Regenerative player BioCardia reverse merges to back PhIII in heart failure

Blue stem cells

BioCardia dropped a planned IPO in April. Now, it’s back with a reverse merger into medical device shell company Tiger X Medical. The company will have a combined $23 million in cash to advance a BioCardia cell therapy system in its ongoing Phase III trial to treat heart failure.

Biopharma and diagnostics company Opko Health ($OPK) is slated to become a “significant shareholder” in Tiger X Medical and will serve as an adviser to the business. The resulting company will focus on the BioCardia business and be known by that name; it is slated to trade on the OTC markets.

“Our CardiAMP cell therapy is seeking to address an enormous unmet need – a treatment for heart failure that develops after a patient has had a heart attack,” said BioCardio CEO Dr. Peter Altman in a statement. “The merger will provide resources necessary to continue our Phase III development of CardiAMP.”

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The candidate is autologous--meaning derived from the patient--minimally processed, bone marrow cells. It’s placed via the company’s Helix transendocardial delivery system and the Morph steerable guide and sheath catheter portfolio. These are used in combination to affix the cell therapeutic to the beating heart wall as guided by fluoroscopic imaging. CardiAMP also includes a companion diagnostic to sort out which patients are most likely to benefit from therapy.

The ongoing Phase III clinical trial is a randomized, controlled, 250-patient study at 40 U.S. sites. CardiAMP is also in clinical testing for sub-acute myocardial infarction. BioCardia also has CardiALLO, which uses younger, universal donor mesenchymal stem cells; it’s intended as an option for patients who are not optimal for CardiAMP and is also in clinical testing for heart failure.

CardiALLO may be appropriate for patients who are not optimal candidates for the CardiAMP therapy. Since these are donor cells, this candidate is allogenic.

Tiger X Medical was previously known as Cardo Medical; it was an orthopedic medical device company that discontinued that business in 2010 and sold off its assets in 2011. Its operations have been sustained by royalty income from an asset purchase by Arthrex.

- here is the release

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