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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44DA055407-02
Agency Tracking Number: R44DA055407
Amount: $1,271,838.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDA
Solicitation Number: DA19-019
Solicitation Year: 2019
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-07-01
Award End Date (Contract End Date): 2025-06-30
Small Business Information
9223 Research Drive
Irvine, CA 92618
United States
DUNS: 966355802
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (949) 250-9792
Business Contact
Phone: (949) 250-9792
Research Institution

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 (rt$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

* Information listed above is at the time of submission. *

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