TSL.L Regulatory News (TSL)

17 Jan 2008 07:00

Tissue Science Laboratories PLC17 January 2008 17 January 2008 Tissue Science Laboratories plc (TSL or the Company) Positive Study for Collagen Dermal Graft in Rotator Cuff Repair after 4.5 years Permacol(R) Safe And Associated With Improved Clinical Outcomes Tissue Science Laboratories plc, the medical technology company specialising inbiologic tissue replacement and repair products, announces that the positiveassessment of its porcine collagen material, Permacol(R) in the treatment ofextensive shoulder rotator cuff tears. The results have been published in theJournal of Shoulder and Elbow Surgery. Sachin Badhe and his team from the Department of Trauma and Orthopaedic Surgery,Derbyshire Royal Hospital wanted to determine the effectiveness of porcinedermal collagen (TSL's Permacol(R)) as a tendon augmentation graft in the repairof extensive rotator cuff tears. The study evaluated the clinical, ultrasound,and magnetic resonance imaging outcome 4.5 years after treatment. The conclusionwas that the use of porcine dermal collagen as an augmentation graft in thetreatment of massive rotator cuff tears is safe and, in most patients, isassociated with improved clinical outcome. The study group consisted of 10 patients (5 men, 5 women) with a mean age of 66years (range, 46-80 years). Patients were evaluated clinically using theConstant score preoperatively, at 1 year, and at final follow-up when ultrasoundand magnetic resonance imaging scans were performed to assess for graft androtator cuff integrity. Average Constant scores improved from 41 preoperatively to 62 at final follow-up(P=0.0003). Pain, abduction power, and range of motion significantly improvedafter surgery (P < 0.05), and patient satisfaction levels were high. Imagingstudies identified intact grafts in 8 patients and graft detachment in 2. Noadverse side effects were reported during the study period. Steve Bloor, Technical Director of TSL, said:"We are pleased to see the positive results of this study which confirms ourbelief in our rotator cuff product and adds to other positive data we haveachieved which we have shared with our marketing partner, Zimmer. We have a wellestablished position in the biologic implant market, particularly in the herniaand obs/gynae applications. The market is an exciting one, with rapid growthbeing experienced as surgeons recognise the benefits of using a sterile,biocompatible tissue for repair and replacement." -Ends- Enquiries: TSL plc Tel: 01252 333 002Martin Hunt, Chief Executive OfficerDavid Jennings, Finance Director Nomura Code Securities Tel: 0207 776 1200Juliet Thompson / Clare Terlouw Hogarth PR Tel: 020 7357 9477Melanie Toyne Sewell / Sarah Richardson Notes to Editors Background on TSL Tissue Science Laboratories plc is a medical technology company specialising intissue repair and replacement. Headquartered in Aldershot, Hampshire, TSLfloated in November 2001 and is listed on AIM (AIM: TSL). TSL has a proprietary sheet product, derived from porcine dermis, calledPermacol(R). The Permacol(R) sheet product has been developed with a range ofunique properties to make it suitable for use in different applications,including urology/gynaecology, complex and recurrent hernia repair, shoulderrotator cuff repair and head and face repair and reconstruction. TSL sellsPermacol(R) directly in the complex and recurrent hernia surgical field and hassigned distribution agreements with CR Bard Inc (urology/gynaecology -worldwide) and Zimmer Inc (orthopaedic - worldwide). Different formulations of Permacol(R) have also been developed successfully,including an injectable version, based on the same core technology. In addition,TSL has built a development pipeline derived from other porcine tissues e.g.bone, ligament and vascular that addresses the large and fast growing surgicalimplant market. Background on Permacol(R) Permacol(R) Surgical Implant is the culmination of many years' research. The keyto the Permacol(R) concept lies in its processing technology which usesnon-reconstituted (intact) porcine dermal collagen, very similar in structure tohuman 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 specific 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-lasting 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