Blueprint MedTech is a National Institutes of Health (NIH) technology incubator program that is part of the NIH Blueprint for Neuroscience Research and for the past two years has provided funding and expertise to fast-track the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. NIH has just awarded $17 million for a group of projects undertaken by small and mid-sized businesses, nonprofit organizations, and academia participating in the MedTech program.
“We are pleased to have seen strong and sustained interest from entrepreneurs engaging with NIH to develop technologies for healthy aging and disorders of the nervous system,” said Michael Wolfson, Ph.D., program director with the National Institute of Biomedical Imaging and Bioengineering (NIBIB), who noted that the program reviewed approximately 700 pre-proposals and invited approximately 150 of those to submit full proposals. “I am thrilled that we are hearing from so many innovators who have not previously proposed to NIH. Over a quarter of the full proposals from these innovators have received funding, mentoring, and other resources.”
Activities supported in this program include commercialization planning, clinical prototype devices, non-clinical safety and efficacy testing, or design verification and validation activities that provides the data to apply for U.S. Food and Drug Administration Investigational Device Exemption (IDE) or, in the case of digital health products, application for a non-significant risk study. NIH program staff provide close monitoring and technical assistance to projects to help them achieve established milestones.
Participants in Blueprint MedTech receive funding for research activities and collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships.
In addition to NIBIB, Blueprint MedTech partners from across NIH include:
- National Institute on Drug Abuse (NIDA)
- National Eye Institute (NEI)
- National Institute on Aging (NIA)
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Dental and Craniofacial Research (NIDCR)
- National Institute of Mental Health (NIMH)
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Center for Complementary and Integrative Health (NCCIH)
- Office of Behavioral and Social Sciences Research (OBSSR)
- Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, or The BRAIN Initiative®, and
- Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®.
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.
Blueprint MedTech projects are administered by two incubator hubs—Center for Innovative NeuroTech Advancement (CINTA) and NeuroTech Harbor (NTH).
The Optimizer designation applies to a team that, in addition to monetary and in-kind support for up to four years, receives the benefit of consultation from industry-experienced mentors who offer guidance in medical device commercialization.
Optimizer awardees who are receiving their first year of funding:
Aneuvas Technologies, Inc., Flagstaff, Arizona. A novel balloon-mesh device to improve the embolization of aneurysms.
- This is a device for adjunctive aneurysm treatment to reduce risks to the patient. The design will alleviate time constraints imposed by temporary balloon protection, provide a smooth surface at the aneurysm neck for device placement, eliminate ischemic effects a distance away from the parent artery, and minimize intra-aneurysmal flow remnants pre- and post-aneurysm treatment.
- NIH funding: NINDS
Battelle Memorial Institute, Columbus, Ohio. EMG sleeve to enable at-home, closed-loop targeted plasticity therapy (CL-TPT).
- Vagus nerve stimulation (VNS) is an FDA-approved neuromodulation therapy for improving upper limb function in chronic stroke; however, the benefits are modest because the total amount of therapy is limited. This wearable, EMG-driven, closed-loop VNS therapy could be used in the home to improve efficacy.
- NIH funding: NINDS
Blackrock Neurotech, Salt Lake City, Utah. Subcutaneous intersectional electrical stimulation (SIES) for seizure freedom.
- Only 10% of surgical candidates with severe drug-resistant epilepsy elect invasive brain stimulation despite data showing that it effectively reduces seizures in more than 60% of cases. Subcutaneous neuromodulation is an alternative approach that may be as effective as invasive brain stimulation at seizure elimination but without the need for highly invasive brain surgery.
- NIH funding: NINDS
Johns Hopkins University, Maryland. Continuous intrapartum fetal brain monitoring using a wearable ultrasound/photoacoustic device.
- Peripartum brain injury produces devastating life-long disabilities with enormous economic and societal costs. However, the current clinical standard, electronic fetal heart rate monitoring, has poor accuracy in predicting childhood neurologic injury. Wearable ultrasound and photoacoustic device that would offer continuous and autonomous monitoring of fetal brain oxygenation and labor progress.
- NIH funding: NINDS
Stanford University, California. A single-cell and cell-type resolution artificial retina for vision restoration.
- This bidirectional, implantable electronic device for restoring vision to people blinded by retinal degeneration is designed to reproduce the precise, complex neural code of vision at single-cell single-spike resolution by interacting adaptively with the retinal circuitry, a major advance over existing neural interfaces.
- NIH funding: NEI
University of Pittsburgh School of Medicine, Pennsylvania. Ventriculo-amniotic shunting for fetal aqueductal stenosis.
- The aventriculo-amniotic shunt is designed to normalize intracranial pressure in the fetal brain caused by aqueductal stenosis, the most common cause of congenital hydrocephalus. Most children with this condition have seizures, developmental delay, and ophthalmologic abnormalities from secondary cerebral ischemia, axonal shear, and gliosis before postnatal shunting.
- NIH funding: NINDS
Washington University in St. Louis, Missouri. Modular non-invasive brain-computer interface system for treating chronic neuropathic pain.
- This modular non-invasive brain-computer interface device that could be a prototype for first-in-human testing to treat chronic neuropathic pain, which impairs quality of life in 16 million Americans.
- NIH funding: HEAL Initiative
Optimizer awardees who are receiving their second year of funding, after meeting milestones:
Biomotum, Inc. and Northern Arizona University, 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.
- NIH funding: 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.
- NIH funding: National Center for Medical Rehabilitation Research at NICHD 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 could replace the standard of care, which is highly invasive and carries a risk of recurrence, and could substantially increasing the safety profile.
- NIH funding: NINDS
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.
- NIH funding: NINDS
Seedling awardees receive support for six months
In addition to the technologies listed above, Blueprint MedTech awarded so-called Seedling innovators small planning grant awards. Each seedling awardee is paired with an industry-experienced mentor to address weaknesses in their commercialization plan.
See a list of the 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 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.
Additional NIH project support is through contracts 75N95022D00020-75N95023F00001 (BP MedTech regulatory support at Thermo Fisher Scientiffic PPDTM) and 75N92022D00013-75N92024F00003 (RADx® commercialization center at VentureWell).