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Congratulations to our Blueprint MedTech Cycle 1 Seedling Awardees

We are pleased to announce the 17 seedling awardees selected from cycle 1 of the NIH Blueprint MedTech program which aims to accelerate patient access to groundbreaking, safe, and effective medical devices.

The seedling awards extend up to $50,000 to each innovator team whose applications had promise but were not ready for a full Blueprint MedTech program award. Each team will also have access to in-kind support via mentoring, regulatory consulting, and other commercialization training.

BluePrint MedTech cycle 1 seedling awardees:

University of California, San Francisco

Sierra, an implantable closed-loop brain-network neuromodulation device: An innovative implantable device that interfaces with circuitries underlying different neuropsychiatric disorders and executes disorder-specific neuromodulation of these circuitries. If successful, closed-loop neuromodulation algorithms will be customized for different conditions, thereby providing a unique opportunity to treat different neuropsychiatric conditions.

Neuroview Technology, New Jersey

Subgaleal Hyper-chronic EEG Monitoring Platform: An implantable device and cloud-based platform that records and stores EEG data and other relevant clinical features, to detect and classify seizures in patients for up to 3 years. The device is implanted in extracranial subgaleal space via a minimally invasive outpatient procedure. If successful, this product is expected to be a chronic EEG based monitor capable of achieving 100% patient compliance and likely to detect almost all clinically relevant seizures.

UNandUP, Missouri

Magneto-Thrombolysis to Improve Acute Ischemic Stroke Care: An application of magnetic nanoparticles and a portable magnet system to enhance the delivery of alteplase to blood clots’ surfaces, facilitating more efficient clot dissolution in the management of acute ischemic stroke. This novel nanoparticle-based thrombolysis platform will accelerate alteplase to blood clots in the brain blood vessels associated with acute ischemic stroke (AIS), thereby overcoming restrictive hemodynamics that prevent alteplase from reaching the occlusion. If successful, lower doses of FDA-approved alteplase will be needed for thrombolysis, thereby reducing the risk haemorrhage from high dose of alteplase.

Longeviti Neuro Solutions & HEPIUS Lab, Baltimore

Monitoring glioblastoma multiforme tumors through an implantable ultrasound transducer: An implantable ultrasound imaging transducer to be encapsulated within an implant, for use in the continuous monitoring of post-surgical glioblastoma tumor growth, thereby eliminating the need for repeated MRIs. The novel implant component shows markedly lower attenuation than native skull bone, thus providing an ideal encapsulation material. Combining this implant with the implantable ultrasound transducer could enable clinicians to monitor tumor growth non-invasively, remotely, and with increased temporal duration, effectively providing a high-resolution time-lapse image of tumor growth. For the patient, a true time lapse of tumor growth could be achieved without the burden of daily visits to the clinic.

Arizona State University, Tempe

Wireless, injectable neurostimulators (WINS) for treating chronic migraine: A platform that combines an injectable microchip implanted near the occipital nerve on an outpatient basis and a wireless, handheld neurostimulation device to stimulate the occipital nerve. This would enable patients with chronic migraine to use the handheld device to deliver ultrasound-based neurostimulation of the occipital nerve to treat migraine episodes.

University of Southern California & Lundquist Institute, Los Angeles

Endovascular Electrode Device for Transvenous Electroencephalography: A commercial-grade endovascular electrode device for minimally invasive transvenous electroencephalography (EEG). This device aims to provide a less invasive means of sampling deep and surface brain activity, particularly in patients with epilepsy, without the need for a craniotomy. By creating a minimally invasive endo-EEG device this product hopes to improve access to accurate diagnosis and effective therapy, with the long-term goal of reducing the global impact of epilepsy.

MuscleMetrix, Boston

Magnetomicrometry: A novel method to enhance signal quality for neural interfacing in limb prostheses compared to surface electromyography (sEMG). Magnetic beads, administered through a minimally invasive procedure are proposed as a stable and biocompatible alternative to traditional electrodes, aiming to address signal quality issues and improve the accuracy of measuring muscle extension. This is achieved by incorporating a mobile sensing electronics, mounted to the outside of the body, for tracking the nuanced movements of each muscle with high accuracy and precision.

Sensate Medical, Utah

Drug Delivering Nervewrap for Peripheral Nerve Regeneration: A drug-delivery nerve wrap embedded with two FDA-approved drugs known to improve nerve regeneration after peripheral nerve injury. It uses biocompatible co-polymers with favorable mechanical properties to deliver neurotropic molecules to sites of nerve injury to enhance nerve regeneration in multiple nerve injury and repair models, including direct repair, compression, gap, and graft.

