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.