Core Insights - BioCardia, Inc. has completed a third preliminary clinical consultation with Japan's PMDA regarding its CardiAMP Cell Therapy for treating Heart Failure with Reduced Ejection Fraction (HFrEF) [1] - The PMDA has indicated that BioCardia can proceed to formal clinical consultation, which may lead to regulatory approval in Japan if the data is deemed sufficient [1] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [5] - The company is headquartered in Sunnyvale, California, and focuses on developing autologous and allogeneic cell therapies [5] Product Development - CardiAMP Cell Therapy utilizes a patient's own bone marrow cells delivered via a minimally invasive procedure to improve heart function [3] - The therapy has received FDA Breakthrough designation and is supported by the Maryland Stem Cell Research Fund [3] Clinical Trial Highlights - Phase 1: TABMMI Heart Failure Trial involved 20 patients [4] - Phase 2: TACHFT Trial included 33 patients, with 29 randomized [4] - Phase 3: CardiAMP HF Trial had 125 patients, with 115 randomized and a 24-month follow-up [4] - Key outcomes include a 90% survival rate at three years and a 7% improvement in left ventricular ejection fraction at 24 months (p=0.001) [4] - Treated patients showed a 20% reduction in major adverse cardiovascular events compared to controls [4] Efficacy Signals - A subgroup of randomized patients with elevated NTproBNP before enrollment (n=57) demonstrated strong efficacy signals [5] - Quality of life improved by 17.4 points (p=0.039) for treated patients compared to controls [4] Future Prospects - The ongoing regulatory discussions in Japan and the United States will determine the next steps for CardiAMP Cell Therapy [2][4]

Core Insights - BioCardia, Inc. is a global leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [2] - The company will present at the CSI Focus Devices in Heart Failure conference in Frankfurt, Germany, on December 5, 2025 [1] - The presentation will focus on "Intramyocardial Cell Therapy for Ischemic Heart Failure of Reduced Ejection" [1] Company Overview - BioCardia is headquartered in Sunnyvale, California, and specializes in biotherapeutic platforms, including CardiAMP® autologous and CardiALLO™ allogeneic cell therapies [2] - The company has three clinical stage product candidates in development, supported by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms [2] Event Details - The CSI Focus D-HF conference will cover advancements in device-based therapy for heart failure, including ventricle restoration strategies and monitoring systems [1] - The session featuring BioCardia's CEO will take place from 10:30 to 11:30 CET [1]

Core Insights - BioCardia, Inc. has appointed Farhan Shahab as Vice President of Quality, bringing over 25 years of experience in executive roles related to quality and regulatory affairs [1][2]. Company Overview - BioCardia is a global leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [1][3]. - The company has two main biotherapeutic platforms: CardiAMP® (autologous cell therapy) and CardiALLO™ (allogeneic cell therapy), with three clinical stage product candidates currently in development [3]. Leadership and Expertise - Farhan Shahab previously held significant roles at Welldoc, Intuity Medical, Moximed, and AngioScore, focusing on quality assurance and regulatory compliance [2]. - Shahab's expertise in product quality management and regulatory submissions is expected to enhance BioCardia's ability to commercialize its investigational products [3].

Core Insights - BioCardia, Inc. has initiated the enrollment of the first patient in its Phase 3 CardiAMP HF II clinical trial targeting ischemic heart failure with reduced ejection fraction (HFrEF) [1][2] - The CardiAMP HF II trial aims to confirm the safety and efficacy of the CardiAMP autologous cell therapy, which has shown promising results in previous studies despite not meeting the primary endpoint [2][3] - The trial is significant as it addresses a critical need for treatment options among the approximately 2 million patients in the U.S. and EU suffering from ischemic HFrEF [2][5] Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics, focusing on cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [7] - The company is developing two main biotherapeutic platforms: CardiAMP autologous and CardiALLO allogeneic cell therapies, with three clinical stage product candidates [7] - The CardiAMP Cell Therapy has received FDA Breakthrough designation and is designed to treat microvascular dysfunction by using a patient's own bone marrow cells [5][7] Clinical Trial Details - The CardiAMP HF II study is a randomized, multicenter, placebo-controlled trial involving 250 patients, focusing on those with elevated NTproBNP levels [3] - The primary outcome measure includes all-cause death, nonfatal major adverse cardiac events, and a validated quality of life measure, similar to the previous CardiAMP HF study [3] - Advances in the trial include improved cell population analysis for treatment dosing and enhancements to the Helix system, including the FDA-approved Morph DNA steerable platform [4][5]

Core Insights - BioCardia, Inc. has enrolled its first patient in the Phase 3 CardiAMP HF II clinical trial at the University of Wisconsin School of Medicine and Public Health, focusing on the treatment of ischemic heart failure [1][2] Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, with a focus on the CardiAMP autologous cell therapy [7] - The company is headquartered in Sunnyvale, California, and has three clinical stage product candidates in development [7] Clinical Trial Details - The CardiAMP HF II study is a 250-patient randomized multicenter, placebo-controlled trial designed to evaluate the safety and efficacy of CardiAMP cell therapy in patients with ischemic heart failure with reduced ejection fraction (HFrEF) [3] - The trial aims to confirm previous safety and efficacy results observed in the earlier CardiAMP HF study, utilizing a composite primary outcome measure that includes all-cause death, nonfatal major adverse cardiac events, and a validated quality of life measure [3] Therapeutic Approach - CardiAMP cell therapy has received FDA Breakthrough designation and involves using a patient's own bone marrow cells delivered to the heart through a minimally invasive procedure [5] - The therapy aims to increase capillary density and reduce tissue fibrosis, addressing microvascular dysfunction in heart failure patients [5] Technological Advancements - The trial incorporates advancements such as cell population analysis for treatment dose definition and improvements to the Helix system, including the FDA-approved Morph DNA steerable platform [4]

