BioBridge® Collagen Matrix receives 510(k) clearance

Fibralign’s first product, the BioBridge® Collagen Matrix has received 510(k) clearance from the FDA on January 07, 2016 for use in soft tissue support/repair (K151083). Click to view.

BioBridge is a sterile thread-like surgical mesh designed for use in surgery to reinforce and repair soft tissue where weakness and deficiencies exist. This novel medical device is made of highly purified aligned collagen fibrils and created using Fibralign’s patented Nanoweave® technology.

BioBridge was shown in a published preclinical study with Stanford University to support and promote the formation of new lymphatic vessels (lymphangiogenesis).*

* The FDA has not approved BioBridge for the treatment of lymphedema.

BioBridge Symposium held at 30th World Congress of the International Society of Lymphology (ISL)

BioBridge Symposium held at 30th World Congress of the International Society of Lymphology (ISL)

Fibralign Corp. and leading physicians presented an update on clinical findings and case studies during the 30th World Congress of the International Society of Lymphology (ISL), which was held 15-19 October 2025 in Antalya, Turkey. As part of this session, Dr. Corrado Campisi, incoming President of ISL, presented his prospective randomized clinical study (n=34) using BioBridge with advanced microsurgerical procedures.

This was the second time that ISL hosted a BioBridge-focused session during their bi-annual congress meeting, with the previous session held in Genoa, Italy in September, 2023.

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Good Moonwha Hospital completes 100th BioBridge surgical case milestone.

Good Moonwha Hospital completes 100th BioBridge surgical case milestone.

Fibralign Corp. and leading physicians presented an update on clinical findings and case studies during the 30th World Congress of the International Society of Lymphology (ISL), which was held 15-19 October 2025 in Antalya, Turkey. As part of this session, Dr. Corrado Campisi, incoming President of ISL, presented his prospective randomized clinical study (n=34) using BioBridge with advanced microsurgerical procedures.

This was the second time that ISL hosted a BioBridge-focused session during their bi-annual congress meeting, with the previous session held in Genoa, Italy in September, 2023.

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Japan BioBridge PMDA Study Completion

Japan BioBridge PMDA Study Completion

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...

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