Business
BioCardia Reports Third Quarter 2022 Business Highlights and Financial Results
SUNNYVALE, Calif., Nov. 09, 2022 (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":"SUNNYVALE, Calif., Nov. 09, 2022 (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 third quarter of 2022 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2022 with the United States Securities and Exchange Commission (SEC). The Company will also hold an update conference call today at 4:30 PM ET. Following management’s formal remarks, there will be a question-and-answer session. “Our team has delivered solid progress on our programs and business development initiatives this past quarter,” said Peter Altman, Ph.D., President, and CEO. “Recent data from our pivotal CardiAMP autologous cell therapy in heart failure trial (BCDA-01) is compelling. The Data Safety Monitoring Board’s support for implementing an adaptive design based on the data in hand is encouraging and we continue to drive toward implementing an adaptive statistical analysis plan in the coming months with the involvement of the study’s executive steering committee and the FDA. An adaptive statistical analysis plan will enable the study to be powered based on the ongoing trial data and may allow earlier study readout. This is coupled with excitement around early clinical outcomes in our roll-in phase of the pivotal chronic myocardial ischemia program with CardiAMP autologous cell therapy (BCDA-02), the anticipated FDA approval in December of our recently filed IND for our allogeneic “off the shelf” cell therapy for heart failure (BCDA-03), and our expected treatment of a first patient with the same cells manufactured in our new facility for the treatment of acute respiratory distress (BCDA-04). We have a modest burn rate due to our program synergies, with nondilutive funding from CMS and have active business development initiatives to strengthen our balance sheet well underway.” RECENT BUSINESS HIGHLIGHTS: CardiAMP® Autologous Cell Therapy The Company’s lead platform, CardiAMP cell therapy, is an autologous cell therapy being advanced for two actively enrolling indications in pivotal clinical trials: ischemic heart failure and chronic myocardial ischemia, with an estimated combined 1.6 million patients in a total addressable US market. The CardiAMP Cell Therapy Heart Fai...