8-K: BioCardia's CardiAMP HF II Trial Enrolls First Patient at Emory University School of Medicine

BioCardia announces that Emory University School of Medicine is now enrolling patients in its Phase III CardiAMP HF II trial for ischemic heart failure.

Summary

• BioCardia, Inc. announced that Emory University School of Medicine in Atlanta, Georgia, has begun enrolling patients in the company's ongoing Phase III CardiAMP HF II trial.
• The trial is evaluating the CardiAMP cell therapy product for treating patients with ischemic heart failure of reduced ejection fraction and elevated markers of cardiac stress.
• CardiAMP cell therapy uses a patient's own bone marrow cells delivered to the heart to stimulate the body's natural healing response.
• The study compares CardiAMP Therapy to a placebo procedure, with all patients receiving stable guideline-directed medical therapy.
• Final study results from the previous CardiAMP Heart Failure Study showed increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE).
• A statistically significant improvement was observed in a composite outcome measure in patients with active heart stress treated with CardiAMP Cell Therapy (p=0.02).
• BioCardia plans to share final results with the FDA and Japan's PMDA to support approval of CardiAMP Cell Therapy and the Helix delivery system.
• The company anticipates strong support from Emory University in accelerating patient enrollment in the CardiAMP HF II trial towards its target completion in 2027.

Sentiment

Score: 7

Explanation: The announcement is positive due to the enrollment of patients at a reputable institution and promising results from previous studies. However, the forward-looking statements and inherent risks associated with clinical trials temper the overall sentiment.

Positives

• Emory University, a leading institution, is participating in the CardiAMP HF II trial, potentially accelerating patient enrollment.
• Previous study results showed increased survival and reduced major adverse cardiac events with CardiAMP Cell Therapy.
• The CardiAMP cell therapy has received Breakthrough Designation by the FDA.
• 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) for both treatment and control procedures.
• The company is actively working to share final results with both the FDA and Japans Pharmaceutical and Medical Device Agency in support of approval of the CardiAMP Cell Therapy for these patients with elevated NTproBNP, for whom existing medications may not be sufficient, and also in support of separate approval for the Helix transendocardial biotherapeutic delivery system, whose approval will have value for many biotherapeutic delivery partners.

Risks

• The press release contains forward-looking statements that are subject to many risks and uncertainties.
• The approvability of the Company's investigational product candidates in Japan and the United States is not guaranteed.
• Actual results may differ materially from the forward-looking statements.

Future Outlook

BioCardia is working towards potential approval of CardiAMP Cell Therapy and the Helix delivery system in the United States and Japan, while continuing to enroll patients in the CardiAMP HF II trial, with an anticipated completion in 2027.

Management Comments

• Dr. Arshed Quyyumi stated that the screening for CD34+ cell composition and high dosage being delivered in a interventional cardiology setting is in alignment with our own past research and enhances both my confidence in the results recently presented and the potential for treated patients to do well in the study ahead.
• Peter Altman, PhD, President and CEO of BioCardia, believes the collaboration with Emory University will assist the Company on many levels, including their anticipated strong support in accelerating patient enrollment in the CardiAMP HF II trial towards its target completion in 2027.

Industry Context

This announcement highlights the ongoing efforts to develop cell-based therapies for heart failure, a significant unmet medical need. BioCardia is positioning itself as a leader in this field with its CardiAMP platform.

Comparison to Industry Standards

• The CardiAMP therapy's approach of using autologous bone marrow cells aligns with other cell therapy companies like Mesoblast, which is developing similar treatments for cardiovascular diseases.
• The focus on patients with elevated NTproBNP levels is similar to strategies used in other heart failure trials to target specific patient populations most likely to benefit from the therapy.
• The Helix delivery system is being compared to other intramyocardial delivery systems, with BioCardia claiming it is safer and more successful in cell retention than alternatives.

Stakeholder Impact

• Positive for shareholders due to the progress in clinical development.
• Potential benefit for patients with ischemic heart failure who may gain access to a new treatment option.
• Positive for Emory University School of Medicine, enhancing its reputation in cardiovascular research.

Next Steps

• Continue patient enrollment in the CardiAMP HF II trial at Emory University and other clinical sites.
• Share final results with the FDA and Japan's PMDA to support approval of CardiAMP Cell Therapy and the Helix delivery system.
• Work towards completing the CardiAMP HF II trial by 2027.

Key Dates

Keywords

CardiAMP HF II, ischemic heart failure, cell therapy, BioCardia, Emory University, clinical trial, CardiAMP, HFrEF