FDA Approves CytexOrtho Hip Human Clinical Trials

CytexOrtho has received U.S. Food and Drug Administration (FDA) approval to launch a Phase I clinical trial, allowing CytexOrtho to initiate a first-in-human clinical study to evaluate the safety and efficacy of its ReNew Hip Implant novel cartilage repair technology.

The proprietary ReNew Hip Implant leverages advanced manufacturing techniques to create a unique, highly porous, bioabsorbable device engineered to mimic the properties of healthy articular cartilage. Proven in animal trials, ReNew Hip provides immediate structural support, while supporting the body’s own regenerative, healing processes to restore the joint.

Brad Estes, Ph.D., CEO and Co-founder, CytexOrtho, said, “There are over one million American patients under the age of 65 who suffer with chronic hip pain. Approximately 20 percent of these patients get hip replacements. The rest avoid them because of the high risk of wearing them out and the complications that come with a revision replacement, and instead choose to live with increasingly crippling pain. FDA’s approval of this first human clinical trial brings us closer to delivering new options to the clinic for patients with hip disease. Our ReNew Hip Implant aims to change the game by restoring the joint’s anatomical contour with natural tissue regeneration.”

CytexOrtho will enroll up to 15 patients aged 14-55 years old with hip disease, resulting in a loss of articular cartilage integrity on the femoral head. The non-randomized, single-arm study will establish an initial safety profile and evaluate efficacy in improving pain and function over 12 months. It will follow patients for 60 months post-implantation.

Farshid Guilak, Ph.D., Co-founder of CytexOrtho, Professor of Orthopedic Surgery, and Director of Research, Shriners Children’s – St. Louis, commented, “This IDE approval is backed up by of years of research and development showing success of the ReNew Hip Implant in pre-clinical animal studies. We believe our approach has the potential to address a significant unmet need in orthopedics.”