Axio Bio gets USFDA nod for first aid product Axiostat

Med-tech startup Axio Biosolutions today said it has received US health regulator's approval for its first aid dressing product Axiostat that stops bleeding within 2-3 minutes of its application.

Axiostat has become the first Indian wound care product to receive 510(K) FDA clearance in the US for its pioneering haemostatic dressing, the company said in a statement.

The United States Food and Drug Administration (USFDA) clearance allows Axiostat to be marketed in the US as over-the-counter (OTC) product.

"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," Axio Biosolutions CEO Leo Mavely said.
 

Earlier this year, Axio Biosolutions had raised USD 7.4 million in a Series B funding round led by Ratan Tata's UC- RNT, along with existing investors Accel Partners and IDG Ventures India.