Exclusive agreement for Terumo to market and distribute Fibralign’s BioBridge® in Japan
Fibralign is a Stanford-spinout company that produces novel therapeutic medical devices to address major unmet medical needs.
The company has launched its first product, the BioBridge® Collagen Matrix, which has been developed to address secondary lymphedema, a global chronic disease that currently has no cure.
Fibralign is already commercially selling BioBridge in the US and clinical benefit has been demonstrated in treating patients with this disease*. BioBridge has recently received CE mark as a Class III device for use in soft tissue repair, specifically lymphatic soft tissue repair.
Fibralign is also developing a compelling pipeline of novel products currently in pre-clinical phase which are based on its proprietary Nanoweave® scaffolding platform that can be tailored to address a wide range of high-value applications. Nanoweave technology provides the means to assemble scaffolding in such a way that mimics human tissue structure and directly influence cell behavior. Using commercially available medical-grade collagen, Nanoweave’s properties assures that the resulting medical devices are naturally accepted by neighboring tissue, supporting the body’s regenerative repair and maintenance process.
The Company has established GMP production (ISO 13485:2016 certified) located at its Union City, CA facility.
* BioBridge has not been approved by the FDA for treating secondary lymphedema.