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Neural Analytics Plans Human Study of Stroke Assessment Robot

Source: Neural Analytics

October 31, 2019      

Neural Analytics, a medical robotics company that is developing and commercializing technologies to measure and track brain health, today announced the first subjects in a study of its Lucid Robotic System.

The IRB-approved CODEX study is a prospective single arm, multi-center, safety and technical feasibility study that uses an investigational device exemption (IDE) version of the company’s robotic system. The system includes the Lucid M1 Transcranial Doppler Ultrasound System and NeuralBot System, which aims to assist physicians in the management of patients suspected of suffering a stroke. The system is designed to non-invasively search, measure, and display objective brain flow information in real-time. The study will take place at the Ochsner Clinical Foundation in New Orleans.

Neural Analytics Lucid M1

The Lucid Robotic System is an autonomous robotic system that assists doctors with monitoring brain health. Image: Neural Analytics

“We are honored to be the first in the world to evaluate the performance of Neural Analytics’ next-generation robotic technology,” said Ifeanyi Iwuchukwu, M.D., assistant professor of neurocritical care and stroke at The Ochsner Clinical Foundation. So far, we have been impressed swith the improved simplicity, and ease of use of the new Lucid Robotic System. Over the past nine months we have generated a tremendous amount of data to support the use of the Lucid Robotic System in the management of patients suffering stroke, and we are excited to be building upon that with this next generation platform.”

Feasibility study

Dr. Iwuchukwu and the Ochsner Clinical Foundation are the first to clinically evaluate the new version of the robotic system, Neural Analytics said. The first generation was FDA cleared in 2018, and Dr. Iwuchukwu and the foundation have been using an investigational version of the device within the CODEX Study System to gather and further explore the technical feasibility of the technology in several patients and neurological pathologies where the monitoring of cerebral blood flow velocities (CBFV) would benefit stroke clinicians.

“We are grateful to be able to continue our partnership with Dr. Iwuchukwu and the Ochsner Clinical Foundation in the evaluation of our next-generation Lucid Robotic System,” said Robert Hamilton, Ph.D., co-founder and chief science officer at Neural Analytics. “This milestone represents our continued commitment to providing the clinical community with critical tools to evaluate suspected patients using our robotic, autonomous, and non-invasive patient management platform.”

The 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 company said. It is not intended to replace other means of evaluating vital patient physiological processes. The company said it is actively enrolling patients into this research feasibility study, and intends on activating up to 15 sites, both domestically and globally.

According to the U.S. Centers for Disease Control, neurological diseases cost the U.S. healthcare system nearly $800 billion, with traumatic brain injury, migraine, Alzheimer’s and stroke accounting for more than $438 billion of that cost. In the U.S., someone has a stroke every 40 seconds, and someone dies from a stroke every four minutes. The American Heart Association/American Stroke Association states that detection of large vessel occlusion by means of noninvasive intracranial vascular imaging greatly improves the ability to make appropriate clinical decisions.

Neural Analytics has raised more than $66 million in funding, the most recent a $22 million Series C round in May 2019 led by Alpha Edison.