Biocardia Inc Stock Price, News & Analysis

BioCardia, Inc. (BCDA) announced the treatment of the first patient in its Phase III CardiAMP Cell Therapy trial targeting chronic myocardial ischemia. Conducted at the University of Wisconsin, the trial aims to enroll up to 343 patients at 40 centers, focusing on improving exercise tolerance at six months. The treatment utilizes the patient's bone marrow cells delivered via a minimally invasive procedure. Additionally, the FDA approved a protocol amendment to shorten the follow-up period to six months. This trial may also enhance enrollment in the concurrent Heart Failure Study.

BioCardia recently announced the issuance of U.S. Patent No: 11,141,568 for a Multi Directional Steerable Catheter, enhancing its Helix™ Biotherapeutic Delivery System. This technology aims to improve physician control during cardiac procedures by reducing torque issues. The patented catheter is integrated into the FDA-cleared Morph® DNA™ guide and AVANCE™ introducer, expected to bolster their clinical biotherapeutics in heart disease. BioCardia estimates a significant market opportunity with approximately 1.6 million potential U.S. patients for its therapies, alongside a growing $490 million transseptal access market.

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.