BioCardia Completes Submission of CardiAMP Cell Therapy System in Heart Failure to Japan’s Pharmaceutical Medical Device Agency - Seite 2

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is a developer of two biotherapeutic platforms – the CardiAMP autologous bone marrow derived mononuclear cell therapy for cardiovascular indications, and the NK1R+ allogenic bone marrow derived mesenchymal stem cell therapies for cardiovascular and pulmonary diseases.  These platforms underlie four product candidates, each with the potential to meaningfully benefit millions of patients. Three of these investigational therapies are enabled by the Company’s proprietary biotherapeutic delivery platforms, which the Company also selectively licenses to other biotherapeutic development firms.  

Upcoming Anticipated Catalysts:

• BCDA-01 Data Safety Monitoring Board Review, July 12, 2023
• BCDA-03 First Patient Enrolled, July 2023
• BCDA-01 PMDA Formal Consultation, September 2023
  

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, references to the Company’s investigational product candidates, efforts in ongoing regulatory discussions with the PMDA towards approval of the CardiAMP Cell Therapy System for the indication of ischemic HFrEF, future Data Safety Monitoring Board reviews and patients enrolled in BCDA-03. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. For information on the factors that could materially affect these forward-looking statements, please see BioCardia’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors.” As a result of these and other factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Media Contact:
Anne Laluc, Marketing
Email: [e-mail]
Phone: [phone]

Investor Contact:
David McClung, Chief Financial Officer
Email: [e-mail]
Phone: [phone]