Axiostat Hemostatic Military Z Fold Gauze Receives FDA Clearance
#AxioBiosolutions #AxiostatHemostaticGauze #FDAClearance“This FDA clearance is indeed special. With this our entire hemostatic range has been USFDA cleared and CE approved.” - Leo Mavely, Founder & CEO, Axio Biosolutions
July 2023 : The US Food and Drug Administration (FDA) has granted Axiostat Gauze, a line of advanced hemostatic gauze that stops severe traumatic bleeding, 510(k) clearance, according to Axio Biosolutions, a pioneer in cutting-edge advanced wound care products.
Z-fold Axiostat Hemostatic gauze, which is used by many military services worldwide to reduce trauma bleeding, is based on a unique biomaterial technology that is 100 percent chitosan-based and has already received CE certification. Since its launch, more than 1.5 million Axiostat units have been used on battlefields across more than 50 different nations.
“This FDA clearance is indeed special. With this our entire hemostatic range has been USFDA cleared and CE approved. The Axiostat Hemostatic Gauze range has been saving the lives of soldiers and civilians since it was launched a few years back in the global market. We have designed this range in multiple formats such as Z-fold, Rolled Gauze and 4ply catering to both deep wounds and lacerations. It has proven to be a lifesaver in ongoing conflicts and will prove to be an affordable, quality addition to IFAK kits worldwide,” said Leo Mavely, Founder & CEO of Axio Biosolutions.
For temporary external dressings to reduce moderate to severe bleeding, Axiostat gauze is recommended. For speedier deployment, Axiostat gauze is available in vacuum sealed all-weather robust metal pouches in the Z-fold, Rolled Gauze and 4 ply formats. The Axiostat Gauze series may be stored for a longer period of time in field IFAK kits thanks to its five-year shelf life and sturdy packaging.
Axiostat gauze is a rapidly acting hemostat made entirely of chitosan that combines with the advanced protonated bioadhesive technology of Axio Biosolutions to stop moderate to severe bleeding from traumatic injuries. Vacuum-sealed Axiostat ZFold gauze, which is compact and lightweight, is now a vital component of the bulletproof vests worn by infantry soldiers and special forces in combat zones.
About Axio Biosolutions: Established in 2008, Axio is a Boston and Bengaluru-based innovative medical device company that has developed proprietary products (Axiostat & MaxioCel) using novel biomaterial-based technology for the haemostat and advanced wound care markets globally. The company’s flagship Axiostat product range is US FDA 510(k) cleared and EU CE-approved while MaxioCel is EU CE-approved. For more information on Axio Biosolutions and its solutions, visit https://axiobio.com/
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