Axio Biosolutions gets USFDA clearance for Axiostat Patch for vascular bleeding control

Axio Biosolutions, an integrated wound care company has announced FDA 510(k) clearance of its hemostatic product Axiostat Patch, which helps control moderate to severe bleeding in vascular procedures, surgical debridement sites, puncture sites and more.

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 a CE mark in Europe earlier and is approved in over 40 countries worldwide.

Commenting on the latest development, Leo Mavely, Founder & CEO, Axio Biosolutions said, “This is a major milestone for us as the FDA clearance opens the door for us to enter markets such as cardiovascular, 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 the US customers very soon.”