Tissue Regenix receives notice of allowance for US meniscus patent
YORK, 25 November 2014 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix" or "the Group"), the regenerative medical devices company, has received notification from the United States Patent & Trademark Office (USPTO) that it will be granted a patent covering its dCELL® meniscus.
Tissue Regenix is currently developing a process for decellularising donated human meniscus, based on the porcine dCELL® Meniscus, which is starting a regulatory human clinical trial in the EU to secure a CE mark. Like the animal tissue product this would be a piece of decellularised human meniscus for use in partial meniscal replacement (which accounts for 80% of procedures) rather than as a full transplant.
The global sports medicine market was estimated at $6.1bn in 2012 with CAGR growth of 4.4% driving it to $8.2bn in 2019. Geographically North America was said to account for the largest share of the global market in 2012 at just under $2.5bn†.
‘Minimally manipulated’ human tissues are designated as transplants by the FDA and do not require approvals in the same way as medical devices. This could see a decellularised human meniscus launched in the US in the next two years
Tissue Regenix's dCELL® meniscus will be used to repair damage from 'tears' in the meniscus knee cartilage as a result of acute injury such as sports injuries. Meniscal injuries affect around 1.5 million people per year in Europe and the US. The dCELL® meniscus has the potential to address this unmet clinical need as there are no implants available in the US at present.
This is the latest US patent covering the use of the dCELL® decellularisation process and follows the announcement in May 2014 that a patent, related to tissue matrices for bladder implantation, has been granted.
Antony Odell, CEO of Tissue Regenix commented: “This meniscus patent marks an important step forward in our US strategy as it defines our intellectual property for both human & animal tissue meniscus products in the world’s largest market for sports medicine. It enables us to pursue, with confidence, the second phase of the roll-out of the Group’s US human tissue strategy following the successful launch of DermaPure™ in June 2014.”
Tissue Regenix has offices in the UK and US and is concentrated on the global commercialisation of its dCELL® technology.
†Sports Medicine Devices Market – Global Industry Analysis, Size, Share, Growth Trends and Forecast, 2013-2019.
Notes to Editors
About Tissue Regenix & dCELL®
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.