A healthcare startup based in Bengaluru, Axio Biosolutions, has become the first of its kind to receive an FDA clearance to market a product in the US.

The product, which is called Axiostat Chitosan Haemostat Dressing and is used to stop external bleeding, can now be sold over-the-counter to customers in the US, where Advamedica will market the product, as reported by Business Wire India.

The Indian Armed forces, BSF, NSG, government hospitals, AIIMS, Manipal, Apollo, Breach Candy and Fortis are all clients of the startup which was founded by Leo Mavely.

“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,” Mavely said. “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.”

The company’s product can stop external bleeding in a matter of a few minutes and was developed as part of Axio Biosolutions’ goal to provide customers with products to solve healthcare issues without solutions, at an affordable rate.

The dressing is patented and has received the CE mark in Europe which is also a mark of clearance and approval. Axio Biosolutions is also ISO 13485 certified.

The startup is the first to produce such a product within the category or emergency care. The product has been found useful in hospitals, war zones as well as in public areas such as roads.

The haemostatic dressing, which is produced in Gujarat, was used by the Indian Armed Forces amid a surgical strike. Accel, IDG Ventures and Rajan Tata’s UC-RNT have all been investors in the company, specifically in a Series B round worth $7.4 million raised by the startup in January 2018.

(Picture courtesy: http://be-safe.co.za/)