NIT Rourkela startup receives CDSCO approval for StopBleed Hemostat

National Institute of Technology Rourkela (NIT Rourkela) spinout startup Miraqules MedSolutions has received regulatory approval for the commercial manufacturing and clinical deployment of its patented rapid nano-biopolymer haemostat technology aimed at emergency haemorrhage control.

India continues to face challenges in trauma care, with a significant proportion of road accident fatalities linked to delays in bleeding control. Many such incidents occur in remote or rural regions where trauma facilities are limited. The technology developed at NIT Rourkela is intended to address this gap and reduce preventable casualties.

StopBleed, developed at NIT Rourkela, has received approval from the Central Drugs Standard Control Organisation (CDSCO) as a Class C medical device. The approval marks the transition of academic research into clinical deployment. The product is designed for rapid control of severe bleeding resulting from road accidents, gunshot wounds, blast injuries, industrial accidents, deep stab wounds, and other trauma situations.

The bleeding control solution is available in powder and pellet forms for use in trauma scenarios, including road accidents, military injuries, and emergency first-aid cases. With a shelf life of three years at room temperature, it is intended for use by medical professionals as well as non-medical first responders. Developed using nanofibrous aggregate technology, the product absorbs blood plasma and traps blood cells within a fibrous mesh. This process accelerates the body’s clotting mechanism and forms a hydrogel seal at the wound site.

The technology was patented by the institute and developed in the Department of Biotechnology and Medical Engineering by Professor Devendra Verma and his research graduate, Sabir Hussain. The technology was subsequently transferred to Miraqules MedSolutions, led by Hussain, for manufacturing, distribution, and deployment.

Prof. K. Umamaheshwar Rao, Director, NIT Rourkela, congratulated the innovators and stated that the product has the potential to strengthen emergency healthcare systems.

Prof. Devendra Verma, Associate Professor and Head of Department, Biotechnology and Medical Engineering, NIT Rourkela, said, “Seeing StopBleed progress from our laboratory at NIT Rourkela to CDSCO-approved real-world use is truly fulfilling. It has the potential to help first responders control hemorrhage quickly and save lives during trauma, whether in military settings or rural emergencies across India. I also hope this milestone encourages more students to embrace entrepreneurship and translate strong research into deployable healthcare solutions. India needs more healthcare startups to reduce import dependence, lower costs, and develop context-specific technologies”

In compliance with ISO 10993 standards and USFDA guidelines, Miraqules conducted laboratory and animal testing of the product and reported satisfactory results. The product was also evaluated in a clinical setting through a first-in-human study conducted in collaboration with the Sanjay Gandhi Institute of Trauma and Orthopedics, Bangalore.

Speaking on the commercial rollout, Sabir Hossain, Founder and CEO, Miraqules MedSolutions, said, “The CDSCO approval validates our years of scientific work and has enabled us to confirm our assumptions around the product–market fit for StopBleed. Now, we have initiated limited deployment of StopBleed® across select clinical settings to gather feedback on its acceptability as a standard of care for managing external bleeding. In parallel, we are actively exploring strategic partnerships for distribution to ensure that this life-saving innovation can be rapidly scaled and made accessible across India’s emergency care ecosystem.”

Aligned with the Government of India’s Make-in-India vision, StopBleed is expected to impact trauma care and emergency response management across the country.