BioCardia Submits Request for Clinical Data Review Meeting with Japan PMDA To Discuss Approval Pathway for CardiAMP® Cell Therapy in Ischemic Heart Failure
BioCardia (NASDAQ:BCDA) has submitted its CardiAMP autologous cell therapy for clinical consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The submission includes comprehensive clinical data from the completed CardiAMP HF trial and the principal clinical portion of the Summary Technical Documentation (STED).
The PMDA consultation will evaluate the therapy's efficacy and safety data, assess target patient populations, and determine its fit within Japan's heart failure treatment landscape. A successful review could enable BioCardia to pursue market approval in Japan, potentially leading to a post-marketing study in 2026.
BioCardia (NASDAQ:BCDA) ha presentato la sua terapia cellulare autologa CardiAMP per una consultazione clinica presso l'Agenzia giapponese per i farmaci e i dispositivi medici (PMDA). La documentazione include dati clinici completi dal trial CardiAMP HF concluso e la parte principale della documentazione tecnica riassuntiva (STED).
La consultazione con la PMDA valuterà i dati di efficacia e sicurezza della terapia, analizzerà le popolazioni di pazienti target e definirà il ruolo della terapia nel contesto del trattamento dell'insufficienza cardiaca in Giappone. Un esito positivo della revisione potrebbe permettere a BioCardia di richiedere l'approvazione di mercato in Giappone, aprendo la strada a uno studio post-commercializzazione nel 2026.
BioCardia (NASDAQ:BCDA) ha presentado su terapia celular autóloga CardiAMP para consulta clínica ante la Agencia de Productos Farmacéuticos y Dispositivos Médicos de Japón (PMDA). La presentación incluye datos clínicos completos del ensayo CardiAMP HF finalizado y la parte principal de la Documentación Técnica Resumida (STED).
La consulta con la PMDA evaluará los datos de eficacia y seguridad de la terapia, analizará las poblaciones de pacientes objetivo y determinará su encaje dentro del panorama del tratamiento de insuficiencia cardíaca en Japón. Una revisión exitosa podría permitir a BioCardia buscar la aprobación de mercado en Japón, con la posibilidad de un estudio post-comercialización en 2026.
BioCardia (NASDAQ:BCDA)는 자사의 자가 세포 치료제 CardiAMP를 일본 의약품의료기기종합기구(PMDA)에 임상 자문을 위해 제출했습니다. 제출 자료에는 완료된 CardiAMP HF 임상시험의 종합 임상 데이터와 요약 기술 문서(STED)의 주요 임상 부분이 포함되어 있습니다.
PMDA 자문은 치료제의 효능 및 안전성 데이터를 평가하고, 대상 환자군을 검토하며, 일본 심부전 치료 환경 내에서의 적합성을 판단할 예정입니다. 성공적인 검토 결과는 BioCardia가 일본에서 시장 승인을 추진할 수 있게 하며, 2026년 이후 시판 후 연구로 이어질 수 있습니다.
BioCardia (NASDAQ:BCDA) a soumis sa thérapie cellulaire autologue CardiAMP pour une consultation clinique auprès de l'Agence japonaise des produits pharmaceutiques et des dispositifs médicaux (PMDA). La soumission comprend des données cliniques complètes issues de l'essai CardiAMP HF achevé ainsi que la principale partie clinique de la Documentation Technique Résumée (STED).
La consultation avec la PMDA évaluera les données d'efficacité et de sécurité de la thérapie, analysera les populations cibles de patients et déterminera son intégration dans le paysage du traitement de l'insuffisance cardiaque au Japon. Une revue positive pourrait permettre à BioCardia de demander une autorisation de mise sur le marché au Japon, ouvrant potentiellement la voie à une étude post-commercialisation en 2026.
BioCardia (NASDAQ:BCDA) hat seine autologe Zelltherapie CardiAMP zur klinischen Beratung bei der japanischen Arzneimittel- und Medizinprodukteagentur (PMDA) eingereicht. Die Einreichung enthält umfassende klinische Daten aus der abgeschlossenen CardiAMP HF-Studie sowie den wesentlichen klinischen Teil der Zusammenfassenden Technischen Dokumentation (STED).
Die PMDA-Beratung wird die Wirksamkeits- und Sicherheitsdaten der Therapie bewerten, die Zielpatientengruppen analysieren und die Einordnung in die Behandlung von Herzinsuffizienz in Japan prüfen. Eine erfolgreiche Prüfung könnte BioCardia ermöglichen, eine Marktzulassung in Japan anzustreben, was möglicherweise zu einer Studie nach der Markteinführung im Jahr 2026 führen würde.
