BioCardia Announces Positive Consultation with Japan PMDA on CardiAMP Cell Therapy for Ischemic Heart Failure
BioCardia (Nasdaq: BCDA) announced a successful consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) regarding its lead therapeutic asset, BCDA-01, for treating ischemic heart failure. The PMDA has invited BioCardia for a follow-up consultation after reviewing final clinical data with two-year follow-up from the CardiAMP Heart Failure Trial.
The agency indicated openness to considering results from the CardiAMP Heart Failure Trial and previous trials as sufficient evidence for registering the CardiAMP Cell Therapy System in Japan. The company expects final data from its fully enrolled 125-patient trial to be available in Q1 2025. The therapy has received FDA Breakthrough Designation and is supported by the Maryland Stem Cell Research Fund and CMS reimbursement.
BioCardia (Nasdaq: BCDA) ha annunciato di aver avuto una consultazione positiva con l'Agenzia Farmaceutica e Dispositivi Medici del Giappone (PMDA) riguardo al suo principale asset terapeutico, BCDA-01, per il trattamento dell'insufficienza cardiaca ischemica. La PMDA ha invitato BioCardia a una consultazione di follow-up dopo aver esaminato i dati clinici finali con un follow-up di due anni provenienti dal CardiAMP Heart Failure Trial.
L'agenzia ha mostrato apertura nel considerare i risultati del CardiAMP Heart Failure Trial e dei precedenti studi come prove sufficienti per la registrazione del Sistema di Terapia Cellulare CardiAMP in Giappone. L'azienda prevede che i dati finali del suo studio completamente arruolato con 125 pazienti saranno disponibili nel primo trimestre del 2025. La terapia ha ricevuto la Designazione di Innovazione della FDA ed è sostenuta dal Maryland Stem Cell Research Fund e dal rimborso CMS.
BioCardia (Nasdaq: BCDA) anunció una consulta exitosa con la Agencia Farmacéutica y de Dispositivos Médicos de Japón (PMDA) sobre su principal activo terapéutico, BCDA-01, para el tratamiento de la insuficiencia cardiaca isquémica. La PMDA ha invitado a BioCardia a una consulta de seguimiento después de revisar los datos clínicos finales con un seguimiento de dos años del CardiAMP Heart Failure Trial.
La agencia indicó que estaba abierta a considerar los resultados del CardiAMP Heart Failure Trial y ensayos anteriores como evidencia suficiente para registrar el Sistema de Terapia Celular CardiAMP en Japón. La compañía espera que los datos finales de su ensayo con 125 pacientes completamente reclutados estén disponibles en el primer trimestre de 2025. La terapia ha recibido la Designación de Innovación de la FDA y cuenta con el apoyo del Maryland Stem Cell Research Fund y el reembolso de CMS.
BioCardia (Nasdaq: BCDA)는 일본의 의약품 및 의료기기청(PMDA)와의 성공적인 상담을 통해 허혈성 심부전 치료를 위한 주요 치료 자산인 BCDA-01에 대해 논의했다고 발표했습니다. PMDA는 CardiAMP Heart Failure Trial의 2년 후속 정보가 포함된 최종 임상 데이터를 검토한 후 BioCardia에 후속 상담을 요청했습니다.
기관은 CardiAMP Heart Failure Trial 및 이전 시험의 결과를 일본에서 CardiAMP 세포 치료 시스템 등록을 위한 충분한 근거로 인정할 용의가 있음을 시사했습니다. 회사는 125명의 환자가 완전히 등록된 시험의 최종 데이터가 2025년 1분기에 제공될 것으로 예상하고 있습니다. 이 치료법은 FDA의 획기적인 치료제로 지정되었으며, 메릴랜드 줄기세포 연구 기금 및 CMS 환급의 지원을 받고 있습니다.
BioCardia (Nasdaq: BCDA) a annoncé avoir eu une consultation réussie avec l'Agence pharmaceutique et des dispositifs médicaux du Japon (PMDA) concernant son principal actif thérapeutique, BCDA-01, pour le traitement de l'insuffisance cardiaque ischémique. La PMDA a invité BioCardia à une consultation de suivi après avoir examiné les données cliniques finales avec un suivi de deux ans provenant de l'Essai CardiAMP sur l'insuffisance cardiaque.
