TSL.L Regulatory News (TSL)

6 Jun 2005 14:15

Tissue Science Laboratories PLC06 June 2005 6 June 2005 Tissue Science Laboratories plc ('TSL' or 'the Company') Launch of Zimmer Collagen Repair(TM) Patch. Tissue Science Laboratories plc (LSE: TSL), the medical devices companyspecialising in human tissue replacement and repair products derived fromporcine dermis, is delighted to note the announcement by Zimmer Holdings, Inc(NYSE and SWX: ZMH) on the launch of the Zimmer(R) Collagen Repair (ZCR) Patchfor the repair of rotator cuff injuries in the shoulder. The full text of theZimmer press release is reproduced below. Martin Hunt, Chief Executive of TSL, said:"The market for primary and revision surgery of the shoulder is large andgrowing, with over 250,000 procedures in the US alone. Our partnership withZimmer on the ZCR Patch represents a further important step in the growth of TSLas we launch another new product at the forefront of medical technology." For further information, please contact: TSL plc Tel: 01252 369603Martin Hunt, Chief Executive Hogarth Partnership Limited Tel: 020 7357 9477Melanie Toyne-Sewell / Kate Catchpole _______________________________________________________________________________ Zimmer Launches Biological Rotator Cuff Repair Product (WARSAW, IN) June 6, 2005 -- Zimmer Holdings, Inc. (NYSE and SWX: ZMH) todayannounced that it has launched an innovative biological patch for the repair ofrotator cuff injuries in the shoulder. The underlying technology was developedby Tissue Science Laboratories plc (TSL) of the United Kingdom and is beingmarketed by Zimmer as the Zimmer(R) Collagen Repair (ZCR) Patch. The twocompanies signed a multi-year, exclusive distribution agreement in 2003. "With nearly 250,000 rotator cuff repairs annually in the United States alone,this is a substantial market segment that is growing in both primary andrevision procedures," said Zimmer Chairman, President and CEO Ray Elliott. "Withthe ZCR Patch, we will be able to address the unique needs of orthopaedicsurgeons who require a material to reinforce their rotator cuff surgical repairsbut with several important new advantages." Zimmer already participates in the shoulder repair market with products such asBigliani/Flatow(R) The Complete Shoulder Solution, one of the world's leadingtotal shoulder replacement systems, and the Anatomical Shoulder(TM) System. Zimmer believes the ZCR Patch offers several potential advantages compared tocurrent products or treatments. For example, the ZCR Patch's high resistance tocollagenase activity and breakdown in the body promotes increased repairstability throughout the healing process. The ZCR Patch also offers reducedinflammatory response characteristics within the body due to TSL's proprietaryprocessing technology. In addition, the ZCR Patch offers ease of use because theproduct is flexible and strong, can be stored at room temperature instead ofrequiring refrigeration and can be used without the need for rehydration by thesurgeon. The ZCR Patch is a chemically crosslinked, acellular sheet of collagen/elastinthat is derived from porcine dermis. It is a durable implant, highly resistantto breakdown by enzymes in the body. In November 2002, the Food and DrugAdministration cleared the technology for use in the United States for treatmentof rotator cuff injuries of the shoulder. Marketed by TSL as Permacol(R), italso has been available in the United Kingdom for rotator cuff repairs and waspreviously cleared in the United States for urological treatments, herniarepairs and plastic and reconstructive surgery of the head and face (sold undervarious brand names). In all, the implant technology has been used in more than100,000 procedures worldwide. The first ZCR Patch procedure was performed in April 2005, by Dr. Greg Nicholsonat the Rush University Medical Center at Rush-Presbyterian-St. Luke's Hospitalin Chicago. "I believe the implantation technique is reproducible and effective," Dr.Nicholson said. "It has only taken 12 to 15 minutes to trim and suture in thegraft after rotator cuff repair, so it does not add any significant OR time." Zimmer has begun marketing the ZCR Patch within the United States, and expectsto make the product available on a global basis later this year. About Zimmer Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer is the worldwide #1pure-play orthopaedic leader in designing, developing, manufacturing andmarketing reconstructive and spinal implants, trauma and related orthopaedicsurgical products. Zimmer has operations in more than 24 countries around theworld and sells products in more than 100 countries. Zimmer's 2004 sales wereapproximately $3 billion. The Company is supported by the efforts of more than6,500 employees worldwide. Visit Zimmer on the worldwide web at www.zimmer.com. About Tissue Science Laboratories 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). For more information, please visit the web site atwww.tissuescience.com. Zimmer Safe Harbor Statement This press release contains forward-looking statements within the safe harborprovisions of the Private Securities Litigation Reform Act of 1995 based oncurrent expectations, estimates, forecasts and projections about theorthopaedics industry, management's beliefs and assumptions made by management.Forward-looking statements may be identified by the use of forward-looking termssuch as "may," "will," "expects," "believes," "anticipates," "plans,""estimates," "projects," "targets," "forecasts," and "seeks" or the negative ofsuch terms or other variations on such terms or comparable terminology. Thesestatements are not guarantees of future performance and involve risks,uncertainties and assumptions that could cause actual outcomes and results todiffer materially. These risks and uncertainties include, but are not limitedto, our ability to successfully integrate Centerpulse AG and Implex Corp., theoutcome of the Department of Justice investigation announced in March 2005 andthe pending informal SEC investigation of Centerpulse accounting, price andproduct competition, rapid technological development, demographic changes,dependence on new product development, the mix of our products and services,supply and prices of raw materials and products, customer demand for ourproducts and services, control of costs and expenses, our ability to form andimplement alliances, international growth, governmental laws and regulationsaffecting our U.S. and international businesses, including tax obligations andrisks, product liability and intellectual property litigation losses,reimbursement levels from third-party payors, general industry and marketconditions and growth rates and general domestic and international economicconditions including interest rate and currency exchange rate fluctuations. Fora further list and description of such risks and uncertainties, see thedisclosure materials filed by Zimmer with the U.S. Securities and ExchangeCommission. Zimmer disclaims any intention or obligation to update or revise anyforward-looking statements, whether as a result of new information, futureevents or otherwise. Readers of this document are cautioned not to place unduereliance on these forward-looking statements, since, while we believe theassumptions on which the forward-looking statements are based are reasonable,there can be no assurance that these forward-looking statements will prove to beaccurate. This cautionary statement is applicable to all forward-lookingstatements contained in this document. This information is provided by RNS The company news service from the London Stock Exchange