CytexOrtho today said it has approval from the FDA to start a Phase 1 clinical trial evaluating the safety and efficacy of its absorbable hip implant in human patients. CytexOrtho’s proprietary ReNew Hip Implant uses advanced 3D manufacturing techniques and polycaprolactone (PCL). The implant is designed to help hip disease patients who don’t yet need or want a hip joint replacement.
“There are over one million American patients under the age of 65 who suffer with chronic hip pain,” CytexOrtho co-founder and CEO Brad Estes said in a statement to MassDevice ahead of today’s announcement. “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.”
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“FDA’s approval of this first human clinical trial brings us closer to delivering new options to the clinic for patients with hip disease,” he continued. “Our ReNew Hip Implant aims to change the game by restoring the joint’s anatomical contour with natural tissue regeneration.”
Under the FDA investigational device exemption (IDE), Durham, North Carolina-based CytexOrtho plans a non-randomized, single-arm study with up to 15 patients (ages 14 to 55 years) who have hip disease resulting in loss of articular cartilage integrity on the femoral head.
The study will establish an initial safety profile and evaluate improvement in pain and function over 12 months, ultimately following the patients for five years after implantation.
“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,” said CytexOrtho co-founder Farshid Guilak, professor of orthopedic surgery and director of research at Shriners Children’s – St. Louis. “We believe our approach has the potential to address a significant unmet need in orthopedics.”
Estes tells MassDevice that a pivotal trial would follow in 2026 to win FDA premarket approval (PMA) in late 2028 or 2029, though he noted those estimates are based on trial enrolment.
In February, CytexOrtho and its ReNew technology won the inaugural OrthoPitch Technology Competition at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS).
