TSL.L Regulatory News (TSL)

12 Dec 2005 07:01

Tissue Science Laboratories PLC12 December 2005 12 December 2005 Tissue Science Laboratories plc ('TSL' or 'the Company') First Patient Enters Parastomal Hernia Clinical Trial Trial comparing Permacol(R) with standard treatment in randomised controlled study Tissue Science Laboratories plc (LSE: TSL), the medical devices companyspecialising in human tissue replacement and repair products, announces that thestudy has commenced to compare the use of Permacol(R) for repair of parastomalhernias with current standard treatment with either synthetic mesh or primarysuture repair. The study will comprise 200 patients across approximately 20 UK centres. Theprincipal investigator is Mr JP Griffith FRCS who is based at the ColorectalSurgical Unit, Bradford Royal Infirmary. Patients will be monitored over 12months. The aim of the study will be to show that a repair with Permacol(R) hasa lower recurrence rate and is associated with less morbidity and pain than other repairs. There are many surgical conditions which can lead to the necessity to form atemporary or permanent stoma, most commonly in the form of a colostomy orileostomy. There are over 1.4 million existing stomas in the US and Europe, andapproximately 160,000 new stomas created per annum. The surgical operation tocreate these stomas is not complicated, but in spite of this, formation of ahernia beside the stoma (parastomal herniation), is a persistent and troublesomeproblem - there is an approximate herniation rate of up to 50%. According to surgeons, the ideal repair would have a low recurrence rate, lowcomplication rate and would not require substantial abdominal surgery tocomplete it. This would avoid the inherent associated problems such as woundinfection, incisional hernia, respiratory complications and prolonged hospitalstay. Martin Hunt, Chief Executive of TSL, said, "Current treatments of parastomalhernias are inadequate, with high recurrence rates requiring additional surgeryand further hardship for patients. With the emergence of biologic materials,surgeons are investigating whether these new materials might be the answer toalleviate these difficult to treat conditions. "With over 100,000 implants based on Permacol(R) technology in existenceworldwide, we believe our product has the required characteristics to treat thiscondition and address the issue of recurring hernias. This study will comparePermacol(R) to current treatments and we believe the results will differentiateour product to surgeons." -Ends- 1.PWG Carne, GM Robertson & FA Frizelle. Parastomal Hernia. British Journal of Surgery 2003; 90: 784-7932.Rieger N, Moore J, Hewett P, Lee S & Stephens. Parastomal hernia repair. Colorectal Disease 2004; 6: 203-205 For further information, please contact: Tissue Science Laboratories plc Tel: 01252 369603Martin Hunt, Chief Executive Hogarth 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 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.About Permacol(R) The key to Permacol(R) lies in its collagen technology which uses non-reconstituted porcine dermal collagen, very similar in structure to humantissue. 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 attack, is recognised and accepted by the body, andis able to provide a long-term support for the in-growth of new tissue and itsassociated blood supply. About Parastomal Hernias Parastomal hernias are protrusions of the abdominal organs adjacent to a stoma.They commonly occur after stoma formation. There are a wide range of incidencesfor parastomal hernias depending upon the type of stoma and the length of followup. A recent review by Carne et al reported incidences of between 4-48% for endcolostomies, up to 31% for loop colostomies to as little as 0-6% for loopileostomies1. Most hernias develop in the first few years after stoma formation, but there isan ongoing risk, especially in patients with risk factors such as obesity andraised intra-abdominal pressure. Parastomal hernias may be asymptomatic but theyfrequently cause difficulty with fixation of the stoma appliance resulting inleakage. There is also a risk of strangulation, which may cause intestinalobstruction. Finally and perhaps most importantly for the patient, hernias causesignificant physical deformity which is distressing to patients. This information is provided by RNS The company news service from the London Stock Exchange