- Potential expansion into Japanese market, a key region for heart failure therapies
- Submission includes comprehensive clinical data package from completed CardiAMP HF trial
- Successful review could lead to post-marketing study opportunity in 2026
- Regulatory approval in Japan not guaranteed
- Additional studies may be required before market entry
Insights
BioCardia's PMDA submission for CardiAMP therapy marks crucial regulatory progress toward potential Japanese market approval.
BioCardia has taken a significant regulatory step by submitting its CardiAMP cell therapy for clinical consultation with Japan's PMDA, which could potentially open the door to the Japanese market for this heart failure treatment. The submission includes comprehensive clinical data from the recently completed CardiAMP HF trial and the principal clinical portion of the Summary Technical Documentation (STED).
This regulatory consultation is particularly noteworthy because Japan represents a key market for advanced heart failure therapies. The PMDA review will evaluate several critical aspects: whether the efficacy and safety of the CardiAMP system are adequately demonstrated, the appropriate target patient populations, and how this therapy fits into Japan's heart failure treatment landscape.
From a regulatory perspective, successful alignment with PMDA on these issues could enable BioCardia to submit for formal market approval in Japan. The CEO's mention of a potential "meaningful post marketing study in Japan next year" suggests the company is optimistic about the timeline and expects positive feedback from regulators.
This consultation builds upon previous interactions with PMDA, indicating an ongoing dialogue with Japanese regulators. For a small biotechnology company like BioCardia, gaining entry to the Japanese market could significantly expand the commercial potential for their lead product candidate and provide validation of their technology platform. The regulatory pathway in Japan can sometimes offer certain advantages for cell therapies compared to other markets, making this an astute strategic move.
SUNNYVALE, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that it submitted its CardiAMP autologous cell therapy investigational heart failure treatment for clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This milestone marks a significant step toward potential regulatory approval in Japan, a key market for advanced heart failure therapies.
Japan’s PMDA consultation process is a critical component of Japan’s regulatory pathway for new medical products. In addition to responding to PMDA’s questions stemming from previous consultations, the submission made consisted of a detailed clinical data package including the full CardiAMP HF Trial data, along with the principal clinical portion of the Summary Technical Documentation, or STED, which is an extensive summary of the technical information to demonstrate to regulatory authorities that the CardiAMP System meets safety and performance requirements.
The PMDA clinical consultation of CardiAMP heart failure therapy will involve a comprehensive review of the clinical data from the recently completed CardiAMP HF trial, including whether the efficacy and safety of the CardiAMP system are adequately ensured, the proposed target patient populations indicated by the data, and how the investigational therapy may appropriately fit into the continuum of care for heart failure patients in Japan.
Alignment with PMDA on the acceptability of the clinical data and positioning of the CardiAMP system for Japanese patients with heart failure could enable BioCardia to submit for approval of the CardiAMP system for market entry in Japan.
“Consulting with the PMDA on the totality of clinical evidence from our three trials supporting CardiAMP cell therapy for heart failure is a pivotal step in our ongoing discussions with PMDA to bring this heart failure therapy to patients in Japan,” said Peter Altman, PhD, CEO of BioCardia. “We look forward to incorporating the agency's insights into our development plans and working towards a successful regulatory submission and review. Success in these efforts could result in our being engaged in a meaningful post marketing study in Japan next year.”
BioCardia remains committed to advancing innovative treatments for heart failure and is evaluating opportunities to collaborate with partners in Japan.
About CardiAMP Autologous Cell Therapy
Granted FDA Breakthrough designation, the proprietary CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to increase capillary density and reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The Phase IIIB CardiAMP HF II Trial (NCT06258447) is actively enrolling in the United States. The principal outcomes from the 125-patient randomized procedure controlled double blind CardiAMP HF Trial (NCT02438306) were presented at the late breaking clinical trial sessions of the American College of Cardiology on March 29th, 2025. Results of the CardiAMP HF Trial showed reduction in all cause death, reduced major adverse cardiac events, and improved quality of life, whose composite endpoint was statistically significant in patients having elevated NTproBNP, a marker of active heart stress. This was preceded by the Phase II 33-patient randomized placebo controlled Transendocardial Autologous Cells in heart Failure Trial (NCT 00768066) and the open label 20-patient Phase I Transendocardial Autologous Bone Marrow in Myocardial Infarction Trial (NCT 00507468), both of which demonstrated enhanced exercise ability and heart function in patients who received therapy.
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, the anticipated PMDA consultation, and future regulatory submission. 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.
MEDIA CONTACT:
Miranda Peto, Investor Relations
mpeto@biocardia.com
(650) 226-0120
INVESTOR CONTACT:
David McClung, Chief Financial Officer
investors@biocardia.com
(650) 226-0120
FAQ
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