Tissue Regenix Group Regulatory News (TRX)

DATE: 14 February, 2013

Successful safety study of Tissue Regenix dCELL® Meniscus

Encouraging results also show early signs of tissue integration

Tissue Regenix ('TRX'), the regenerative medical device company, is targeting the fast-growing market for soft-tissue knee (meniscus) repairs. A pre-clinical study to assess the safety of Tissue Regenix's dCELL® meniscus has delivered positive results that pave the way for clinical studies to begin in Europe following regulatory review.

The six month study to assess the biocompatibility of the dCELL® meniscus involved a standard procedure called a partial meniscectomy where the dCELL meniscus is implanted next to existing tissue.

Key findings at the conclusion of the study indicate that the device is safe with no adverse or inflammatory responses related to the device detected. In addition there were signs of cells entering the dCELL® meniscus and signs of remodelling (characterised by the appearance of collagen - a key component of healthy tissue), which indicate that the meniscus is successfully integrating with the existing tissue.

Antony Odell, Managing Director, Tissue Regenix Group plc commented, "This important piece of safety data allows us to continue to move towards the clinical evaluation of the dCELL® Meniscus which will be the pivotal study to enable EU regulatory approval so this approach can deliver real benefits to patients. It is encouraging that we are seeing early signs of cells entering the matrix indicative of the same effects we have seen with other dCELL® devices."

Tissue Regenix is developing the dCELL® meniscus for use in knee repair. The menisci are two c-shaped pieces of cartilage in the knee joint which can be torn (a common injury in footballers, skiers and other sports people) or degenerate with age.

The number of meniscal repair procedures is forecast to rise driven by an ageing population, rising obesity rates and a growing number of sports-related injuries. Over 1.5 million meniscal procedures are expected in the US and Europe in 2013.1

Patients suffering a meniscus tear typically feel a "pop" at the time of injury, often followed by joint tenderness, knee pain, and recurrent knee catching. Furthermore, the knee may "lock" making it difficult or impossible to straighten the leg out.

The most common treatment option involves the removal of the damaged material but clinical studies indicate this can result in a significantly increased risk of arthritis, which can lead to knee replacement surgery - an expensive operation (each knee replacement is estimated to cost the NHS £7,458).2 

ENDS

For Further Information

Tissue Regenix Group plc: 01904 435 176

Antony Odell

Ian Jefferson

Peel Hunt LLP (Nominated Adviser) 020 7418 8900

James Steel

Vijay Barathan

Newgate Communications 020 7680 6550

Alistair Kellie

Andrew Adie

Martin Greig

About Tissue Regenix

Tissue Regenix (AIM: TRX) 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.