BioCardia Announces First Patient in Phase 3 Randomized Controlled Double-Blind CardiAMP HF II Clinical Trial of the Company’s Lead Cell Therapy for Treatment of Heart Failure

Rhea-AI Summary

BioCardia (NASDAQ: BCDA) has announced the enrollment of the first patient in its Phase III CardiAMP HF II clinical trial at BayCare Morton Plant Hospital in Florida. The trial evaluates the company's lead autologous cell therapy for heart failure treatment. The CardiAMP cell therapy is unique as it personalizes treatment using the patient's own cells, avoiding immune suppression needs. The procedure utilizes the Helix minimally invasive delivery platform and new Morph DNA steerable navigation catheter for targeted cell delivery into heart muscle. Dr. Leslie Miller, Chief of the Congestive Heart Failure and Heart Function Clinic, serves as Principal Investigator. BioCardia is preparing regulatory submissions in Japan and the USA for approvals of both the cell therapy and delivery platform based on existing clinical data.

Positive

• First patient enrolled in Phase III confirmatory trial for heart failure treatment
• Previous trials showed promising clinical outcomes and enhanced microvascular function
• Therapy preserves all future treatment options including repeated cell therapy
• Company preparing regulatory submissions in both Japan and USA markets

Negative

• Regulatory approvals still pending in major markets
• Additional clinical evidence needed for approval, adoption, and reimbursement

Insights

Biotech/Clinical Trials Expert

BioCardia's Phase III heart failure cell therapy trial initialization represents significant advancement toward potential regulatory approval and commercialization.

The enrollment of the first patient in BioCardia's Phase III CardiAMP HF II trial marks a critical milestone in their clinical development pathway. This isn't just another trial - it's a confirmatory study following their completed CardiAMP HF Trial, which reportedly demonstrated enhanced microvascular function and promising clinical outcomes in heart failure patients.

The trial's design includes gold-standard scientific controls: randomized, double-blind, and procedure placebo-controlled methodology, which substantially strengthens the validity of any future results. As a specialist evaluating this approach, I find several aspects particularly noteworthy:

• The autologous approach (using the patient's own cells) eliminates rejection risks and immune suppression requirements
• The therapy preserves all future treatment options, including repeated applications
• Treatment is personalized based on a patient's cellular characteristics
• The Helix delivery platform with the new Morph DNA steerable navigation catheter enables precise targeting of specific heart segments

BioCardia's concurrent regulatory submissions in Japan and the USA based on existing data from multiple trials (TABMMI, TAC-HFT, and CardiAMP HF) suggests confidence in their clinical program. The fact that this is described as "the world's first confirmatory Phase 3 cardiac cell therapy trial for heart failure" positions BioCardia at the forefront of cellular therapeutics for cardiovascular applications.

Biotechnology Financial Analyst

Phase III trial commencement significantly derisks BioCardia's lead therapy, creating dual potential revenue streams from both therapy and delivery platform.

The advancement to a Phase III confirmatory trial represents a substantial derisking event for BioCardia's lead autologous cell therapy program. For clinical-stage biotechnology companies, reaching late-stage trials is a crucial inflection point that typically reduces development uncertainty and enhances company valuation potential.

What's particularly strategic about BioCardia's approach is their dual commercialization strategy:

• Parallel regulatory submissions planned in both Japan and USA, potentially accelerating path to market
• Seeking approvals for two distinct products: the CardiAMP cell therapy and the Helix biotherapeutic delivery platform
• Leveraging existing clinical data from multiple completed trials (TABMMI, TAC-HFT, and CardiAMP HF)

The cardiovascular disease market represents one of the largest therapeutic areas, with heart failure affecting approximately 6.2 million adults in the US alone according to CDC estimates. Current heart failure treatments primarily manage symptoms rather than address underlying cardiac dysfunction, creating substantial opportunity for regenerative approaches.

While Phase III trials typically require significant time and capital to complete, this announcement of first patient enrollment demonstrates operational execution. The ability to proceed to a confirmatory trial suggests their previous clinical data showed sufficient promise to warrant this investment. The CardiAMP HF II trial will generate the confirmatory evidence needed to support regulatory approvals, physician adoption, and ultimately reimbursement.

SUNNYVALE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial of the Company’s lead autologous cell therapy program for the treatment of heart failure at BayCare Morton Plant Hospital in Clearwater, Florida.

