BioCardia Chairman of the Board Letter to Shareholders
November 18, 2016
To the Shareholders of BioCardia:
I welcome you all to the recently reorganized BioCardia, now trading Over-the-Counter under the ticker BCDA. BioCardia has long been an innovator in the forefront of the stem cell treatment of cardiovascular diseases and, though our website and SEC filings detail the scope of our overall activities, I wish to inform you in the broadest sense about our Company and the importance of our Phase 3 trial about to begin for the stem cell treatment of heart failure.
Heart failure affects some 5.7 million Americans, and is a leading cause of hospitalization in patients over the age of 65. Almost a half million Americans are added to this number each year, and the expected mortality is 50% in five years. Our CardiAMP cell therapy has the potential to be the first therapy approved that does not merely slow the progression of the disease, but fundamentally changes its treatment, improving functional capacity, quality of life, and heart function.
The FDA has approved us to begin enrollment of patients in our CardiAMP Phase 3 pivotal, pre-commercial trial using a patient's own cells, administered in the cardiac catheterization lab directly into the heart muscle in cases of serious heart failure following a prior heart attack. The trial is expected to begin in approved centers in late 2016 or early 2017.
After 14 years as a private company, BioCardia is now publicly traded as it pursues the leadership role in cardiovascular cell therapy. Our immediate focus is upon the Phase 3 heart failure trial, but we have a pipeline of biotherapeutic, device, and diagnostic product candidates that all have great promise for the future. We welcome you as investors, and hope you will follow our progress with the enthusiasm and expectation shared by our scientific staff and all of our employees.
Very truly yours,
Simon H. Stertzer M.D., FACP, FACC, FAHA
BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. The Company's current products include the Helix™ transendocardial delivery system and the Morph® steerable guide and sheath catheter portfolio. CardiAMP® and CardiALLO® cell therapies are the company’s biotherapeutic product candidates in clinical development. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
Forward Looking Statements:
This press release contains forward-looking statements as that term is defined under the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, among other things, references to the commencement of our Phase 3 trial, commercialization and efficacy of our products and therapies, the product development timelines of our competitors. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, competition in the industry in which BioCardia operates and overall market conditions, and whether the combined funds will support BioCardia’s operations and enable BioCardia to advance its pivotal Phase 3 CardiAMP cell therapy program. 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.
Investors and Media:
David McClung, Vice President Finance & CFO