Matricelf Receives FDA Feedback Supporting Key Elements of Proposed First in Human Clinical Trial for NewRal Spinal Cord Injury Program

FDA feedback is supportive of Matricelf’s proposed NewRal NESS clinical development plan, including the target patient population, single-arm open-label trial design, and its primary safety assessments and exploratory efficacy measures. The guidance is intended to steer preparations for a future IND submission as the company advances its regulatory pathway.