Fibralign Corporation (“Fibralign”), a developer of advanced therapeutic medical devices, announced today that the first surgery has been performed in a clinical study of secondary lymphedema treatment being conducted at Stanford University. This investigator-initiated study, which recently received FDA approval, aims to evaluate the efficacy of a new surgical device, Fibralign’s BioBridge® Collagen Matrix, in supporting and guiding lymphatic repair in patients with acquired lymphedema of upper and lower extremities. Stanford is currently enrolling patients and expects to have at least 36 patients in the study.
“We are pleased to receive FDA approval to move forward with this important study,” said Stanley G. Rockson, MD, Principal Investigator and Professor of Cardiovascular Medicine and Director of the Stanford Center for Lymphatic and Venous Disorders. “Our preclinical studies suggest that BioBridge has the potential to facilitate repair of lymphatic function, providing a much needed treatment for this chronic disease.”
More information about this study and enrollment can be found at www.ClinicalTrials.gov (Identifier NCT02734979: “Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transfer for Upper Extremity Lymphedema”).
“Lymphedema is a debilitating disease that can profoundly impact a patient’s quality of life and have psychosocial implications” stated Dimitris Dionyssiou, MD, Ph.D., Chief Medical Officer of Fibralign and Visiting Assistant Professor, Division of Plastic and Reconstructive Surgery at Stanford University. “We are grateful to be working closely with Stanford University in advancing new and novel treatments to improve the quality of care. The advanced surgery with the addition of BioBridge aims to improve the outcomes of the Lymph Node Transfer procedure and reduce the recurrence or reappearance of limb lymphedema after the treatment.” About BioBridge: The BioBridge® Collagen Matrix is a sterile surgical mesh that has 510(k) clearance from the FDA for use in surgery to reinforce and repair soft tissue where weakness and deficiencies exist. The device is not cleared for the treatment of lymphedema. This novel medical device is made of highly purified aligned collagen fibrils and created using Fibralign’s patented Nanoweave® technology. BioBridge was shown in a published preclinical study with Stanford University to support and promote the formation of new lymphatic vessels (lymphangiogenesis) by encouraging endothelial cell attachment, alignment and migration, which are prerequisites for new lymphatic vessel formation. About Secondary Lymphedema: Acquired [secondary] lymphedema is a serious, global, progressive disease that can develop as a result of cancer treatments. Such interventions, while life-saving, sometimes encumbrance enough lymphatic function that the cancer survivor is left with a condition in the affected limb that includes painful swelling, frequent infections and, ultimately, irreversible structural changes in the tissues, which can result in severe deformity, and serious reduction in function and quality-of-life. Current treatments for lymphedema are limited with moderate outcomes, and for the majority of patients there is no cure. About Fibralign: Fibralign produces advanced therapeutic biomedical devices utilizing its patented Nanoweave® 3D scaffolding technology for addressing significant unmet medical needs. For more information, please visit http://www.fibralignbio.com. Fibralign Corporation Contact: