Appligraf - Graftskin - Shown to Perform Similarly to Patient Skin on Donor Site Wounds; Data on Human Skin Equivalent Published in Current issue of The Lancet.

CANTON, Mass.--(BW HealthWire)--Oct. 20, 1997--Organogesis Inc. (AMEX:ORG) announced today the publication in The Lancet of "Bioengineered Skin," a research letter which discusses findings from a study comparing Apligraf(TM) (Graftskin) to patient skin.

This publication, authored by M. Muhart, S. McFalls, R. Kirsner, F. Kredel and W. Eaglstein of the University of Miami School of Medicine, presents the team's research comparing Apligraf to patient skin (autograft), as well as to polyurethane film (PUF), in the treatment of donor site wounds. In the study, Apligraf was found to perform comparably to patient skin, and better than PUF, in both time to 100 percent healing and reduction in pain. Both Apligraf and autograft provided a better cosmetic outcome than PUF.

"We were impressed that Apligraf performed like the patient's own skin," noted William Eaglstein, MD, who led the study team at the University of Miami School of Medicine. "The ability to provide the benefit of a skin graft with a manufactured product is a major advance for medicine."

The authors reported on the findings in eleven patients with donor site wounds. Donor site wounds are highly uniform in size and depth, making them an excellent model for comparing alternative wound care treatments. These wounds are created during autografting when skin is harvested for use elsewhere on the patient; an estimated 100,000 such procedures are performed each year in the U.S. Each patient in this study received meshed Apligraf, meshed autograft and PUF at separate sites on the donor wound. Having each patient serve as his/her own control enables important contributions between treatments with relatively few patients. Study endpoints were time to 100 percent healing, pain and cosmetic outcome.

The authors reported the following results:

-- Average time to 100 percent healing was comparable between Apligraf (7.4 days) and autograft (7.9 days). Both treatments achieved 100 percent wound healing significantly faster (p=0.0006) than did the polyurethane film dressing (10.4 days);

-- Both Apligraf and autograft reduced pain at the donor wound site. No pain was reported for the autograft and Apligraf treatments, while over half of the patients complained of mild pain with the polyurethane film; and

-- Both Apligraf and autograft "afforded a more desirable cosmetic result" when compared with PUF. In addition to differences in coloration, the polyurethane film-treated sites remained elevated in most patients at the end of the study (2 months).

The investigators are submitting the results from the full 20 patient study for publication as a complete manuscript. The results from the full study are consistent with those reported in The Lancet research letter. This study is part of Organogenesis' research program assessing the efficacy and safety of Apligraf in the treatment of wounds due to skin surgery. In addition to donor site wounds, Apligraf studies have been completed in venous ulcers, burn wounds and dermatological surgery wounds. A study is currently underway in diabetic ulcers. Apligraf has been approved and launched for the treatment of venous ulcers in Canada, and its venous ulcer premarket approval application (PMA) is currently pending at the U.S. FDA. Additional international registrations for the product are also being pursued.

Apligraf is a living, dual-layered human skin equivalent. The product features both an epidermis and dermis, composed of living human epidermal (keratinocytes) and dermal (fibroblasts) cells. The epidermal layer of Apligraf is fully differentiated and includes a stratum corneum - the outer protective layer of skin. The product is all natural and is not removed after application.

Organogenesis Inc. designs, develops and manufactures medical therapeutics containing living cells and/or natural connective tissue components. Organogenesis' product development focus includes living tissue replacements, cell-based organ assist devices and guided tissue regeneration scaffolds. In addition to Apligraf, the company's product portfolio includes the GRAFTPATCH surgical product (recently cleared for marketing in the U.S.), a cell-based liver assist device, a vascular graft for coronary artery bypass procedures, and a tissue filler product for female urinary incontinence.

Statements in this press release which express the "intent," "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 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 U.S. Food and Drug Administration regulation, 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, 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 Inc.

Carol Hausner, 617/575-0775