YORK medical device specialist Tissue Regenix has seen the world's first tendon implants completed using its technology.
The York Science Park-based firm has announced that two patients have received the first OrthoPure XT decellularised tendons using Tissue Regenix's patented dCELL technology.
The operations were done as part of a clinical safety study by Tissue Regenix which is being conducted to secure a CE mark to enable the launch of the OrthoPure XT in the EU in 2017.
Orthopaedic & Trauma Surgeon, Dr. Gabriel Oliver performed both surgical procedure at the Bellvitge University Hospital in Barcelona on December 3.
Both patients had ruptured an anterior cruciate ligament (ACL) due to recreational sports; the first a 31-year-old male playing football, the second a 32-year-old female injured whilst skiing.
Dr Oliver was able to replace damaged ligament with Tissue Regenix's technology which removes cells from donor tissue, allowing the surgeon to make a 'like for like' repair.
The ACL is responsible for 90 per cent of the stability of the knee and instability can lead to long-term damage and the need for further high cost procedures.
Tissue Regenix's OrthoPure XT has been developed as an effective and cost-efficient solution to ACL rupture which is the second most common injury of the knee requiring reconstruction, around 900,000 ACL procedures performed in the US & Europe in 2014.
Peter Hamer, commercial director of Orthopaedics at Tissue Regenix, 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.
"The main surgical options for this type of injury are currently limited to taking tissue from the patient, human donor material and, to a much lesser extent, using synthetics. An 'off the shelf' biologic replacement would represent a significant step forward in this type of surgery."
Mr Hamer said he hoped the recruitment of the first 20 patients in the OrthoPure XM (meniscus) clinical trial would be completed early in the first quarter of 2016, keeping the firm on track for CE mark submission in the second half of the year.
During the last year Tissue Regenix has also launched its DermaPure product in the US acute care chronic wound market, marking a major step in the commercialisation of its technology, which works by taking human donor skin and removing the DNA and cells to leave a natural scaffold to treat wounds.
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