Pioneering medical method passes safety review

First published in Business news

A YORK regenerative medical device company is targeting the fast-growing market for soft-tissue knee repairs after receiving positive results in pre-clinical studies.

Clinical studies can now begin in Europe following a regulatory review of Tissue Regenix’s patented dCell formula of “washing” the DNA from animal tissues to enable them to form a scaffold which can be used in human transplants.

The pre-clinical study indicated the device was safe with no adverse or inflammatory responses, and there were signs of cells starting to integrate the scaffold into the existing tissue.

Antony Odell, managing director, said: “This important piece of safety data allows us to continue to move towards the clinical evaluation of the dCELL meniscus, which will be the pivotal study to enable EU regulatory approval so this approach can deliver real benefits to patients."

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