Photo courtesy of Sense Neuro Diagnostics
Sense Neuro Diagnostics, a medical technology company involved in improving outcomes for stroke and brain injuries, was awarded a $2 million contract by the Department of Defense (DoD), Congressionally Directed Medical Research Programs (CDMRP) via the Traumatic Brain Injury and Psychological Health Research Program (TBI PHRP).
The aim of the funding is to support clinical trials for Sense's NeuroHawk device, which is designed to find hemorrhage in specific regions of the brain and quickly diagnose traumatic brain injury (TBI) in field conditions.
Set to begin in June 2025, the clinical trial is designed to evaluate the capabilities of the NeuroHawk device to diagnose TBI and localize brain hemorrhage, offering critical insights in high-pressure surroundings.
With a period of performance of 30 months, the contract marks the second direct military funding the company has received. The first came through the Medical Technology Enterprise Consortium to build the device's technology, including deriving initial algorithms for hemorrhage detection.
The company describes the NeuroHawk device as a noninvasive brain scanner that utilizes advanced, low-power radio frequency (RF) technology to detect and monitor TBI and brain hemorrhage in seconds.
According to Sense Neuro Diagnostics, the quick, impartial diagnosis capability could improve triage and treatment decisions on the battlefield, thereby reducing the risk of secondary injury and improving outcomes for those with the most acute needs.
"We are honored to receive this contract from CDMRP as it recognizes the potential of our technology to address a significant unmet need for both military personnel and civilian patients," Geoff Klass, CEO of Sense Neuro Diagnostics, said in a statement.
"The NeuroHawk is designed for use in field conditions, allowing for rapid detection and monitoring of brain injuries. With this support, we are poised to advance the development and deployment of life-saving technology."
The NeuroHawk device is also being tested for use in hospital and EMS markets, where it could be used to provide rapid diagnosis and continuous monitoring for stroke and brain injury patients.
Sense Neuro Diagnostics plans to file for FDA clearance in the first quarter of 2025, then start a full commercial launch in mid-2025.
THE LARGER TREND
In October, Sense Neuro Diagnostics appointed Gary Kurdziel as executive vice president, chief commercial officer. Kurdziel previously held a leadership role for two-decades at Medtronic, which develops, manufactures and sells medical therapy devices.
In July, Sense Neuro Diagnostics joined the American Heart Association Center for Health Technology & Innovation Innovators’ Network. The Center concentrates on building and fostering health technology relationships to develop innovative and scalable solutions.
According to Dr. Robert Harrington, past president of the AHA, the center aims to advance the quick, efficient and effective development of healthcare technology. Joining the Innovator's Network gives members the chance to utilize the consortium and work toward expanding and deepening their engagement in this space.
Other companies that market similar products include Kernel, which offers a helmet that uses optical sensors to measure oxygen in the brain by sending small amounts of infrared light through the skull. The light is scattered throughout the brain and then returns to the source to provide data.
BioSerenity's ICECap is a disposable EEG net for routine and long-term EEG studies. The lightweight net allows EEG recording during daily activities.