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 […]
BioCardia
BioCardia raises $8.5M
BioCardia (OTC:BCDA) announced that it entered into a securities purchase agreement for the sale of shares worth approximately $8.5 million. San Carlos, Calif.-based BioCardia’s agreement includes the sale and issuance of an aggregate of nearly 1.8 million shares at an offering price of $4.75 per share, totaling the gross proceeds of approximately $8.5 million before deductions […]
BioCardia announces $11.5m offering
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 […]
BioCardia wins CE Mark renewal for Helix, Morph catheters
BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]
BioCardia registers for $18m offering
BioCardia (NSDQ:BCDA) has registered for an upcoming offering of its common stock, looking to raise approximately $18 millions according to an SEC filing. The company has not yet set a price range for the offering, nor has it stated how many shares it is looking to float. San Carlos, Calif.-based BioCardia did note the closing price […]
Bone adhesive dev Launchpad Medical raises $9m | Medtech Funding Roundup
Launchpad Medical has raised $8.5 million in a new round of equity financing, according to recently posted SEC filings. The Lowell, Mass.-based medtech company is developing the Tetranite injectable, synthetic adhesive solution intended for bone repair. Tetranite is bioresorbable and is designed to provide instant adhesive capabilities to treat fractured bone and to stabilize metal […]
BioCardia submits bid for FDA clearance of Avance transseptal introducer
BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of […]
Google taps ex-Geisinger CEO Feinberg to lead consolidated Google Health biz | Personnel Moves – November 14, 2018
Google (NSDQ:GOOG) has picked up former Geisinger Health CEO David Feinberg to lead its fragmented health divisions under the Google Health moniker, according to a recent CNBC report. The tech giant had been searching for a head for several months, with artificial intelligence head Jeff Dean heavily involved in the process, according to the report. Other […]
BioCardia touts preliminary data from heart failure trial
BioCardia (OTC:BCDA) touted data today from the first 10 patients treated in its Phase III CardiAmp heart failure trial. The company’s investigational therapy uses a patient’s bone marrow cells to trigger the body’s natural ability to heal itself, according to BioCardia. These data are the first to be published from any pivotal trial of a stem […]
Report: Amazon adds MGH cardiologist Majmudar | Personnel Moves – August 21, 2018
Amazon (NSDQ:AMZN) has picked up well-known cardiologist Dr. Maulik Majmudar for a new role within the company as it looks to continue its foray into healthcare, according to a recent CNBC report. The announcement was made by Majmudar himself on Twitter, according to the report, though he did not state what his specific role within the […]
BioCardia wins FDA nod for chronic myocardial ischemia pivotal trial
The FDA has approved a trial to test BioCardia‘s (OTC:BCDA) CardiAMP cell therapy in chronic myocardial ischemia patients with refractory angina. The San Carlos, Calif.-based company could enroll up to 343 patients in the pivotal trial, which is designed to support benefit claims for the cell therapy product without the need for a second confirmatory trial. […]
