CytexOrtho gets FDA approval for first-in-human trial of absorbable hip implants

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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