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BioCardia reports Q3 EPS (17c), consensus (23c)
The Fly

BioCardia reports Q3 EPS (17c), consensus (23c)

Reports Q3 revenue $212,000, consensus $70,000. "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 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, the anticipated FDA approval in December of our recently filed IND for our allogeneic "off the shelf" cell therapy for heart failure, and our expected treatment of a first patient with the same cells manufactured in our new facility for the treatment of acute respiratory distress. 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."

Published first on TheFly

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