Motif Neurotech, Houston

Minimally invasive implants for treatment-resistant depression: An implantable magnetoelectrical device for precise at-home delivery of neurostimulation to treat treatment-resistant depression (TRD). This minimally invasive technology is implanted below the skin but above the dura to deliver the precision and effectiveness of rTMS in the comfort of the patient’s home without a brain surgery. The device is very tiny, making it compatible with a standard burr hole drill or perforator, and allowing it to sit flush with the skull with no indication that the patient has an implant. If successful, this product will allow patients to receive potentially effective antidepressive neuromodulation without clinical visits.

IntraStim, Florida

Sexual Health Neurostimulator: A neurostimulation device implanted in the sacral hiatus to access peripheral nervous system regions related to sexual function. It can be used for restoring sexual function in spinal cord injury patients. The implantation of this device can be conducted through an inpatient procedure by a urologist.

Vonova, Los Angeles

Minimally Invasive Device for Brain Surface Diagnostics: A minimally invasive device for evaluating patients with drug-resistant focal epilepsy for potential surgery. It involves using the jugular vein to access the subdural space and deploy an electrode array, providing a more patient-friendly alternative to the current, more invasive techniques.

Asayena, San Diego

Neuromodulation Device for Restoration of Motor Function: A closed loop neuromodulation device designed to restore volitional, graded motor function in the upper extremities, with a focus on individuals who have experienced stroke-related impairments around in upper limb muscles. It uses signal detection and machine learning algorithms to detect weaknesses in the innervations to upper limb muscles, to guide selective, discrete stimulation of these regions to promote graded motor function.

MacHouse Designs, Saint Louis

In vivo visualization of peripheral nerves using novel CT contrast agents: A novel CT contrast agents tailored for in vivo visualization of peripheral nerves. By addressing the current limitations in nerve visualization, this product aims to improve the precision and clarity of imaging, benefiting surgical procedures and interventions that rely on accurate nerve identification.

HEPIUS Lab, Johns Hopkins University, Baltimore

An Implantable Ultrasound Transducer for Remote Diagnostics of Spinal Cord Injury: A wireless ultrasound imaging device implanted for spinal cord injury after surgery to measure and monitor spinal cord blood flow and transmit images to continually assess injury and guide drug delivery. This novel wireless ultrasound imaging array, implanted above the spinal dura, can be remotely controlled to acquire co-registered ultrasound and blood flow images at regular intervals following surgery. By pairing the device to a desktop or a smart device, ultrasound and blood flow images can be remotely analysed.

Johns Hopkins University, Baltimore

Photoacoustic Retinal Prosthesis: A photoacoustic retinal stimulation (PARS) approach to restore functional vision with minimally invasive implantation of an epiretinal PA-sensitive layer, an external goggle system to recognize the surrounding environment and projection of raster-scan focused light pulses onto the layer to generate a spatiotemporal pattern at high resolution. If successful, it offers a new paradigm to safely restore functional vision with higher spatial acuity, wider field-of-view, flexible configurability, and upgradability.

Johns Hopkins University, Baltimore

A Non-Invasive Imaging Device to Modernize Treatment of Peripheral Nerve Injuries: A novel photoacoustic imaging system designed for intraoperative, non-invasive assessment of peripheral nerve injuries. It aims to enhance the identification and surgical reconstruction of damaged nerves, potentially improving outcomes for patients with acute peripheral nerve injuries.

Johns Hopkins University, Baltimore

Smart Cerebrospinal Fluid Management Implant in Patients with Spinal Cord Injury: A smart design of spinal catheters with in-built sensors to enable cerebrospinal fluid drainage and simultaneous real-time monitoring of biomarkers, temperature, and pressure. The drainage system would relieve pressure on spinal cord and reduce secondary damage by increasing blood flow. Upon successful completion, this product could be used to monitor treatment, increase Spinal Cord Perfusion Pressure, and predict a patient’s recovery following Spinal Cord Injury to improve neurological function.

This award aims to provide the training and mentoring necessary to further refine product profiles, regulatory and reimbursement strategies to strengthen subsequent applications to the NIH Blueprint MedTech program or other translational funding programs in the future.

To learn more about the Blueprint Medtech program and subsequent cycles please visit blueprintneurotech.org.

*This project has been funded by grant #U54EB033664.

Supported by a $5M investment over 5 years (scalable up to +$20M annually) by the National Institutes of Health (NIH), Johns Hopkins University and Howard University are teaming up to accelerate the creation of groundbreaking solutions to disorders of the nervous system. More than 1 billion people worldwide suffer from these disorders, which range from Alzheimer’s and Parkinson’s disease to chronic pain, addiction, mental health, multiple sclerosis, stroke, migraines, brain and nerve injuries, and more.

