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A milestone for Indian medtech, NIT Rourkela-developed StopBleed receives regulatory approval

Our Bureau, Chennai
Friday, February 27, 2026, 12:40 Hrs  [IST]

Miraqules MedSolutions Pvt. Ltd, a startup spun out from NIT Rourkela, has received regulatory approval to manufacture and clinically deploy its patented nano-biopolymer haemostat. This innovation aims to revolutionize emergency haemorrhage control by bridging the gap between laboratory research and real-world application.
 
As India faces a significant challenge in trauma care, a major part of road accident fatalities occurs due to delays in patients’ bleeding control. Many of these incidents take place in remote or rural areas where trauma care is not readily available. The technology developed at NIT Rourkela can bridge this gap and reduce preventable casualties.
 
StopBleed, the technology developed at NIT Rourkela, has received approval from the Central Drugs Standard Control Organisation (CDSCO) as a Class C medical device, marking a significant step in translating academic research into real-life-saving medical technology. The product facilitates for rapid control of severe bleeding arising from road accidents, gunshot wounds, blast injuries, industrial accidents, deep stab wounds, and other critical or life-threatening trauma situations.
 
The developed innovation is an advanced bleeding control solution available in powder and pellet forms, designed to be used in trauma situations such as road accidents, military injuries, and emergency first-aid situations. With a shelf life of three years (at room temperature), it can be easily used by medical professionals and non-medical first-aid responders, making it suitable for emergency cases, which could lead to saving lives. Developed using nanofibrous aggregate technology, the product rapidly absorbs blood plasma while trapping blood cells within a high-surface-area fibrous mesh. This helps in accelerating the body’s natural clotting mechanisms and forms a strong hydrogel seal at the wound.
 
This technology was originally patented by the institute and developed in the Department of Biotechnology and Medical Engineering by Professor Devendra Verma and his research graduate, Sabir Hussain. Subsequently, the technology was transferred to the startup Miraqules MedSolutions Pvt. Ltd., led by Hussain, for manufacturing, distribution, and field deployment.
 
On this achievement Prof K Umamaheshwar Rao, director, NIT Rourkela congratulated the innovators and stated that the product has the potential to strengthen emergency healthcare systems.
 
Speaking about bringing the technology from his lab to the real world for saving lives, Prof Devendra Verma, Associate Professor and HOD, 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 haemorrhage 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 international safety standards (ISO 10993) and USFDA guidelines, team Miraqules, has conducted multiple laboratory and animal testing of the developed innovation and found satisfactory results. It has also been tested in a real-life clinical setting through a first-in-human study conducted in collaboration with Sanjay Gandhi Institute of Trauma and Orthopedics, Bengaluru.
 
Speaking about the commercial rollout of the developed product, NIT Rourkela Alumnus Sabir Hossain (founder & CEO, Miraqules MedSolutions Pvt. Ltd.) 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 transform trauma care and medical facilities’ approach to rapid bleeding control and emergency response management across the country.
 
NIT Rourkela is one of the premier national level institutions for technical education in the country and is funded by the Government of India.

 

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