PAXMAN have gained Shonin approval for the market-leading PAXMAN Scalp Cooling system in Japan.
The market approval was granted by Japanese regulatory bodies, similar to the FDA in the USA and based on a successful clinical evaluation at five leading Japanese cancer clinics. This also covered a much larger patient group compared to PAXMAN’s earlier market certification (Ninsho).
As the world’s second largest single market for medical technology products, Japan has approximately 1 million new cancer cases every year. PAXMAN are keen to empower Japanese cancer patients with access to scalp cooling and will continue to work closely with their global partner for the territory, Century Medical, to build awareness of scalp cooling and access to this important treatment in the year ahead.
“Shonin approval constitutes an important milestone for PAXMAN as the leading global expert in scalp cooling. We are truly excited to fulfil the strong demand from Japanese cancer centres and patients,” says PAXMAN CEO Richard Paxman.
PAXMAN’s market approval (Shonin) in Japan covers the clear “indication for use” to prevent chemotherapy-induced hair loss in all cases with solid tumour cancers. Shonin applications are handled by the Japanese Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA), thus making the process similar to an FDA approval in the USA. A market certification (Ninsho) is by comparison similar to the CE marking process in the EU as it is carried out by a third party.