Early clinical experience shows product equivalence to autologous palatal grafts

Advanced Tissue Sciences, Inc. today announced that its human-based tissue was featured in a scientific presentation to the American Academy of Periodontology during its 87th annual meeting held October 6-10 in Philadelphia.

The session, titled "Tissue Engineering in Periodontics: The Next Step in Therapeutics," included preliminary clinical results of a study conducted by Dr. Michael K. McGuire. In the study of more than 20 patients, Dr. McGuire observed that Advanced Tissue's core product, fibroblast cells grown on a bio-absorbable scaffold, demonstrated equivalence to autologous palatal grafts in a within-patient paired comparison trial. One side of the patient's mouth was treated with the tissue-engineered product, and the other with a palatal graft harvested from the roof of the patient's mouth. A comparison of the results of the two procedures demonstrated equivalence.

Traditionally, periodontists have repaired damaged gum tissue by harvesting palatal tissue from the roof of the patient's mouth and grafting it onto the diseased area. In cases of extensive damage, this procedure is repeated several times, allowing for healing of the palate between grafts. Advanced Tissue Sciences' tissue-engineered product could obviate the need for the second wound, thereby lowering patient morbidity. In addition, the product may allow periodontists to treat patients with extensive gum disease without the need for repeat surgeries. According to the American Dental Association, approximately 500,000 people undergo periodontal soft tissue grafts annually in the U.S.

"I am pleased with the preliminary results of this off-the-shelf, bio-engineered graft," Dr. McGuire said. "The cells are viable and able to contribute to healing and native integration immediately. This new therapy has the potential to broaden our scope of practice and provide predictable regenerative results."

"We are both gratified and excited by Dr. McGuire's preliminary findings," said Gail K. Naughton, president of Advanced Tissue Sciences. "Periodontology is just one of many new applications of our tissue-engineered product that we are pursuing. Together, these applications promise to broaden our product portfolio while enhancing the quality of human life."

In his opening remarks for the meeting, Dr. McGuire said that tissue engineering is poised to have a powerful impact on periodontology. "More than anything else on the horizon, I see tissue engineering as having the greatest potential for dramatically and positively affecting our specialty. We need to make certain we capture this new technology for periodontics."

Advanced Tissue Sciences is a tissue engineering company utilizing its proprietary core technology to develop and manufacture human-based tissue products for tissue repair and transplantation. It is the only company to have gained FDA approval for a tissue-engineered, living dermal substitute that is human-based, mass produced and cryopreserved.

The company has two joint ventures with Smith & Nephew. The first covers the application of Advanced Tissue Sciences' tissue engineering technology for skin wounds. This includes Dermagraft(R), which has been approved in the United States and other countries for the treatment of diabetic foot ulcers and has been approved in Canada for all chronic wounds. The joint venture also includes TransCyte(R) for the temporary covering of second-and third-degree burns, and future developments for venous ulcers, pressure ulcers, burns and other non-aesthetic wound care treatments. The second joint venture is developing tissue-engineered orthopedic cartilage, initially focusing on the repair of cartilage in knee joints.

The company also has a strategic alliance with Inamed Corporation for the development and marketing of several of Advanced Tissue Sciences' human-based, tissue-engineered products, such as collagen for aesthetic and certain reconstructive applications. In addition, the company is developing products such as NouriCel(TM) for skincare and cosmetic markets and other products for cardiovascular applications. For more information on Advanced Tissue Sciences, visit our web site at www.advancedtissue.com.