Genzyme Tissue Repair launches cartilage cell service; Biotech approach uses patients' own cells to treat knee damage.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 30, 1995--Genzyme Tissue Repair (NASDAQ: GENZL) is launching its Carticel service, which employs a commercial process to grow a patients' own cartilage cells for use in treating knee damage.

The first procedure is slated to take place today at Massachusetts General Hospital, Boston. Several other patients are scheduled for treatment in April at Massachusetts General and at Brigham and Women's Hospital, Boston.

"Carticel has the potential to revolutionize the way cartilage damage is treated," said Gregory D. Phelps, president of Genzyme Tissue Repair, a Genzyme Corp. division represented by a separate class of common stock. "The Carticel service has emerged as the most significant program within Genzyme Tissue Repair. Its near-term revenue potential promises to dramatically change the nature of our division."

Genzyme Tissue Repair estimates that between 100,000 and 200,000 people annually in the United States and Europe will be potential candidates for treatment with cells grown by the Carticel service. The division is charging $10,000 per patient to process the cells. One major insurance company has already agreed to pay for the treatment, and the division is confident that others will follow suit.

The Carticel service will be available in other U.S. cities in the coming months. Genzyme Tissue Repair will provide the service to orthopedic surgeons who agree to receive training in the procedure. Anticipating growth in the service, the division is expanding its direct sales force in the United States and Europe.

Several weeks ago, the two Boston hospitals supplied Genzyme Tissue Repair with biopsies of healthy cartilage from patients with knee cartilage defects. Technicians at the division's processing facility in Cambridge used proprietary methods to grow millions of new cells for each patient. The cells will be delivered to the hospitals, where orthopedic surgeons will use each patient's own, or autologous, cells to repair that patient's cartilage defect.

The first procedure will be performed by Massachusetts General's Bertram Zarins, M.D., the team physician for the New England Patriots and the Boston Bruins. Within a few weeks, Tom Minas, M.D., of Brigham and Women's also will start performing the new operation.

"This is an exciting and innovative procedure which offers hope and improved quality of life for young patients with injured knees," said Minas, clinical instructor in orthopedic surgery at Brigham and Women's and Harvard Medical School. "Hopefully, this will prevent more radical surgery for their future, eliminating the need for total knee replacements."

Said Zarins: "Injuries to joint cartilage are among the most frustrating problems that orthopedic surgeons treat. This new therapy seems to be an important step forward."

In today's procedure, Zarins will implant the cultured cells into a cartilage defect on the portion of the femur, or thigh bone, that makes up part of the knee (diagram available). A small flap of autologous periosteum, the membrane that covers bone surfaces, will be sutured over the defect to hold the cells in place. Clinical research has shown that the cells integrate into the surrounding tissue and mature into normal cartilage, restoring nearly frictionless movement of the knee. Since the replacement cartilage is autologous, there is no danger of rejection by the immune system.

Joint cartilage does not normally regenerate in the body. As a result, damage to such cartilage tends to become more severe over time, as small tears increase friction, which causes larger defects. Such damage can cause severe pain and reduced mobility and may lead to debilitating osteoarthritis. These manifestations can severely hinder a person's normal activities. Many athletes have had their careers shortened by knee injuries.

Current treatments sometimes provide symptomatic relief, but when they do, the benefit usually lasts only a few years. Approximately 650,000 such procedures are performed in the United States annually. Some people undergo arthroscopic surgery to smooth the surface of the damaged area. In others, a hole is drilled in the bone to allow cells from the bone marrow to infiltrate the defect. The latter procedure results in fibrous cartilage, which lacks the strength and durability of normal joint cartilage.

Eventually, the entire joint may need to be resurfaced with metal and plastic. About 170,000 of these total knee replacement operations are performed annually, at a cost of $25,000 each. The artificial surface generally lasts only 10 to 15 years.

The Carticel treatment was designed to provide a better therapy for people with joint cartilage damage. The new treatment was initially developed at the University of Goteborg and Sahlgrenska University Hospital, Goteborg, Sweden.

In a five-year study published last October in the New England Journal of Medicine, the Swedish researchers reported "good-to-excellent results" in 14 of 16 patients with the type of knee defect to be treated at the Boston hospitals. The researchers said the new cartilage had the look and consistency of the surrounding cartilage. The Swedish surgeons have now treated about 150 people. The Harvard Health Letter selected the Swedish research as one of the "Top 10 Medical Advances of 1994."

Under an exclusive collaborative agreement, the Swedish group and Genzyme Tissue Repair developed the proprietary techniques used to prepare the cells for today's operation in Boston.

Genzyme Tissue Repair was established last December when Genzyme Corp. acquired BioSurface Technology Inc., merged it with several other tissue repair programs, and issued a class of common stock that represents the value of the new division. Genzyme is one of the world's top five biotechnology companies.

CONTACT: Genzyme Tissue Repair

Steve Push, 202/296-3280 (W)

703/757-2220 (H) (Media Contacts)

Lori Lass, 617/252-7570

or

Susan Cogswell, 617-252-7580 (Investor Contact)