Apligraf Human Skin Equivalent Approved for Marketing in Canada.

CANTON, Mass.--(BW HealthWire)--April 7, 1997--Organogenesis Inc. (AMEX: ORG) today announced that the Canadian Health Protection Branch has approved Apligraf Human Skin Equivalent for marketing. The basis for this approval is the Apligraf venous ulcer pivotal trial conducted by Organogenesis in the U.S. Apligraf is the first living manufactured organ -- skin -- to be approved for marketing by a major regulatory agency following review of its efficacy and safety data.

The approval was granted to Novartis, which has global Apligraf marketing rights. Novartis' introduction of Apligraf in Canada will begin with an educational campaign targeted to the medical community, followed by full launch. Canada has a reputation for providing high quality medical care, making it an important market for therapeutics even though its population size is smaller than that of the U.S. Organogenesis is responsible for supplying Novartis' global requirements for Apligraf and will manufacture product for Canada at its Canton, Massachusetts facility.

David T. Rovee, Ph.D., President and Chief Operating Officer of Organogenesis, said, "The Canadian Health Protection Branch's approval of Apligraf represents the first of Novartis' international registrations for the product. In preparation for Apligraf commercialization, Organogenesis has recently completed an expansion of the manufacturing facility in Canton. We look forward to supplying product to Canada."

Apligraf features both layers of skin -- upper epidermis and the lower dermis -- comprised of living human epidermal cells (keratinocytes) and dermal cells (fibroblasts). The U.S. venous ulcer pivotal trial results showed that Apligraf achieves complete wound closure in more patients and in a shorter time than standard compression therapy. The Apligraf premarket approval application (PMA) for the treatment of venous ulcers is currently pending at the U.S. Food and Drug Administration, with international registrations being pursued by Novartis.

Organogenesis Inc. designs, develops and manufactures medical therapeutics containing living cells and/or natural connective tissue components. The Company's products are designed to promote the establishment and growth of new tissues to restore, maintain or improve biological function. Organogenesis' product development focus includes living tissue replacements, organ assist treatments and guided tissue regeneration scaffolds.

Statements in this press release which express the "belief", "anticipation" or "expectation," 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 on 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 U.S. 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 pilot-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.

CONTACT: Organogenesis

Carol Hausner, 617/575-0775