Company Directory

Fibralign is an award-winning, commercial-stage, Stanford-spinout that designs, develops and produces novel therapeutic medical devices to address major unmet medical needs. Based in the San Francisco Bay Area, the company’s team has established GMP commercial production (ISO 13485:2016 certified), quality system and development labs co-located at its main facility (Union City, CA).

Fibralign is supported in its mission by meaningful collaborations with leading research universities, renowned medical leaders and strategic partnerships. These relationships have proven invaluable in advancing research and development, resulting in a compelling pipeline of novel products that are based on Fibralign’s proprietary Nanoweave® scaffolding platform.

Privately held, Fibralign has been able to accomplish this progression with the support of investors and grant funding from the Department of Defense, National Institutes of Health and the National Science Foundation.

Fibralign is currently conducting a multi-site clinical study for breast cancer-related acquired lymphedema* ($3M funding from the National Cancer Institute) and a pilot clinical study in Europe for the prevention of lymphedema. Working together with Terumo, the company is also preparing for a clinical study to be conducted in Japan in 2021 that will be used for PMDA regulatory engagement.

Fibralign won the prestigious Medtech Innovator Award, taking first out of over 300 startups that participated in this annual competition. The team has maintained a strong relationship with its Stanford roots, working closely with several research groups in preclinical and clinical studies and as an active member of the Stanford StartX community. Fibralign is also an alumnus of JLABS , having been selected to join in the initial cohort of startup members for its South San Francisco location (JLABS@SSF).