BioCardia, Inc. - BCDA STOCK NEWS

BioCardia, Inc. (Nasdaq: BCDA) announced the granting of Patent Number 11,357,463 by the US Patent Office, which covers an innovative imaging system for cardiac biotherapeutics, expected to enhance treatment delivery precision. The patent is valid until late 2034 and is designed to integrate 3D imaging with 2D visualization for accurate therapeutic interventions in the heart. This development could bolster BioCardia's existing portfolio, which includes therapies for ischemic heart failure and chronic myocardial ischemia. CEO Dr. Peter Altman noted the system's compatibility with current catheter systems.

BioCardia, Inc. (Nasdaq: BCDA) reported its Q1 2022 financial results, highlighting an increase in revenues to $60,000 from $46,000 in Q1 2021, attributed to collaborations. The company ended the quarter with $9.9 million in cash, providing a runway into Q1 2023. Significant developments include FDA Breakthrough Designation for CardiAMP Cell Therapy for heart failure and positive reviews from the Data Safety Monitoring Board. However, the net loss increased to $3.3 million, up from $3.0 million in the previous year, alongside a 19% rise in R&D expenses due to trial costs.

BioCardia, Inc. (NASDAQ:BCDA) will announce its financial results for Q1 2022 on May 11, 2022, at 4:30 PM ET. The conference call will include a Q&A session following management remarks. The company's CardiAMP cell therapies, which focus on cardiovascular and pulmonary diseases, are in development, with several trials supported by CMS reimbursement and FDA Breakthrough designation. Interested parties can listen via phone or webcast, with a replay available afterwards.

BioCardia, Inc. (Nasdaq: BCDA) announced FDA approval for its Investigational New Drug (IND) application for BCDA-04, a mesenchymal stem cell therapy targeting patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. The Phase I/II trial is set to begin in Q3 2022. This therapy, based on promising clinical results, aims to improve recovery outcomes by leveraging NK1 receptor interactions to reduce lung inflammation. The FDA's acceptance of this IND marks a significant milestone in BioCardia's allogeneic cell therapy development strategy.

BioCardia, Inc. (Nasdaq: BCDA) reported its 2021 financial results, ending the year with cash and cash equivalents of $12.9 million, ensuring operational continuity through 2022. Revenue surged to $1 million from $145,000 in 2020, primarily due to collaborations. The company reduced R&D expenses to $8.6 million and administrative costs to $5.1 million. The net loss decreased to $12.6 million, improving from $15.0 million in 2020. BioCardia's CardiAMP cell therapy has advanced significantly, receiving FDA Breakthrough Device Designation, with active trials in heart failure and chronic myocardial ischemia.

BioCardia, Inc. [NASDAQ:BCDA] will release its financial results for the year ending December 31, 2021, during a conference call on March 29, 2022, at 4:30 PM ET. The event will include a formal management presentation followed by a Q&A session. Interested parties can register for the call via provided links and dial in 10 minutes early. A replay will be available through June 29, 2022. BioCardia focuses on developing cellular therapies for cardiovascular and pulmonary conditions, leveraging innovative biotherapeutic platforms.

BioCardia (NASDAQ: BCDA) announced the designation of a new reimbursement code, C9782, by the U.S. Centers for Medicare and Medicaid Services (CMS) for its CardiAMP® Cell Therapy procedure. This code, effective April 1, 2022, allows hospitals to receive reimbursement for studies involving autologous bone marrow cell treatment for heart failure. This designation supports ongoing pivotal trials in two cardiovascular indications, enhancing CMS's commitment to treating ischemic heart failure and providing financial clarity for clinical institutions involved in these trials.

BioCardia (Nasdaq: BCDA) announced the receipt of a No Objection Letter from Health Canada, allowing the expansion of its CardiAMP Heart Failure Trial into Canada. The Phase III trial, which is currently enrolling patients in the U.S., aims to assess the effectiveness of CardiAMP Cell Therapy for patients with ischemic cardiomyopathy. Four Canadian clinical sites are preparing to start patient enrollment soon. CEO Peter Altman noted that the rigorous approval process has strengthened the trial, which utilizes innovative patient selection and delivery methods to enhance treatment outcomes.

BioCardia, Inc. (Nasdaq: BCDA) announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of the Phase III pivotal CardiAMP™ Cell Therapy Heart Failure Trial. The DSMB confirmed no significant safety concerns and recommended continuation of the trial, which has enrolled 108 patients. CEO Peter Altman stated that the trial is positioned to meet its primary endpoint and aims to enroll 260 patients across 40 centers. The trial utilizes proprietary techniques to enhance patient outcomes.