Business
BioCardia Reports First Quarter 2020 Financial Results and Business Highlights
SAN CARLOS, Calif., May 15, 2020 (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., May 15, 2020 (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 first quarter of 2020 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2020 with the Securities and Exchange Commission on May 15, 2020.\n First Quarter 2020 Business Highlights: CardiAMP® Heart Failure Trial received positive review by Data Safety Monitoring Board - In March 2020, the independent DSMB completed a prespecified review and issued a positive recommendation to continue the Company’s Phase III pivotal CardiAMP Heart Failure Trial as planned, since they found no safety concerns. To date, 74 patients have been enrolled in the study at 25 world class centers throughout the U.S.FDA clearance received for guide catheter used in cell therapy delivery - The Company received FDA clearance for the Morph® DNA Deflectable Guide Catheter in January 2020. The Morph DNA is designed to enhance the procedural control of the Helix™ Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart. The device is designed to be virtually whipless around curves, offer bidirectional deflection within the heart, and further enhance both control and ease of use for physicians.Three new patents granted in U.S. and Asia – Also in January 2020, the Company was issued three new patents. An additional U.S. patent now protects its proprietary cell potency assay used to identify candidates for CardiAMP cell therapy, in addition to an existing European patent. Japan and China both issued new patents covering the Company’s biotherapeutic delivery approaches using radial artery access for trans-endocardial delivery of cardiac cell therapy. “We have started the year off well by achieving key regulatory and clinical milestones and adding to our already-strong intellectual property portfolio,” said BioCardia Chief Executive Officer Peter Altman, PhD. “While CardiAMP Heart Failure Trial cases have been paused as clinical sites care for COVID-19 patients, sites continue to screen candidates and there are patients scheduled for treatment in the second quarter as centers resume elective procedures.” First Quarter 2020 Financial Results: Net loss was $4.6 million fo...