EnteroMedics received the European CE Mark Certification for the Maestro RC System, the St. Paul company announced. The CE Mark, granted by the European Commission, is recognized by Australia and other nations.
EnteroMedics previously announced its intention to target approval from regulatory bodies, local governments or agencies in other countries as part of its annual report, and stated it had completed initial steps to both work toward regulatory approval and commercialize the neuroblocking product in Australia. The company is also exploring commercialization opportunities in additional international markets.
CE Mark approval is a prerequisite for Australia’s Therapeutic Goods Administration (TGA) approval. Once TGA approval is obtained, EnteroMedic expects commercial sales of the Maestro system to begin in the second half of 2011. The company has signed a distribution agreement with Australian medical technology distributor Device Technologies Australia.
Maestro RC is an anti-obesity device that uses electricity to suppress hunger by blocking the nerve signals between the brain and stomach. Initial results from the “Empower” studies showed that those implanted with a dummy device lost just as much weight as those using the Maestro device. However, the U.S. Food and Drug Administration approved a new clinical trial called “ReCharge.” EnteroMedics further announced that the new trials were on track. The company hopes to gain FDA approval for the Maestro device in 2012.
EnteroMedics reported a net loss of $17.3 million for the full year 2010, and a net loss of $4 million for the fourth quarter ending Dec. 31, 2010. Much of this was due to the expenses associated with clinical trials, and with the continued development of the vagal-blocking therapy delivered through the Maestro System.
EnteroMedics’ senior vice president and chief financial officer, Greg S. Lea, did not return a phone call for comment.