Fibralign is currently conducting three clinical studies to further demonstrate clinical benefit for addressing lymphedema:
- LYMPHBRIDGE [link] is a multi-site blinded clinical study evaluating the use of BioBridge in the treatment of acquired breast cancer-related lymphedema being conducted in the United States. This study, which is funded by a $3M SBIR Phase IIB Bridge grant by the National Cancer Institute (NCI), will begin enrollment in September 2020 and is being led by University of Chicago Medicine and Stanford Medicine.
- A pilot clinical study is being conducted in Europe to evaluate using BioBridge as a preventative treatment for patients who are at high risk of developing lymphedema from required surgery to address advanced stage breast cancer. This multi-site, blinded study will begin enrollment in September 2020 and is based on strong preclinical studies that demonstrated BioBridge was effective in providing an infrastructure that supported lymphatic tissue repair before lymphedema would develop. This initial preventative clinical study is sponsored by the Terumo Corporation.
- Fibralign is working with Terumo Corporation to prepare a clinical study in Japan scheduled for 2021 to evaluate the treatment of acquired lymphedema using BioBridge as a surgical implant. This study, which is being funded and managed by Terumo, will be used to gather clinical data to support PMDA regulatory engagement to market BioBridge in Japan.