Helix biotherapeutic delivery platform

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BioCardia to Host Q2 2025 Corporate Update and Financial Results Conference Call on August 11, 2025
Globenewswire· 2025-08-06 19:18
Core Insights - BioCardia, Inc. will provide a corporate update and report its financial results for Q2 2025 on August 11, 2025, at 4:30 PM ET [1] - The company specializes in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [4] Company Overview - BioCardia is headquartered in Sunnyvale, California, and is recognized as a global leader in its field [4] - The company has developed two main biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates currently in development [4] - BioCardia's therapies are supported by its Helix biotherapeutic delivery and Morph vascular navigation product platforms [4] Conference Call Details - Participants can register for the conference call via a specific link and will receive their dial-in number upon registration [2] - For those not registered, U.S. callers can dial 1-833-316-0559, while international callers should use 1-412-317-5730, with a recommendation to join the call 10 minutes early [2] - A live webcast of the call will also be available through a provided link [2] Replay Information - A replay of the conference call will be accessible approximately one hour after its conclusion through the same links [3] - Telephonic replay options are available for domestic and international callers using specific access codes [3]
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
Globenewswire· 2025-05-01 13:00
Core Insights - BioCardia, Inc. has initiated the Phase III CardiAMP HF II clinical trial for its autologous cell therapy aimed at treating heart failure, with the first patient enrolled at BayCare Morton Plant Hospital in Clearwater, Florida [1][2]. Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP and CardiALLO cell therapies in clinical development [7]. Clinical Trial Details - The CardiAMP HF II study is a 250-patient randomized multicenter trial designed to confirm the safety and efficacy of the CardiAMP autologous cell therapy in patients with ischemic heart failure and reduced ejection fraction (HFrEF) [3]. - The trial aims to replicate the statistically significant composite efficacy endpoint achieved in the previous CardiAMP HF study, focusing on patients with elevated NTproBNP (p=0.02) [3]. Therapeutic Approach - CardiAMP cell therapy utilizes a patient's own bone marrow cells delivered via a minimally invasive procedure to stimulate natural healing, targeting mechanisms of microvascular dysfunction [5]. - The therapy has received FDA Breakthrough designation and is supported by the Maryland Stem Cell Research Fund, with reimbursement from the Centers for Medicare and Medicaid Services (CMS) [6]. Technological Advancements - The CardiAMP HF II trial incorporates cell population analysis for dose definition, enhancing patient eligibility, and features improvements to the Helix delivery system, including the FDA-approved Morph DNA steerable platform [4].