Regulatory approval for a digital therapeutic app for insomnia and preparations for insurance reimbursement
First written in FY2022-Q2. 8 of 24 entries say "Advanced", first in FY2022-Q2. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026AchievedAnnual report
「Reimbursement listing was approved in May 2026, and sales began in June 2026.」
For the insomnia disorder treatment app, reimbursement listing was approved and sales began, moving the previous targets for insurance coverage and launch into the achievement stage. - FY2026-H1RestatedAnnual report
「The Company obtained marketing authorization from the Ministry of Health, Labour and Welfare for the Application on 15 February 2023 and subsequently applied in August 2024 for approval of partial changes to the approved marketing authorization particulars. The Ministry of Health, Labour and Welfare approved this application on 2 September 2025, and the Company submitted its request for reimbursement coverage on 4 September. Preparations for reimbursement listing and product launch are currently proceeding in parallel.」
Following approval of the partial changes to the approved marketing authorization particulars and submission of the request for reimbursement coverage, preparations for reimbursement listing and product launch continue. - FY2025AdvancedAnnual report
「The Ministry of Health, Labour and Welfare approved this application on 2 September 2025, and the Company submitted its request for reimbursement coverage on 4 September. Preparations for reimbursement listing and product launch are currently proceeding in parallel.」
The application submitted in August 2024 for approval of partial changes to the approved marketing authorization particulars was approved on 2 September 2025, and the request for reimbursement coverage was submitted on 4 September. The process progressed to the preparation stage for reimbursement listing and product launch. - FY2025-H1RestatedAnnual report
「The Company obtained marketing authorization from the Ministry of Health, Labour and Welfare for the Application on 15 February 2023 and had been proceeding with reimbursement listing procedures. However, following the review of the reimbursement system for medical materials in the fiscal 2024 medical fee schedule revision, the Company applied in August 2024 for approval of partial changes to the approved marketing authorization particulars and is proceeding with preparations for reimbursement coverage and product launch.」
Following the deferral of reimbursement listing, preparations for reimbursement coverage and product launch continue after the application in August 2024 for approval of partial changes to the approved marketing authorization particulars. - FY2024SoftenedAnnual report
「Although reimbursement listing was deferred during discussions on the fiscal 2024 medical fee schedule revision, the Company consulted with relevant authorities and submitted an application in August 2024 for approval of partial changes to the approved marketing authorization particulars in order to resume the reimbursement listing process.」
Because reimbursement listing was deferred, the process moved from preparations for reimbursement coverage and launch to the stage of applying for approval of partial changes to the approved marketing authorization particulars in preparation for resuming the process. - FY2024-Q3RestatedAnnual report
「The Company obtained marketing authorization from the Ministry of Health, Labour and Welfare for the Application on 15 February 2023 and is currently preparing for reimbursement coverage and product launch.」
Following the receipt of marketing authorization as a medical device, preparations for reimbursement coverage and product launch continue. - FY2024-Q2RestatedAnnual report
「The Company obtained marketing authorization from the Ministry of Health, Labour and Welfare for the Application on 15 February 2023 and is currently preparing for reimbursement coverage and product launch.」
Following the receipt of marketing authorization as a medical device, preparations for reimbursement coverage and product launch continue. - FY2024-Q1RestatedAnnual report
「The Company obtained marketing authorization from the Ministry of Health, Labour and Welfare for the Application on 15 February 2023 and is currently preparing for reimbursement coverage and product launch.」
Following the receipt of marketing authorization as a medical device, preparations for reimbursement coverage and product launch continue. - FY2023AdvancedAnnual report
「The Company is currently consulting with relevant authorities, including the Medical Device Review Division and the Economic Affairs Division of the Ministry of Health, Labour and Welfare, toward inclusion in the reimbursement system.」
Following the receipt of marketing authorization as a medical device, the process progressed to consultations with relevant authorities toward reimbursement listing and preparations for launch. - FY2023-Q3AdvancedAnnual report
「On 15 February 2023, the Company obtained marketing authorization from the Ministry of Health, Labour and Welfare for the therapeutic application for insomnia disorder.」
The process progressed from the previous stage of submitting the application and responding to the review to obtaining marketing authorization as a medical device on 15 February 2023. - FY2023-Q2AdvancedAnnual report
「At the Ministry of Health, Labour and Welfare’s Committee on Medical Devices for Programmed Medical Devices, held in December 2022, the therapeutic application for insomnia disorder received approval in principle for marketing authorization as a medical device.」
The disclosure describes the stage at which, following submission of the application for regulatory approval, marketing authorization as a medical device received approval in principle at the Ministry of Health, Labour and Welfare committee meeting in December 2022. - FY2023-Q1AdvancedAnnual report
「Under the sales partnership agreement with Shionogi & Co., Ltd. concerning the therapeutic application for insomnia disorder, the Company, as the marketing authorization holder for the Application, is responding to the PMDA review as it proceeds with development and seeks regulatory approval.」
The disclosure describes the stage of responding to the PMDA review following submission of the application for regulatory approval. - FY2022RestatedAnnual report
「The clinical trial achieved its primary endpoint, and in February 2022 the Company submitted an application to the Ministry of Health, Labour and Welfare for marketing authorization.」
The application remains submitted, and preparations for obtaining approval and inclusion in the reimbursement system continue. - FY2022-Q3RestatedAnnual report
「Based on the results of the clinical trial, the Company submitted an application for regulatory approval of the Application, product name “SUSMED Insomnia Disorder Therapeutic Application Med CBT-i.”」
The application for regulatory approval has been submitted, and preparations for obtaining approval and reimbursement continue. - FY2022-Q2AdvancedAnnual report
「As the marketing authorization holder for the Application, the Company is proceeding with preparations for its development, regulatory approval and reimbursement.」
Following achievement of the primary endpoint in the clinical trial, the Company submitted an application for regulatory approval of the Application. Obtaining approval and reimbursement continue to be stated as objectives.