Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

("Tissue Regenix" or "the Group")

World's first OrthoPure™ XT (dCELL® Tendon) implants successfully undertaken at Barcelona Hospital

York 4th December 2015, Tissue Regenix Ltd, (AIM:TRX) "Tissue Regenix" or "The Group" the regenerative medical device company, is pleased to announce that two patients have received the first OrthoPure™ XT decellularised tendons using Tissue Regenix patented dCELL® technology. This has been done as part of a clinical safety study by Tissue Regenix which is being conducted to secure a CE mark to enable 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 Thursday 3rd December. Both patients had ruptured an 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 anterior cruciate ligament (ACL) with TR's decellularised tissue which allows the surgeon to make a 'like for like' repair.

The ACL is responsible for 90% 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 commented:

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.

Additionally, we hope the recruitment of the first 20 patients in the OrthoPure™ XM (meniscus) clinical trial will be completed early Q1 2016 which keeps us on track for CE mark submission H2 2016".

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Notes to Editors

About the Global Sort Tissue Repair Market

What causes an ACL Injury?

The classic injury scenario is a change in direction or jump/landing that goes wrong, twisting the knee and causing damage to the ACL. This often happens during sporting activities when the body rotates but the foot remains firmly on the ground (typically during football, rugby or skiing) or a bad landing (during netball or basketball)

What are the symptoms?

· A significant number of patients hear a 'pop' or 'snap': and/or the knee gives way, followed by swelling within a few hours

· Patient may find they are unable to put all their weight on the affected leg and cannot fully straighten or bend it

· In the longer term the knee may feel unstable and even give way, particularly with a change of direction or rotation. Over time this leads to repetitive damage to the joint surface and meniscus potentially leading to the early onset of osteoarthritis.

Professional Sport ACL injury facts

· Premier League: Of the 32 knee injuries sustained in 2015 over 37% were ligament related

o source: www.physioroom.com

· NFL: In just training camp, practice and 2 meaningless preseason games, 27 players are out for the season from tearing their ACLs, nearly enough to form a team

o source: http://dailysnark.com/2015-torn-acl-team 

· Rugby: ACL tears were reported by Brooks and colleagues to be the most severe injury, leading to a mean of 235 in missed days

o source: Brooks JH, Fuller CW, Kemp SP, Reddin DB. A prospective study of injuries and training amongst the England 2003 Rugby World Cup squad. Br J Sports Med. 2005;39(5):288- 93.) ]

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.