Reimbursement Review of Inspire Therapy Completed by Japan Ministry of Health Labour and Welfare (MHLW); National Health Insurance Payment Listing Expected in June 2021
Initial Inspire Therapy Implants in Japan Anticipated to Occur in Second Half of 2021
MINNEAPOLIS, Minn., April 26, 2021 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) ("Inspire"), 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 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 (MLHW). Formal listing of Inspire therapy in the Japan National Health Insurance Payment Listing is expected to occur in June 2021.
Inspire therapy received regulatory approval in Japan in 2018. Inspire and JLL worked closely with the MHLW in order 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,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “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,” stated Keisuke Suzuki, President and CEO of Japan Lifeline Co. Ltd., “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.”
Japan is one of the largest markets for medical technologies in the world and recent published data indicates that approximately 9 million Japanese have an Apnea Hypopnea Index (“AHI”) greater than 15, which qualifies them at least as moderate OSA patients.
About Inspire Medical Systems
Inspire is a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.
For additional information about Inspire, please visit www.inspiresleep.com.
About Japan Lifeline Co., Ltd.
Japan Lifeline is a manufacturer and full-service distributor of medical devices specializing in the cardiovascular space with a track record of about 40 years in Japan. The company's proprietary products developed based on its wealth of experience of arrhythmias and cardiovascular surgery have been highly evaluated, and the company holds a top-class market share in Japan. Japan Lifeline is a publicly traded company, ticker symbol 7575 (TSE 1st Section).
For more information about Japan Lifeline, please visit www.japanlifeline.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding the expected timing of the formal listing of Inspire therapy in the Japan National Health Insurance Payment Listing and the first implants of the Inspire therapy in Japan, and our ability to realize the anticipated benefits of the planned commercialization of Inspire therapy in Japan. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ “future,” “outlook,” “guidance,” ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential,’’ ‘‘continue,’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.
These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release can be found under the captions “Risk Factors” and "Management's Discussion and Analysis of Financial Condition and Results of Operations“ in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC, and as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website at www.inspiresleep.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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