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Tissue Regenix kicks off tendon trial

Published: 02:34 04 Dec 2015 EST

kneepain
Knee injuries are being treated with the new, artificial ACL.

Tissue Regenix (LON:TRX) said it had treated its first two patients using its OrthoPure XT decellularised tendons.

Orthopaedic and trauma surgeon, Dr Gabriel Oliver, used OrthoPure to replace ruptured anterior cruciate ligaments (ACL) in a 31-year-old man who was injured during football and a 32-year-old woman hurt while skiing.

The procedure using Tissue Regenix’s technology was part of a clinical trial aimed at securing regulatory sign off in the form of a CE Mark in the EU in 2017.

Commercial director Peter Hamer said: “This is an exciting time for orthopaedics at Tissue Regenix.

“The beginning of the OrthoPure XT clinical trial is the next step towards securing regulatory approval to launch in 2017.”

ACL ruptures are the second most common knee injury with around 900,000 procedures a year performed in Europe and the US.

The main surgical options for this type of injury are limited to taking tissue from the patient, human donor material and, to a much lesser extent, using synthetics.

An off-the-shelf replacement would represent a significant step forward in this type of surgery, the company said. OrthoPure potentially offers a cost-effective solution.

Separately, Tissue Regenix (TR) said it hopes to complete the recruitment of the first 20 patients for its OrthoPure XM treatment for the meniscus, which acts like a shock absorber in the knee.

Clinical trials will be completed early in the first quarter of next year, which keeps the firm on track for CE mark submission in the second half.

Both products use TR’s patented dCELL technology, which uses decellularised animal parts.

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