Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

Orthopaedics Update 

- Positive discussion with FDA regarding regulatory approval routes - Initial clinical evidence renders OrthoPure™ XM biocompatible - CE Mark application for OrthoPure™ XT brought forward 

Leeds, 11 July 2016 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Group") the regenerative medical devices company today updates on its strategy for OrthoPure™ XT and XM (porcine tendon and meniscus) market clearance pathways.

The Group is currently undertaking clinical trials within the EU for both products, and due to the success of the clinical data for OrthoPure™ XT to date, is now expected to gain a CE mark for the product by the end of 2016, more than 6 months ahead of schedule. Positive FDA discussions have also encouraged the Group to apply for a US pilot clinical trial, with submission expected in Q4 2016, signalling a key milestone towards gaining regulatory approval for this product in the US.

Tissue Regenix has also established that 510(k) market clearance could be possible for OrthoPure™ XM - a considerably less expensive and time consuming option than previously thought. The EU clinical trial data has proven the implant to be biocompatible, showing integration into the patient's own tissues, and has been beneficial in highlighting improvements to the implant which Tissue Regenix are investigating further. The Group will only bring to market one version of the product and therefore the current EU trial will be superseded by a new study, with an identical protocol, using the updated implant. However, the current clinical trial will continue to be closed out and the patients currently enrolled will continue to be monitored. It is expected that the process to begin regulatory application for the second trial will begin before the end of 2016.

Antony Odell, CEO Tissue Regenix Group commented: "The possibility of earlier EU approval for OrthoPure™ XT, and the potential for a US pilot study, would allow us to access these key markets via a more rapid regulatory route, where sales momentum can be quickly established, particularly with our 'off the shelf' alternative to the existing approaches.

Positive data from the OrthoPure™ XM EU clinical trial, and the confirmation of a 510(k) route to the US market, means that we can undertake the additional study to implement improvements and pursue one common version of the product, expected for launch within the EU during 2018, and allow us to initiate the work required for US regulatory approval."

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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.