Inspire Medical Systems said this week it won approval from Japan’s Ministry of Health, Labour and Welfare for its Inspire therapy system, now cleared to treat moderate to severe obstructive sleep apnea.
The Inspire system is a closed-loop, pacemaker-like system designed to stimulate nerves to keep airways open during sleep to treat obstructive sleep apnea.
Inspire Medical Systems said that it will pursue reimbursement in the country, with plans to launch the device in the second half of next year.
“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. 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. We would like to thank Cobridge Co., Ltd., a leading regulatory affairs consulting firm that provides comprehensive product registration services for medical products in Japan, for their outstanding efforts and expertise in assisting us to gain approval in Japan,” prez & CEO Tim Herbert said in a press release.
Last month, Inspire Medical Systems up-sized its initial public offering to $108 million, or some $124 million if the underwriters option is exercised in full.