Carmat gains on French approval to resume artificial heart trial

Carmat (EPA:ALCAR) shares are up today after the company said French regulators approved the resumption of a clinical trial for its artificial heart. France’s national device & drug agency, the Agence Nationale de Sécurité du Médicament, said late yesterday that “Carmat has provided the elements allowing for the resumption of the trial, meeting satisfactory conditions of safety and risk control.” The ANSM suspended the the trial in December 2016 after a 5th patient died; in February Carmat said the patient’s death was not related to a problem with the device. The company rescinded its bid for resuming the trial to gather more data for the agency, before re-applying to start it up again. The 5th deceased patient was the 1st in the study’s pivotal phase; the ANSM said Carmat can implant the device in 5 more patients for the Phase III portion. Carmat said it plans to expand the study to other nations and intends to open a new, more-automated plant to manufacture the device. “The site should be operational by the end of the year and would also eventually enable the manufacturing requirements for the prosthesis’ 1st commercial launch phases to be met,” the company said. Carmat in August 2016 launched the pivotal phase of the trial for the bioprosthetic artificial heart, hoping to use the data to win CE Mark approval in the European Union. Carmat’s 1st transplant patient, a 76-year-old man, died in March 2014, 2½ months...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Wall Street Beat Artificial Organs Carmat Inc. Source Type: news