An Innovative AI-Powered Wearable Physiological Sensor System for Real-Time Pain Monitoring and Management (PainVitals)

PROJECT SUMMARY/ABSTRACT This SBIR Phase I project focuses on the design and development of Pain Vitals, a non-invasive, innovative wearable, and AI-supported biosensor system specifically designed for continuous and objective pain monitoring and management. Approximately 80% of patients experience pain after surgery. Of those who experience post-surgical pain, 86% report moderate, severe, or extreme pain. About 88% of patients receive analgesic medications to manage pain, but 39% still report moderate to severe pain even after receiving their first dose. In addition to causing patient distress and anxiety, postoperative pain is associated with delayed discharge, increased morbidity, persistent pain, prolonged consumption of opioids and higher health-care costs. These statistics highlight the ongoing challenges in effectively managing post-surgical pain and the need for improved pain management strategies. To address this public health emergency, Aventusoft working with large healthcare systems in Florida is developing Pain Vitals. Placed comfortably on user's chest via a biocompatible patch, Pain Vitals continually monitors multiple physiological parameters and provides an objective pain index for patients. In Phase I, we will complete the development of Pain Vitals AI-supported algorithm for continuous monitoring of pain level and demonstrate through an IRB approved clinical testing that Pain Vitals respond better to noxious stimuli than any individual parameter. A continuous, objective monitor will help reduce the subjectivity in dosing analgesics, reduce the risk of overdosing or underdosing, and improve patient safety during general anesthesia. Pain Vitals can help the clinician reduce the uncertainty of drug effect and improve patient outcomes. The easy-to-use form factor of Pain Vitals will enable careful titration of medications, improving the treatment and management of pain in the peri- operative period and for continuation during home monitoring. Pain Vitals is based on our commercial HEMOTAG Vitals FDA medical device of home monitoring for cardiac decompensation. Encouraged by the availability of our HEMOTAG Vitals solution, we are now applying for funding to facilitate the development and clinical validation of Pain Vitals. Pain Vitals helps the development of improved pain management for acute and chronic pain conditions, improved pain management and resulting in the enhanced continuity of care of patients with chronic pain. This early-stage technology development through first in human demonstrations and early feasibility clinical studies, reduces barriers to pain management in underserved and health disparity populations. Provides new screening tools and will enable models that focus specifically on pain and development of pain therapies.