Last Updated on July 2, 2021 by The Health Master
Axio Biosolutions, an integrated wound care company has received the USFDA 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 bio-adhesive technology which 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.
Earlier the product 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.
Commenting on the latest development, Leo Mavely, founder & CEO, Axio Biosolutions said, “This is a major milestone for us as the USFDA clearance opens the door for us to enter markets such as Cardio-vascular, haemodialysis 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.”
The 2008 founded Bengaluru-based Axio develops novel biomaterial-based products for wound and surgical care. Its flagship product Axiostat that stops bleeding instantly is sold in over 40 countries and 400 top hospitals in India such as AIIMS, Manipal, Apollo, Breach Candy and Fortis, among others.
Axio has raised over $15 million from Accel, University of California – Ratan Tata (UC-RNT) Fund, Omidyar Network India, and Chiratae Ventures. It is also the one of the largest chitosan medical products manufacturer globally and has a state-of-the-art manufacturing facility at Ahmedabad, India which is GMP, ISO 13485 certified and registered with USFDA.