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 [Nasdaq: BCDA] has initiated patient enrollment for its pivotal Phase 3 trial of CardiAMP Cell Therapy, targeting ischemic heart failure with reduced ejection fraction (HFrEF). The 250-patient randomized, controlled trial aligns with FDA guidelines and features a 12-month primary composite endpoint. CardiAMP has received Breakthrough Device Designation from the FDA, potentially expediting development and review processes.
Dr. Leslie Miller, a trial investigator, emphasized the therapy's potential to be groundbreaking for heart failure patients. BioCardia CEO Peter Altman expressed optimism about swift enrollment and the therapy's potential to enhance survival, reduce adverse events, and improve quality of life, addressing a significant need in ischemic heart failure treatment.
BioCardia, Inc. [Nasdaq: BCDA] has been granted U.S. Patent No. 12,036,371 for its Morph DNA multi-directional steerable catheter transseptal application. The patent, expiring in 2035, covers medical methods for transseptal access to the heart using steerable introducers based on BioCardia's Morph DNA technology. This innovation enhances shareholder value by protecting current and future products in the transseptal access systems market, which was valued at $941.3 million in 2022 and is projected to reach $2.1 billion by 2033.
The Morph DNA design allows for consistent catheter performance in any direction, preventing sudden jumps or 'whip' during procedures. BioCardia aims to provide or partner this solution for approximately 500,000 transseptal procedures performed annually in the United States, as well as other vascular access markets.
CellProthera and BioCardia announced the successful completion of a collaborative Phase II trial of ProtheraCytes for treating acute myocardial infarction (AMI). The EXCELLENT Trial results showed that the transendocardial injection of ProtheraCytes, which are autologous, expanded CD34+ stem cells, in combination with standard care, helped prevent heart failure progression in high-risk heart attack patients.
The treatment demonstrated improvements in multiple efficacy endpoints, including better segment viability, consistent positive trends in LV volumes, and faster decreases in NTproBNP, a key heart failure biomarker. The therapy was well tolerated with no unexpected serious adverse events. Both companies plan to continue their collaboration into Phase III trials.
BioCardia announces the issuance of a new U.S. patent for its radial and transendocardial delivery catheter, Patent No. 11,986,611, which will expire in 2036.
This patent pertains to methods and systems for delivering substances to the heart via the radial artery, enabling minimally invasive procedures.
The radial artery approach allows patients to leave the hospital soon after the procedure and significantly reduces overall healthcare costs.
BioCardia's Helix system, used in ongoing clinical trials, is the only known system capable of radial transendocardial biotherapeutic delivery and the new patent enhances its protection and value.
Therapeutic cell aggregates have potential advantages over single cell suspensions but also carry risks like strokes if they leak into the ventricular chamber.
BioCardia's delivery systems are designed to mitigate these risks by preventing leakage during the delivery process.
According to CEO Dr. Peter Altman, the patent issuance strengthens the company's technology and product offerings, benefiting both shareholders and patients.
BioCardia announced a 1-for-15 reverse stock split of its common stock, effective May 30, 2024, to meet Nasdaq's minimum bid price requirement. Shares will trade on a split-adjusted basis under the ticker BCDA. The reverse stock split will uniformly affect all shareholders, converting every 15 shares into 1 share without altering percentage ownership. Fractional shares will not be issued; instead, cash payments will be made. The authorized shares of common stock will be reduced from 100 million to 50 million. Further details are available in the company's proxy statement on the SEC's website.
BioCardia (Nasdaq: BCDA) reported its Q1 2024 financial results and business highlights. Key developments include a 37% relative risk reduction in mortality for patients with ischemic heart failure using CardiAMP therapy, and a confirmatory pivotal trial with CMS reimbursement. CardiAMP therapy for refractory angina improved exercise tolerance and reduced chest pain. CardiALLO therapy showed no adverse events in the low-dose cohort. The company reported Q1 revenues of $55,000, a net loss of $2.3 million, and a $1.5 million operational cash burn. Significant milestones for 2024 include advancing pivotal trials, FDA submissions, and biotherapeutic delivery partnerships.
BioCardia, Inc. will host a conference call on May 14, 2024, to discuss its financial results for the first quarter of 2024 and provide a corporate update. The company specializes in developing therapeutics for cardiovascular and pulmonary diseases.
BioCardia, Inc., a developer of therapeutics for cardiovascular and pulmonary diseases, announced positive results from the CardiAMP Cell Therapy Trial in Chronic Myocardial Ischemia. Patients showed increased exercise tolerance and reduced angina episodes, outperforming FDA-approved therapies. The webcast can be accessed for further details. The results support BioCardia's efforts in transforming angina treatment through cost-effective cell-based therapy.
FAQ
What is BioCardia, Inc.?
What are the main products of BioCardia?
What recent achievements has BioCardia accomplished?
What is the CardiAMP Cell Therapy?
What diseases are targeted by CardiALLO therapy?
What are BioCardia’s delivery systems?
How is BioCardia funded?
What partnerships does BioCardia have?
Where is BioCardia headquartered?
Where can I learn more about BioCardia?
