Fibralign Announces Start of European Lymphedema Prevention Clinical Study
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema.
The study plans to enroll 40 patients that have been diagnosed with advanced stage breast cancer and require axillary lymph node dissection (ALND), a common surgical intervention that involves removal of compromised lymph nodes to address the spread of cancer. Peer reviewed publications have estimated that 15-25% of patients who undergo ALND develop breast cancer-related lymphedema (BCRL) due to the surgery. ALND combined with radiation therapy increases the likelihood of BCRL further up to 40%.
Led by Dr. Dimitris Dionysiou, Associate Professor in Plastic Surgery at the Aristotle University of Thessaloniki (Greece) and principal investigator, the trial aims to demonstrate the effectiveness of BioBridge as a prophylactic remedy for reducing patient risk in development of lymphedema. This off-the-shelf solution would provide a much-needed treatment that could be utilized as a simple adjunct procedure in support of current cancer interventions, significantly advancing the quality of care for patients.
