NIH Blueprint MedTech Cohort 2 Seedling Awardees 

 

Congratulations to our Blueprint MedTech Cohort 2 Seedling Awardees! 

 

We are pleased to announce the seedling awardees selected from cohort 2 of the NIH Blueprint MedTech program which aims to accelerate patient access to groundbreaking, safe, and effective medical devices. 

 

The seedling awards provide support for six months including a $25,000 stipend and $25,000 to hire subject matter experts to each innovator team whose applications had promise but were not ready for a full Blueprint MedTech program award. Mentors will work with awardees throughout the project to help resolve specifically identified gap on the path to commercialization. 

 

AutonomUS Medical Technologies, Inc., Boston, Massachusetts  

Reducing opioids after knee replacement through AI-enabled robotic nerve block. Ultrasound-guided adductor canal nerve block (USgACNB) is an established and effective opioid-sparing post-knee-replacement analgesic technique. Access to this treatment is limited by the requirement for specialized sonographic needle placement skill. The product is a low-cost, handheld, AI-enabled surgical robotic system to permit non-subspecialists to safely perform USgACNB, which may reduce post-operative opioid dependency risk. 

NIH funding: NIDA 

 

Brain Temp Inc., Bryn Mawr, PA 

BrainTemp BTneo brain temperature monitoring system. The proposed device is a noninvasive, passive system for monitoring brain temperature. This missing critical vital sign will enable more precise care and guide therapy across a range of clinical indications, improving clinical outcomes for patients and economic outcomes for burdened health systems. 

NIH funding: NINDS 

 

Carnegie Mellon University, Pittsburgh, Pennsylvania  

Point-of-care transcranial focused ultrasound neuromodulator for treating chronic pain. Twenty percent of U.S. adults have chronic pain, with 19 million suffering from high impact chronic pain. Pharmacological interventions, e.g., opioids, are the mainstay to treat pain. Point-of-care transcranial focused ultrasound neuromodulator is a non-invasive, drug-free, device-based solution to target and modulate specific brain regions, thus alleviating chronic pain on demand. 

NIH funding: NIDA 

 

Drizzle/CoolSpine, LLC, Woodbury, Connecticut  

Intrathecal Cooling Catheter to provide neuroprotection to avoid paraplegia resulting from open and endovascular thoracic aneurysm repair. The catastrophic complications from open and endovascular repair of the aorta remains unacceptably high at 4-8%. CoolSpine’s Intrathecal Cooling Catheter has been shown to reliably induce localized hypothermia to the spinal cord while maintaining systemic normothermia, providing a potential prophylactic tool to reduce ischemic injury during this essential surgery. 

NIH funding: NINDS 

 

Columbia University; CranioSense, New York, NY 

Development and clinical evaluation of a novel non-invasive intracranial pressure assessment and monitoring device. Intracranial hypertension (IH) is a prevalent cause of secondary brain damage resulting in poor patient outcomes. High fidelity continuous monitoring can be used to guide treatment and prevent injury. This is a non-invasive device for the rapid assessment and continuous monitoring of IH for emergency department settings and beyond. 

NIH funding: NINDS 

 

Drexel University, Philadelphia, Pennsylvania 

Minocycline-releasing drug delivery system for treating spinal cord injury. Spinal cord injury (SCI) causes deleterious functional loss without an effective treatment. High concentrations of minocycline have been shown to target all the major secondary injury mechanisms after SCI. This biomaterial-based drug delivery system aims to locally deliver high concentrations of minocycline that systemic delivery cannot safely achieve. 

NIH funding: NINDS 

 

FavFacture LLC; Duke University, Durham, North Carolina 

Epileptogenic zone localization to improve outcomes of epilepsy surgery. Resective surgery can be curative for patients with drug-resistant epilepsy. However, surgery requires determining the location and extent of tissue where seizures originate, which is a challenging, non-systematic, and time-consuming process. This computer-based algorithm aims to rapidly, objectively, and automatically determine the location of seizure origin. 

NIH funding: NINDS 

 

Emboa Medical, Inc., West Lafayette, Indiana  

Thrombus Retriever Aspiration Platform (TRAP) for medium vessel occlusion thrombectomy. Ischemic stroke caused by medium vessel occlusions often results in severe neurological morbidity. Medium vessels are smaller, more distal and tortuous, limiting the efficiency of blood clot extraction tools. A novel aspiration catheter with embedded clot-trapping microstructures designed to enhance clot extraction with single-pass aspiration can improve clinical outcomes. 

NIH funding: NINDS 

 

Haystack Diagnostics, Brookline, Massachusetts  

Gemini Electrodiagnostic System (Gemini EDx). Treatments for neuromuscular disorders require laborious characterization to develop individualized treatment plans. This impedance-electromyography (iEMG) technology offers improved neuromuscular disease diagnosis and the capability to assess disease progression and treatment efficacy.  

NIH funding: NINDS 

 

Mayo Clinic; UpStim, LLC, Rochester, Minnesota 

Cortically-controlled virtual Reality (VR)-guided robotic rehabilitation enhanced with spinal cord stimulation. The proposed technology integrates rehabilitation robotics, non-invasive spinal cord stimulation and a brain-computer interface guided by VR. It represents the next generation of rehabilitation products for patients paralyzed as result of stroke and spinal cord injury to regain neural functions.  

