ImThera Medical Gets Ethics Committee Clearance

ImThera Medical, has received Ethics Committee clearance to begin human clinical trials in Belgium. The trials will include ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy to treat obstructive sleep apnea (OSA).

The company said that along with the clinical trial approvals, ImThera has received ISO 13485 certification of its quality system as a pre-requisite for the future CE mark application for European commercialisation of medical products.

ImThera’s European clinical trial, a pilot study involving ImThera’s THN sleep therapy system, is expected to publish its first results in the first quarter of 2010.

Marcelo Lima, chairman, president and CEO of ImThera Medical, said: “Our mission is to help moderate-to-severe OSA patients enjoy better lives while substantially reducing health care costs related to serious complications associated with Obstructive Sleep Apnea. The ISO 13485 certification and launch of the pilot study are critical steps in our path to provide a safe and efficacious treatment.”