Biocardia Inc Stock Price, News & Analysis

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.

BioCardia, Inc. (NASDAQ:BCDA) will announce its financial results for Q1 2022 on May 11, 2022, at 4:30 PM ET. The conference call will include a Q&A session following management remarks. The company's CardiAMP cell therapies, which focus on cardiovascular and pulmonary diseases, are in development, with several trials supported by CMS reimbursement and FDA Breakthrough designation. Interested parties can listen via phone or webcast, with a replay available afterwards.