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) 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.
BioCardia (Nasdaq: BCDA) announced it will present at the H.C. Wainwright 23rd Annual Global Investment Virtual Conference from September 13-15, 2021. The company’s presentation will be available on demand starting at 7 AM Eastern Time. CEO Dr. Peter Altman will also conduct one-on-one meetings during the conference for interested institutional or retail investors. This participation showcases BioCardia's commitment to transparency and engagement with potential investors.
BioCardia announced its participation in two virtual investor conferences. The Q3 Investor Summit Virtual Conference will take place from August 17-18, 2021, with a corporate presentation on August 17 at 2pm ET. The SNN Network Virtual Event Conference, scheduled for August 17-19, 2021, will feature a corporate presentation on August 19 at 3pm ET. Attendees can sign up for one-on-one meetings with company representatives via the conference websites. BioCardia focuses on developing therapeutics for cardiovascular and pulmonary diseases.
BioCardia, Inc. (BCDA) reported Q2 2021 results, posting a net loss of $3.5 million, a slight decrease from $3.7 million in Q2 2020. Research and development expenses rose by 6% to $2.4 million, primarily due to the ongoing CardiAMP Heart Failure Trial. The independent Data Safety Monitoring Board recommended continuing the pivotal trial after reviewing data from 97 patients. The company ended the quarter with $18.5 million in cash. They anticipate continued patient enrollment for CardiAMP and plans for Phase I/II trials for NK1R+ therapies for ischemic heart failure and COVID-19 related distress.
BioCardia, a leader in cardiovascular therapies, will have its CEO, Peter Altman, participate in a fireside chat and one-on-one meetings at the BTIG Virtual Biotechnology Conference on August 10, 2021. The chat is scheduled from 3:30-3:55 pm ET. Interested attendees can register for the event, and a replay will be available for BTIG clients until the end of the day on August 10. BioCardia focuses on developing regenerative biologic therapies for cardiovascular and pulmonary diseases and offers advanced delivery systems for biotherapeutic applications.
BioCardia, Inc. (Nasdaq: BCDA) announced the Japan Patent Office granted Patent No: 6887216, titled “Target Site Selection, Entry, and Update With Automatic Remote Image Annotation,” expiring January 8, 2034. This patent enhances image-guided delivery for heart treatments, allowing 3D images from MRI or CT scans to inform therapeutic interventions. The patent is expected to bolster BioCardia's intellectual property for cardiovascular therapies. Their cardiac biotherapeutics include CardiAMP® autologous cell therapy, currently undergoing clinical trials.
BioCardia (Nasdaq: BCDA) announces that the independent Data Safety Monitoring Board (DSMB) has completed its review of the Phase III CardiAMP Cell Therapy Heart Failure Trial. The DSMB found no safety concerns and recommended continuing the study, which enrolls 260 patients across 40 centers. This trial aims to analyze the potential benefits of using autologous bone marrow cells for heart disease treatment. The trial's primary goal is to assess various health-related outcomes, ensuring patient safety through rigorous oversight.
BioCardia announced encouraging results from its pivotal trial, CardiAMP Cell Therapy, for ischemic heart failure. The trial achieved a mean therapeutic dosage of 627 million total nucleated cells, including 4.5 million CD34+ cells. This data was shared at the European Society of Cardiology Heart Failure Annual Meeting 2021. The therapy aims to process and deliver patient-specific cells to damaged heart regions, addressing key challenges in safe and effective treatment.
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