ReGen Biologics Receives CE Marking for Collagen Meniscus Implant.
ReGen Biologics, Inc. announced today that the European Community has granted a CE Marking for the company's Collagen Meniscus Implant (CMI), thus permitting commercialization of that product throughout Europe. With this approval, ReGen is preparing to launch the CMI in Europe through its existing distribution partnership with SulzerMedica, one of the world's leading orthopedic and cardiology device manufacturers.
The CMI is used in treating tears of the meniscus of the knee, the most frequently damaged cartilage in the human body. Loss of this tissue can lead, over time, to degenerative osteoarthritis in the knee joint. The device is a resorbable collagen scaffold designed to prevent or delay progressive degenerative changes in the knee joint by providing a biological alternative to the permanent loss of meniscus tissue after a partial meniscectomy. Once sutured in place, the CMI is designed to support the natural regeneration of meniscal tissue, thereby restoring function, reducing pain and arresting the degenerative process that begins with meniscal tissue loss.
Results of a European multi-center clinical study established the efficacy of the CMI in providing significant improvement in pain and function in patients with meniscal damage.
Dr. Gerald E. Bisbee, Jr., chairman and CEO said, "We are delighted to receive expedited approval of the Collagen Meniscus Implant. The CMI is the first tissue engineered meniscus repair product to receive CE marking. With the positive results of the European clinical study, we are anticipating excellent response by the market."
ReGen is currently conducting multi-center clinical trials in the United States with the CMI. The company anticipates the completion of patient enrollment in the first of these trials by year-end. Enrollment in a second clinical trial is scheduled to begin in the third quarter of 2000.
ReGen Biologics is a privately held tissue engineering company with a focus on the repair and preservation of the knee. The company designs, develops, and manufactures minimally invasive implants and medical devices for the repair and regeneration of damaged or degenerating cartilage. In addition to the CMI, ReGen distributes the SharpShooter(TM) Tissue Repair System, an evolutionary approach to inside-out suture repair of the torn meniscus.