Apligraf PMA Supplement Submitted for Diabetic Foot Ulcers; Approval Sought to Allow Marketing of Product for This Frequent Cause of Amputation.

Business Editors and Health/Medical Writers

CANTON, Mass.--(BW HealthWire)--Dec. 22, 1999

Organogenesis Inc. (AMEX:ORG) today announced that it has applied to the US Food and Drug Administration for its Apligraf(R) skin construct to be marketed for use in the treatment of diabetic foot ulcers. As Apligraf has already been approved by the FDA for a use (venous leg ulcers), a PMA supplement was submitted which refers to the approved PMA for shared information. Organogenesis developed and manufactures Apligraf, which is marketed in the US by Novartis Pharmaceuticals Corporation.

The basis of the PMA supplement was the large, prospective, randomized Apligraf diabetic ulcer pivotal trial. In this multi-center trial, 208 patients were treated with either Apligraf plus standard care or diabetic ulcer standard care alone. In the trial, use of Apligraf healed 56% of ulcers within twelve weeks, compared to 38% healing with standard care alone (p less than 0.01). Use of Apligraf was also found to reduce time to healing, with complete healing achieved in an average (median) of 65 days, compared to 90 days with standard care alone (p less than 0.01).

Healing more diabetic ulcers - quickly - is important because of their potentially serious consequences. In the past, these wounds were a common cause of mortality among diabetics. While the mortality has been decreased substantially in recent years, the reduction was achieved in part through vigilant use of hospitalization and amputation. Today, foot ulcers remain a leading cause of hospitalization among diabetics and account for over 1000 amputations per week in the US alone. Between 600,000 - 800,000 Americans currently suffer from diabetic foot ulcers.

"We are delighted to announce the submission of this PMA supplement," said Herbert M. Stein, Chairman and Chief Executive Officer. "Apligraf is the only product containing living human skin cells to have shown efficacy in a large, prospective, randomized pivotal trial, and Apligraf has done this twice - first in venous leg ulcers, and again in diabetic foot ulcers. Organogenesis is proud of these achievements, and I am proud to have been able to advance the Company to this stage prior to my retirement on January 1, 2000."

Like human skin, Apligraf is all-natural and bi-layered, with both an upper epidermal and a lower dermal layer. It contains living human skin cells - epidermal keratinocytes and dermal fibroblasts. The keratinocytes are differentiated to form the strata of the human epidermis, including the outer stratum corneum. Unlike human skin, Apligraf does not contain Langer-han's cells, melanocytes, macrophages or lymphocytes, or structures such as blood vessels, hair follicles and sweat glands. Novartis Pharma AG has global Apligraf marketing rights.

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. The research pipeline includes VITRIX(TM) living soft tissue replacement, a bioartificial liver and a vascular graft.

Statements in this press release which are not historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. There can be no assurance that this Apligraf PMA supplement for use in diabetic ulcers will be approved by the FDA in a timely manner, if at all. Apligraf(R) is a registered trademark of Novartis.