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) is a cutting-edge clinical-stage company based in Sunnyvale, California, specializing in the development of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. The company’s biotherapeutic platforms, CardiAMP™ and CardiALLO™, are designed to address serious unmet medical needs and are supported by compelling clinical data.
Core Business:
BioCardia’s primary focus is on advancing novel therapies for cardiovascular diseases. The CardiAMP™ platform utilizes autologous bone marrow cells for treating ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia (CMI). Meanwhile, CardiALLO™ leverages allogeneic mesenchymal stem cells (MSC) to offer an “off-the-shelf” solution for HFrEF and acute respiratory distress syndrome (ARDS).
Recent Achievements:
BioCardia has made significant strides in its clinical trials. Recently, the Phase III trial for CardiAMP in advanced chronic heart failure patients showed promising interim results, including a 37% relative risk reduction in heart death equivalents and significant improvements in various clinical endpoints. Additionally, the FDA has approved the CardiAMP Heart Failure II Trial with reimbursement coverage from CMS.
Current Projects:
The company is actively enrolling patients in multiple clinical trials. The CardiAMP HF II Trial aims to confirm the efficacy of the CardiAMP Cell Therapy, while the CardiALLO trial is progressing through its dose escalation phase with no observed adverse events to date.
Partnerships and Products:
BioCardia collaborates with several biotherapeutic companies, providing its proprietary Helix™ transendocardial delivery systems and Morph® vascular access products. These platforms are designed for precise and safe delivery of therapeutic agents to the heart, enhancing the efficacy of the treatments.
Financial Condition:
BioCardia continues to secure funding through various channels, including federal reimbursements and partnerships. The company’s robust pipeline and strategic collaborations provide a solid foundation for future growth and development.
Conclusion:
BioCardia, with its focus on innovative biotherapeutic solutions and strong clinical data, is poised to make a significant impact in the treatment of cardiovascular diseases. The company’s ongoing trials and partnerships underscore its commitment to advancing medical science and improving patient outcomes. For more information, visit www.BioCardia.com.
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.
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