ReGen Biologics' Meniscus Implant Supports Regeneration of Damaged Knee Cartilage.

REDWOOD CITY, Calif.--(BW HealthWire)--January 6, 1998--Damaged meniscal cartilage in the knee was regenerated in the first group of clinical study patients using a naturally resorbable collagen scaffold developed by ReGen Biologics, Inc. according to a new study published in the December issue of The Journal of Bone and Joint Surgery by Kevin Stone, M.D. Results of this clinical study of the Meniscus Implant showed that the device was arthroscopically implantable, safe and supported the regeneration of tissue in meniscal defects of various sizes, with no adverse reactions.

"The meniscus is the most frequently damaged cartilage in the human body, and loss of this cartilage can lead to degenerative osteoarthritis in the knee joint," said J. Richard Steadman, M.D., co-chairman of ReGen Biologics and co-author of the publication. "Results of this initial feasibility study confirm that meniscal cartilage can be regrown if given an appropriate environment to do so, as with the resorbable collagen scaffold developed by ReGen. While additional studies are underway to determine the long-term efficacy of this approach, the clinical results to date are positive."

Ten patients with irreparable tears of the meniscal cartilage or major loss of meniscal cartilage resulting from a variety of conditions participated in the Phase I study. The aim of the study was to evaluate the safety and implantability of the Meniscus Implant and its ability to support tissue regeneration. Nine patients remained in the study for at least 36 months, and one patient voluntarily withdrew after three months for personal reasons.

On second-look arthroscopy, performed either three or six months after implantation, evaluation of the patients revealed newly formed tissue replacing the Meniscus Implant as it was resorbed. The majority of patients reported a decrease in symptoms including pain and an increase in their level of activity 36 months after the implantation. In addition, magnetic resonance imaging (MRI) scans of the patients' knees demonstrated progressive maturation of the regenerated meniscus at three, six, 12 and 36 months. Based on these results, the Food and Drug Administration (FDA) granted permission for a multi-center trial that is currently underway in 12 sites across the United States. A similar trial is also ongoing at several other sites in Europe.

Each year approximately 1.5 million Americans undergo knee surgery, two-thirds of which relate to problems of the meniscus. The meniscus is a c-shaped disc of fibrous cartilage located in the knee joint between the femur and the tibia that plays a crucial role in joint stability and lubrication, and provides protection between the articular cartilage covering the ends of the femur and tibia. Currently, the treatment for torn meniscal cartilage usually involves the removal of the damaged tissue, but occasionally the tear is repaired with sutures. Some researchers have reported the replacement of damaged or removed cartilage with artificial materials, cartilage from other areas of the body (autogenous tissue) or donated (allograft) tissue, but results generally have been poor.

ReGen Biologics is a privately held company that designs and develops minimally invasive systems for the repair and regeneration of damaged or degenerating cartilage that, left untreated, can cause osteoarthritis. In addition to developing the Meniscus Implant, ReGen Biologics plans to launch in 1998 the SharpShooter Meniscal Repair System, a disposable device that facilitates meniscus repair.

CONTACT: ReGen Biologics, Inc.

Lori Murray

650/306-8269 or 650/562-0800