Technology which could detect bleeding on the brain is entering its final clinical trial ahead of commercialisation, after almost ten years of development.
Sense Neuro Diagnostics has devised non-invasive technology which is set to play a key role in the earliest possible diagnosis of brain haemorrhage or stroke, and continuous monitoring of brain injury, with the potential to collect 360 data points in 2.5 seconds.
The device has already been through extensive tests, with more than 20 sites across the United States, Canada and India taking part in a pivotal trial evaluating its in-hospital use, and five US Department of Defense sites evaluating its impact in the military field.
Now, medtech startup Sense Neuro Diagnostics is entering a new clinical trial, after approval by the US Food and Drug Administration (FDA), which will focus on validating the algorithm for haemorrhage detection.
The trial could begin as soon as this month and will involve up to 300 patients at 30 sites. It has been approved by the FDA Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices.
Following the successful completion of the study, which is targeted for by the end of 2023, Sense Neuro Diagnostics will submit for clearance for commercialisation.
Other products to support stroke and brain injury patients through technology innovations are also planned after the launch of its initial device.
“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 of 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.”
“This technology is truly a springboard for a series of product launches that we anticipate over the next several years,” says Dr Opeolu Adeoye, chief medical officer of 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.”
