NIH MedTech program aims to accelerate medical devices to treat, diagnose nervous system disorders


Science Highlights
November 18, 2022
Raymond A. MacDougall

Pilot phase provides funding to seven projects that successfully navigated shark tank reviews

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The National Institutes of Health has awarded research funding for seven pilot projects developing early stage, yet groundbreaking neuro-technologies. The innovative projects would enable new medical devices to diagnose and treat both acute and chronic disorders, from neuropathic pain to mental illness. The one-year, $100,000 awards are the first for a new program within the NIH Blueprint for Neuroscience Research, called Blueprint MedTech.

“The Blueprint MedTech program is building a translational ecosystem to accelerate new solutions for disorders of the nervous system across a wide range of unmet needs,” said Michael Wolfson, Ph.D., director for the program at the National Institute of Biomedical Imaging and Bioengineering (NIBIB). “These pilot projects offer potential interventions to address motor impairment, stroke, pain, nerve injury, obstetric monitoring, mental illness, and rare diseases.”

The MedTech program relies on the collaborative framework of the NIH Blueprint for Neuroscience Research, which includes the NIH Office of the Director and 12 NIH institutes and centers that support research on the nervous system. Following the initial pilot awards, NIBIB is now administering the MedTech incubator hubs program, incorporating many lessons learned from the NIH Rapid Acceleration of Diagnostics (RADx®) Tech program, which brought 46 new rapid COVID test products to market within two years.

The MedTech call for applications elicited more than 150 responses, at least three times as many as expected, according to Steven C. Schachter, MD, chief academic officer at the Boston-based Consortia for Improving Medicine with Innovation & Technology (CIMIT), which NIH engaged to manage the pilot solicitation and review. “Successful applicants prevailed through progressively challenging evaluation gates—pre-proposal, full proposal, deep dive review—to reach this award stage.”

Along with funding, MedTech will provide an array of specialized support from mentors who bring decades of experience commercializing neurotechnology devices. Project teams will learn to navigate business, manufacturing and regulatory aspects of developing their respective technologies, and prepare to build human-grade prototypes. While the science supporting each technology has met rigorous standards, clinical studies will be needed prior to their authorization for use in patients. “Our hope is that with our planned companion funding opportunities, the technologies will be ready for first-in-human studies in two to five years,” Wolfson said.

Recipients of Blueprint MedTech pilot project funding:

University of Minnesota, Minneapolis

Project title: Neurostimulation to enhance human cognitive control and treat severe mental illness

A novel method to optimize neurostimulation therapy for treatment of people with mental disorders, including severe depression and anxiety. The system will allow clinicians to select parameters for deep brain stimulation that target specific brain circuits identified as areas of dysfunction and restore patterns of neural activity that are necessary for healthy cognitive function and control.

John’s Hopkins University, Baltimore

Project title: Intrapartum monitoring of vulnerable fetal brain and labor progress using ultrasound/photoacoustic sensor

A hybrid ultrasound and photoacoustic device that will directly monitor the potential of fetal distress during labor, providing continuous status updates on fetal brain health and cervix dilation. The device will provide non-invasive transcranial photoacoustic sensing for detection of challenges to oxygen supply and blood flow to the fetal brain that could lead to permanent brain injury due to hypoxic-ischemic encephalopathy and stroke. Use of the device will also simplify the current clinical labor monitoring protocol of frequent cervical palpitation.

John’s Hopkins University School of Medicine, Baltimore

Project title: Viopsy: a non-invasive imaging device to modernize treatment of peripheral nerve injuries

A handheld, photoacoustic imaging device that will provide high-resolution images of peripheral nerve structures and enable the quantitative assessment of viable axons within nerve tissue, where nerve damage has occurred due to trauma or other causes. The non-invasive technology could better inform clinical decisions, improve surgical outcomes, and enable post-operative monitoring of nerve regeneration. The device, called Viopsy, aims to modernize treatment of peripheral nerve injuries.

Albany Medical College, New York

Project title: External low-intensity focused ultrasound device for treatment of neuropathic pain

A low-intensity focused ultrasound device for non-pharmacological treatment of aggravated chronic pain. This condition, also called neuropathic pain, when treated with opioid-based drugs, has led to addiction in some patients. The device uses a hand-held probe to direct low-intensity ultrasound at the dorsal root ganglia—small bundles of nerves along the spine that control pain signals reaching the spinal cord.

University of California, Davis

Project title: A simpler and more accurate non-radioimmunoassay for diagnosing myasthenia gravis

A laboratory assay to simplify and improve accuracy in diagnosing the chronic autoimmune disorder, myasthenia gravis, which affects the voluntary muscles of the body, especially those that control the eyes, mouth, throat, and limbs. The new assay, an alternative to one that uses radioactive materials and the human acetylcholine receptor, targets just pathogenic anti-receptor antibodies and can help physicians better determine the disease state and more quickly determine appropriate treatment.

NeuraStasis, Houston

Project title: Transcutaneous stimulation of cranial nerves to mitigate cerebral damage during acute ischemic stroke

Noninvasive stimulation of cranial nerves during acute ischemic stroke allows for successful rerouting of blood flow in the affected region of the brain.  The neurostimulation controls the activation of two cranial nerves—trigeminal and vagus—engaging the body’s innate oxygen-preserving and anti-inflammatory reflexes and pausing the progression of cerebral damage. The neurostimulation device is integral to achieving decreased brain injury and patient disability.

Boston University, Sargent College

Project title: The reNeu propulsion neuroprosthesis for gait restoration after neurological injury

Slow, unstable gait is a common result of neuromotor injury or neurodegenerative disease. The reNeu propulsion device is a soft exo-suit that enables the heel-to-toe motion required for the propulsive phase of walking. It uses algorithms that transform biosensor data into properly timed electrical stimulation pulses that can augment and rehabilitate the muscles used to support and propel the body during walking, helping people with neurological injuries to walk with improved gait and speed.

The pilot projects are funded under NIBIB grant U54 EB015408.

About Blueprint MedTech: Blueprint MedTech is an NIH incubator that aims to address challenges that innovators contend with in the process of developing cutting-edge medical devices to diagnose and/or treat disorders of the nervous system. It 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 and Centers that support research on the nervous system. By pooling resources and expertise, the Blueprint supports transformative neuroscience research, and the development of new tools, training opportunities, and other resources to assist neuroscientists.