Inspire Medical Systems Announces Regulatory Approval of Inspire Therapy for Treatment of Moderate to Severe Obstructive Sleep Apnea in Japan

Inspire Medical Systems (NYSE:INSP) a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea (OSA), today announced that Japan’s Ministry of Health, Labour and Welfare has approved its Inspire therapy to treat moderate to severe OSA.

As quoted in the press release:

Inspire therapy is an innovative, closed-loop, minimally invasive solution that provides comfort and convenience, resulting in high compliance for patients with moderate to severe OSA. The safety and efficacy of Inspire therapy is supported by a significant body of clinical data, which includes a publication in the New England Journal of Medicine and more than 50 peer-reviewed publications. Inspire obtained CE Mark for its Inspire therapy in 2010 and U.S. Food and Drug Administration approval in 2014.  To date, physicians have treated more than 3,000 patients worldwide with Inspire therapy.

“With this approval for our Inspire therapy, we are able to provide patients and physicians in Japan with a new alternative for the treatment of moderate to severe OSA,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems.  “Our Inspire therapy is supported by a strong body of evidence with more than five years of clinical experience demonstrating the efficacy and safety of our therapy for patients and physicians. We look forward to commercializing our Inspire therapy in Japan.”

Click here to read the full press release.