Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group Plc

TISSUE REGENIX GAINS REGULATORY APPROVAL TO START MENISCUS

CLINICAL TRIAL IN THE UK, PLUS UPDATES ON DERMAPURE US COMMERCIALISATION

YORK, 30 July 2014 - Tissue Regenix Group plc (AIM: TRX) ("Tissue Regenix" or "the Group"), the regenerative medical devices company, today announces it has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA), to start the first UK clinical trial of its dCELL® meniscal device to aid knee repairs. Following completion of final tests and preparations it is anticipated the trial will start in Q4, 2014.

The trial approval marks a critical stage towards gaining EU clearance (and a CE Mark) which will enable full commercialisation of the dCELL® meniscus, and allow it to be used by clinics and doctors to help UK and European patients.

Tissue Regenix's dCELL® meniscus will be used to repair damage from 'tears' in the meniscus knee cartilage as a result of acute injury or degeneration. Meniscal injuries affect around 1.5 million people per year in Europe and USA, and the dCELL® meniscus potentially addresses this substantial unmet clinical need.

Designed to encourage tissue growth and regeneration the Tissue Regenix dCELL® meniscus aims to support the body's own physiological pathways for healing by providing a 3D matrix for cell adhesion and vascular ingrowth.

The UK trial for the dCELL® meniscus will be conducted at The Hillingdon Hospitals NHS Foundation Trust, Uxbridge (overseen by Consultant Orthopaedic and Sports Injury Surgeon, David Houlihan-Burne), The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry (overseen by Consultant Orthopaedic and Sports Injury Surgeon, Simon Roberts) and at the Clifton Park Hospital, York (Ramsay Health Care), (overseen by Consultant Orthopaedic Surgeon, Neil Hunt).

Peter Hamer, Orthopaedic Business Development Manager explained: "Tissue Regenix's dCELL® meniscus is virtually identical in structure to the tissue being replaced, so it has the potential to provide a permanent repair. The dCELL® device is implanted via an established 'keyhole' surgical procedure, meaning it is ready for rapid clinician uptake."

David Houlihan-Burne, Orthopaedic and Sports Injury Surgeon and Principle Investigator for the UK study explained: "Meniscus problems in the UK are undoubtedly increasing. I personally conduct 300-400 meniscal surgeries per year, and have seen a real surge in such injuries in recent years, mainly down to the uptake of sport by the British population. At present, we do not have an effective solution for meniscal replacement, which is why I am extremely excited to be involved in the UK trial for Tissue Regenix's dCELL® meniscus. Unlike current synthetic products, Tissue Regenix's porcine meniscus looks and feels exactly like a human meniscus."

In addition to announcing MHRA approval for clinical trials to begin on its dCELL® Meniscus, Tissue Regenix is also today providing an update on the commercialisation of its DermaPure™ decellularised dermal allograft, which was launched in June in the USA in conjunction with Tissue Regenix's partner CTS (Community Tissue Services).

Sales activity for DermaPure™ is steadily increasing and initial orders have been received, and shipped to customers. A key part of the inpatient sales process is securing approvals by hospital new product evaluation committees. Tissue Regenix is actively working to obtain new product approvals to increase product adoption within the facilities.

In addition, two of the sites participating in the US diabetic foot ulcer randomised control clinical trial for DermaPure™ are actively screening patients for enrollment following their recent SIV's (site initiation visits). The clinical trial will have up to nine sites enrolling patients. The remaining sites will have their SIV over the coming weeks. 

Antony Odell, CEO of Tissue Regenix commented: "Today's decision by MHRA will allow Tissue Regenix to commence the first UK trial of the dCELL® meniscus and marks a significant step for the Group towards bringing this pioneering device to market. We feel the dCELL® meniscus has the potential to provide a ground breaking new approach to help permanently replace damaged meniscus and return patients to full mobility.

"We are equally encouraged by the early interest in DermaPure™, since its US launch in June. We have already received orders and are encouraged by progress in the enrolment of patients into human trials in the US. We look forward to gaining additional hospital new product evaluation committee approvals as a trigger for further product adoption. Today's announcement is further validation of the quality of our product pipeline." 

 - ENDS -

For Further Information

Tissue Regenix Group Plc: +44 19 0443 5176

Antony Odell

Ian Jefferson

Jefferies International Ltd: +44 20 7029 8000

Simon Hardy

Harry Nicholas

Newgate Communications: +44 207 6806550

Andrew Adie

Stephanie Dobbs

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.