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 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 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.