Hogan Lovells advises CartiHeal in securing FDA premarket approval for knee implant
Washington, D.C., 15 April 2022 — Global law firm Hogan Lovells advised CartiHeal Ltd, developer of implants for the treatment of cartilage and osteochondral defects in arthritic and non-arthritic knee-joints, in securing FDA Premarket Approval (PMA) for its Agili-C implant. PMA approval was granted based on the results of a two-year IDE pivotal clinical study. Further details of the approval can be found here.
“This milestone achievement was made possible due to the support of our regulatory advisors, Hogan Lovells, our statistical consultants, Biomedical Statistical Consulting, and the many dedicated investigators and patients who participated in our studies,” said CartiHeal Founder and CEO Nir Altschuler. “We are grateful for all their help. FDA’s approval enables us to initiate commercialization and provide a superior solution for patients compared to the current standard of care options.”
The Hogan Lovells team was led by Global Regulatory & IPMT Practice Group Leader Janice Hogan (Philadelphia, Washington), with support from partners Blake Wilson, Kelliann Payne (both Philadelphia), and Mike Heyl (Washington); directors of regulatory sciences Michael Kasser and Megana Sankaran (both Washington); director of regulatory affairs Jemin Dedania (Washington); associates Gabrielle Field and Christine Zimmerman (both Philadelphia); law clerk Sanchita Bose (Washington); and paralegal Justine Chang (Washington).