Posted by Michael Wonder on 17 Dec 2020
FDA grants RMAT designation for Cook MyoSite’s investigational autologous muscle derived cells for urinary sphincter repair
17 December 2020 - Cook MyoSite today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to Cook MyoSite’s investigational product, Autologous Muscle Derived Cells for Urinary Sphincter Repair, for treatment of women with persistent or recurrent stress urinary incontinence following surgical treatment.
Cook MyoSite’s regenerative medicine advanced therapy application was based on retrospective analyses of two open-label clinical studies and two double-blind, randomized, placebo-controlled clinical studies.
