The Postgraduate Institute of Medical Education and Research (PGIMER) formally transferred its indigenously developed TrueOxy+ High Flow Nasal Cannula (HFNC) device to a medical technology company, Clarity Medical Pvt Ltd, on Monday.
Aiming to facilitate large-scale indigenous manufacturing, this device will secure regulatory approvals, and facilitate the wide clinical deployment of HFNC devices at an affordable cost. The initiative is expected to substantially reduce dependence on imported high-end respiratory care equipment and to strengthen India’s self-reliant ecosystem in critical care technologies.
The HFNC devices are commonly used in hospitals, especially in intensive care units (ICUs), to help patients who have trouble breathing or low oxygen levels. The respiratory support system was conceived, designed, and developed at PGIMER under a research project supported by the department of science and technology with the aim of providing a cost-effective, high-quality, Made in India solution for patients with acute hypoxemic respiratory failure and related conditions.
The project, entitled “development of low-cost indigenous HFNC device for non-invasive ventilation amid COVID-19 pandemic”, was first initiated in 2021 under the leadership of professor GD Puri, and was completed in 2024.
The TrueOxy+ system incorporates precise automatic control of flow rates up to 60 litres per minute and a fraction of inspired oxygen from 21% to 100% at temperatures between 31-37°C, integrated monitoring capabilities with an advanced alarm system, and robust patient-safety features, in line with contemporary global standards. The device underwent rigorous testing at the Biomedical Hub of PGIMER’s testing lab for over a year before being evaluated in the Phase 1 clinical trial in 2024 at the CPU of the institute. For the past year, it has been undergoing Phase 2 of clinical trials.
{{/usCountry}}The TrueOxy+ system incorporates precise automatic control of flow rates up to 60 litres per minute and a fraction of inspired oxygen from 21% to 100% at temperatures between 31-37°C, integrated monitoring capabilities with an advanced alarm system, and robust patient-safety features, in line with contemporary global standards. The device underwent rigorous testing at the Biomedical Hub of PGIMER’s testing lab for over a year before being evaluated in the Phase 1 clinical trial in 2024 at the CPU of the institute. For the past year, it has been undergoing Phase 2 of clinical trials.
{{/usCountry}}The core development team for the TrueOxy+ HFNC system from the department of anaesthesia and intensive care also include Dr Shiv Lal Soni (current project principal investigator), Dr Ajay Singh, associate professor, Dr Naveen Naik B, associate professor, and Er Harpreet Singh, research scientist.