L'agence a indiqué être ouverte à considérer les résultats de l'essai CardiAMP sur l'insuffisance cardiaque et des essais précédents comme des preuves suffisantes pour l'enregistrement du Système de thérapie cellulaire CardiAMP au Japon. La société s'attend à ce que les données finales de son essai avec 125 patients entièrement recrutés soient disponibles au premier trimestre 2025. La thérapie a reçu la désignation de percée de la FDA et est soutenue par le Maryland Stem Cell Research Fund et le remboursement CMS.
BioCardia (Nasdaq: BCDA) gab bekannt, dass es eine erfolgreiche Beratung mit der Pharmazeutischen und Medizinprodukteagentur Japans (PMDA) bezüglich seines führenden therapeutischen Vermögens, BCDA-01, zur Behandlung von ischämischer Herzinsuffizienz hatte. Die PMDA hat BioCardia eingeladen, nach der Überprüfung der endgültigen klinischen Daten mit zwei Jahren Nachbeobachtung aus der CardiAMP Heart Failure Trial zu einer Folgeberatung zu kommen.
Die Agentur zeigte sich offen dafür, die Ergebnisse der CardiAMP Heart Failure Trial sowie früherer Studien als ausreichende Beweise für die Registrierung des CardiAMP Zelltherapiesystems in Japan zu betrachten. Das Unternehmen erwartet, dass die endgültigen Daten aus seiner vollständig rekrutierten 125-Patienten-Studie im ersten Quartal 2025 vorliegen werden. Die Therapie hat die FDA Breakthrough Designation erhalten und wird vom Maryland Stem Cell Research Fund sowie durch CMS-Honorare unterstützt.
- PMDA's openness to consider existing trial data for Japanese market registration
- FDA Breakthrough Designation status for CardiAMP Cell Therapy
- CMS reimbursement support for clinical trials
- Fully enrolled 125-patient trial with data expected in Q1 2025
- None.
Insights
The PMDA consultation marks a significant milestone for BioCardia's CardiAMP Cell Therapy program. The invitation for a follow-up consultation after final data submission suggests potential regulatory progress in Japan. The upcoming Q1 2025 data from the 125-patient CardiAMP Heart Failure Trial will be important for both Japanese and U.S. market prospects.
The therapy's Breakthrough Designation from FDA CBER indicates its potential to address an unmet medical need in heart failure treatment. The CMS reimbursement support for clinical trials demonstrates strong institutional backing and could facilitate commercialization if approved. This regulatory pathway in Japan could potentially offer faster market access compared to traditional approval routes.
For a micro-cap company with a market cap of
The CMS reimbursement support reduces trial costs and validates the therapy's potential commercial viability. However, investors should note that final approval depends on the upcoming clinical data results in Q1 2025.
Next PMDA Consultation after Review of CardiAMP HF Trial Data
SUNNYVALE, Calif., Dec. 04, 2024 (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 the successful completion of a consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on the next steps for the submission for registration of its lead therapeutic asset, BCDA-01, for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).
“This most recent meeting with PMDA had several important outcomes,” said Peter Altman, Ph.D., BioCardia’s President and Chief Executive Officer.” First, PMDA has invited our next consultation after the submission of our final clinical data with two-year follow-up to review the sufficiency of evidence to support claims of safety and efficacy for the BCDA-01 program. Second, PMDA remains open to the results from the CardiAMP Heart Failure Trial and our previous trials being sufficient evidence for registering CardiAMP Cell Therapy System for patients with heart failure in Japan.”
Dr. Altman continued, “We are working on data lock from our fully enrolled 125 patient CardiAMP Heart Failure Trial and anticipate final data will be available in the first quarter of 2025.”
CardiAMP Cell Therapy for the treatment of HFrEF (BCDA-01) has received Breakthrough Designation from Food and Drug Administration Center for Biological Evaluation and Research (FDA CBER), with development supported by the Maryland Stem Cell Research Fund. All CardiAMP Cell Therapy clinical trials in the United States (BCDA-01 and BCDA-02) are also supported by reimbursement from the Center for Medicaid and Medicare Services (CMS).
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 the Company’s investigational product candidates, the timing of data lock on the CardiAMP Heart Failure Trial, the timing of availability of data from this trial, and future consultations with Japan PMDA. 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 27, 2024, 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
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
FAQ
When will BioCardia (BCDA) release final data for the CardiAMP Heart Failure Trial?
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