BioCardia, Inc. develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. Its recurring company updates center on the CardiAMP autologous cell therapy platform, CardiALLO allogeneic cell therapy programs, and device and software technologies used to deliver therapies to the heart, including the Helix transendocardial delivery catheter and Heart3D Fusion Imaging software.
News about BCDA commonly covers clinical results in ischemic heart failure with reduced ejection fraction, FDA and Japan PMDA regulatory interactions, patent protection for procedure-planning and navigation technology, and annual financial results. Company communications also address the role of Helix and related vascular navigation platforms in minimally invasive intramyocardial delivery of therapeutic and diagnostic agents.
BioCardia, Inc. (Nasdaq: BCDA) announced that the FDA has granted Breakthrough Device Designation for its CardiAMP® Cell Therapy System aimed at treating heart failure. This designation marks it as the first cardiac cell therapy to receive such status. The therapy utilizes a patient's own bone marrow cells delivered minimally invasively, intending to enhance treatment efficacy and patient safety. Currently, the CardiAMP Heart Failure Trial is enrolling patients to assess the therapy's effectiveness, with promising past results indicating significant improvements in exercise tolerance and quality of life.
BioCardia (Nasdaq: BCDA) announced its participation in two virtual investor meetings: the H.C. Wainwright BioConnect Virtual Conference from January 10-13 and the Biotech Showcase from January 10-12. CEO Dr. Peter Altman and CFO David McClung will engage in one-on-one meetings with investors during these events. Interested institutional or retail investors can request meetings through the conference platforms. BioCardia develops biotherapeutics for cardiovascular and respiratory diseases, driven by its CardiAMP and NK1R+ platforms.
BioCardia has announced a long-term lease for a new facility in Sunnyvale, California, aimed at enhancing the manufacturing of its cell and device products. This facility will support the development of BioCardia's CardiAMP Cell Therapy Systems, NK1R+ MSC, and Biotherapeutic Delivery Devices for clinical trials and early commercial activities. The company’s CEO emphasized the strategic importance of maintaining manufacturing proximity to accelerate product development and innovation, indicating expectations for multiple therapeutic programs to progress in clinical settings.
BioCardia, Inc. (BCDA) reported Q3 2021 results showing a revenue increase to $821,000, up from $34,000 year-over-year. The net loss narrowed to $2.7 million compared to $3.8 million in Q3 2020. The CardiAMP® Cell Therapy trial faces enrollment challenges due to COVID-19 but has enrolled 106 patients across 24 sites. Upcoming milestones include data reviews and IND submissions for various therapies. The company ended the quarter with $15.9 million in cash.
BioCardia, Inc. (NASDAQ:BCDA), a developer of cell-derived therapeutics for cardiovascular and pulmonary diseases, will release its third quarter 2021 financial results on November 10, 2021, at 4:30 PM ET. The company focuses on two biotherapeutic platforms: CardiAMP for cardiovascular indications and NK1R+ for potential treatments in cardiovascular and pulmonary diseases. These platforms support four product candidates aimed at benefiting millions of patients.
BioCardia, Inc. (BCDA) announced the treatment of the first patient in its Phase III CardiAMP Cell Therapy trial targeting chronic myocardial ischemia. Conducted at the University of Wisconsin, the trial aims to enroll up to 343 patients at 40 centers, focusing on improving exercise tolerance at six months. The treatment utilizes the patient's bone marrow cells delivered via a minimally invasive procedure. Additionally, the FDA approved a protocol amendment to shorten the follow-up period to six months. This trial may also enhance enrollment in the concurrent Heart Failure Study.
BioCardia recently announced the issuance of U.S. Patent No: 11,141,568 for a Multi Directional Steerable Catheter, enhancing its Helix™ Biotherapeutic Delivery System. This technology aims to improve physician control during cardiac procedures by reducing torque issues. The patented catheter is integrated into the FDA-cleared Morph® DNA™ guide and AVANCE™ introducer, expected to bolster their clinical biotherapeutics in heart disease. BioCardia estimates a significant market opportunity with approximately 1.6 million potential U.S. patients for its therapies, alongside a growing $490 million transseptal access market.
BioCardia, Inc. (Nasdaq: BCDA) has announced the treatment of the first cross-over patient in its Phase III CardiAMP® Cell Therapy trial aimed at ischemic heart failure. This milestone signifies a promising step in the trial, which allows patients initially assigned to the control group to elect therapy after completing a two-year follow-up. The procedure was conducted at Stanford University and demonstrates the minimally invasive nature of the therapy. The FDA approved an amendment to enhance patient access to this investigational treatment.
BioCardia (Nasdaq: BCDA) announced its participation in the A.G.P Biotech & Specialty Pharma Conference scheduled for October 13, 2021. The event will feature one-on-one meetings with management, led by CEO Dr. Peter Altman. This conference aims to connect institutional and retail investors with BioCardia's leadership. The company specializes in developing cellular therapies targeting cardiovascular diseases, with notable products including CardiAMP and NK1R+ platforms.
BioCardia, Inc. (Nasdaq: BCDA) announced data from its pivotal CardiAMP Cell Therapy Heart Failure trial, presented at the Heart Failure Society of America Annual Meeting on September 11, 2021. Dr. Natasha Altman discussed trial design, while Dr. Leslie Miller highlighted findings on female participants. Preliminary data suggest women may qualify for the cell potency assay at a higher rate than men (83% vs 67%), addressing underrepresentation in heart failure studies. BioCardia's trial has enrolled more patients than most previous US trials, showcasing significant progress in autologous cell therapy.