Announcement Regarding Insurance Coverage Decision for Celeration Cell Therapy Kit SUI

Section heading

ADR Therapeutics Inc. has received manufacturing and sales approval forセルレーション セルセラピーキット SUI, which was listed in the JSCIC deliberation materials and preliminarily categorized under insurance coverage as C2 (new function/new technology). The provisional reimbursement price is expected to be 860,000 yen, with cost calculation method and K019-2 “Autologous fat injection” under 50 mL, 1st case treated as a corresponding technology fee. The formal insurance coverage timing is scheduled for December 1, 2026. Going forward, final determination will be made after deliberation results and Ministry of Health, Labour and Welfare notices; after coverage, post-marketing surveillance (PMS) will be conducted for all cases. The direct impact on performance is under assessment, and additional information will be disclosed if available.

Section 2 heading

As next steps toward formal coverage decision, once the JSCIC deliberation results and MOH notices are finalized, the exact start date of coverage will be formally confirmed. After coverage, PMS is conditioned, and the impact on sales and profit from market introduction remains undecided at this time. Current disclosure pertains to deliberation status and future disclosure policy.