Fibralign Corp., a Stanford spin-out developer of therapeutic biomedical devices, has announced today that it has executed a long term distributor agreement with Terumo Corporation to market and distribute the BioBridge® Collagen Matrix in Japan for treating and preventing secondary lymphedema. Secondary lymphedema is a serious, global, progressive disease that can develop as a result of cancer treatments. Such interventions, while life-saving, sometimes destroy enough lymphatic function that the cancer survivor is left with a condition in the affected limb that includes painful swelling, frequent infections that can be life-threatening and, ultimately, irreversible structural changes in the tissues, which can result in severe deformity, and serious reduction in function and have a profound impact on quality-of-life. Current treatments for lymphedema are limited, and there is no cure.
BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh made of highly purified collagen and is created with Fibralign’s patented Nanoweave® technology. This novel medical device is commercially available in the US and has 510(k) clearance from the FDA for use in surgery to reinforce and repair soft tissue where weakness and deficiencies exist. Published preclinical studies and early clinical usage have shown that BioBridge supports the repair of damaged lymphatic vessels, a condition that can occur as a result of cancer treatments. Fibralign is currently pursuing regulatory approval in the US, Europe and other key markets to market BioBridge for addressing lymphedema.
This agreement is an outcome of an ongoing collaboration between Fibralign and Terumo where the two companies have agreed to partner in efforts to commercialize BioBridge in Japan. Terumo has received exclusive distributor rights to BioBridge in Japan for treating and preventing lymphedema and has agreed to provide defined milestone payments to Fibralign. Terumo is also taking the lead in conducting clinical studies and completing the regulatory review before introducing BioBridge commercially in Japan. Additional terms of the agreement were not disclosed.