NIH Blueprint MedTech spurs innovation in diagnosing and treating nervous system disorders

Tech incubator centers award initial cycle of funding for device developers Within one year of launching its incubator hubs, the National Institutes of Health Blueprint MedTech program has issued nine awards in its first competition cycle. The MedTech program seeks to accelerate transformative medical devices to restore brain health, improve healthy aging and treat disorders of the nervous system. The first round of these awards totals $11 million. These projects aim to build commercially viable technologies that address unmet clinical needs. The projects will be administered by the two Blueprint MedTech incubator hubs—CIMIT’s Center for Innovative NeuroTech Advancement (CINTA) and NeuroTech Harbor (NTH). “In addition to monetary and in-kind support for up to four years, each team will benefit from industry-experienced mentors who will offer guidance in medical device commercialization,” said Michael Wolfson, Ph.D., program director with the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and co-lead of the Blueprint MedTech program. “These mentors provide business, regulatory, clinical, and technical insights that are essential ingredients to success in the medical devices marketplace.” Blueprint MedTech is funded by the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute on Drug Abuse (NIDA), the National Institute of Neurological Disorders and Stroke (NINDS), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and by the Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative. Blueprint MedTech Cycle 1 awardees: *participant in the 2022 Blueprint MedTech pilot Icahn School of Medicine at Mount Sinai, New York; University of California, San Diego; and Johns Hopkins University, Baltimore MonOs. A wearable, non-invasive biosensor that monitors the body for the presence of opioids. The data provided by the biosensor could support clinicians in treating adolescents and adults with opioid use disorder, as an alternative to daily lab-based collection of urine toxicology data. Funding NIH institute: NIDA NeuraStasis, Inc., Houston* Development/Testing of BlueStem Dual Nerve Stimulation Device for Ischemic Stroke. A novel, non-invasive, electrical stimulation technology that complements current treatments as a bridge to care. The BlueStem system will expand the “golden hour,” offering more protection of the brain during an ischemic stroke and to reduce the likelihood of long-term disability. Funding NIH institute: NINDS Florida Atlantic University Charles E. Schmidt College of Medicine, Boca Raton* External focused ultrasound modulation of the dorsal root ganglia. A non-addictive treatment for neuropathic pain, using low intensity focused ultrasound. By using a higher intensity than imaging ultrasound, but not enough to damage tissue, this project aims to provide pain relief for up to a month after only three minutes of stimulus. The device is a combined imaging and therapeutic ultrasound device to target and immediately treat specific portions of the dorsal root ganglia involved in generating pain signals. Funded NIH institutes: NIDA and NINDS Endovascular Horizons and University of California San Francisco Embodrain technology for chronic subdural hematomas. A fully endovascular technology for trans-vascular drainage of chronic subdural hematomas (blood collections over the brain surfaces) and for middle meningeal artery embolization. This product would replace the standard of care which is highly invasive and carries a risk of recurrence, substantially increasing the safety profile. Funding institute: NINDS Boston University and Harvard University, Boston* reNeu propulsion rehabilitation platform for gait restoration after neurological disease. A wearable neuroprosthesis to diagnose, assist, and restore safe and efficient walking. The system is a wearable cuff that measures muscle activity in the leg and, using computational methods to generate an optimal pattern, stimulates further muscle activity to approach normal gait. Funding NIH center and institute: National Center for Medical Rehabilitation Research at NICHD and NINDS. Northern Arizona University and Biomotum, Inc., Flagstaff A wearable rehabilitation robot for children to use at home. A device to train children with cerebral palsy to walk with an efficient gait. This at-home system would provide significantly more rehabilitative capability than time-limited sessions with a physical therapist. Funding NIH institute: NINDS Openwater, Inc., San Francisco Wearable noninvasive, transcranial focused ultrasound neuromodulation with near-infrared optical neuromonitoring. This compact, non-invasive system provides high resolution observation of neural activity combined with delivery of a therapeutic stimulus to treat circuit disorders in the brain. The system is designed to support a wide range of diagnostics and treatments. Funding NIH initiative: BRAIN Initiative SecondWave Systems, Inc., Minneapolis Treatment of Facial Pain using an Injectable Ultrasonically Powered Neurostimulator. A method to treat craniofacial pain with ultrasonic energy via a miniaturized neurostimulator. The stimulator can be implanted in the vicinity of the trigeminal nerve without invasive surgery and is powered by an external pad when pain relief is desired. Funding NIH institute: NIDCR In addition to the technologies listed above, Blueprint MedTech will extend seedling awards of up to $50,000 each to 17 innovators whose applications represented special merit but were not quite ready for a larger development award. Each of these participants also has access to $50,000 of in-kind support via mentoring, regulatory consulting, and other commercialization training. See a list of these “seedling” technologies. Blueprint MedTech is a constituent program of the NIH Blueprint for Neuroscience Research, a cooperative effort among the NIH Office of the Director and 12 of the NIH Institutes, Centers and Offices that support research on the nervous system and related technology development. By pooling resources and expertise, Blueprint supports transformative neuroscience research, and the development of new tools, training opportunities, and other resources to assist neuroscientists. CINTA is a component of the CIMIT, a Boston-based organization working to help accelerate progress in healthcare technology. NTH is a collaboration among scientists, engineers, and clinicians from Johns Hopkins University, Baltimore, and Howard University, Washington, D.C. CIMIT’s CINTA is supported by NIH grant U54EB033650; NTH is supported by NIH grant U54EB033664.