BioCardia, Inc. (OTC Pink: BCDA) is engaged in stem cell treatment for cardiovascular diseases. The stem cell company is seeing shares climb 28.46%, during early trading on the holiday-shortened trading on Friday, November 25, 2016. BioCardia, Inc. has seen average daily volume of 279,174 shares. However, volume of 942,895 shares or dollar volume of $313,512, has already exchanged hands on Friday.
BioCardia, Inc. is rallying on Friday, after the company’s chairman of the board recently wrote a letter to shareholders. The letter detailed of company’s recent reorganization from being Tiger X Medical, Inc. through October 2016. The most important takeaway from the letter was the fact that 5.7 million Americans are affected by heart failure. BioCardia, Inc. has developed CardiAMP, which is positioned to be the first therapy to dramatically change the current treatment and survival rates from heart failure. The FDA has given BioCardia, Inc. the approval to begin gathering patients for its Phase 3 clinical trials for the stem cell treatment. The company expected to kick off Phase 3 trials later 2016 or early 2017. Here is the full letter to shareholders from the chairman:
BioCardia, Inc. Press Release:
SAN CARLOS, Calif.–(BUSINESS WIRE)– BioCardia, Inc.:
To the Shareholders of BioCardia:
I welcome you all to the recently reorganized BioCardia, Inc. 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
Chairman of the Board of Directors, BioCardia
About BioCardia, Inc.:
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.