Business
BioCardia Reports Third Quarter 2021 Financial Results and Business Highlights
SAN CARLOS, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment
About this update from Biocardia, Inc.
[{"type":"text","content":"SAN CARLOS, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the third quarter of 2021 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2021 with the Securities and Exchange Commission. Q3 and Recent Business Highlights: CardiAMP® Cell Therapy for ischemic heart failure (BCDA-01) The 260-patient randomized controlled clinical study of the Company’s lead program is intended to provide the primary data to support safety and efficacy in pursuit of market clearance. Clinical investigators at 24 active partner sites across the United States have enrolled 106 patients. In addition, three of the patients in the trial who were initially randomly assigned to the control arm and who did not receive therapy elected to cross over and receive the investigational autologous CardiAMP Cell Therapy after completing two-year follow-up. The COVID-19 case rate increase that occurred this quarter across the United States had significant impact on enrollment with many clinical sites halting elective procedures. Many sites have since restarted.Continued efforts to complete enrollment and enhance the trial accomplished and ongoing this quarter include: Expansion of our dedicated field clinical research team in the field to take on responsibilities formerly held by our third-party Clinical Research Organization, to enhance interactions with and support for our world class partner sites;Implementation and realization of the early crossover treatment option recently approved by FDA at the end of Q2, to enhance attractiveness to patients and expand the trial data set;Completion of trial submission and responses to Health Canada to enable expansion of the trial to additional sites in Canada ; andAdvancing additional sites in the USA and Canada through the lengthy on-boarding process. CardiAMP Autologous Cell Therapy was featured in two presentations at the Heart Failure Society of America Annual Meeting 2021. CardiAMP Cell Therapy for Chronic Myocardial Ischemia (BCDA-02) The pivotal CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial has been activated and one patient has been treated.FDA approved a detailed protocol amendment to sh...