Development and Commercialization of a pupillometer to predict postoperative opioid-induced respiratory depression in children

PROJECT SUMMARY With about 50 million surgeries performed annually in the US. Opioids are commonly used as primary analgesics to control severe surgical pain. However, opioids are associated with several adverse effects including nausea, vomiting, sedation, and more serious respiratory depression and death. Respiratory depression is recognized as one of the most serious, life threatening and costly complications from perioperative opioids. Although preventable in patients undergoing surgery with effective and early predictions, opioid-induced respiratory depression continues to be a major contributor to increased morbidity, mortality, length of hospital stay, cost of healthcare and malpractice claims. The cost associated with postoperative opioid-induced respiratory depression in the US is over $650 million annually and $231 million for children alone. While adults with respiratory and cardiovascular concerns are at high risk of respiratory depression, children are particularly vulnerable. Over 60% of children undergoing tonsillectomy – the most common surgical procedure in children – are likely to experience adverse post-operative effects including respiratory depression. Current approaches rely on reactive and delayed identification of respiratory depression using costly monitoring and extended hospital stay for patients. Currently, there is no effective tool to proactively and reliably identify patients at high risk of opioid-induced postoperative respiratory depression. To address this urgent and unmet need, NeurOptics is developing a first-in-class pupillometry-based tool to proactively predict postoperative respiratory depression in children. This technology is based on the patented pupillometry-based respiratory depression prediction model developed by Dr. Sadhasivam through his NIH-funded clinical research. NeurOptics and Dr. Sadhasivam aim to bring this technology to wide clinical use through this accelerated SBIR Fast-Track proposal. In Phase I, NeurOptics will complete the development of a fully functional prototype, the A-100 device and Intelligent Patient Interface (IPI), as proof-of-concept. Additionally, during this phase, NeurOptics will engage with the FDA for feedback on the regulatory pathway including the first-of-kind, breakthrough device designation for the A-100. In Phase II, NeurOptics will manufacture beta units of the device and patient interface. These will be verified and used to validate the proposed technology through a clinical study with children undergoing tonsillectomy conducted in collaboration with Dr. Sadhasivam. The perioperative use of this technology will help clinicians to prevent respiratory depression, improve safety of opioids while allowing hospitals to optimize resources. Based on the current opioid-epidemic related public health crisis and socio-economic burden of opioids (>$500 billion/year), a significant commercial market exists for NeurOptics to proactively identify and effectively reduce opioid-related adverse effects including respiratory depression and overdoses in millions of Americans each year.