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 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Inc.","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-10-15","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/10\/3750-20261015-01.pdf","jir_short_summary":"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.","jir_summary":"### News Summary\nADR 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.\n\n### Future Impact and Schedule\nWith 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.","jir_financial_highlights":"Insurance Coverage Approval: Formal Approval (Transition from provisional notification to formal approval)","jir_category":"","jir_hashtags":"#ADRBiomedical, #InsuranceCoverageApproval, #CelusionCellTherapyKitSUI","jir_key_figures":"Insurance Coverage Category: C2 (new function\/new technology)\nProvisional Insurance Reimbursement Price: 860,000 yen\nFormal Approval Date: 2026-09-16\nDeliberative Body: Central Social Insurance Medical Council Plenary Session (No. 657)\nPublication Date: 2026-09-16","jir_meta_title":"ADR Biomedical Holdings Inc. \u2014 Formal Insurance Coverage Approval for Celusion SUI\uff5cSeptember 2026","jir_meta_description":"Formal approval granted for insurance coverage of Celusion Cell Therapy Kit SUI developed by an ADR group subsidiary. Summary of the process from provisional category C2 designation and provisional reimbursement price of 860,000 yen through to formal approval, and potential impact on future sales rollout.","jir_og_title":"ADR Biomedical Holdings Inc. \u2014 Formal Insurance Coverage Approval for Celusion SUI\uff5cSeptember 2026","jir_og_description":"Celusion SUI has received formal insurance coverage approval following a provisional C2 designation and provisional reimbursement price notification. Review of the approval process and implications for market rollout.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":59367,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"disclosure_update","footnotes":""},"sector":[],"importance":[],"class_list":["post-131853","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n