Regeneus to fast-track human cellsunder new Japanese lawsSydney,...

Regeneus to fast-track human cells
under new Japanese laws
Sydney, Australia – 25 November 2013

The Japanese parliament has passed new laws that provide a rapid approval process specifically
designed for human stem cell therapies. Regenerative medicine company, Regeneus (ASX:RGS), is ready
to move on the opportunity. These new laws give the company a unique opportunity 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 into the Japanese market.
“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,” said John Martin, Executive Chairman of Regeneus. “These new laws
will help drive innovation in the regenerative medicine space and will attract the attention of other health
regulators”.
Under the new laws, there will be a separate approval channel for regenerative medicine products like
cell therapies. Once you have demonstrated limited safety and efficacy data in humans, the new cell
therapy can be approved for commercial use with data reporting requirements and potential for national
insurance coverage.
Professor Graham Vesey, CEO of Regeneus said: “This exciting opportunity in Japan provides us with a well
defined pathway to fast-track the clinical trial and potential approval of our new human off-the-shelf cell
therapy to treat osteoarthritis and other inflammatory musculoskeletal conditions”.
“CryoShot® is our off-the-shelf cell therapy platform and the canine and equine versions have been used
to treat over 2000 dogs and horses with osteoarthritis in extensive field trials in Australia. The results have
been very encouraging and we anticipate the canine CryoShot product entering into an FDA approved
trial for canine osteoarthritis in 2014”, said Professor Vesey.
Human CryoShot uses donor adipose (fat) derived mesenchymal stem cells which are manufactured in a
proprietary method to optimise their potency and viability. Once injected into an arthritic joint, the stem
cells used in CryoShot seek to embed at the site of inflammation and secrete a range of cytokines which
encourage a reduction of inflammation and repair and regeneration of the damaged tissue.
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