next prespecified DSMB review is anticipated in the last quarter of 2020.
About the CardiAMP Therapy Program
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. The CardiAMP Heart Failure Trial is the first multicenter clinical trial of a stem cell therapy to prospectively screen for stem cell therapeutic potency in order to improve patient outcomes.
BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP™ and CardiALLO™ cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company's current products include the Helix™ Biotherapeutic Delivery System and the Morph® steerable guide and sheath catheter portfolio, including the new AVANCE™ Steerable Introducer family. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
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-Q filed with the Securities and Exchange Commission on November 19, 2019, 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.
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