Healing from within
Conquering lymphatic disorders, restoring the body’s immune system

Latest News

 

Fibralign receives ISO 13485:2016 upgrade certification

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...

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Fibralign receives ISO 13485:2012 Certification

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,...

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About Us

Fibralign is an award-winning, commercial-stage Stanford-spinout 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 now been used in over 750 surgeries by leading surgeons in 19 countries for the treatment of secondary lymphedema, a global chronic disease that currently has no cure.

 

 

BioBridge® Collagen Matrix

  • BioBridge is a novel thread-like scaffold that has been shown in preclinical and clinical studies to repair damaged lymphatic tissue.
  • FDA 510(k) cleared Class II device* for use in soft tissue repair.
  • CE mark approved, Class III device for surgical treatment of lymphedema.
  • KFDA approval (South Korea).
  • Commercially available now in the US, Europe, South Korea and Middle East.

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

Nanoweave® Technology

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.