ADR Biomedical Holdings said a cell-therapy kit for stress urinary incontinence (SUI), made and sold by one of its subsidiaries, was taken up for deliberation at the 657th general meeting of the Central Social Insurance Medical Council, known as Chuikyo, on September 16. The device treats mild to moderate male stress urinary incontinence caused by urethral sphincter dysfunction after surgery for benign prostatic hyperplasia or prostate cancer.
The draft listing puts the device in reimbursement category C2, reserved for new function and new technology, at a proposed price of ¥860,000 calculated under the cost-calculation method. Chuikyo's materials cross-reference an existing technical fee, K019-2 for autologous fat injection under 50mL on a first session, valued at 22,900 points, as the applicable procedure code. The company had already flagged this price and category on August 7, when it disclosed the preliminary indication from Japan's medical-materials review panel.
Formal insurance coverage is targeted for December 1, but the company is explicit that the date depends on Chuikyo's deliberation results and a subsequent notification from the Ministry of Health, Labour and Welfare. As a condition of manufacturing and sales approval, the subsidiary must run a post-marketing surveillance study covering every patient who uses the device once it reaches the market. ADR Biomedical said the effect on group earnings remains under review, with no figures yet attached to the launch.
The preliminary price indication in August and Chuikyo's formal deliberation in September leave two steps before commercial reimbursement: Chuikyo's deliberation results and the ministry's public notice.