SUNNYVALE, Calif., March 12, 2024 (Globe Newswire) — Biocardia Co., Ltd. [Nasdaq: BCDA]The company, a developer of cells and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced confirmation by the Centers for Medicare and Medicaid Services (CMS) of its CardiAMP autologous cell therapy for the treatment of cancer. Announced approval for reimbursement for Phase III clinical trials. Patients with ischemic heart failure.

CMS reviewed the CardiAMP Heart Failure II study and approved the investigational product, related items, and routine items and services for Medicare coverage. CMS previously issued new technology APC (Ambulatory Payment Classification) codes covering investigational procedures for CardiAMP cell therapy. This includes BioCardia investigational products utilized in the conduct of clinical trial procedures and allows clinical trial centers to receive reimbursement for clinical trial procedures and products.

The CardiAMP Heart Failure II trial has been approved by the FDA to enroll up to 250 patients at up to 40 clinical centers. This study includes an eligibility requirement that patients exhibit a prespecified NT-proBNP level at baseline. The primary endpoint was a hierarchical composite consisting of all-cause mortality, equivalent cardiac deaths from heart transplantation and left ventricular assist device (LVAD) implantation, heart failure hospitalization, worsening of outpatient-treated heart failure events, and quality change. It’s an evaluation. Follow-up period ranges from a minimum of 12 months to a maximum of 24 months.

CMS coverage approval is supported by the scientific rigor of the protocol design and interim data results from the CardiAMP Heart Failure Trial, which were recently presented at the Technology and Heart Failure Treatments 2024 Annual Meeting. Cardiac death equivalents and major cardiac and cerebrovascular events were reduced in all patients. In the subgroup of patients included in the CardiAMP Heart Failure II trial, results showed a significant reduction in the absolute and relative risk of equivalent cardiac death for patients in the treatment arm. Treated patients also had fewer major adverse cardiac events and significantly improved quality of life.

“We are pleased that CMS has provided coverage support for the confirmatory CardiAMP Heart Failure II study,” said Peter Altman, Ph.D., President and CEO of BioCardia. “To my knowledge, there is no proven treatment that reduces mortality in these patients. CardiAMP Heart Failure II has great potential to achieve this outcome by confirming the results of the CardiAMP Heart Failure trial. I am.”

About the CardiAMP Cell Therapy Program

Designated as a breakthrough therapy by the FDA, CardiAMP cell therapy uses a patient’s own bone marrow cells delivered to the heart through a minimally invasive catheter-based procedure and has the potential to stimulate the body’s natural healing response. there is. CardiAMP cell therapy incorporates three unique elements not previously utilized in investigational cardiac cell therapies. Preoperative cell analysis for patient selection, high targeted doses of cells, and a unique delivery system proven to be safer than other intramyocardial delivery systems. And it achieves dramatic success in cell retention. Her clinical development of CardiAMP for heart failure was supported by the Maryland Stem Cell Research Foundation and is reimbursed by his CMS for both treatment and management procedures.

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About Biocardia^®

BioCardia, Inc., headquartered in Sunnyvale, California, develops cells and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP autologous cell therapy and CardiALLO allogeneic cell therapy are the company’s biotherapeutic platforms for the treatment of heart disease. BioCardia works with partners to provide preclinical and clinical development services for biotherapeutic delivery to the heart, as well as proprietary biotherapeutic delivery systems.

Forward-looking statements:

This press release contains forward-looking statements that are subject to a number of risks and uncertainties. Forward-looking statements include, among other things, the completion of follow-up in the CardiAMP heart failure trial, the probability of success of the CardiAMP clinical trial, the ability to offset clinical costs using Medicare reimbursement, anticipated milestones and events, and our clinical The ultimate success of the therapy program. These forward-looking statements are made as of the date of this press release.

“believe”, “estimate”, “anticipate”, “expect”, “plan”, “intend”, “may”, “could”, “might”, “will” , and may use terms such as “should.” We identify these forward-looking statements by the use of “approximately” or other words that convey uncertainty as to future events or results. Although the Company believes that it has a reasonable basis for each forward-looking statement contained herein, forward-looking statements are not guarantees of future performance and the Company’s actual results may differ from this press release. Please note that forward-looking statements contained herein may differ materially. release. Factors that may cause or contribute to such differences include, but are not limited to, our liquidity position and ability to raise additional financing and our ability to successfully advance our clinical trials. yeah. Due to these factors, there can be no assurance that the forward-looking statements in this press release will prove to be accurate. Other factors that could materially affect actual results are described under the heading “Risk Factors” in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023; as set forth in subsequently filed Quarterly Reports on Form 10-Q. . BioCardia expressly disclaims any intention or obligation to update these forward-looking statements, except as required by law.

Media contact:
Miranda Peto, Marketing/Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor contact information:
David McClung, Chief Financial Officer
Email: Investors@BioCardia.com
Phone: 650-226-0120