Core Insights - BioCardia, Inc. has had a positive preliminary clinical consultation with Japan's PMDA regarding the CardiAMP Heart Failure Trial results, which is a step towards formal clinical consultation for regulatory approval [1][2][3] - The PMDA has requested additional details on various aspects of the trial, including statistical power and risk-benefit profiles, indicating a thorough review process [2] - BioCardia aims to provide access to its therapies for patients with significant needs, particularly those with limited treatment options, as highlighted by the benefits observed in the CardiAMP HF study [3] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics focused on cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [4] - The company is developing three cardiac clinical stage product candidates, utilizing its Helix™ biotherapeutic delivery and Morph vascular navigation platforms, along with the upcoming Heart3D™ fusion imaging platform [4] - BioCardia selectively partners with other organizations to enhance biotherapeutic delivery and develop important biologic therapies [4]

Group 1 - BioCardia, Inc. announced a public offering of 4,800,000 shares of common stock and short-term warrants at a combined price of $1.25 per share [1][3] - The gross proceeds from the offering are expected to be $6 million, with an additional potential $6 million from the exercise of short-term warrants [3] - The company plans to use the net proceeds for working capital and general corporate purposes, including advancing investigational biotherapeutic candidates [3][6] Group 2 - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The offering is being conducted under a registration statement on Form S-1, which was declared effective by the SEC on September 18, 2025 [4] - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with three clinical stage product candidates in development [6]

Core Insights - BioCardia, Inc. is set to present a corporate update at the H. C. Wainwright 27th Annual Global Investment Conference, highlighting recent progress and milestones in their therapeutic developments [1][4] - The presentation will focus on three clinical cell therapy programs aimed at treating ischemic heart disease, along with ongoing regulatory efforts for FDA and Japan PMDA approvals for their CardiAMP cell therapy [2][3] - BioCardia has recently formed a partnership to develop and commercialize Heart3D fusion imaging and is pursuing nondilutive funding for its CardiALLO allogeneic mesenchymal stem cell program [3] Presentation Details - Dr. Peter Altman, President and CEO of BioCardia, will present on September 10, 2025, at 2:00 PM ET at the Lotte New York Palace Hotel [2][7] - The conference will take place from September 8-10, 2025, and registered attendees can access the presentation through the conference platform [4][5] - Attendees are encouraged to request one-on-one meetings with the company through various channels [4]

Core Insights - BioCardia, Inc. reported its financial results for Q2 2025, highlighting advancements in its cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [1][6] Recent Business Highlights - The CardiAMP autologous cell therapy for ischemic heart failure (BCDA-01) demonstrated a 107-second increase in exercise tolerance and an 82% reduction in angina episodes at the six-month follow-up [2] - The CardiALLO allogeneic cell therapy (BCDA-03) is progressing with a Phase 1/2 trial, having completed a low dose cohort with no adverse events reported [2][4] - The CardiAMP HF Trial results indicated a lower incidence of all-cause death and non-fatal major adverse cardiovascular events (MACCE) compared to the control group [3] Financial Results - Research and development expenses rose to approximately $1.4 million for Q2 2025, up from $0.8 million in Q2 2024, primarily due to activities related to the CardiAMP HF Trial [8] - The net loss for Q2 2025 was approximately $2.0 million, compared to $1.6 million in Q2 2024, attributed to increased trial-related expenses [8][15] - Cash balance as of June 30, 2025, was approximately $980,000, with subsequent stock sales increasing the balance to approximately $1.1 million [8][16] Intellectual Property - BioCardia's patent portfolio was strengthened with the issuance of US patent No. 12,311,127 for a delivery catheter system, enhancing its capabilities in minimally invasive heart therapies [5] Anticipated Upcoming Milestones - The company plans to submit for approval of the Helix biotherapeutic delivery system in Q3 2025 and anticipates key meetings with regulatory agencies in Q4 2025 [9][13]

Core Insights - BioCardia, Inc. has submitted its CardiAMP autologous cell therapy for heart failure to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for clinical consultation, marking a significant step towards regulatory approval in Japan [1][4] Group 1: Regulatory Process - The PMDA consultation process is essential for new medical products in Japan, involving a detailed clinical data package that includes the full CardiAMP HF Trial data and Summary Technical Documentation (STED) [2] - The consultation will review clinical data from the CardiAMP HF trial, focusing on efficacy, safety, target patient populations, and the therapy's role in heart failure care in Japan [3] Group 2: Clinical Development - The CardiAMP therapy has received FDA Breakthrough designation and utilizes a patient's own bone marrow cells to treat microvascular dysfunction through a minimally invasive procedure [6] - The recently completed CardiAMP HF Trial demonstrated significant outcomes, including reduced all-cause death and improved quality of life in patients with elevated NTproBNP [6] Group 3: Future Prospects - Successful alignment with PMDA could lead to market entry approval for the CardiAMP system in Japan, with potential for a post-marketing study next year [4][5] - BioCardia is committed to advancing heart failure treatments and is exploring collaboration opportunities in Japan [5]