Research and development, regulatory approval and insurance reimbursement for a therapeutic app in otolaryngology
First written in FY2023-Q1. 11 of 17 entries say "Advanced", first in FY2024-Q1. Latest entry: FY2026.
1 other company's latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「For the tinnitus treatment app being jointly developed with KYORIN Pharmaceutical Co.,Ltd., the company began a confirmatory study and received a ¥240 million milestone payment upon the first subject beginning to use the app.」
For the tinnitus treatment app, the company began a confirmatory study after completing the specified clinical research and received a ¥240 million milestone payment when the first subject began using the app. - FY2026-H1AdvancedAnnual report
「For the tinnitus treatment app jointly developed with Kyorin Pharmaceutical Co., Ltd., we completed the specified clinical research study, and the results were presented at the 70th Annual Meeting of the Japanese Audiological Society. Going forward, under the agreement concerning joint research and development and sales, we expect to receive milestone payments as development progresses, as well as royalties based on sales after product launch.」
Following completion of the specified clinical research study on the tinnitus treatment app, the results were presented at an academic conference. - FY2025AdvancedAnnual report
「In November 2022, we entered into an agreement with Kyorin Pharmaceutical Co., Ltd. concerning the joint research and development and sale of a treatment app in the otolaryngology field, with the aim of providing a new treatment option for tinnitus. The specified clinical research study (Note 21) has now been completed.」
The tinnitus treatment app progressed from the specified clinical research stage to the completed stage. - FY2025-H1RestatedAnnual report
「For the tinnitus treatment app jointly developed with Kyorin Pharmaceutical Co., Ltd., we are conducting a specified clinical research study. Going forward, under the agreement concerning joint research and development and sales, we expect to receive milestone payments totaling up to ¥500 million as development progresses, as well as royalties based on sales after product launch.」
The company is conducting specified clinical research on the tinnitus treatment app and continues to operate under a framework providing for future milestone payments of up to ¥500 million and royalties after launch. - FY2024-Q3RestatedAnnual report
「For the tinnitus treatment app jointly developed with Kyorin Pharmaceutical Co., Ltd., we began a specified clinical research study and received a ¥100 million milestone payment upon the first subject beginning to use the app. Going forward, under the agreement concerning joint research and development and sales, we expect to receive milestone payments totaling up to ¥500 million as development progresses, as well as royalties based on sales after product launch.」
For the tinnitus treatment app, the company received a ¥100 million milestone payment upon the start of the specified clinical research study and the first subject beginning to use the app, and continues to operate under a framework providing for future milestone payments of up to ¥500 million and royalties after launch. - FY2024-Q2AdvancedAnnual report
「For the tinnitus treatment app jointly developed with Kyorin Pharmaceutical Co., Ltd., we began a specified clinical research study and received a ¥100 million milestone payment upon the first subject beginning to use the app. Going forward, under the agreement concerning joint research and development and sales, we expect to receive milestone payments totaling up to ¥500 million as development progresses, as well as royalties based on sales after product launch.」
For the tinnitus treatment app, the company received a ¥100 million milestone payment upon the start of the specified clinical research study and the first subject beginning to use the app. The cap on future milestone payments has changed from the previous ¥600 million to ¥500 million. - FY2024-Q1AdvancedAnnual report
「On 2 November 2023, we achieved a development milestone under the agreement with Kyorin Pharmaceutical Co., Ltd. concerning the joint research and development and sale of a tinnitus treatment app. This milestone was achieved when the first subject began using the app in the exploratory study. As a result, we expect to receive the ¥100 million development milestone payment stipulated in the agreement.」
The first subject began using the tinnitus treatment app in the exploratory study, resulting in the achievement of a development milestone. The company stated that it expects to receive ¥100 million in connection with this milestone. - FY2023RestatedAnnual report
「Going forward, we expect to receive milestone payments totaling up to ¥600 million from Kyorin Pharmaceutical Co., Ltd. as development progresses, as well as royalties based on sales after product launch.」
The framework for up to ¥600 million in milestone payments and royalties after launch for the tinnitus treatment app developed with Kyorin Pharmaceutical remains in place. - FY2023-Q3RestatedAnnual report
「In November 2022, under an agreement with Kyorin Pharmaceutical Co., Ltd. concerning the joint research and development and sale of a therapeutic app for tinnitus, the Company received an upfront contractual payment of ¥100 million. It expects to receive total milestone payments of up to ¥600 million depending on future development progress and other factors, as well as royalties based on sales after product launch.」
The Company continues to describe the framework for the tinnitus treatment app under its agreement with Kyorin Pharmaceutical Co., Ltd., including the ¥100 million upfront contractual payment, milestone payments of up to ¥600 million, and royalties after launch. - FY2023-Q2RestatedAnnual report
「In November 2022, under an agreement with Kyorin Pharmaceutical Co., Ltd. concerning the joint research and development and sale of therapeutic apps in otolaryngology, the Company received an upfront contractual payment of ¥100 million. It expects to receive total milestone payments of up to ¥600 million depending on future development progress and other factors, as well as royalties based on sales after product launch.」
The Company continues to describe the framework for the therapeutic app in otolaryngology under its agreement with Kyorin Pharmaceutical Co., Ltd., including receipt of the upfront contractual payment, milestone payments of up to ¥600 million, and royalties after launch. - FY2023-Q1First statedAnnual report
「Under this agreement, the Company is jointly pursuing with Kyorin Pharmaceutical Co., Ltd. the research and development of therapeutic apps in the field of otolaryngology, obtaining regulatory approval, and preparations for health insurance reimbursement, and」
The Company first described its objective of pursuing joint research and development of therapeutic apps in otolaryngology with Kyorin Pharmaceutical Co., Ltd., obtaining regulatory approval, and preparing for health insurance reimbursement under their agreement.