CytexOrtho has secured FDA approval to initiate a Phase 1 clinical trial for its ReNew Hip Implant, an innovative absorbable device intended for patients suffering from hip disease. The trial will evaluate the safety and efficacy of the implant in human subjects.
The ReNew Hip Implant is constructed using advanced 3D manufacturing techniques and a biocompatible material called polycaprolactone (PCL). It is specifically designed for individuals with hip conditions who are not yet candidates for, or do not desire, a total hip replacement. The goal is to provide a less invasive option that can delay or even prevent the need for more extensive surgery.
Addressing Unmet Needs in Hip Disease
According to CytexOrtho co-founder and CEO Brad Estes, over one million Americans under 65 experience chronic hip pain. He noted that only about 20% of these patients undergo hip replacements, while the remainder often endure debilitating pain due to concerns about implant wear and complications associated with revision surgeries. The ReNew Hip Implant seeks to address this significant unmet need by promoting natural tissue regeneration and restoring the joint's anatomical structure.
Trial Design and Objectives
The FDA's investigational device exemption (IDE) allows CytexOrtho to conduct a non-randomized, single-arm study involving up to 15 patients, aged 14 to 55 years. These participants will have hip disease characterized by a loss of articular cartilage integrity on the femoral head. The primary objectives of the study are to establish an initial safety profile for the ReNew Hip Implant and to assess improvements in pain levels and hip function over a 12-month period. Patients will be followed for five years post-implantation to monitor long-term outcomes.
Pre-clinical Success and Future Plans
CytexOrtho co-founder Farshid Guilak emphasized that this IDE approval is supported by years of research and development demonstrating the success of the ReNew Hip Implant in pre-clinical animal studies. The company believes that its approach has the potential to revolutionize the treatment of hip disease in orthopedics.
Estes anticipates a pivotal trial in 2026, with the aim of securing FDA premarket approval (PMA) in late 2028 or 2029, contingent upon trial enrollment progress. In February, CytexOrtho and its ReNew technology were recognized at the American Academy of Orthopaedic Surgeons (AAOS) 2024 annual meeting, winning the inaugural OrthoPitch Technology Competition.
