Regeneus to fast track human stem cell osteoarthritis …

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Regeneus Limited (ASX:RGS) is a regenerative medicine company that develops and commercialises proprietary technologies for the preparation of point-of-care and off-the-shelf cell therapies.

Regeneus will fast-track clinical trials and approvals for its human off-the-shelf CryoShot cell therapy to treat osteoarthritis in Japan.

Regenerative medicine company Regeneus' (ASX: RGS) will use Japans new laws to fast-track the clinical trial and potential approval of its new human off-the-shelf CryoShot cell therapy to treat osteoarthritis.

The Japanese parliament has passed new laws that provide a rapid approval process specifically designed for human stem cell therapies.

This provides a significant market opportunity for Regeneus to explore a new accelerated cell therapy approval process in Japan with limited safety and efficacy data.

This will be achieved through a separate approval channel for regenerative medicine products that will allow the new cell therapy to be approved for commercial use once limited safety and efficacy data in humans has been demonstrated.

Japan, the second largest healthcare market in the world, is setting itself up to be a world leader in regenerative medicine by providing a clear risk-adjusted regulatory framework for swift and safe translation of regenerative medicine research to early access to the latest cell therapies that can address a range of unmet medical needs, Regeneus executive chairman John Martin said.

These new laws will help drive innovation in the regenerative medicine space and will attract the attention of other health regulators.

Chief executive officer Professor Graham Vesey added the Japanese law provided the company with a well-defined pathway to fast-track the clinical trial and potential approval of its new human off-the-shelf cell therapy to treat osteoarthritis and other inflammatory musculoskeletal conditions.

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Regeneus to fast track human stem cell osteoarthritis ...