Approvals

Clinical stage medical device company CytexOrtho has announced approval from the US Food and Drug Administration (FDA) for its planned phase 1 clinical trial into orthopaedic joint preservation and repair.

The first-in-human study aims to assess the safety and efficacy of the company’s ReNew Hip Implant novel cartilage repair technology. There are plans to enrol up to 15 patients with hip disease that has resulted in the loss of articular cartilage integrity. The patients will be aged 14-55, and the nonrandomised, single-arm study will follow pain and functions ratings over 12 months pre-implementation and 60 months post-implementation.

The ReNew technology uses a unique, highly porous and bioabsorbable device to mimic healthy cartilage, providing structural support and facilitating natural healing processes to start.

Farshid Guilak PhD, co-founder of CytexOrtho, professor of Orthopedic Surgery, and director of Research, Shriners Children’s – St. Louis, US added, “This investigational device exemption 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 orthopaedics.”