Significant Unmet Needs
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...
Fibralign receives ISO 13485:2016 upgrade certification
Fibralign received Certification Notification on January 21, 2019 from DEKRA Certification B. V. that the Company's management system meets the requirements of EN ISO 13486:2016. This internationally agreed standard sets out the requirements for a quality management...
Fibralign receives ISO 13485:2012 Certification
Fibralign received Certification Notification on February 18, 2018 from notifying body DEKRA Certification B. V. that it's management system meets the requirements of EN ISO 13486:2016:2012 + AC:2012. The scope of the certification is for the design, development,...
Fibralign is an award-winning, Stanford-spinout company that produces novel therapeutic biomedical devices that are designed to address major unmet medical needs.
The company has launched its first product, the BioBridge Collagen Matrix, which has received FDA 510(k) clearance for use in soft tissue repair. The company is currently studying BioBridge for use in treating secondary lymphedema, a global chronic disease that currently has no cure
BioBridge® Collagen Matrix
- FDA 510(k) cleared device for use in soft tissue repair.
- BioBridge currently being studied for use in treating secondary lymphedema.
- FDA 510(k) cleared device*
- CE mark approved, Class III device
- Commercially available now in the US and Europe
* BioBridge has not been approved by the FDA for treating secondary lymphedema.
Fibralign is developing a pipeline of compelling novel products 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 precisely print 3D scaffolding in such a way that mimics human tissue nano structure and directly influence the body’s repair function.
Grants, Awards, Partners and Collaborators
Fibralign has been recognized for its vision and potential to impact lives globally. We are supported in our mission by world class partners and collaborators.