NIH funding: NINDS 

 

Nationwide Children’s Hospital, Columbus, Ohio  

ForeVR: Biofeedback-based virtual reality (VR) to treat pain in children and adolescents. The ongoing opioid epidemic highlights an urgent need for safe and effective nonpharmacologic therapies to reduce pain and opioid consumption. The product is a novel technology that combines biofeedback (BF) with virtual reality (VR), VR-BF (ForeVR), to decrease pain and opioid consumption, reducing the need for pharmacologic interventions. 

NIH funding: NIDA 

 

NeuroNexus Technologies, Inc., Ann Arbor, Michigan  

Activus – Minimally-invasive neural interface device for critical care neuromonitoring. Subgaleal (SG) continuous EEG has promise as a “vital sign” for the brain. Difficulties in accessing and recording in the SG space has limited its widespread deployment and use. Activus is a novel electrode system with a minimally invasive delivery method to enable use across the spectrum of critical neurological conditions. 

NIH funding: NINDS 

 

Pioneer Neurotech, Inc., Louisville, Kentucky  

Long-gap nerve-repair device. Current solutions for repairing severed nerves with a gap (where the nerve ends cannot be directly reattached) are poor, and longer gaps are not treatable. A novel implant provides a means of regrowth with mechanical innovation and a unique biologics cocktail supports reestablishing the key components of a functional nerve. 

NIH funding: NINDS 

 

Rutgers University, Departments of Neurosurgery and Biomedical Engineering, New Brunswick/Piscataway, New Jersey  

Wearable diaphragmatic pacemakers to prevent sudden unexpected death in epilepsy. People with epilepsy are at high risk of sudden death due to seizure-induced respiratory arrest. There is no preventative treatment to avoid this fatal occurrence. This wearable, closed-loop device, capable of detecting seizures and seizure-induced respiratory arrest, is designed to transcutaneously stimulate the diaphragm to prevent mortality. 

NIH funding: NINDS 

 

Teliatry Inc., Richardson, Texas  

Implantable near-infrared spectroscopy sensor: Optical monitoring of spinal cord injury (SCI). No tools exist to monitor oxygenation and blood flow at the site of injury after SCI during the critical week after injury. To preserve neurological functions, the product is an implantable NIRS sensor at the injury site to monitor oxygenation and blood flow which would enable tailored blood pressure management and optimize neurological function preservation. 

NIH funding: NINDS 

 

Thermeutics, LLC, Dallas, Texas  

Novel neural cooling implant to halt glioblastoma. Glioblastoma (GBM) remains lethal as current therapies are unable to eradicate cancer. Cytostatic hypothermia safely halts tumor growth and extends survival in rat models of GBM. The team will develop an implantable device to translate this promising therapy to humans.
NIH funding: NINDS 

 

FavFacture, LLC, Baltimore, MD 

Disruptive multi-site (TMS) tools for improving impaired brain connectivity. Brain imaging studies suggest that the more effective treatment for craving and smoking cessation may require engaging multiple nodes of one or more circuits simultaneously or through precisely controlled timing. Disruptive multisite TMS coils with small-footprints, deep and focused field distributions may accomplish higher treatment efficacy than conventional coils. 

NIH funding: NIDA 

 

University of California, San Francisco, California 

An Automated Process for Optimizing and Predicting Spinal Cord Stimulation for Chronic Pain​. Spinal cord stimulation can relieve pain but optimizing parameters and predicting trial success are challenging. This project aims to address this by using EEG-identified neural features to predict optimal stimulation parameters with the goal of integrating these features into a predictive model that will guide clinical programming and provide estimates of trial success. 

NIH funding: HEAL 

 

University of Michigan, Ann Arbor, Michigan  

PAIM (Personalized Automated Intelligent Management) – Effectively addressing chronic pain assessment. Chronic pain is a devastating condition affecting an outsized proportion of Americans. Despite advances in pain research, assessing and treating chronic pain remains challenging. The proposed system is a 3D mobile/application programming interface platform that leverages advanced generative artificial intelligence tools to optimize pain care for each individual patient. 

NIH funding: NINDS 

 

University of Southern California, Los Angeles, California 

Innovative Sight Recovery: Non-Invasive Ultrasound Retinal Stimulation​. This project aims to harness non-invasive extraocular ultrasound stimulation of the retina and optic nerve to effectively and safely treat Retinitis pigmentosa (RP) and age-related macular degeneration (AMD). 

NIH funding: NEI 

 

University of Texas at Austin, Austin, Texas  

A wearable fabric sensing device for dysphagia in Parkinson’s disease. Swallowing dysfunction (dysphagia) is a major concern in Parkinson’s disease, wherein aspiration pneumonia (food/liquid entering the lungs) is the leading cause of death. Improvements in dysphagia detection and monitoring will decrease negative outcomes and improve quality of life. A wearable knitted fabric device can non-invasively quantify dysphagia. 

NIH funding:  NICHD’s National Center for Medical Rehabilitation Research 

 

Vizma.AI, Raleigh, North Carolina  

PolarEasePro prepares injectable MRI contrasts for molecular imaging. A lack of molecular diagnostics has impeded diagnosis, treatment, and monitoring of neurologic diseases, including traumatic brain injury (TBI). Clinical hyperpolarized MRI has been validated as a solution but relies on costly devices. This is an alternative device that is scalable and can make hyperpolarized MRI for TBI widely accessible. 

NIH funding: NINDS 

 

These awards 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. 

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.