Komori
Occurring Fact3750ADR Biomedical Holdings Inc.Electrical Equipment and Precision Instruments

(Update on Previously Disclosed Matter) Notice Regarding Deliberations by the Central Social Insurance Medical Council on the “Cellution Cell Therapy Kit SUI” Medical Device for Treating Male Stress Urinary Incontinence

The Central Social Insurance Medical Council deliberated on the insurance coverage category C2 and proposed reimbursement price for the subsidiary’s medical device. Formal insurance coverage is expected to be determined following the relevant notices and notifications issued by the Ministry of Health, Labour and Welfare.

Worth reading
30Immaterial
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Neutral
Direction inferred from the company’s description.
Scale
860000
Yen (proposed reimbursement price)
Wording
Avoiding a definitive answer
How definitive the wording is.

Deliberations by the Central Social Insurance Medical Council on the Medical Device for Treating Male Stress Urinary Incontinence, “セルーション セルセラピーキット SUI”

Subject Entity

ADRセラピューティクス株式会社 (a subsidiary of the filing company)

Target Locations / Products

Medical device for treating male stress urinary incontinence, “セルーション セルセラピーキット SUI”

Occurrence16 September 2026 (the date deliberated at the plenary meeting of the Central Social Insurance Medical Council)
This disclosure09/17/2026

Related procedures

Type

Deliberations on insurance coverage by the Central Social Insurance Medical Council

Court or authority

Central Social Insurance Medical Council; Ministry of Health, Labour and Welfare

Impact on Earnings Forecast

The impact of this matter on the performance of the Group is currently under review. The company will promptly disclose any matters that should be made public.

Outlook

Insurance coverage is expected to be finalized following the results of the deliberations and the prescribed procedures, including notices and notifications issued by the Ministry of Health, Labour and Welfare. Formal insurance coverage is scheduled to begin on 1 December 2026, but the effective date will be finalized through notices and notifications issued by the Ministry of Health, Labour and Welfare. After the product is marketed, a post-marketing surveillance study (PMS) covering all cases will be conducted.

Planned follow-up disclosure

The company will promptly disclose the results of the deliberations once they become available.

Event that occurred
ItemDetails
Event nameDeliberations by the Central Social Insurance Medical Council on the Medical Device for Treating Male Stress Urinary Incontinence, “セルーション セルセラピーキット SUI”
Date of occurrence16 September 2026 (the date deliberated at the plenary meeting of the Central Social Insurance Medical Council)
Subject EntityADRセラピューティクス株式会社 (a subsidiary of the filing company)
Target Locations / ProductsMedical device for treating male stress urinary incontinence, “セルーション セルセラピーキット SUI”
Impact on Earnings ForecastThe impact of this matter on the performance of the Group is currently under review. The company will promptly disclose any matters that should be made public.
Type of litigation or proceedingDeliberations on insurance coverage by the Central Social Insurance Medical Council
Court or authorityCentral Social Insurance Medical Council; Ministry of Health, Labour and Welfare
OutlookInsurance coverage is expected to be finalized following the results of the deliberations and the prescribed procedures, including notices and notifications issued by the Ministry of Health, Labour and Welfare. Formal insurance coverage is scheduled to begin on 1 December 2026, but the effective date will be finalized through notices and notifications issued by the Ministry of Health, Labour and Welfare. After the product is marketed, a post-marketing surveillance study (PMS) covering all cases will be conducted.
Planned follow-up disclosureThe company will promptly disclose the results of the deliberations once they become available.
Items this document does not state (16)
Date recognized / date notice receivedCauseAmount of Impact on Business PerformanceAccounting period in which recognizedPlaintiffDefendantDate of filing / date of actionClaim amount / surcharge amountAmount of receivables at risk of non-collection or delayed collectionSuspended operationsScheduled resumption dateInvestigation structureMeasures to prevent recurrenceDirectors' and officers' liabilityVoting rights ownership percentage before the changeVoting rights ownership percentage after the change

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

At the plenary meeting of the Central Social Insurance Medical Council held on 16 September 2026, materials concerning insurance coverage and other matters that included this product were deliberated. Formal insurance coverage is expected to be finalized following the results of the deliberations and the procedures including notices and notifications issued by the Ministry of Health, Labour and Welfare.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
(Update on Previously Disclosed Matter) Notice Regarding Deliberations by the Central Social Insurance Medical Council on the “Cellution Cell Therapy Kit SUI” Medical Device for Treating Male Stress Urinary Incontinence | ADR Biomedical Holdings Inc. (3750) timely disclosure | Komori