Neural Analytics has started the clinical study to assess next generation portable diagnostic platform for early detection of stroke.
The company recruited first patient in the EXPEDITE (evaluate a next generation portable diagnostic platform for determination and immediate triage of emergency large vessel stroke) phase I clinical study at Erlanger Health System in Chattanooga, Tennessee.
The study will assess the firm’s portable monitoring platform for patients suffering an acute ischemic stroke.
The company will recruit around 150 patients who are suspected of having a large vessel occlusion (LVO) stroke and determine whether its technology will assist clinicians in more rapidly assessing stroke risk in the emergency room setting.
Neural Analytics plans to reveal the results of the trial in the next year.
Currently, Neural Analytics’ technology under FDA and CE mark review for the monitoring of blood flow in the cerebral vasculature.
The study’s principal investigator Dr Tom Devlin said: “We are thrilled to be the first site in the world to begin evaluation of this promising technology, which uses ultrasound to rapidly assess blood flow in the brain and may help healthcare professionals determine if a patient is suffering a stroke.”
Neural Analytics CEO Leo Petrossian said: “We are pleased to enroll our first patient in the EXPEDITE study which will help us develop clinical evidence to demonstrate that our next-generation ultrasound technology can help clinicians rapidly assess and monitor stroke patients.
"We plan to use the data to support the company’s multiple global regulatory submissions as well as commercialization in 2017.”