Tissue Regenix Group Regulatory News (TRX)

26 January 2016

Tissue Regenix Group plc

Joint Venture Agreement

York, 26 January 2016 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix" or "The Group") announces first step towards the commercialisation of human dCELL® heart valves and DermaPure® in the EU through a Joint Venture Agreement with German tissue bank.

Highlights

· Joint Venture Agreement ("JVA") entered into with GTM-V to form GBM-V gGmbH ("GBM-V"), a tissue bank based in Rostock, Germany

· Non-exclusive licences granted to GBM-V for human dCELL® heart valves & DermaPure® covering the EU

· First licence granted for dCELL® heart valves

· Regulatory submissions to German authorities being prepared by GBM-V

· First products targeted to be launched in 2017 subject to regulatory approval

· The Group anticipates replicating this business model in other countries, with initial discussions already held

The establishment of the JVA is an important milestone in the Group's overall commercialisation strategy, allowing Tissue Regenix to licence its patented dCELL® technology process for human tissue for the first time in the EU, in anticipation of bringing to market a portfolio of decellularised human tissue treatments subject to regulatory approval. Entering the JVA with GTM-V, who will be responsible for sourcing the donated tissue, the Group will be making an initial investment of €250,000 under the JVA to fund development and distribution.

The JVA allows Tissue Regenix to work with an accomplished group of individuals at GBM-V, with over 20 years of tissue medicine experience, who will produce and distribute the Group's decellurised tissue treatments in accordance with German regulations. The regulatory submissions to the German authorities to obtain approval are being prepared by GBM-V and the Group currently anticipates launch of its treatments under the JVA initially in Germany in 2017, with European wide distribution to follow. 

Importantly, this is the first licence Tissue Regenix has granted for decellularised human heart valves, which is supported by 10 years of clinical data from Professor Francisco da Costa's pioneering work at the Pontifical Catholic University of Paraná (PUCPR), Brazil, validating the safety and success of the treatment. GBM-V's experience will also be important to the Group in developing improvements to human tissue applications of the dCELL® technology.

Antony Odell, CEO of Tissue Regenix said:

"This is a key agreement for Tissue Regenix, because it is an important step forward towards establishing dCELL® as a truly global brand. We see this as a business model that the Group can replicate elsewhere and we have already begun discussions with a number of potential tissue bank partners in other countries.

The establishment of this JVA will ultimately allow European clinicians and patients access to two clinically proven treatments. Germany is particularly stringent with its human tissue regulations, which provides a high benchmark from which wider EU approvals can follow.

We feel that this agreement reiterates the strength of our technology base and offers us a unique commercial opportunity. GBM-V is an important partner for the future of Tissue Regenix and we greatly look forward to working with the team."

Dr Frank Peter Nitschke, Managing Director, GBM-V said:

"We see this joint venture as an exciting opportunity to utilise Tissue Regenix regenerative medical technology, dCELL®, and bring to European patients a portfolio of products that have the potential to change the treatment and recovery of many.

We believe that with our expertise dealing with human tissue, and Tissue Regenix's experience we will build a strong and successful partnership." 

For more information:

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.