Neural Analytics, Inc. has announces the first site initiation and first subjects enrolled into the CODEX Study, a prospective, single arm multi-center safety and technical feasibility study utilizing an investigational iteration of the Lucid Robotic System (Lucid™ M1 Transcranial Doppler Ultrasound System® and NeuralBot™ System). The news was announced at the Ochsner Clinical Foundation in New Orleans, Louisiana.
“There is a growing interest in the diagnostic potential of measuring the dynamic changes of cerebral blood flow in different neurological conditions. Participating in the CODEX Study using the Lucid Robotic System to offer an autonomous measurement of cerebral blood flow velocities has been exciting. We look forward to advancing the field and expanding the clinical relevance of non-invasive measurement of cerebral blood flow in neurological conditions.” – Dr. Ifeanyi Iwuchukwu, MD, assistant professor of Neurocritical Care and Stroke at The Ochsner Clinical Foundation
“We are pleased and privileged that we are able to partner with Dr. Iwuchukwu and the Ochsner Clinical Foundation in the enrollment of our first patients into the CODEX Study,” said Robert Hamilton, Ph.D., Co-Founder and Chief Science Officer of Neural Analytics. “This is a big milestone for us, as we are committed to advancing brain healthcare through transformative technology that empowers clinicians with the critical information needed to make clinical decisions and improve patient outcomes.”
Dr. Iwuchukwu and the Ochsner Clinical Foundation are the first to enroll subjects into the global multi-center study. Although the Lucid Robotic System is a CE Marked and FDA cleared device, the primary objective of the CODEX Study is to employ an investigational iteration of the Lucid Robotic System to gather and further explore the technical feasibility of the novel technology in a wider range of patients and neurological pathologies where the monitoring of cerebral blood flow velocities (CBFV) would be of benefit.
Each year, neurological diseases cost the U.S. healthcare system nearly $800 billion.2 Traumatic brain injury, migraine, Alzheimer’s and stroke account for more than $438 billion of that cost.1 Stroke affects more than 795,000 people in the U.S. – someone has a stroke every 40 seconds, and someone dies from stroke every 4 minutes.2 It is a time sensitive disease and requires intervention within 24 hours of onset of symptoms.3 Incorrect assessment of large vessel stroke leads to misdiagnosis and treatment delays, resulting in death or disability for stroke patients. Despite recent advances in life-saving treatments for acute ischemic stroke, less than five percent of stroke patients qualify for intervention because they do not present early enough.4 The American Heart Association/American Stroke Association Guidelines for Early Management of Acute Ischemic Stroke state that detection of large vessel occlusion by means of noninvasive intracranial vascular imaging greatly improves the ability to make appropriate clinical decisions.5
The Lucid Robotic System is a medical ultrasound device intended for use as an adjunct to standard clinical practices for measuring and displaying CBFV and the occurrence of transient emboli within the brain. The device is not intended to replace other means of evaluating vital patient physiological processes. Neural Analytics is actively enrolling patients into this research feasibility study and intends on activating up to 15 sites, both domestically and globally.
1 Clifton L. Gooch, Etienne Pracht, Amy R. Borenstein. The Burden of Neurological Disease in the United States: A Summary Report and Call to Action. Annals of Neurology, 2017; DOI: 10.1002/ana.24897
2 Center for Disease Control. Stroke Facts. https://www.cdc.gov/stroke/facts.htm. Accessed April 25, 2018
3 2018 Guidelines for the Early Management of Patients with Acute Ischemic Stroke: A Guideline for Healthcare Professionals from the American Heart Association/American Stroke Association. Stroke 2018; January 24
4 Christopher R. Bernheisel, MD, Jeffrey D. Schlaudecker, MD, Katelyn Leopold, MD. Subacute Management of Ischemic Stroke. American Family Physician, 2011 Dec 15;84(12):1383-1388
5 Guidelines for the Early Management of Patients with Acute Ischemic Stroke: A Guideline for Healthcare Professionals from the American Heart Association/American Stroke Association. Stroke 2013; February 25