Therapeutic biomedical devices Fibralign has entered into a long term distributor agreement with medical technology firm Terumo for the BioBridge collagen matrix.
Under the deal, Terumo will exclusively distribute the BioBridge collagen matrix in Japan to treat and prevent secondary lymphedema, a serious and progressive disease, which may develop due to cancer treatments.
BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh
BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh, which is produced by using highly purified collagen with the support of Fibralign’s patented Nanoweave technology.
The novel medical device has already secured 510(k) clearance from the US Food and Drug Administration (FDA) for use in surgery to boost and repair soft tissue where weakness and deficiencies exist.
According to the company, published preclinical studies and early clinical usage have demonstrated that BioBridge supports the repair of damaged lymphatic vessels.
At present, Fibralign is pursuing regulatory approval in the US, Europe, and other crucial markets to sell BioBridge to treat lymphedema.
As per terms of the agreement, Fibralign will secure defined milestone payments from Terumo.
Terumo is also taking the responsibility to carry out clinical studies and complete the regulatory assessment before launching BioBridge commercially in Japan.
In June 2019, Terumo entered into a strategic partnership with biomedical innovation firm Orchestra BioMed to develop and commercialise Virtue sirolimus-eluting balloon (SEB).
Fibralign is a commercial-stage healthcare company engaged in the development of advanced therapeutic biomedical devices to address major unmet medical needs.
With over 25,000 associates across the world, Terumo offers advanced medical solutions for the customers in more than 160 countries and regions.
