Medtronic Inc. (NYSE:MDT) spinout Inspire Medical Systems Inc. received the go-ahead from regulators to sell its obstructive sleep apnea device in Europe and test it for the U.S. market.
CE Mark approval in hand, the Maple Grove, Minn.-based device developer expects to mount a market development push for its Inspire upper airway stimulation therapy in Europe near year-end 2011.
The company has also received a Food & Drug Administration nod to begin testing the device for safety and efficacy among patients with moderate or severe obstructive sleep apnea at several medical centers in the U.S. and Europe. Implantations in U.S. patients enrolled in a pivotal trial are expected to begin early next year.
Results of the pivotal trial likely will form the base for U.S. market approval of the device, which delivers a gentle electrical pulse during sleep to restore tone to the muscles that hold the tongue in place. More than 15 million adults in the United States alone are believed to suffer from obstructive sleep apnea, a condition in which the airway relaxes too much during sleep, cutting off breathing.
Several therapies for OSA, including continuous positive airway pressure systems, can significantly affect the lifestyles and comfort of patients and their bed partners, Inspire Medical president and CEO Tim Herbert said in prepared remarks.
“As a result, patient compliance for these front-line therapies is sub-optimal,” Herbert said. “A substantial number of patients suffering from OSA are looking for a new approach to treat this challenging condition.”
“Inspire’s stimulation therapy is well-suited to address the root cause of OSA for many patients, which is a decrease in airway muscle tone during sleep,” said Dr. Paul Van de Heyning, director of otolaryngology and head and neck surgery at the University of Antwerp in Belgium, who recently implanted the first patient in the company’s pivotal STAR trial.
Minnesota has become a bit of a hub for startups looking to correct breathing-related sleeping problems. Cardiac Concepts Inc. in Minnetonka recently raised $27.2 million for its pacemaker-like device that uses electricity to treat sleeping disorders. And Apnex Inc. in St. Paul is developing an implantable device that uses electricity to open airways closed by obstructive sleep apnea.
Inspire Medical last raised money in 2009 — a $17 million B Round led by Synergy Life Science Partners that included existing investors Kleiner Perkins Caufield & Byers, U.S. Venture Partners, Medtronic and Dr. Glen Nelson (through GDN Holdings).