Japan BioBridge PMDA Study Completion

Jun 15, 2025

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.

 

Fibralign Selected as a UCSF Rosenman Institute Innovator

Fibralign Selected as a UCSF Rosenman Institute Innovator

Jun 10, 2021

NCI-funded study evaluating Fibralign’s BioBridge® as an adjunct to microsurgical treatment SAN FRANCISCO, June 10, 2021 /PRNewswire/ -- The UCSF Rosenman Institute is proud to announce the 2021 cohort of the Rosenman Innovators, a group of early-stage health...

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Fibralign Announces CE Mark Approval for BioBridge®

Fibralign Announces CE Mark Approval for BioBridge®

Sep 14, 2020

European approval for novel device supporting surgical treatment of lymphedema September 14, 2020 (Union City, CA) – Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced that it has received CE mark for its first...

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