“We are excited to lead enrollment in the CardiAMP HF II trial and be able to offer this cell therapy study to our heart failure patients. This investigational therapy has been shown to enhance microvascular function and demonstrated promising clinical outcomes in the recently completed CardiAMP HF Trial, particularly for the patients we are targeting for this trial,” said Dr. Leslie Miller, M.D., Chief of the Congestive Heart Failure and Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida. Dr. Miller is also a CardiAMP HF II Trial Principal Investigator and member of the Executive Steering Committee. “The unique ability to personalize this treatment based on a patient’s own cellular characteristics make CardiAMP cell therapy attractive for treating heart failure. The approach preserves all therapeutic options for our patients, including repeated cell therapy, and avoids the need for immune suppression. I congratulate and thank our team at Morton Plant Hospital for achieving this important milestone in enrolling the first patient in the world’s first confirmatory Phase 3 cardiac cell therapy trial for heart failure.”

“Our first CardiAMP HF II study procedure went smoothly and per protocol,” said Dr. Rakesh Sharma, M.D., Interventional Cardiologist at BayCare Morton Plant Hospital in Clearwater, and CardiAMP HF II investigator. “Our efforts in cardiac cell therapy over many years have supported the potential of this CardiAMP cell therapy where cells are harvested, processed, and delivered into the heart muscle by our research team. I value the Helix minimally invasive cell intramyocardial delivery platform for its ability to enable targeting of specific segments in the heart with confidence and find the new Morph DNA steerable navigation catheter to be an elegant enhancement.”  

“We are thankful for the BayCare Morton Plant team led by Dr. Miller and Dr. Sharma as well as the many other world-class clinical teams engaged in the CardiAMP cell therapy trials,” said Peter Altman, PhD, BioCardia President and Chief Executive Officer. “We are preparing regulatory submissions in Japan and the USA intended to seek separate approvals of the CardiAMP cell therapy and Helix biotherapeutic delivery platform based on our existing TABMMI¹, TAC-HFT^2,3, and CardiAMP HF⁴ clinical data. The CardiAMP HF II trial is intended to collect confirmatory evidence to support this autologous cell therapy with respect to approvals, adoption, and reimbursement.”

About the CardiAMP Heart Failure II Study

CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with reduced ejection fraction (HFrEF) on guideline directed medical therapy having elevated NTproBNP.   The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study⁴. The CardiAMP HF II study uses a similar three-tier composite primary outcome measure to CardiAMP HF, with tier 1 all cause death, tier 2 nonfatal major adverse cardiac events, but with tier 3 using a validated quality of life patient self-assessment instrument. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBNP that are the focus of the CardiAMP HF II study (p=0.02). 

Advances in this therapeutic approach in CardiAMP HF II include using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, which include the introduction of the FDA approved Morph DNA steerable platform.  

About CardiAMP Autologous Cell Therapy

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms.

The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). 

CAUTION - Limited by United States law to investigational use. 

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP^® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph^® vascular navigation product platforms.  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, among other things, references to our investigational product candidates, the potential benefits and mechanism of actions of the CardiAMP cell therapy, future regulatory approvals, enrollment in our clinical trials, and the safety and efficacy of our product candidates and therapies. 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 may differ materially from the forward-looking statements contained in this press release. 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 Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.  

References:

1. de la Fuente LM, Stertzer SH, Argentieri J, et al. Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study). EuroIntervention. 2011 Nov;7(7):805-12.
2. Heldman AW, DiFede DL, Fishman JE, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014 Jan 1;311(1):62-73.
3. Wong Po Foo et al., The transendocardial autologous cells in ischemic heart failure trial bone marrow mononuclear cells (TAC-HFT-BMC) randomized placebo controlled blinded study, Regenerative Medicine 2015, 10(7s), S169.
4. Raval A, on behalf of the CardiAMP HF Investigators. A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial, American College of Cardiology Scientific Sessions, March 30, 2025.

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

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

FAQ

What is the current phase of BioCardia's (BCDA) CardiAMP HF II clinical trial?

BioCardia has just enrolled its first patient in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial for heart failure treatment.

How does BioCardia's CardiAMP cell therapy work for heart failure?

The therapy uses the patient's own cells (autologous), which are harvested, processed, and delivered into the heart muscle using the Helix minimally invasive delivery platform and Morph DNA steerable navigation catheter.

What are the advantages of BioCardia's (BCDA) CardiAMP cell therapy?

The therapy is personalized based on patient's own cells, avoids immune suppression, preserves future treatment options, and has shown promising clinical outcomes in enhancing microvascular function.

Where is BioCardia (BCDA) seeking regulatory approvals for CardiAMP therapy?

BioCardia is preparing regulatory submissions in Japan and the USA for approvals of both the CardiAMP cell therapy and Helix biotherapeutic delivery platform.

Who is leading the CardiAMP HF II trial for BioCardia (BCDA)?

Dr. Leslie Miller, Chief of the Congestive Heart Failure and Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida, is serving as Principal Investigator and member of the Executive Steering Committee.