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Neural Analytics announces first site initiation and first subject enrollment into CODEX Study

Press releases may be edited for formatting or style
LOS ANGELES--(BUSINESS WIRE)--Neural Analytics, Inc., a medical robotics company developing and commercializing technologies to measure and track brain health, announces today 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), 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

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“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
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