Inspire Medical Systems Inc has entered into an exclusive distribution agreement with Japan Lifeline Co Ltd (JLL), an independent full-service distributor of medical devices, to commercialize Inspire therapy in Japan. The parties entered into this agreement following successful completion of reimbursement review of Inspire therapy by the Minister of Health Labour and Welfare (MHLW). Formal listing of Inspire therapy in the Japan National Health Insurance Payment Listing is expected to occur in June 2021.

Inspire therapy, an implantable device for obstructive sleep apnea, received regulatory approval in Japan in 2018. Inspire and Japan Lifeline Co Ltd worked closely with the Minister of Health Labour and Welfare to advance the reimbursement application for Inspire therapy, which was approved by an expert panel this month. The formal listing of Inspire therapy is the final step prior to the training of centers and physicians in Japan.

“We are thrilled to provide patients and physicians in Japan with a clinically validated treatment option for moderate to severe OSA,” says Tim Herbert, president and CEO of Inspire Medical Systems, in a release. “Inspire therapy is supported by a strong body of evidence and years of clinical experience demonstrating the efficacy and safety of our therapy. Through our partnership with JLL, Inspire therapy has the potential to address the significant unmet need in the treatment of OSA patients in Japan. We are grateful for the dedicated efforts of the MHLW and authorities in Japan in advancing our reimbursement application forward. Further, we are pleased to partner with JLL, a leader in the distribution of innovative medical technologies in Japan.”

“Our team at JLL has worked closely with the Japan authorities and our partners at Inspire in preparation for this significant event,” says Keisuke Suzuki, president and CEO of Japan Lifeline Co Ltd, in a release. “We are proud to have the opportunity to make this important therapy commercially available to patients in need and to focus our efforts on a successful product launch in Japan.”

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