ADR Biomedical Holdings Inc.
Notice Regarding Approval for Insurance Coverage of the Male Stress Urinary Incontinence Treatment Medical Device “Celusion Cell Therapy Kit SUI”
The Company announces that Celusion Cell Therapy Kit SUI, a male stress urinary incontinence treatment medical device manufactured and marketed by subsidiary ADR Therapeutics, has been formally approved for insurance coverage as of September 16, 2026, following a provisional designation of insurance coverage category C2 and subsequent provisional notification of the insurance reimbursement price.
Key Figures
- Insurance Coverage Category: C2 (new function/new technology)
- Provisional Insurance Reimbursement Price: 860,000 yen
- Formal Approval Date: 2026-09-16
- Deliberative Body: Central Social Insurance Medical Council Plenary Session (No. 657)
- Publication Date: 2026-09-16
AI要約
News Summary
ADR Biomedical Holdings Inc. announces that Celusion Cell Therapy Kit SUI, a male stress urinary incontinence treatment medical device developed by its subsidiary ADR Therapeutics, was provisionally designated as insurance coverage category C2 (new function/new technology) and, following deliberation by the Central Social Insurance Medical Council, has been formally approved for insurance coverage.
Future Impact and Schedule
With formal approval for insurance coverage, the product is expected to become eligible for reimbursement, which will enable market distribution and price setting. Specific sales impact and timing of introduction are unknown, but since the approval process has completed and been announced, sales commencement and application of the reimbursement price may proceed going forward.
ADR Biomedical Holdings Inc.
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