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) reported its Q1 2021 financial results, highlighting key advancements in its CardiAMP autologous and allogeneic cell therapy pipelines. The CardiAMP trials (BCDA-01 and BCDA-02) are progressing with 94 patients enrolled and FDA crossover approvals. Financially, the net loss decreased to $3.0 million from $4.6 million YoY, with R&D expenses down 34% to $1.8 million. The company also engaged in a $20 million equity line, selling $2 million in common stock. Upcoming milestones include a DSMB review on June 22, 2021, and additional patient enrollments.
BioCardia has announced a collaboration with a leading Japanese biotechnology company regarding its Helix catheter biotherapeutic delivery products. The agreement, valued at $500,000, spans one year and includes options for a non-exclusive worldwide license for certain cardiac cell types. CEO Peter Altman emphasized the significance of their Helix technology, which has shown superior efficiency and clinical performance in recent studies. This partnership represents a strategic advancement, aiming for clinical development and commercialization of biotherapeutic products targeting heart conditions.
BioCardia, Inc. (Nasdaq: BCDA) reported Q4 and full-year financial results for 2020, with a significant revenue drop to $145,000 from $710,000 in 2019 due to lower partnership activities and reduced catheter sales. The company closed a $19 million financing and a $20 million equity line in Q4. The CardiAMP™ Heart Failure Trial received positive DSMB recommendations, indicating no safety concerns. Upcoming milestones include the Phase III CardiAMP Chronic Myocardial Ischemia trial. The net loss for 2020 was $15 million, a slight increase from the previous year.
BioCardia (Nasdaq: BCDA) announces CEO Dr. Peter Altman will present at the Maxim Group’s Inaugural Emerging Growth Virtual Conference, scheduled for March 17-19, 2021. Dr. Altman's live fireside chat is set for 3:30 PM ET on March 19. Registered attendees can also access a corporate presentation on the conference website and request a 1x1 meeting with Dr. Altman post-conference. BioCardia focuses on developing regenerative therapies for cardiovascular disease, with notable products like the CardiAMP cell therapy and the Helix Biotherapeutic Delivery System.
BioCardia, Inc. (Nasdaq: BCDA) announced an agreement with a leading Japanese pharmaceutical company for the Helix catheter biotherapeutic delivery system. The deal includes a $500,000 upfront payment, partially applicable to products and services. This one-year agreement allows for negotiation of a non-exclusive worldwide license for specific cardiac-related cell types. CEO Peter Altman emphasized the Helix system's unique position in the market and its efficiency in delivering therapies, which supports ongoing clinical developments in heart failure treatments.
BioCardia, Inc. (Nasdaq: BCDA) announced leadership changes in its clinical team, effective February 15, 2021. Dr. Sujith Shetty has been appointed as Chief Medical Officer, succeeding Dr. Eric Duckers, who resigned to explore new opportunities but will remain as a consultant. Ms. Debby Holmes-Higgin retains her position as Vice President of Clinical with broader responsibilities. The changes follow a successful Data Safety Monitoring Board Review of the CardiAMP Heart Failure Trial, aimed at enhancing the trial's success.
BioCardia, Inc. (Nasdaq: BCDA) announced the election of Krisztina Zsebo, Ph.D., to its Board of Directors during the 2020 Annual Meeting of Stockholders. With over 30 years in biotech, Dr. Zsebo has raised more than $200 million and launched products generating over $3.5 billion in annual sales. She replaces Fernando L. Fernandez, who completed his term. Dr. Zsebo is expected to chair the Science and Technology Committee, enhancing BioCardia's product development initiatives. The company focuses on regenerative therapies for cardiovascular and respiratory diseases.
BioCardia, Inc. (Nasdaq: BCDA) has announced the issuance of U.S. Patent No. 10,874,831 for a new device designed to enhance the delivery of biotherapeutics in cardiovascular treatments. This technology is expected to improve physician control during procedures involving complex vascular anatomy. The patented design is incorporated in the company’s recently approved products, Morph DNA and AVANCE steerable catheters, which could bolster clinical programs for heart failure and chronic ischemia. CEO Peter Altman emphasizes the importance of delivery systems in therapeutic success.
BioCardia, Inc. (Nasdaq: BCDA) announced the sale of 2,038,836 shares of common stock at $5.15 per share in a registered direct offering, expected to close around December 18, 2020. A.G.P./Alliance Global Partners serves as the sole placement agent. This transaction is executed under an effective shelf registration statement previously filed with the SEC. Investors are encouraged to review the upcoming prospectus supplement for further details.
BioCardia, Inc. (Nasdaq: BCDA) announced a registered direct offering of 1,789,474 shares of common stock at $4.75 per share, totaling approximately $8.5 million. The offering is expected to close around December 16, 2020, subject to customary conditions. A.G.P./Alliance Global Partners is the sole placement agent. The offering is made under an effective shelf registration statement with the SEC. Investors are encouraged to review the prospectus supplement and related documents for complete details.
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