Experts at the new NeuroTech Harbor (NTH) technology accelerator will partner with diverse teams of top innovators from around the globe to supercharge the development of medical devices that improve diagnosis, treatment, and management of these conditions while also ensuring those technologies are accessible to all communities. Funded from NIH’s Blueprint MedTech program through grant U54EB033664, NTH is a biotechnology incubator which aims to accelerate the development of cutting-edge medical devices to diagnose and treat nervous system disorders. NIH selected NTH as one of two incubator hubs to foster innovative medical products, to prepare them for first-in-human demonstrations.

“Disorders of the nervous system constitute a true public health crisis and are one of the leading causes of disability and death worldwide,” says Sri Sarma, NTH Executive Director and Associate Professor of Biomedical Engineering at Johns Hopkins University. “Potentially life-saving and life-changing solutions addressing these conditions are out there, but the pace of their development is slow. Many of the most promising concepts often languish due to a lack of resources and the high risks associated with early development phases. NeuroTech Harbor’s approach will overcome those barriers, helping fast track the development of real-world solutions to conditions that affect one in six people around the globe.”

At the cornerstone of NTH’s approach is a belief that bringing together diverse experts, leadership, and perspectives will amplify and accelerate innovation resulting in technologies and solutions that are more equitable and more accessible.

“Studies show that diversity unlocks innovation, drives growth, stimulates novel thinking, improves outcomes, and produces solutions that work for everyone. So, we are committed to diversity and inclusion during early-stage translation as the first critical step toward creating lasting and meaningful long-term clinical and societal impact,” Sarma says.

Sarma will lead NTH’s team of investigators and personnel from Johns Hopkins University and Howard University. The principal investigators (PI)– 67% of whom are women or from historically under-represented groups— exemplify the commitment to inclusive excellence. In addition to Sri Sarma, the PI’s from Johns Hopkins University include Nitish Thakor (Professor of Biomedical Engineering), Youseph Yazdi (Director of the Johns Hopkins Center for Bioengineering Innovation & Design), and Ralph Etienne-Cummings (Vice Provost of Faculty Affairs and Professor of Electrical and Computer Engineering). The PIs from Howard University include Evaristus Nwulia (Professor of Psychiatry) and Kebreten F. Manaye (Professor and Chair of the Department of Physiology and Biophysics).

“Our collective aim is to provide unique opportunities to innovators from all backgrounds to find effective solutions to neurological conditions that cause substantial sufferings in all populations, including underserved populations that historically and continually experience disparities in health outcomes,” Nwulia says.

NTH will connect innovators to engineers and specialists with deep and broad biomedical engineering and commercialization expertise by leveraging access to state-of-the-art facilities like the Johns Hopkins University Applied Physics Laboratory, as well as NTH’s established global networks of angel investors and venture capitalists. NTH’s consultant network of world-renowned neurotech experts represents diverse backgrounds and experiences and includes clinicians, scientists, technologists, commercialization experts, and patient advocates. In addition, NTH is planning education and mentorship of teams in business development, translation, and project management to help ensure their success.

Howard University will lead outreach efforts to build pathways for aspiring women and underrepresented minority innovators at a national scale. “Howard University is excited to collaborate with Johns Hopkins University on the NeuroTech Harbor accelerator. This partnership will bring together global teams of diverse experts to provide innovative solutions for neurological conditions, which impact our communities,” said Bruce Jones Ph.D., Professor and Vice President for Research Office of Research at Howard University. “This grant supports a key pillar in the Howard Forward strategic plan to Inspire New Knowledge, while increasing the diversity of research and innovation. We look forward to the growth and success of this collaborative partnership.”

Over the next five years, NTH expects to launch 45 new neurological health innovation projects. With funding and research support from NIH, the selected projects will engage with NTH and the other incubator recipient under grant U54EB033650, CIMIT’s Center for Innovative NeuroTech Advancement (CINTA) program. CINTA leverages CIMIT’s experience and network of world-class academic and medical institutions partnering with industry and government to foster collaboration and accelerate innovative healthcare technologies. Both NTH and CINTA leaders will collaborate in an unprecedented manner to ensure the translational objectives of this NIH program are accomplished most efficiently and effectively, sharing resources and expertise.

The joint Blueprint MedTech funding opportunity on behalf of NIH launches Tuesday, Sept. 27, with teams applying for support of up to $500K in direct costs per year for up to four years. In addition to funding, the selected teams will receive ongoing, specialized support from mentors experienced in commercializing neurotech devices. NTH leaders expect to choose up to eight teams, with two yearly selection cycles.

“Our vision is to blaze a trail to alleviate suffering from neurological conditions for all, including those historically underserved,” Sarma says.

Category Archives: News

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