PROJECT SUMMARY Dandelion™ was founded in 2020 to develop digital therapeutics for neurologic and psychiatric disorders by interacting with the brain via the eyes. The goal of this SBIR is to design and test a safe, effective, and non- addictive pain-relief digital therapeutic in the form of visual stimuli. The platform will use artificial intelligence (AI) and real-time biofeedback to “read” (decipher) brain signals and “write” to (neuromodulate) the brain with rapid-changing visual stimuli composed of optimized patterns, colors, and frequencies. This is the first attempt to use AI-guided visual stimuli as a treatment for pain. In 2017, 11 million of the 191 million prescriptions written for opioid pain medications were misused, and 35% of opioid-related deaths (nearly 17,000 cases) were connected to these prescriptions. In the search for safe, effective alternatives, a range of opioid-sparing interventions have been developed through pharmacologic, clinical, and digitized behavioral platforms but none has proved fully successful. Dandelion hypothesizes that the complexity and variability of pain demands a therapeutic approach that mimics the way the brain itself processes and integrates data for pain perception. Through its novel neuromodulatory platform, using artificial intelligence to parameterize potentially useful visual information, Dandelion will develop a safe, low-cost digital therapeutic that patients can view on a smartphone or tablet for immediate pain relief. By correlating stimulus with response across different types of pain, Dandelion also hopes to build a pain-perception map of wider applicability. In Phase I a prototype AI-guided platform will be developed that can synthesize novel stimulation combinations and optimize them based on feedback from an array of biosensors; their efficacy in reducing the perception of induced pain will then be tested in healthy subjects. In Phase II, Dandelion will develop the prototype into a commercially available product and test the pain-relief digital therapeutic for efficacy and generalizability in randomized controlled trials. The commercial opportunity is estimated to be $5.9 billion.