Komori
Other Disclosures3750ADR Biomedical Holdings Inc.Electrical Equipment and Precision Instruments

Notice regarding the preliminary indication of the insurance coverage category and reimbursement price for the medical device “Cellution Cell Therapy Kit SUI” for treating male stress urinary incontinence

The Company has received preliminary notification of the insurance coverage category and reimbursement price for a medical device for treating male stress urinary incontinence for which its subsidiary has obtained manufacturing and marketing approval. The coverage and price will be formally determined following future procedures, including notification by the Ministry of Health, Labour and Welfare.

Worth reading
59In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
860000
Japanese yen (insurance reimbursement price, preliminary indication)
Wording
Avoiding a definitive answer
How definitive the wording is.

Announced details

Cellution Cell Therapy Kit SUI
Applicable field (uses covered by this announcement)

Mild to moderate male stress urinary incontinence caused by urinary sphincter dysfunction occurring after surgery for benign prostatic hyperplasia or prostate cancer, in patients for whom behavioral therapy and drug therapy are ineffective or insufficiently effective.

What the company reported numerically
Quantitative Effects

Estimated peak eligible patient population: 2,118.

Relationship between the counterparty and the company
ADR Biomedical Holdings Inc.3750
Relationship with the Company

The Company's subsidiary, ADRセラピューティクス株式会社, manufactures and markets this product, and the Company Group is proceeding with the insurance coverage application process.

CounterpartyMedical Materials Expert Organization of the Central Social Insurance Medical Council (保材専)

The Medical Materials Expert Organization of the Central Social Insurance Medical Council. It is described as the organization that deliberates on the categories and prices of medical materials before formal notification and other procedures by the Ministry of Health, Labour and Welfare.

Offering price

Insurance reimbursement price (preliminary indication): ¥860,000. The price was calculated using the cost-based pricing method.

Impact on Business Performance

The impact on consolidated results for the fiscal year ending March 2027 is currently under review, taking into account the timing of formal insurance coverage, the implementation plan for the post-marketing study, and the product supply structure.

The company does not address Contract Value.

Source (materials cited by the company)

National Cancer Center Cancer Information Service (National Cancer Registry); Medical Materials Expert Organization materials

Announced details
ItemDetails
Names of Products / Services CoveredCellution Cell Therapy Kit SUI
CounterpartyMedical Materials Expert Organization of the Central Social Insurance Medical Council (保材専)
Counterparty overviewThe Medical Materials Expert Organization of the Central Social Insurance Medical Council. It is described as the organization that deliberates on the categories and prices of medical materials before formal notification and other procedures by the Ministry of Health, Labour and Welfare.
Relationship with the CompanyThe Company's subsidiary, ADRセラピューティクス株式会社, manufactures and markets this product, and the Company Group is proceeding with the insurance coverage application process.
Offering priceInsurance reimbursement price (preliminary indication): ¥860,000. The price was calculated using the cost-based pricing method.
Applicable areaMild to moderate male stress urinary incontinence caused by urinary sphincter dysfunction occurring after surgery for benign prostatic hyperplasia or prostate cancer, in patients for whom behavioral therapy and drug therapy are ineffective or insufficiently effective.
Quantitative EffectsEstimated peak eligible patient population: 2,118.
Impact on Business PerformanceThe impact on consolidated results for the fiscal year ending March 2027 is currently under review, taking into account the timing of formal insurance coverage, the implementation plan for the post-marketing study, and the product supply structure.
SourceNational Cancer Center Cancer Information Service (National Cancer Registry); Medical Materials Expert Organization materials
Items this document does not state (9)
Contract ValueContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleUsage history

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.

Following deliberations by the Medical Materials Expert Organization of the Central Social Insurance Medical Council, the Company received preliminary notification of the insurance coverage category and reimbursement price.

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.
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Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice regarding the preliminary indication of the insurance coverage category and reimbursement price for the medical device “Cellution Cell Therapy Kit SUI” for treating male stress urinary incontinence | ADR Biomedical Holdings Inc. (3750) timely disclosure | Komori