Brain health technologist, Neural Analytics Inc., talks of promising data in support of its Transcranial Doppler Technology Platform. The data were presented at the 26th annual European Stroke Conference, taking place from May 24-26 in Berlin.
Background
Severe blood flow disorders affect more than 30 million people each year around the world. Traumatic Brain Injury and stroke contribute the most to the global disease burden for these disorders. Stroke is the second most common cause of death in Europe and about 1.1 million die of stroke in Europe each year. Globally stroke affects about 16 million people and kills an estimated 5.7 million, with an annual U.S. healthcare cost of $104 billion. There are 14.8 million people affected by Traumatic Brain Injury globally each year, with 2.5 million in the United States.
Neural Analytics is a medical device company developing and commercializing technology to measure, diagnose and track brain health. Its Lucid M1 Transcranial Doppler Ultrasound System™ is an all-in-one ultrasound system designed for measuring and displaying cerebral blood flow velocities and monitoring of patients with brain disorders. The Lucid System is a battery operated medical grade tablet device. It uses a type of ultrasound called Transcranial Doppler (TCD) to assess the brain’s blood vessels from outside the body. This analysis can be performed in the physician’s office, and can help the physician diagnose brain disorders, potentially without the need for additional, more invasive tests. Many significant brain disorders are caused by blood flow disruption.
The Lucid System received its CE Mark in January of 2017 and sales in Europe began in Europe in the first quarter of 2017. Neural Analytics opened its European office in Hamburg, Germany in April 2017 as we reported here.
The EXPEDITE study, conducted at Erlanger Health System, examined the effectiveness of Neural Analytics’ transcranial Doppler (TCD) platform in assessing patients for stroke.
The research study evaluated 45 subjects either experiencing computed tomography angiography (CTA) confirmed Acute Ischemic Stroke due to Large Vessel Occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA) or matched healthy controls. TCD scans were recorded in 30 second intervals across multiple depths for each brain hemisphere while patients awaited treatment. Data were analyzed using two different stroke assessment algorithms. A Stroke Asymmetry Index (SAI) which compared depth matched bilateral scans and a Stroke Waveform Morphology Index (SMI) which used an algorithm to assess Doppler waveform morphology changes. Both methods were 96% accurate for assessing large vessel occlusion.
The company will now expand the EXPEDITE study, projected to enroll 140 patients, to Baptist Hospital in Jacksonville, Florida.
Investigator comments
“Current standard of care for stroke diagnosis can be expensive and time consuming, underscoring a significant unmet need for an improved method for first responders and ER physicians to rapidly and accurately assess and triage patients for appropriate clinical intervention,” said Thomas Devlin, MD, PhD, principal study investigator and Medical Director of Erlanger Health System’s Southeast Regional Stroke Center in Chattanooga, Tennessee. “These results show Neural Analytics’ portable diagnostic platform has the potential to fundamentally change how we detect stroke, and could lead to significantly improved patient outcomes as patients are more rapidly triaged for treatment.”
Company comments
“We are encouraged by these study results, demonstrating that under research our novel TCD platform may prove to bridge the significant gap in current stroke detection and management,” said Dr. Robert Hamilton, Chief Scientific Officer of Neural Analytics. “Today, fewer than 10 percent of eligible stroke patients are treated surgically due to the lack of a portable diagnostic device for early detection which would enable earlier stroke diagnoses for first responders and ER physicians.”1,2,4
Source: Business wire
published: May 25, 2017 in: Clinical Studies/Trials, Neuro