TSL.L Regulatory News (TSL)

15 Jun 2005 07:00

Tissue Science Laboratories PLC15 June 2005 15 June 2005 Tissue Science Laboratories plc ('TSL' or 'the Company') TSL granted Canadian Medical Device Licence for Permacol(R) Tissue Science Laboratories plc (LSE: TSL), the medical devices companyspecialising in human tissue replacement and repair products derived fromporcine dermis, is pleased to announce the receipt of a Licence from HealthCanada to sell its product, Permacol(R) Surgical Implant (Permacol(R)) inCanada. Permacol(R) has been registered for use as a soft tissue patch to reinforce softtissue where weakness exists and for the surgical repair of damaged or rupturedsoft tissue membranes. It is specifically indicated for the repair of abdominalwall defects and hernias. This includes but is not limited to abdominal,inguinal, diaphragmatic, femoral, scrotal, umbilical, incisional (includingparastomal hernias), rectal prolapse (including intussusception), rectocele andmuscle flap reinforcement. Additional registrations will be required for TSL's other brands in Canada andthese will be submitted later in 2005. Before commencing sales operations inthis market, TSL will assess the most appropriate routes to market for theproduct and discuss the opportunity with its strategic partners. Aside from Canada, TSL is also targeting countries within the Asia-Pacificregion to gain regulatory access. Martin Hunt, Chief Executive of TSL, said:"The Canadian Licence enables us and our partners to take advantage of new salesopportunities in another new territory and continue to raise the profile ofPermacol(R) with an increasing population of surgeons. We are pleased with thisresult and will submit the further required registrations for our other brandsin due course." -Ends- For further information, please contact: TSL plc Tel: 01252 369603Martin Hunt, Chief ExecutiveHogarth Partnership Limited Tel: 020 7357 9477Melanie Toyne-Sewell / Kate Catchpole Notes to Editors Background on TSL Founded in 1995, with headquarters in Aldershot, Hampshire, TSL is a medicaltechnology company specialising in tissue repair and replacement with aproprietary sheet product, derived from porcine dermis, called Permacol(R). TSLhas launched successfully different formulations of the product and built adevelopment pipeline that addresses the large and fast growing surgical implantmarket. The Company floated in November 2001 and is listed on the AIM (LSE:TSL). TSL has a family of products based on the same core technology. Each producthas been adapted, with unique properties, to make it suitable for use indifferent applications, including urology/gynaecology, complex and recurrenthernia repair, shoulder rotator cuff repair and head and face repair andreconstruction. The Company has signed distribution agreements with CR Bard Inc(urology/gynaecology - worldwide), Zimmer Inc (orthopaedic - worldwide) andPorex Surgical Inc (head & face-US and Canada). Further variations of the sheetand injectable forms of Permacol(R) are being developed. Background on Permacol(R)Permacol(R) was developed at Dundee University over a 20 year time period andhas been patented worldwide. The key to the Permacol(R) concept lies in itscollagen Technology which uses non-reconstituted porcine dermal collagen, verysimilar in structure to human tissue. Non-collagenous material, except elastin,is removed by the TSL manufacturing process. The remaining collagen, whichretains its original 3-D structural architecture, is stabilised by a patentedcross-linking process. The result is a non-reconstituted, non-allergenic,collagen implant which is resistant to biodegradation attack, is recognised andaccepted by the body, and is able to provide a long-term support for thein-growth of new tissue and its associated blood supply. This information is provided by RNS The company news service from the London Stock Exchange