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Tissue Regenix's knee cartilage passes safety study

Result paves the way for move towards clinical trials that will be pivotal for EU regulatory approval.
Tissue Regenix's knee cartilage passes safety study

Regenerative tissue specialist Tissue Regenix's (LON:TRX) replacement knee cartilage has passed a pre-clinical study with no adverse effects or inflammation.

A six month study to assess the biocompatibility of the replacement meniscus indicated that the device is safe, with signs of cells entering the replacement cartilage and remodelling. This happens when the meniscus is successfully integrating with the existing tissue.

A standard procedure called a partial meniscectomy where the new meniscus is implanted next to existing tissue was used in the study.

Antony Odell, Tissue Regenix’s 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.

“It is encouraging that we are seeing early signs of cells entering the matrix indicative of the same effects we have seen with other dCELL devices."

Cartilage surgery is a huge market with other 1.5mln procedures expected in the US and Europe in 2013, a figure that is expected to rise further as the population's age.

Tissue Regenix's patented technology dCELL, removes DNA and other cellular material from animal and human tissue.

The process leaves the acellular tissue scaffold intact, so that the tissue is not rejected by the patient's body and can then be used to repair diseased or worn out body parts.

Tissue Regenix's said the appearance in the study of collagen in the knees treated with the replacement cartilage was a sign of healthy tissue.

The most common treatment for a cartilage in jury involves the removal of the damaged material but clinical studies indicate this can result in a significantly increased risk of arthritis, which can lead to knee replacement surgery.

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