Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

OrthoPure™ XT update

- Early patient outcomes show statistically significant improvement over gold standard procedure

- First European distributors appointed 

Leeds, 28 November 2016 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Group") the regenerative medical devices company today provides an update on OrthoPure™ XT (porcine tendon). 

The early clinical data provided to support the CE mark application has shown results highlighting the clinical relevance of the product, with the outcomes at 6 months post-operation showing a statistically significant improvement when compared to the current gold standard treatment which uses the patients' hamstring tendons or patellar tendon (autograft).

Dr Gabriel Oliver who performed the first OrthoPure™ XT implant commented: "Clinically our patients have progressed very well, with a reduction in inflammation, pain and faster rehabilitation allowing for a return to normal life ahead of other techniques. OrthoPure™ XT also offers benefits to hospitals and surgeons, removing the need for a second surgical site (for tissue harvest), therefore making the operation faster and easier."

The launch of OrthoPure™ XT remains on track for H1 2017, with CE mark approval in the same period. The first distribution agreements within Europe have been signed, indicators of the strong commercial and clinical support for OrthoPure™ XT, in preparation for rapid commercialisation in key European markets once approval is granted.

Peter Hamer, Commercial Director TRX Orthopaedics Ltd: "We are extremely encouraged by the initial results returned from the study. Having entered our first distributor agreements, which highlight the demand and market opportunity for OrthoPure™ XT, we remain on track for launch of OrthoPure™ XT by the end of H1 2017."

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About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company's patented decellularisation ('dCELL®') technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient's body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

 Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercialises academic research conducted by our partners around the World.

 In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States - 'Tissue Regenix Wound Care Inc.', as part of its commercialisation strategy for its dCELL® technology platform.