In a boost to India’s trauma care ecosystem and indigenous medical innovation, the National Institute of Technology Rourkela has successfully translated academic research into a deployable, life-saving solution. The institute’s spin-out startup, Miraqules MedSolutions Pvt. Ltd., on Tuesday received regulatory approval to commercially manufacture and clinically deploy its patented rapid nano-biopolymer hemostat, StopBleed, a potentially transformative technology for emergency hemorrhage control.
The approval comes at a time when India continues to face a severe trauma care challenge. A large proportion of road accident fatalities in the country occur not because injuries are unsurvivable, but due to delays in controlling bleeding, particularly in rural and remote regions where advanced trauma care is scarce. By enabling rapid, effective bleeding control at the site of injury, StopBleed has the potential to sharply reduce preventable deaths and ease the burden on overstretched emergency healthcare systems.
Developed at NIT Rourkela, this technology has received clearance from the central drug regulator, Central Drugs Standard Control Organisation (CDSCO), as a Class C medical device. The regulatory approval marks a critical step in India’s efforts to convert laboratory-scale innovations into real-world medical technologies with direct public health impact, according to the developers.
Designed for use in severe bleeding arising from road accidents, gunshot and blast injuries, industrial mishaps, deep stab wounds and other life-threatening trauma scenarios, the product addresses one of the most time-critical gaps in emergency response.
A Miraqules statement on Tuesday said that StopBleed is available in both powder and pellet forms, allowing flexibility across diverse emergency settings, from hospitals and ambulances to first-aid response at accident sites. With a shelf life of up to three years at room temperature, it can be stored and deployed easily, even in low-resource environments. Importantly, the product can be used not only by trained medical professionals but also by non-medical first responders, significantly widening its potential impact.
Built on nanofibrous aggregate technology, the hemostat rapidly absorbs blood plasma while trapping blood cells within a high-surface-area fibrous mesh, accelerating the body’s natural clotting process and forming a strong hydrogel seal over the wound.
The technology was originally patented by NIT Rourkela and developed in the Department of Biotechnology and Medical Engineering by Professor Devendra Verma and his research graduate, Sabir Hussain. The institute subsequently transferred the technology to Miraqules MedSolutions for manufacturing, distribution and field deployment, exemplifying a successful academia-to-startup commercialisation pathway.
“Seeing the product's 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,” says Prof. Varma.
From a regulatory and clinical validation standpoint, the innovation has cleared key benchmarks. In compliance with international safety standards under ISO 10993 and USFDA guidelines, the Miraqules team has conducted extensive laboratory and animal testing with satisfactory outcomes. The product has also been evaluated in a real-world clinical environment through a first-in-human study carried out in collaboration with Sanjay Gandhi Institute of Trauma and Orthopedics, strengthening confidence in its safety and effectiveness.