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SANTA BARBARA, Calif.--(BUSINESS WIRE)--Dec. 15, 2004--Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it has initiated the Phase 1 study of its proprietary botulinum toxin type A product, focused on the cosmetics indication in the United States. "Mentor's product formulation has been designed to yield a more purified product than any botulinum based pharmaceuticals in current use or development," commented Gary E. Borodic, M.D., Assistant Clinical Professor, Harvard Medical School and a leading botulinum toxin researcher. "This product has the potential to significantly advance the field of botulinum toxin research for a variety of medical conditions." "I am pleased with the potential we have to improve outcomes for patients," added Kenneth A. Buchwach, M.D., a board certified facial plastic surgeon and principal investigator of Mentor's Phase 1 study. "I look forward to evaluating the product in the clinical setting and to working with Mentor to support the approval process." The Phase 1 safety and dose escalation study will be a single exposure study with six months follow-up. Upon completing the study, Mentor plans to move quickly into the Phase 2 dose-finding study and then the Phase 3 product registration study, all of which are required to be completed before seeking approval to market and sell the product from the U.S. Food and Drug Administration. "The initiation of the U.S. clinical program is another significant milestone for Mentor and our botulinum toxin development program," commented Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. "We are aggressively advancing our facial aesthetics development pipeline and believe that the botulinum toxins as well as the dermal filler products have significant potential in this rapidly expanding market." Mentor established its botulinum toxin program through a broad licensing agreement with the Wisconsin Alumni Research Foundation in December 2003. Under terms of the agreement, Mentor obtained the exclusive rights to all strains of the botulinum toxin, including botulinum toxin type A, and has the right to manufacture, develop and commercialize the underlying technology for all applications in all markets, worldwide. About Mentor Corporation Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The Company develops, manufactures and markets innovative, science-based products for the aesthetics and urologic specialties markets around the world. The Company's Aesthetics franchise includes prosthetic mammary implants for breast augmentation and reconstruction, and lipoplasty products for body contouring. Mentor's Urologic Specialties franchise includes surgical slings for the treatment of urinary stress incontinence, brachytherapy seeds for the treatment of prostate cancer, prosthetic implants for the treatment of erectile dysfunction and disposable medical devices for the treatment and care of urinary incontinence and other urological conditions. Mentor employs approximately 2,000 people around the world and is headquartered in Santa Barbara, California, with manufacturing and research operations in the United States, France, the Netherlands and the United Kingdom. The Company's website is www.mentorcorp.com. Safe Harbor Statement All statements included or incorporated by reference in this release, other than statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on our current expectations, estimates and projections about our industry, management's beliefs and certain assumptions made by us. Forward-looking statements can often be identified by words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "could," "potential," "continue," similar expressions, and variations or negatives of these words. In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements speak only as of the date hereof and are based upon the information available to us at this time. Such information is subject to change, and we will not necessarily inform you of such changes. These statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statement as a result of various factors. The Securities and Exchange Commission filings of Mentor, including, without limitation, its Annual Reports on Form 10-K, subsequent quarterly reports on Form 10-Q, and recent Current Reports on Form 8-K, discuss important risk factors that could contribute to such differences or otherwise affect its business, results of operations and financial condition. Mentor undertakes no obligation to revise or update publicly any forward-looking statement for any reason. |
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