NEWS | May 18, 2023
Pivotal Study is Final Hurdle Before Commercialization; Will Focus on Validating Algorithm for Hemorrhage Detection
The new trial approved by the FDA Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices will begin as soon as June 2023 and involve up to 300 patients at 30 sites in the United States, as well as Canada and India. This non-invasive technology has the potential to collect 360 data points in 2.5 seconds to detect brain hemorrhage or stroke type, thereby helping first responders, emergency department personnel, neuro ICU teams, and military field hospitals assess and monitor traumatic brain injuries.
More than 20 sites across the United States, Canada, and India have already engaged with the startup for a prior pivotal trial evaluating an in-hospital device, and five U.S. Department of Defense sites have been evaluating the company’s military field device. Sense Neuro Diagnostics executives hope to complete this new study by the end of the year, at which time they will submit to the FDA for clearance for commercialization.
“Once we finish this last clinical trial, we hope to be in a position to celebrate Sense’s first commercial device and its launch into the marketplace,” says Geoffrey Klass, chief executive officer, Sense Neuro Diagnostics. “This trial should be our last hurdle before we establish a commercial platform and transcend beyond startup status to a commercial company. It’s a watershed moment for our entire team and everyone who has supported Sense in its nearly ten years of effort.”
Sense Neuro Diagnostics has developed its technology in collaboration with the University of Cincinnati Medical Center, the region’s only Level 1 Trauma Center. UC Medical Center and Grady Memorial Hospital at Emory University in Atlanta, Georgia, are committed to participate in this next clinical trial, and Sense Neuro Diagnostics intends on partnering with research sites that have participated in its previous trials.
“This technology is truly a springboard for a series of product launches that we anticipate over the next several years,” says Opeolu Adeoye, M.D., chief medical officer, Sense Neuro Diagnostics. “The approval of this device and technology will give us a framework for a series of innovative devices with the goal of improving patient outcomes.”
About Sense Neuro Diagnostics
Sense Neuro Diagnostics is focused on improving outcomes for stroke and brain injury patients through technology innovations that enable faster detection and more effective triage. Sense Neuro Diagnostics is developing non-invasive technology to enable continuous, real-time brain injury monitoring as well as rapid detection of traumatic brain injury and important stroke subtypes. Learn about the ongoing pivotal trial for continuous monitoring of intracranial hemorrhage, and successful first-in-human pilot study of triage technology to determine stroke subtype at senseneuro.com.