BioCardia

BioCardia (Nasdaq:BCDA) announced today that it completed the submission of its CardiAMP cell therapy system to Japan’s regulatory authorities.

Sunnyvale, California-based BioCardia submitted CardiAMP to Japan’s Pharmaceutical and Medical Device Agency (PMDA). It seeks approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF). It expects a formal consultation with PMDA to review the submission within three months. This would mark BioCardia’s third consultation with PMDA.

BioCardia designed CardiAMP to use a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. It potentially stimulates the body’s natural healing response. The company’s multicenter clinical trial screened for cell characteristics in order to improve patient outcomes — marking the first such trial.

CardiAMP incorporates a pre-procedural cell analysis, a hi…

Heart failure therapy developer BioCardia (OTC:BCDA) announced that it is offering shares of common stock worth $11.5 million.

The San Carlos, Calif.-based company is offering nearly 2.9 million shares of its common stock at a $0.001 par value per share.

It is also offering an opportunity for certain purchasers whose purchase would otherwise result in it beneficially owning more than 4.99% of BioCardia’s outstanding common stock to purchase pre-funded warrants exercisable for one share of common stock.

For each pre-funded warrant BioCardia sells, the number of shares of common stock in the offering will be reduced on a one-for-one basis.

As of June 12 when the company put out a prospectus for the offering, its stock on the Nasdaq market traded at $3.45 per share. In late-afternoon trading today, shares of BCDA are down -2% at $3.38 per share. The company does not intend to list the pre-funded warrants on the Nasdaq or any other exchange.