EVAHEART MEDICAL USA, Inc
EVAHEART MEDICAL USA, Inc. (“EMUSA”) is a subsidiary of a Japanese medical device company, Sun Medical Technology Research Corporation (“Sun Medical”) located in Suwa City, Nagano, Japan. EMUSA was established in 2002 as a subsidiary of Sun Medical to gain regulatory approval and commercialize the EVAHEART Left Ventricular Assist System in the North American market. In 2004, EMUSA began assisting Sun Medical with engineering tasks such as durability testing and product development activities. The Company provided assistance as requested for developing a training program, manual development, usability testing, review of pre-clinical testing, protocol development and engineering assistance. In January, 2009, EMUSA submitted an IDE application for a bridge-to-transplant (BTT) clinical trial for the EVAHEART LVAS. In December, the FDA approved a study which the Company hopes to initiate during the summer of 2010.