TSL.L Regulatory News (TSL)

10 May 2005 07:00

Tissue Science Laboratories PLC10 May 2005 10 May 2005 Tissue Science Laboratories plc ('TSL' or 'the Company') Permacol(R) Injectable Patent Tissue Science Laboratories plc (LSE: TSL), the medical devices companyspecialising in human tissue replacement and repair products derived fromporcine dermis, announced that its US patent application for composition ofmatter for its injectable form of Permacol(R) has been allowed by the US Patentand Trademark Office. It is anticipated that the patent will be granted at theend of Q2 2005. Permacol(R) Injection is indicated for use as a Urethral Bulking Agent (UBA) forfemale urinary stress incontinence (FUSI). Stress incontinence is a commoncondition affecting one in eight women over the age of 45 and, in the US alone,there are an estimated 11 million sufferers. The Company's main focus is on theUS market where injectable bulking agents have been more widely adopted andwhere the Company believes that its product would offer advantages over existingtreatments. Permacol(R) Injection UBA is a natural product and therefore has none of thesafety concerns associated with synthetics and, as a one-off treatment, itprovides a long-lasting solution. Initial analysis of a double-blinded studyindicates that Permacol(R) Injection is an effective bulking agent for thetreatment of female stress incontinence. Once fully analysed and published, thedata will be used to support marketing in Europe, where the product is alreadybeing sold. Commenting on today's announcement, Martin Hunt, CEO of TSL, said:"Achieving a patent for our injectable product is an important milestone for theCompany in the development of a strong intellectual property portfolio toprotect our products." -Ends-Enquiries: TSL plc Tel: 01252 369603Martin Hunt, Chief Executive Hogarth Partnership Limited Tel: 020 7357 9477Melanie Toyne-Sewell / Kate Catchpole Mob: 07767 66 00 40 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 AlternativeInvestment Market (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