Study to Evaluate Portable Diagnostic Platform for Stroke Detection

Neural Analytics Inc., a medical device company developing technology for the early detection of traumatic brain injury and stroke, today announced that the first patient has enrolled 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 EXPEDITE study will evaluate the company’s portable monitoring platform for patients suffering an acute ischemic stroke.
 
Despite significant advances for stroke treatment in recent years, a reliable diagnostic and monitoring method for first responders and emergency room physicians is unavailable to the clinical community. Current diagnostic assessments for stroke have limited accuracy and often result in lengthy delays to treatment which decrease outcomes for patients and increase the cost of care. The EXPEDITE study will examine Neural Analytics’ technology to assess patients for stroke and if rapid early assessment in the emergency room can expedite treatment and improve patient outcomes.¹
 
“The creation of a convenient, quantitative assessment system for the early detection of stroke is one of our most critical needs. We believe such a diagnostic tool will transform global patient management when it becomes available,” said Dr. Tom Devlin, medical director of Erlanger’s Southeast Regional Stroke Center and Principal Investigator of the study. “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.”
 
The study will enroll 150 patients who are suspected of having a Large Vessel Occlusion (LVO) Stroke and determine if Neural Analytics’ technology can assist clinicians in more rapidly assessing stroke risk in the Emergency Room setting. The study results are projected to be available in 2017.
 
“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,” said Leo Petrossian, chief executive officer of Neural Analytics. “We plan to use the data to support the company’s multiple global regulatory submissions as well as commercialization in 2017.”
 
Globally each year strokes affect about 16 million people and kill an estimated 5.7 million, with an annual U.S. healthcare cost of $104 billion. Stroke is a very time sensitive disease and requires intervention within six hours. Without appropriate diagnosis and treatment, a majority of patients suffer permanent disability or death. Despite recent advances in life saving surgical treatments, less than 10 percent of eligible stroke patients are treated surgically due to the lack of a portable diagnostic device for early detection.^2-4
 
Neural Analytics’ technology is currently under FDA and CE mark review for the monitoring of blood flow in the cerebral vasculature. It is not available for commercial use or sale.
 
References
¹ Ganesalingam, J. Cost Utility Analysis of Mechanical Thrombectomy Using Stent Retrievers in Acute Ischemic Stroke. Stroke. 2015 Sep;46(9):2591-8. doi: 10.1161/STROKEAHA.115.009396. Epub 2015 Aug 6.
² Saver, J. et. Al. Stent Retriever Thrombectomy after Intraveneous t-PA vs. t_PA alone in stroke. N Engl J Med 2015; 372:2285-2295
³ Ovbiagele, B. et. Al Forecasting the Future of Stroke in the United States. Stroke. 2013. http://stroke.ahajournals.org/content/44/8/2361.abstract,
⁴ Age Ageing (2009) 38 (1): 4-5.doi: 10.1093/ageing/afn282