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Tissue Science Laboratories plc: Positive Clinical Results for Permacol'R' as a Dermal Filler

(press release from Tissue Science Laboratories plc)

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LONDON----Dec. 5, 2005--Tissue Science Laboratories plc (LSE:TSL), the medical devices company specialising in human tissue replacement and repair, announces good results for its cosmetic variant of Permacol(R) injection in its use as a dermal filler compared to two market-leading fillers.

In a randomised single centre double-blind clinical evaluation by the University of Glasgow, TSL's injectable collagen (a form of Permacol(R) injection milled to finer particles for dermal injection) was compared to Perlane(R) (Hyaluronic acid) and Zyplast(R) (cross-linked bovine-sourced collagen), two leading products in the dermal filler market, for lip augmentation. 79 female patients between 25 and 55 were treated and followed up over 12 months. The Principal Investigator was Professor Ashraf Ayoub.

The study was looking for longevity of effect of each treatment as rated by a standardised assessment scale. Longevity was also measured by mathematically-derived 3D facial volume 'Stereophotogrammetry'. This is the first time a scientific measurement rather than a subjective (before and after photographs) approach has been applied to a cosmetic trial of this kind. The study also gauged other features such as ease of application.

Using 3D mapping of the injected area to demonstrate results, Permacol(R) provided longevity and lip bulking effect to the same degree as the market-leading products. The effect and presence of the filler material was also confirmed by high resolution ultrasound assessment. In addition, Permacol(R) exhibited a good safety profile and showed good handling characteristics. The next step in the assessment of Permacol(R) injection's performance as a cosmetic product will be in facial wrinkles.

Martin Hunt, CEO of TSL, said: "We are very excited by these initial results. We have demonstrated that Permacol(R) is directly comparable with the market leaders, is safe and offers an effective alternative for cosmetic practioners. Another advantage to the patient is that Permacol(R) does not require a skin-test, unlike bovine-sourced collagen. We believe these positive data highlight Permacol(R) as an attractive product for potential partners either in or interested in entering the cosmetic collagen dermal filler market."

According to the American Society of Plastic Surgeons, in 2004, there were over 9.2 million surgical and non-surgical cosmetic procedures performed in the US (2003: 8.8 million). Of that number, soft tissue fillers represent 1.1 million procedures, of which c. greater than 500,000 procedures used collagen cosmetic fillers.

Tissue Science Laboratories plc (LSE:TSL)

Hogarth Partnership Limited
Melanie Toyne-Sewell
+44 (0)20 7645 3958


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