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BioCardia Completes Enrollment of CardiAMP Cell Therapy for the Treatment of Chronic Myocardial Ischemia Trial Open Label Roll-In Cohort

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BioCardia, Inc. (NASDAQ: BCDA) has completed the enrollment and primary endpoint results collection for the open label roll-in cohort of the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. The company will discuss the results and details of the pivotal randomized trial with clinical leadership on April 30, 2024, at 3:00 PM ET.
BioCardia, Inc. (NASDAQ: BCDA) ha completato il reclutamento e la raccolta dei risultati dei punti finali primari per la coorte di inserimento in aperto del trial CardiAMP Cell Therapy in Chronic Myocardial Ischemia. La compagnia discuterà i risultati e i dettagli del trial randomizzato e fondamentale con la leadership clinica il 30 aprile 2024, alle ore 15:00 ET.
BioCardia, Inc. (NASDAQ: BCDA) ha completado el reclutamiento y la recolección de resultados de los objetivos primarios para la cohorte inicial de etiqueta abierta del ensayo de Terapia Celular CardiAMP en Isquemia Miocárdica Crónica. La compañía discutirá los resultados y detalles del ensayo aleatorizado y pivotal con el liderazgo clínico el 30 de abril de 2024, a las 3:00 PM ET.
BioCardia, Inc. (NASDAQ: BCDA)는 만성 심근 허혈에서의 CardiAMP 세포 치료 임상 시험의 오픈 라벨 롤인 코호트의 등록과 주요 종료 점 결과 수집을 완료했습니다. 회사는 2024년 4월 30일 오후 3시 ET에 임상 리더십과 함께 획기적인 무작위 임상 시험의 결과와 세부 사항을 논의할 예정입니다.
BioCardia, Inc. (NASDAQ: BCDA) a terminé l'enrôlement et la collecte des résultats des points finaux primaires pour la cohorte ouverte de pré-introduction de l'essai de la thérapie cellulaire CardiAMP dans l'ischémie myocardique chronique. La société discutera des résultats et des détails de l'essai randomisé pivot le 30 avril 2024, à 15h00 ET, avec la direction clinique.
BioCardia, Inc. (NASDAQ: BCDA) hat die Einschreibung und die Sammlung der Ergebnisse der primären Endpunkte für die offene Roll-in-Kohorte der CardiAMP-Zelltherapie in der Studie zur chronischen myokardialen Ischämie abgeschlossen. Das Unternehmen wird die Ergebnisse und Details der wegweisenden randomisierten Studie am 30. April 2024 um 15:00 Uhr ET mit der klinischen Führung besprechen.
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Call Scheduled for Study Clinical Leadership to Discuss Results and Details on Pivotal Randomized Trial

SUNNYVALE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced completion of enrollment and collection of the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial.

The Company will report results from this trial and host a call with study clinical cardiology leadership to review the opportunity, early positive results, and randomized study on Tuesday, April 30, 2024, at 3:00 PM ET.

Participants can register for the conference by navigating to https://dpregister.com/sreg/10188810/fc71df44d6. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=neFatBOQ.

About Chronic Myocardial Ischemia with Refractory Angina
Chronic myocardial ischemia occurs in the setting of coronary artery disease when there is reduced blood flow to the heart. This causes angina, a type of chest pain which is characterized as refractory angina when this pain cannot be controlled by a combination of optimal medical therapy, angioplasty or bypass surgery, and is estimated to impact 600,000 to 1.8 million patients in the United States. Included in these patients are up to 15% of patients undergoing cardiac catheterization who have ischemia or angina and are suboptimal candidates for conventional revascularization. Although prognosis of refractory angina has improved in recent years, patients with refractory angina experience a significantly impaired quality of life with disproportionately high utilization of healthcare services. These observations reflect the great need for new therapies for these patients. Promising results in treating this patient population with an autologous bone marrow derived cell therapy have been shown previously(1).

Reference:
(1)Henry TD, Losordo DW, Traverse JH, Schatz RA, Jolicoeur EM, Schaer GL, Clare R, Chiswell K, White CJ, Fortuin FD, Kereiakes DJ, Zeiher AN, Sherman W, Hunt AS, and Povsic TJ. Autologous CD34 cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials, European Heart Journal, 2018.
  

About the CardiAMP Cell Therapy Program
Designated by the FDA as a Breakthrough Therapy for Ischemic Heart Failure, 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. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP cell therapy trials for the indications of both chronic myocardial ischemia and ischemic heart failure are covered by the Center for Medicare and Medicaid for both treatment and control procedures. CAUTION - Limited by United States law to investigational use. 

About BioCardia, Inc.
BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary biotherapeutic delivery system along with preclinical and clinical development services for biotherapeutic delivery to the heart.

Forward Looking Statements:
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements may include, among other things, statements relating to having a conference call with Key Opinion Leaders of the CardiAMP Chronic Myocardial Ischemia Trial, initiating the randomized pivotal cohort of the CardiAMP Chronic Myocardial Ischemia Trial, the probability of success of the CardiAMP clinical trials, ability to offset clinical costs utilizing Medicare reimbursement, anticipated milestones and events, and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release.

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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. 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”. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Media Contact:
Miranda Peto, Marketing / 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 did BioCardia complete the enrollment for the CardiAMP Cell Therapy trial?

BioCardia completed the enrollment for the CardiAMP Cell Therapy trial on April 25, 2024.

What is the ticker symbol of BioCardia, Inc.?

The ticker symbol of BioCardia, Inc. is BCDA.

When is the call scheduled to discuss the results of the trial?

The call to discuss the results of the trial is scheduled for April 30, 2024, at 3:00 PM ET.

How can participants register for the conference call?

Participants can register for the conference call by navigating to https://dpregister.com/sreg/10188810/fc71df44d6.

What should participants do to listen to the call by phone?

Interested parties within the U.S. should call 1-833-316-0559, and international callers should call 1-412-317-5730. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call.

How can participants access the live webcast of the conference call?

Participants can access the live webcast of the conference call through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=neFatBOQ.

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