To: Link Lady who wrote (1128 ) 8/31/1998 12:49:00 PM From: Bruce Cullen Read Replies (1) | Respond to of 1223
Company Press Release Monday August 31, 11:51 am Eastern Time Organogenesis Announces Growth in Market Acceptance of Apligraf CANTON, Mass.--(BUSINESS WIRE)--Aug. 31, 1998--Organogenesis Inc. (AMEX:ORG - news) today reported information on the market acceptance of Apligraf, which was launched in the US in June by Novartis Pharmaceuticals Corporation. The initial Novartis market strategy is to focus on the key hospitals in the US which will be the first adopters of this New Standard of Care for venous leg ulcers. By concentrating on these centers first, the plan is to build a solid base of physician and patient awareness and enthusiasm for Apligraf which will lead to a significant and sustained sales growth. Two and one half months into the launch, Organogenesis is pleased to announce broadening product acceptance in institutions across the country. Leading indicators used to track product acceptance are (1) the number of sites that have ordered Apligraf (one or more units) for commercial use and (2) the number of sites that have placed at least one re-order for Apligraf (for one or more units) for commercial use. The two charts below show growth of both of these measures through June, July and August. The continued growth of these curves means that Organogenesis will enter 1999 with a strong business base for the expansion of Apligraf sales. Organogenesis Inc. designs, develops and manufactures medical products containing living cells and/or natural connective tissue. The Company's product development focus includes living tissue replacements, cell-based organ assist devices and other tissue-engineered products. Lead product Apligraf(tm) has been approved for the treatment of venous leg ulcers in the United States and Canada; Novartis Pharma AG has global Apligraf marketing rights. In addition to Apligraf, Organogenesis' portfolio includes the Graftpatch(tm) surgical product (also FDA-cleared for marketing in the US), VITrix(tm) connective tissue replacement product, injectable engineered collagen, a liver-assist device and a vascular graft. Statements in this press release which express ''planned'', ''expectation'' and ''anticipation'', as well as other statements which are not historical fact, and statements as to product compatibility, design, features, functionality and performance insofar as they may apply prospectively, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. The Company's actual results may differ significantly from the results discussed in this press release or in other forward-looking statements presented by management. Factors that might cause such a difference include, but are not limited to, development by the Company's competitors of new technologies or products that are more effective than the Company's, risks of failure of clinical trials, dependence on and retention of key personnel, protection of proprietary technology, compliance with US Food and Drug Administration regulations, continued availability of raw material for the Company's products, availability of product liability insurance upon commercialization of the Company's products, ability to transition from small-scale manufacturing to full-scale commercial production of products, uncertainty as to the availability of additional capital on acceptable terms, if at all, and the demand for the Company's products, if and when approved.