BioBridge® Collagen Matrix receives 510(k) clearance

Jan 12, 2016

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.

Fibralign Announces CE Mark Approval for BioBridge®

Fibralign Announces CE Mark Approval for BioBridge®

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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Fibralign Announces Strategic Partnership with Terumo

Fibralign Announces Strategic Partnership with Terumo

Exclusive agreement for Terumo to market and distribute Fibralign’s BioBridge in Japan June 02, 2020 06:00 AM Eastern Daylight Time UNION CITY, Calif.--(BUSINESS WIRE)--Fibralign Corp., a Stanford spin-out developer of therapeutic biomedical devices, has announced...

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Fibralign Awarded SBIR Phase IIS from Department of Defense

Fibralign Awarded SBIR Phase IIS from Department of Defense

Fibralign announced today that it has been awarded a Small Business Innovation Research (SBIR) Sequential Phase II (Phase IIS) from the Department of Defense (DoD) Defense Health Program (DHP). This two-year grant provides $996,609 in funding to continue advancing...

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