Business
BioCardia Reports 2019 Third Quarter Financial Results and Business Highlights
SAN CARLOS, Calif., Nov. 19, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for
About this update from Biocardia, Inc.
[{"type":"text","content":"SAN CARLOS, Calif., Nov. 19, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the third quarter 2019 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2019 with the Securities and Exchange Commission.\n Update on Ongoing CardiAMP™ Autologous Cell Therapy Pivotal Heart Failure Trial:The company recently received FDA approval for an IDE supplement for the Phase III pivotal CardiAMP Heart Failure Trial of its lead therapeutic candidate. This will enable patients in the control group to cross over to CardiAMP treatment once their follow-up for the CardiAMP Trial has been completed. The IDE supplement also enables BioCardia to cover all out-of-pocket insurance co-pays for patients with Medicare coverage, so their participation in the trial will now be free. These two areas were previously barriers to participation for patients, who were eager to receive the therapy and less interested in being in the control arm, and were also responsible for their own co-pays. The company expects these changes, coupled with site-specific action plans, to further accelerate trial enrollment, which currently stands at 58 patients enrolled to date at 24 world class U.S. centers. Third Quarter 2019 Business Highlights: Positive DSMB recommendation for CardiAMP Heart Failure Trial – The independent Data Safety Monitoring Board completed its prespecified data review for the Phase III pivotal CardiAMP Heart Failure Trial and issued a positive recommendation to continue the trial, as planned. They indicated there were no safety concerns associated with its review of safety follow-up results on 35 patients and all additional data available on all 50 patients enrolled in the trial as of August 31, 2019.New European patent for CardiAMP diagnostic assay – The European Patent Office issued the company a new patent for “Methods of Measuring Potential for Therapeutic Potency and Defining Dosages for Autologous Cell Therapies.” This patent addresses the problem of patient cell variability and high manufacturing costs associated with typical autologous cell therapy by identifying a specific biomarker signature in a patient’s bone marrow that is utilized in t...