Welcome to our dedicated page for Biocardia news (Ticker: BCDA), a resource for investors and traders seeking the latest updates and insights on Biocardia stock.
BioCardia, Inc. (NASDAQ: BCDA) generates news centered on its development of cellular and cell-derived therapeutics for cardiovascular and pulmonary disease. As a clinical-stage company headquartered in Sunnyvale, California, its updates often relate to progress in late-stage trials, regulatory interactions, and advances in its enabling delivery and imaging technologies.
Investors and clinicians following BCDA news can expect regular coverage of the CardiAMP autologous cell therapy platform in ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia with refractory angina, as well as the CardiALLO allogeneic mesenchymal stem cell platform in ischemic heart failure. Recent announcements have highlighted Phase 3 CardiAMP HF II trial enrollment at leading centers, subgroup efficacy signals from prior trials, and discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the potential approvability of CardiAMP Cell Therapy for HFrEF.
News items also address BioCardia’s Helix transendocardial biotherapeutic delivery system, Morph vascular navigation platform, and Heart3D fusion imaging platform, including updates on planned regulatory submissions and performance in preclinical and clinical settings. Corporate developments such as leadership appointments, board changes, financing activities, and Nasdaq listing compliance updates are disclosed through press releases and corresponding SEC filings.
This BCDA news page brings together these announcements so readers can follow clinical milestones, regulatory consultations, device platform progress, and governance developments in one place. For those tracking investigational therapies in heart failure, refractory angina, and related conditions, the BioCardia news feed provides an ongoing view into how the company’s programs and platforms are evolving over time.
BioCardia, Inc. (NASDAQ: BCDA) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022, at the Lotte New York Palace Hotel. Dr. Peter Altman, CEO, will present an overview of the company's business.
The firm focuses on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, boasting two key products: CardiAMP® autologous and NK1R+ allogeneic cell therapies, with significant FDA designations and CMS reimbursements.
BioCardia, Inc. [Nasdaq: BCDA] will present at Cantor Fitzgerald’s Cell and Genetic Medicines Conference on September 15, 2022, held at the Lotte New York Palace Hotel, NYC. The conference will focus on advancements in cell therapies, including CRISPR technologies and regulatory pathways. CEO Dr. Peter Altman will join a panel discussing the significance of partnerships with large-cap pharma. Attendance is in person only, with no live broadcast. BioCardia specializes in cell-based therapeutics for cardiovascular diseases, with its CardiAMP therapies receiving FDA Breakthrough designation and CMS reimbursement.
BioCardia (Nasdaq: BCDA) announced favorable results from its Phase III CardiAMP® Cell Therapy Heart Failure Trial. The independent Data Safety Monitoring Board (DSMB) reported no significant safety concerns and recommended continuing the study. The trial includes data from 101 patients past the 12-month primary endpoint, showing a higher one-year survival rate compared to similar trials. An adaptive statistical analysis plan is suggested for future evaluations. The study aims to enroll 260 patients across 40 U.S. and Canada centers, with results pending formal unblinding and analysis.
BioCardia (Nasdaq: BCDA) announced a collaboration with BlueRock Therapeutics to deliver cell therapy for heart failure. This agreement includes a substantial up-front payment, contributing to BioCardia's efforts to enhance cardiovascular treatments. CEO Peter Altman emphasized the significant potential benefits for both BlueRock's programs and patients with cardiovascular disease. The partnership offers an option for a non-exclusive, worldwide license for specific cardiac indications. However, forward-looking statements indicate that actual results may vary and are subject to risks disclosed in BioCardia's SEC filings.
BioCardia, Inc. (Nasdaq: BCDA) reports Q2 2022 financial results, with revenues reaching $1.0 million, up from $0.1 million in Q2 2021, largely due to collaboration revenue. The net loss decreased to $2.5 million from $3.5 million year-over-year. The company is advancing its CardiAMP cell therapy for ischemic heart disease and lung inflammation in pivotal clinical trials, with key milestones expected, including a data review on August 30, 2022. BioCardia is optimistic about regulatory discussions in Japan and securing FDA IND acceptance for its allogeneic cell therapy for ARDS.
BioCardia, Inc. (NASDAQ:BCDA) announced it will report its financial results and provide a corporate update for the six months ended June 30, 2022, via conference call on August 10, 2022, at 4:30 PM ET. Interested participants can register and access the call by phone or through a live webcast. A replay of the call will be available for a limited time. BioCardia specializes in developing cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases and has received Breakthrough designation for its CardiAMP Cell Therapy.
BioCardia (Nasdaq: BCDA) announces the activation of the Ottawa Heart Institute as the first Canadian clinical site for its CardiAMP Cell Therapy Heart Failure Trial. The trial aims to assess the effectiveness of a patient’s own bone marrow cells to enhance heart healing. Dr. Peter Altman, CEO, anticipates each of the planned four sites will enroll six patients annually. A crucial Data Safety Monitoring Board Review is set for August 30, 2022, to evaluate trial safety and futility, with results expected shortly thereafter.
BioCardia (Nasdaq: BCDA) announced CEO Peter Altman's participation in two upcoming symposia focusing on therapeutic developments in heart failure and acute respiratory distress syndrome. The first event, on July 14, 2022, at 10:00 a.m. ET, is hosted by Maxim Group LLC, featuring discussions with other players in the heart failure space. The second symposium, on July 15, 2022, at 9:10 a.m., will showcase BioCardia's research on NK1R+ MSC in treating acute respiratory distress syndrome. Further details can be found on BioCardia's website.
BioCardia, Inc. (Nasdaq: BCDA) announced the granting of Patent Number 11,357,463 by the US Patent Office, which covers an innovative imaging system for cardiac biotherapeutics, expected to enhance treatment delivery precision. The patent is valid until late 2034 and is designed to integrate 3D imaging with 2D visualization for accurate therapeutic interventions in the heart. This development could bolster BioCardia's existing portfolio, which includes therapies for ischemic heart failure and chronic myocardial ischemia. CEO Dr. Peter Altman noted the system's compatibility with current catheter systems.
BioCardia, Inc. (Nasdaq: BCDA) reported its Q1 2022 financial results, highlighting an increase in revenues to $60,000 from $46,000 in Q1 2021, attributed to collaborations. The company ended the quarter with $9.9 million in cash, providing a runway into Q1 2023. Significant developments include FDA Breakthrough Designation for CardiAMP Cell Therapy for heart failure and positive reviews from the Data Safety Monitoring Board. However, the net loss increased to $3.3 million, up from $3.0 million in the previous year, alongside a 19% rise in R&D expenses due to trial costs.