Biocardia Inc Stock Price, News & Analysis

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.

BioCardia (Nasdaq: BCDA) announced the issuance of European Patent No. 3593810, which focuses on autologous cell therapy patient diagnostics to address therapeutic variability. This patent enhances the protection of BioCardia’s CardiAMP programs aimed at treating heart failure. The therapeutic could apply to 1.7 million heart failure patients in the U.S. and a similar number in Europe. Cardiovascular diseases cause significant mortality, with over 11 million new cases annually in Europe, resulting in a €210 billion economic impact.

BioCardia, Inc. (Nasdaq: BCDA) will join the Russell Microcap Index, effective June 28, 2021, following the annual reconstitution of the Russell Indexes. This inclusion is expected to attract more investors and enhance liquidity. Russell Indexes are a significant reference for approximately $10.6 trillion in assets, making this a notable milestone for BioCardia. The membership will last for one year and will automatically include the company in relevant growth and value style indexes, provided by FTSE Russell.

BioCardia, Inc. (Nasdaq: BCDA) announced that CEO Peter Altman will present a corporate overview at the LD Micro Virtual Invitational Conference from June 8-10. His presentation is scheduled for June 8 at 4:30 PM ET on Track 3. Investors can register to watch the presentation online. BioCardia is focused on developing regenerative biologic therapies for cardiovascular and pulmonary diseases, with key products like CardiAMP™ cell therapies and various delivery systems.

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.