Axiostat has become the first Indian wound care product to receive 510(K) FDA clearance in the US for its external hemostatic 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 is the de-facto product of Indian armed forces.
Commenting on the FDA approval, Leo Mavely, CEO of Axio Biosolutions, said, “The FDA clearance of Axiostat in the US is a major milestone in our journey so far. This is a validation of the performance, safety and efficacy of Axiostat in bleeding control. We developed Axiostat to be a world-class quality product and this clearance reiterates that. We could not have done it without the trust and support of our entire team as well as investors.’
Axiostat is currently manufactured at their GMP, ISO 13485-certified manufacturing facility in Gujarat. In the US, the product will be marketed by Advamedica Inc, headquartered in Boston.
Product Page: Axiostat
About Axio Biosolutions:
Axio is a ISO 13485 medical device company with focus on advanced woundcare. Funded by Accel Partners, IDG Ventures and UC-RNT, Axio uses innovative biopolymer based medical technology to create novel woundcare products. Its flagship product is Axiostat – a 100% chitosan haemostatic dressing that controls external bleeding within minutes through its active adhesion to the wound. The award winning CE approved product is being used in frontline battlefield by many defence forces across the globe. Visit AxioBio for more information. Reach at LinkedIn or Twitter