Indian medical device maker Axio Biosolutions became the first Indian company with a wound care product cleared by the FDA, according to a press release from the company posted yesterday.
The federal watchdog granted 510(k) clearance to Axio’s Axiostat chitosan hemostatic dressing, which is cleared as an over-the-counter product to stop external bleeding.
The dressing is designed to stop uncontrollable bleeding within two to three minutes of application, and is used by the Indian armed forces, the company 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. This is a ‘proudly made in India’ product for the global market. The achievement of US FDA 510(k) clearance represents a significant undertaking for us at Axio, and we could not have done it without the trust and support of our entire team as well as investors, who have always supported our vision and made this day possible,” CEO Leo Mavely said in a press release.
The Axiostat has already received CE Mark approval in the European Union, and the company said that last year it raised $7.4 million in a Series B round to support its products.