Kensey Nash Corporation announced that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to study the use of the Company’s unique biomaterials technology for treating articular cartilage defects of the knee. The clinical trial will utilize the Company’s Cartilage Repair Device, which consists of a proprietary bi-phasic, bioresorbable implant designed to treat chondral lesions.
Articular cartilage injury is commonly encountered in people with active lifestyles. Unlike other tissue types, cartilage possesses a limited capacity to heal. Surgical treatment options available today usually generate a repair tissue that is insufficient in absorbing or distributing loads and is prone to failure. Worldwide, physicians perform approximately one million procedures each year to repair damaged articular cartilage in the knee and a majority of these are repeat procedures, illustrating the ineffectiveness of current therapeutic approaches. Over time, debilitating osteoarthritis may develop in the afflicted joint ultimately requiring partial or total knee replacement. The Company believes that an early and successful treatment of traumatized articular cartilage may prevent the long-term onset of osteoarthritis, and consequently reduce the number of radical knee joint replacement surgeries performed each year.
“Our cartilage repair product team has made great progress in the development of this device over the past few years. Significant preclinical research has been conducted with some of the premier academic institutions in the U.S.,” stated Douglas G. Evans, COO of Kensey Nash Corporation. “Our IDE submission for this clinical trial represents an important accomplishment towards achieving full commercialization of this proprietary product and technology,” he concluded.
The Company’s Cartilage Repair Device (CRD) is a composite of several bioresorbable biomaterials, utilizing the Company’s proprietary collagen technology, and beta-tricalcium phosphate mineral suspended in a synthetic polymer Porous Tissue Matrix (PTM). This device architecture is designed to repair damaged articular cartilage in the knee or other articulating joints. The Company’s Cartilage Repair implant is housed in an insertion tool, which facilitates arthroscopic insertion, allowing the surgeon to avoid open procedures. The design also allows implants to be cut to length and easily hydrated with autologous blood products. The Company has also developed a full complement of specialized color-coded instruments to estimate implant size and prepare the defect site for the delivery of this proprietary bi-phasic implant.
“We believe that our product development team has created a sophisticated solution for the treatment of focal articular cartilage defects,” commented Russell T. Kronengold, Ph.D., VP of Biomaterials R&D of Kensey Nash Corporation. “We believe that the CRD provides the requisite biomechanical and biological properties that promote successful osteochondral repair. The KNC approach utilizes well established biomaterials that have a proven safety record,” he added.
The Company has established an advisory board of leading clinicians and researchers to counsel on the clinical application of the device, and the design and execution of the upcoming human clinical trial.
Source: Kensey Nash Corporation
published: February 25, 2009 in: Companies, Knee, Orthopaedics, Products, Regulatory, Specialty