NIT Rourkela's StopBleed® Receives CDSCO Approval for Commercial Deployment
In a significant breakthrough for emergency healthcare, the National Institute of Technology (NIT) Rourkela has secured regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) for the commercial manufacturing and clinical deployment of its patented nano-biopolymer hemostatic technology. This innovation, branded as StopBleed®, is designed to control severe bleeding in critical situations such as road accidents and gunshot wounds, among other trauma cases.
Addressing a Critical Gap in Trauma Care
According to a statement released by NIT Rourkela on Tuesday, the hemostatic powder, initially developed in the institute's laboratories, targets a vital need in trauma management. The institute highlighted that a substantial number of road-accident fatalities in India result from delays in bleeding control, particularly in remote or rural regions where access to advanced trauma care is limited. StopBleed® aims to bridge this gap and help reduce preventable deaths by providing an effective, accessible solution for rapid hemorrhage management.
Features and Functionality of StopBleed®
Available in both powder and pellet forms, StopBleed® offers a practical advantage with a three-year shelf life at room temperature, making it suitable for storage in various settings. It is intended for use by medical professionals as well as trained first responders, enhancing its utility in diverse emergency scenarios.
The technology leverages nanofibrous aggregate innovation to function efficiently. When applied to a wound, it quickly absorbs blood plasma while entrapping blood cells within a high-surface-area fibrous mesh. This process accelerates the natural formation of clots and creates a firm hydrogel seal over the injury, effectively staunching bleeding and promoting healing.
Development and Commercialization Journey
The groundbreaking hemostat was conceived and developed within NIT Rourkela's department of biotechnology and medical engineering. The project was spearheaded by professor Devendra Verma and research scholar Sabir Hussain, who later established Miraqules MedSolutions to bring the product to market. This entrepreneurial move underscores the potential for academic research to translate into real-world healthcare solutions.
To date, the technology has achieved robust intellectual property protection, with patents granted in multiple countries including India, the United States, China, Israel, and Australia, reflecting its global relevance and innovation standards.
Leadership Endorsement and Future Implications
NIT Rourkela director, Prof K Umamaheshwar Rao, extended his congratulations to the innovators, emphasizing the device's potential to significantly strengthen India's emergency healthcare ecosystem. He remarked, "This milestone should encourage more young researchers to embrace entrepreneurship and develop indigenous healthcare solutions. India needs more such innovations to reduce import dependence and address local challenges effectively."
This approval marks a pivotal step forward in enhancing trauma care capabilities across the nation, potentially saving countless lives through timely and efficient bleeding control.
