Industry News July 2003

Cook Biotech Starts Major Expansion Project

Cook Biotech Inc., one of the few companies to successfully bring to market products in the emerging field of tissue engineering, has initiated a major expansion that will increase its production and office space by more than 500 percent.

The expansion project, located adjacent to the company’s existing facility in the Purdue Research Park in West Lafayette, Indiana, broke ground May 7 and is expected to be completed in mid-2004. Once completed, the company expects to expand its workforce in raw material processing, production, research and development, quality assurance, and other critical areas.

Cook Biotech manufactures tissue-engineered medical products from a specific portion of the porcine (swine) small intestine. This special tissue is harvested and developed into strong, pliable sheets that provide a rich environment for cell attachment and growth. These sheets act as biocompatible scaffolds for surrounding cells that facilitate the repair of damaged tissues. As the tissues heal, the scaffold is assimilated into surrounding tissues.

To date, Cook Biotech has received 11 clearances from the US Food and Drug Administration for medical products used to help patients undergoing wound care, burn management, hernia repair, urological procedures, and general surgery.

Ortec to be Granted Fifth Patent

Ortec International, Inc. announces that it has received notification from the US Patent Office that the company’s claims covering the cryopreservation process for its tissue engineered product, Orcel®, have been
granted.

A patent, incorporating these approved claims, is expected to be issued by the end of this year. The patent to be issued will expire in 2020 and will be the fifth issued to Ortec, four by the US Patent Office and one by the European Patent Office. Ortec is currently completing a pivotal (final stage) venous ulcer clinical trial using OrCel, which was cryopreserved using the process covered by the claims.

Commenting on the allowance of the claims, Ron Lipstein, Vice-Chairman and CEO of Ortec said, “Granting of our claims for cryopreserving OrCel represents continued progress in the implementation of our business model and marketing strategy. We expect to deliver to the market place a product with an extended shelf life and readily available on site, which will further differentiate us from the competition. Manufacturing a frozen product, in contrast to fresh, allows for significant manufacturing efficiencies by reducing waste, overhead, and plant capacity requirements. Ortec is focused on making the most cost-effective tissue engineered product, and having a cryopreserved product is critical in achieving this goal.”

Ortec received its first US patent in February 1994. In March 1994, Ortec’s primary competitor challenged the issuance of the patent by requesting the US Patent Office to reexamine the issuance of the patent. Ortec successfully defended that challenge, and the patent was reissued by the Patent Office in December 1996 without any material modification to its claims. Ortec’s original patent and its reissued patent expire in 2011. In March 2000, the US patent office granted Ortec a second patent. That patent extended protection to Ortec’s collagen scaffold containing cells other than skin cells, such as those for regenerating such organs and tissues as heart muscle, blood vessels, ligaments, cartilage, and nerves. Ortec was originally granted a European patent on its OrCel technology on December 29, 1997, and received notification in November 1998 that it was being challenged by another competitor. In March 2002, Ortec successfully defeated that opposition.

Ortec International, Inc. is a tissue-engineering company involved in the commercialization of a proprietary and patented technology to stimulate the repair and regeneration of human tissue. Ortec’s current focus is the application of its OrCel (Bilayered Cellular Matrix) to heal chronic and acute wounds. OrCel is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds and are believed to have a beneficial role in promoting tissue repair. In addition to having received FDA approvals for the treatment of epidermolysis bullosa and donor sites in burn patients, a pivotal clinical trial is ongoing in venous ulcers, and the FDA has granted Ortec approval to initiate a pivotal trial in diabetic foot ulcers. Ortec believes that its platform technology may extend to the regeneration of other human tissue, such as tendons, ligaments, cartilage, bone, muscle, and blood vessels. For more information, visit Ortec’s website at http://www.ortecinternational.com. •••

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