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Thursday, October 29, 2020

BioCardia Inc (OTCMKTS:BCDA) Launches on Phase 3 Trial News

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BioCardia Inc (OTCMKTS:BCDA) is a stock that’s been launching ever since the company put out a recent communication in the form of a Letter to Shareholders from the Chairman of the Board of Directors. In that letter, the following key revelation hit the market: “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.”

Overall, we’ve witnessed nearly 160% piled on for shareholders of the stock during the trailing month. In addition, the name has registered increased average transaction volume recently, with the past month seeing greater than 150% beyond its prior sustained average level This is particularly important with a float in play that’s relatively small — not even 18M shares. This type of thing is something to watch out for: a restricted trading float and a jump in trading volume can crimp supply and push share prices higher.

BioCardia Inc (OTCMKTS:BCDA) bills itself as a clinical-stage regenerative medicine company that develops therapeutics for cardiovascular diseases.

The company offers the Helix biotherapeutic delivery system product line that offers a catheter system for the local delivery of cells, gene, and protein therapeutics to the heart; and the Morph vascular access product line, which offers catheter products for interventional medicine.

Its lead therapeutic candidate is the CardiAMP Cell Therapy System that is in Phase III pivotal trial for ischemic systolic heart failure. The CardiAMP Cell Therapy System comprises cell potency screening test, a point of care cell processing platform, and a biotherapeutic delivery system.

BioCardia, Inc. is also developing CardiALLO Cell Therapy System, which is an allogeneic mesenchymal stem cell-based product candidate from universal donors for use in multiple unrelated patients. The company was formerly known as BioCardia DeviceCo, Inc. and changed its name to BioCardia, Inc. in August 2002.

BioCardia, Inc. was incorporated in 2002 and is based in San Carlos, California.

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According to the company’s press materials, “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.”

The Letter to Shareholders that appears most directly responsible for BCDA stock’s recent 120% 4-day rip also contained some other key notes for the market.

“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 company also noted that “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.”

At this time, carrying a capital value in the market of $83.5M, BCDA has a decent store ($552.00k) of cash on the books, alongside total assets greater than $19M, which must be weighed relative to an appreciable load ($6.91M) of total accumulated debt. This is not a pretty balance sheet. But that is often the case with early-stage biotechs. The beauty of being at a phase 3 trial is that, if results start to come in meeting milestones, more cash will be all-too-easy to come by. We will follow up on this exciting story as details become available. For continuing coverage on shares of $BCDA stock, as well as our other hot stock picks, sign up for our free newsletter below and get our next hot stock pick!

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