Axiostat Becomes India's 1st Wound Dressing Product Get USFDA Clearance

Axiostat Becomes India's 1st
Wound Dressing Product Get USFDA Clearance
Giving a fillip to the Government’s ‘Make in India’ initiative, Axiostat has become the first Indian wound care product to receive 510(K) FDA clearance in the US for its pioneering haemostatic dressing. Axiostat, a 100% chitosan haemostatic dressing to stop external bleeding, was earlier approved with CE mark in Europe. The FDA clearance now allows Axiostat to be marketed in the US as over-the-counter (OTC) product for control of bleeding.
Axiostat Chitosan Hemostatic Dressing is a patented product that has prevented countless deaths due to bleeding in battlefields, hospitals, and on roadsides, worldwide. The innovative first-aid dressing stops uncontrollable bleeding within just two-three minutes of its application. Axiostat has become the de-facto product of Indian armed forces, since its life-saving quality came to the fore during a surgical strike.

Axio Biosolutions has its corporate office in Bengaluru and Axiostat is currently manufactured at their GMP, ISO 13485-certified manufacturing facility in Gujarat. In the US, the product will be marketed by its subsidiary, Advamedica Inc headquartered in Boston.

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