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.
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