Miraqules MedSolutions, a startup spun out from the National Institute of Technology Rourkela, has secured regulatory approval for its innovative hemorrhage control product, StopBleed. This milestone marks a significant advancement for India's trauma care system, translating academic research into a commercially available life-saving solution. The approval from the Central Drugs Standard Control Organisation (CDSCO) paves the way for its deployment in critical emergency situations nationwide.
Addressing a Critical Gap in Trauma Care
India faces a persistent challenge with trauma-related fatalities, many of which are preventable deaths caused by uncontrolled bleeding from accidents. A significant number of these incidents occur in rural and remote regions where immediate access to advanced medical facilities is scarce. StopBleed is engineered to address this critical gap by providing an effective, on-the-spot solution to manage severe hemorrhage before professional medical help arrives.
Innovative Technology and Application
The product's efficacy is rooted in its advanced nano-biopolymer technology, which rapidly absorbs blood plasma while trapping blood cells in a fibrous mesh. This mechanism significantly accelerates the body's natural clotting process, forming a robust hydrogel seal over the wound to halt bleeding. Available in both powder and pellet forms, StopBleed offers versatile application for diverse injuries, from deep stab wounds to industrial mishaps.
Designed for broad accessibility, StopBleed can be effectively used by trained medical personnel as well as non-medical first responders. This feature is crucial for empowering immediate action at accident sites, potentially saving countless lives during the critical moments after an injury. With a three-year shelf life at room temperature, the product is easy to store and deploy, even in resource-limited settings.
From Academic Research to Commercial Reality
The journey of StopBleed began in the laboratories of NIT Rourkela's Department of Biotechnology and Medical Engineering, where it was developed by Professor Devendra Verma and his research graduate, Sabir Hussain. The institute patented the technology and subsequently transferred it to Miraqules MedSolutions, a company founded by Hussain to spearhead its manufacturing and distribution. This successful transition exemplifies an ideal pathway for converting academic innovation into impactful commercial ventures.
Professor Verma expressed his fulfillment in seeing the product advance from a laboratory concept to a CDSCO-approved tool for saving lives in both civilian and military emergencies. He highlighted the achievement as an inspiration for students to pursue entrepreneurship and develop indigenous healthcare solutions. This milestone supports India's goal of reducing import dependency and creating cost-effective, context-specific medical technologies.
Rigorous Validation and Market Strategy
Before receiving commercial approval, StopBleed underwent a rigorous validation process to ensure its safety and effectiveness. The product successfully cleared extensive laboratory and animal testing in compliance with international ISO 10993 standards and USFDA guidelines. Furthermore, its performance was confirmed in a real-world clinical environment through a first-in-human study conducted with the Sanjay Gandhi Institute of Trauma and Orthopedics.
According to Sabir Hossain, Founder and CEO of Miraqules, the CDSCO approval validates years of dedicated scientific work and confirms the product's market fit. The company has initiated a limited deployment in select clinical settings to gather user feedback and establish it as a standard of care. Concurrently, Miraqules is actively seeking strategic distribution partners to ensure the rapid and widespread availability of this innovation across India.
The commercial launch of StopBleed represents a landmark achievement for India's medical technology sector and the "Make-in-India" initiative. By providing a domestically developed solution to a pressing public health issue, this innovation is poised to transform emergency response protocols. Ultimately, its widespread adoption has the potential to significantly reduce preventable deaths and build a more resilient national trauma care ecosystem.