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BioCardia FDA Approval

BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure

[Nasdaq: BCDA], BioCardia, Inc. a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, announced FDA approval of its Phase III clinical trial for CardiAMP autologous cell therapy in treating ischemic heart failure.

BioCardia reveals FDA approval for CardiAMP Heart Failure II study protocol. The ongoing CardiAMP Heart Failure trial is set to report final data analyses in Q4 2024. In an interim analysis, patients with elevated NT-proBNP levels at screening-baseline showed significant clinical improvements, including a 59% relative risk reduction in heart death and a 54% reduction in Major Adverse Cardiovascular or Cerebrovascular events (MACCE).

Moreover, clinical outcome measures favored cell therapy over medical therapy, with statistical significance for reduced heart death equivalents and improved quality of life. FDA approval for CardiAMP Heart Failure II includes modified eligibility requirements and primary efficacy endpoint. The trial, designated as a Breakthrough therapy, utilizes a patient’s own bone marrow cells to stimulate the body’s natural healing response.

Peter Altman, BioCardia’s CEO, expressed confidence in the study’s efficiency, supported by positive outcomes from the ongoing trial. CardiAMP Heart Failure II aims to address an unmet clinical need, with modifications to enhance logistics and reduce study costs.

The company is a leading developer of cardiovascular therapeutics, with the CardiAMP Cell Therapy Program holding Breakthrough therapy designation. The company is dedicated to advancing innovative treatments for heart failure, backed by strong clinical support and ongoing research initiatives.

Forward-Looking Statements

This press release contains forward-looking statements subject to risks and uncertainties. Although BioCardia believes in the reasonable basis of these statements, actual results may differ. Factors affecting results include liquidity position, fundraising ability, and successful trial advancement. BioCardia disclaims any intent or obligation to update forward-looking statements.

Media Contact: 

Miranda Peto, Marketing / Investor Relations 

Email: mpeto@BioCardia.com 

Phone: 650-226-0120

Investor Contact: 

David McClung, CFO 

Email: investors@BioCardia.com 

Phone: 650-226-0120

SOURCE: BioCardia 

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