The study will assess the BioBridge collagen matrix as a novel preventative treatment for secondary lymphedema
Therapeutic biomedical devices developer Fibralign has recruited the first patient in a multi-site and randomised clinical trial of the BioBridge collagen matrix.
The clinical trial, which is being conducted in Europe, will assess the BioBridge collagen matrix as a novel preventative treatment for secondary lymphedema.
Lymphedema is a serious, global and progressive disease, which may result due to cancer treatments.
Fibralign intends to recruit up to 40 patients in the trial, who have been diagnosed with advanced stage breast cancer and need axillary lymph node dissection (ALND).
The ALND is a common surgical intervention, which includes the removal of compromised lymph nodes to restrict the spread of cancer.
Greece’s Aristotle University of Thessaloniki plastic surgery associate professor Dr Dimitris Dionysiou is the principal investigator of the trial, which is being conducted to show the efficacy of BioBridge as a prophylactic remedy to reduce patient risk in the development of lymphedema.
BioBridge is a sterile, biocompatible and biodegradable surgical mesh
BioBridge is a sterile, biocompatible and biodegradable surgical mesh, which already secured CE mark approval for use in the surgical support of lymphatic tissue repair.
The company also secured 510(k) clearance from the US Food and Drug Administration for BioBridge to use as a surgical mesh to reinforce and repair soft tissue.
According to the company, published preclinical studies and early clinical usage have demonstrated that BioBridge supports the repair of damaged lymphatic vessels that causes lymphedema.
Fibralign is engaged in the development and manufacturing of advanced therapeutic biomedical devices by using its patented Nanoweave 3D scaffolding technology.