Reprocell Submits Approval Application for Stemchymal® to Treat SCA3 and SCA6 Ataxia

TOKYO, Jun 24 (Pulse News Wire) – ReproCELL Incorporated (4978.T) submitted an application for manufacturing and marketing approval for its stem cell product, Stemchymal®, targeting spinal cerebellar atrophy types 3 and 6 (SCA3 and SCA6). The application seeks approval for the treatment's ability to inhibit the progression of motor dysfunction associated with these conditions.

Manufacturing of Stemchymal® will be handled by Steminent Biotherapeutics Inc. based in Taiwan, while ReproCELL will manage sales and distribution within Japan. The product was designated as a priority review item by the Ministry of Health, Labour and Welfare in December 2018 due to its potential as a regenerative medical product for rare diseases.

Priority reviews aim to complete assessments within nine months of application submission. Spinal cerebellar atrophy is a debilitating condition characterized by gradual loss of motor function, and effective treatments have been limited until now. We believe Stemchymal® can significantly contribute to slowing disease progression and improving patients' quality of life.” While the impact on the current fiscal performance is expected to be minor, the company anticipates significant contributions to long-term growth and sustained enterprise value.

ReproCELL will continue to update stakeholders promptly on any further developments related to this application.