Terumo Corporation announced that the first clinical trial conducted in Japan for evaluation the BioBridge® Collagen Matrix in the surgical treatment of lymphedema has reached its endpoint. Terumo is managing and funding clinical studies in Japan which are being used for regulatory (PMDA) approval.
The PMDA study evaluated BioBridge in a procedure for women that have acquired breast cancer-related lymphedema. Enrollment in this single-arm study was completed across four clinical sites (Chiba Univ. Hospital, Yokohama City Univ. Hospital, Okayama Univ. Hospital, and Saitama Medical Center) in January 2024, with a total of 21 patients enrolled.
This clinical study final report is being prepared for PMDA submission.
