Cambridge, Massachusetts: Advamedica Inc., a biomaterial-focused MedTech startup has announced FDA 510(k) clearance of its hemostatic product, Axiostat Patch that helps control moderate to severe bleeding in vascular procedures, surgical debridement sites, puncture sites and more.
- Clearance granted several months ahead of the initial schedule
- Launch in the United States expected by early 2022
Axiostat Hemostatic Patch is based on a protonated bioadhesive technology that works by providing a strong mechanical barrier to the injury site. It controls bleeding from puncture sites within minutes of application, providing a barrier to bacteria protection while reducing the ambulation time in patients significantly.Axiostat had also received CE mark in Europe earlier and is approved in over 40 countries worldwide. Over half a million units have been deployed since inception globally especially in battlefields to control bleeding from trauma injuries and in hospitals to control for vascular closure bleeding.
Commenting on the latest development, Leo Mavely, President, Advamedica Inc. said, “This is a major milestone for us as the FDA clearance opens the door for us to enter markets such as Cardio-vascular, Hemodialysis and Military bleeding control in the US. Axiostat is already a market leader for these in many countries and we intend to bring this technology to US customers very soon.