Business
BioCardia Reports First Quarter 2023 Business Highlights and Financial Results
SUNNYVALE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of
About this update from Biocardia, Inc.
[{"type":"text","content":"SUNNYVALE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the first quarter of 2023 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2023 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session. “Our autologous and allogeneic cell therapy programs are advancing in the clinic, with three enabled by our Helix cardiac biotherapeutic delivery system and a fourth using intravenous delivery,” said Peter Altman, Ph.D., President, and CEO. “This past quarter our lead CardiAMP cell therapy for heart failure program had positive two-year data, additional patients enrolled and new centers consenting their first patients. For this program, we have had productive interactions with the FDA towards implementing an adaptive statistical analysis plan and have been preparing for submission towards approval in Japan. We are also engaged in discussions for six out licensing and product distribution opportunities with an intent to close two in 2023, in parallel to delivering our product milestones.” RECENT BUSINESS HIGHLIGHTS: CardiAMP® Autologous Cell Therapy for Patients with Ischemic Heart Failure (BCDA-01) The CardiAMP Cell Therapy Trial for Heart Failure is a Phase III, multi-center, randomized, double-blinded, sham-controlled study intended to include up to 260 patients. The Phase III pivotal trial, which was granted Breakthrough designation by the U.S. Food and Drug Administration (FDA), is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for the treatment of heart failure with reduced ejection fraction (HFrEF). This trial is active at 20 clinical sites in the United States and Canada. One hundred twenty (120) patients have been enrolled to date, with 10 additional control patients having crossed over to receive the study treatment after completing their two-year follow-up study visit. In March, positive echocardiography data from the trial was presented at the 2023 American College of Cardiology annual m...