TSL.L Regulatory News (TSL)

12 Jul 2006 07:00

Tissue Science Laboratories PLC12 July 2006 12 July 2006 Tissue Science Laboratories plc ("TSL" or "the Company) Tissue Science Laboratories Presents Further Supportive Data on Permacol(R) Studies Positive results for Permacol(R) as a prophylactic treatment for parastomal hernias and as a treatment for anal fistulae At the Annual Meeting of the ACPGBI (Association of Coloproctology of GreatBritain & Ireland) held in Gateshead, 3-6 July, Tissue Science Laboratories plc,the medical devices company specialising in human tissue replacement and repairproducts, presented supportive evidence from two pilot studies - the first, anapplication of Permacol(R) as a treatment for parastomal hernias and the second,for the treatment of anal fistulae. There are over 1.4 million existing stomas in the US and Europe, andapproximately 160,000 new stomas created per annum. Parastomal herniation (theformation of a hernia beside the stoma) is a persistent and troublesome problemwith an approximate occurrence rate of up to 50%. The first study presentedlooked at the efficacy of Permacol(R) as a prophylactic to prevent parastomalherniation. The study comprised 20 patients - 10 treated prophylactically withPermacol(R). 3 out of 10 patients without Permacol(R) were found to haveexperienced parastomal hernias; none of the patients with the Permacol(R)prophylactic showed herniation. Contrary to current treatments such as syntheticmesh, there were no complications related to infection or related to theproximity to the bowel associated with the use of Permacol(R). A full scalerandomized controlled prophylactic study is now underway. The second pilot study aimed to assess the short-term safety, feasibility andefficacy of using Permacol(R), either as a solid implanted seton (a thread ofmaterial that is passed through the fistula) or as fibres suspended in fibringlue, to heal idiopathic anal fistulae whilst preserving continence. This hastraditionally been treated by surgery, but more recently fibrin glue is beingused with variable success. Its drawbacks include that it is broken downrelatively rapidly and it fails to eradicate secondary tracts and acute sepsisin advance. The results of the study using Permacol(R) revealed that at threemonths post-operation, no patient in either the collagen implant or collagenglue mixture groups had experienced symptoms of continence disturbance or acuteperianal sepsis, which are usually common with this condition. Also, sphincterintegrity and anorectal movement were unchanged. The results of this studysuggest that Permacol(R) is a safe, potentially effective sphincter-conservingtechnique, and the results allow an extension of the study. Stephen Bloor, Technical Director, said: "We are pleased to report furthersuccessful studies for Permacol(R), which has proven to offer many advantagessuch as greater comfort, durability and without the many side effects of currenttreatments. The results of these studies offer further supportive examples forthe multiple applications of Permacol(R)." -Ends- For more information please contact: Tissue Science Laboratories Media EnquiriesplcMartin Hunt, Chief Executive Hogarth PROfficerSteve Bloor, Technical Melanie Toyne-Sewell/Sarah RichardsonDirectorTel: 01252 369 603 Tel: +44 207 357 9477Email: Email: Mtoyne-sewell@hogarthpr.co.uk information@tissuescience.com srichardson@hogarthpr.co.uk Website:www.tissuescience.com 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 and face - US and Canada). Further variations of thesheet and injectable forms of Permacol(R) are being developed. For moreinformation on TSL, please visit the website at www.tissuescience.com. Background on Permacol(R) Permacol(R) was developed at Dundee and Cambridge Universities over a 20-yeartime period. The key to the Permacol(R) concept lies in it collagen technologywhich uses non-reconstituted porcine dermal collagen, very similar in structureto human tissue. Non-collagenous material, except elastin, is removed by the TSLmanufacturing process. The remaining collagen, which retains its original 3-Dstructural architecture, is stabilised by a patented cross-linking process. Theresult is a non-reconstituted, non-allergenic, collagen implant which isresistant to biodegradation, is recognised and accepted by the body, and is ableto provide a long-term support for the in-growth of new tissue and itsassociated blood supply. This information is provided by RNS The company news service from the London Stock Exchange