BioCardia Announces Clarification and Next Steps on its Autologous CardiAMP Cell Therapy Programs - Seite 2

“We have three synergistic clinical programs for the treatment of ischemic heart disease utilizing the leading transendocardial delivery platform which we also developed,” continued Peter Altman. “Our expectation is that we can move all of these programs through significant milestones in the next year on less capital than we have utilized in previous years.”

Anticipated Upcoming Milestones and Events:

• BCDA-01: CardiAMP Cell Therapy for Heart Failure Phase III Trial
  • Q3 2023: Clarity on Second Pivotal Study Design
  • Q4 2023: Japan PMDA Formal Consultation

• BCDA-02: CardiAMP Cell Therapy for Chronic Myocardial Ischemia Phase III Trial
  • Q4 2023: Completion of Roll-in Cohort and Transition to Randomized Pivotal Trial
• BCDA-03: NK1R+ MSC Allogeneic Cell Therapy in ischemic HFrEF Phase I/II Trial
  • Q3 2023: First Patient Enrolled
• Helix Biotherapeutic Delivery System
  • Q4 2023: Completion of Enrollment in Partner CellProthera’s EXCELLENT Trial
  • Q4 2023: Update on Licensing / Partnerships

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About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the Company’s biotherapeutic platforms that enable four product candidates in development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS Reimbursement. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information visit: www.BioCardia.com.

Forward Looking Statements:

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to future data analysis, future protocol submissions to FDA, anticipated milestones and events, conclusions of results based on interim data generated by the CardiAMP Heart Failure statistics core, the likelihood of safety and patient benefit, and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release.