October 31, 2019
First Patient Enrolled in CODEX Safety and Feasibility Study of Neural Analytics' Next-Generation Lucid Robotic System
October 31, 2019—Neural Analytics, Inc., a medical robotics company developing and commercializing technologies to measure and track brain health, announced that the first patients were enrolled in the CODEX study of the company’s next-generation Lucid robotic system platform.
Enrollment was initiated at the Ochsner Clinic in New Orleans, Louisiana, under the leadership of Ifeanyi Iwuchukwu, MD, Assistant Professor of Neurocritical Care and Stroke. Neural Analytics is actively enrolling patients into this feasibility study at up to 15 sites, both domestically and globally.
According to the company, the Lucid robotic system is a medical ultrasound device intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocities (CBFVs) and the occurrence of transient emboli within the brain. The device is not intended to replace other means of evaluating vital patient physiological processes.
The prospective, single-arm, multicenter study of the safety and technical feasibility of the investigational device exemption (IDE) version of the Lucid robotic system (Lucid M1 transcranial Doppler ultrasound system and NeuralBot system) is being evaluated at the Ochsner Clinic under an institutional review board approval.
The new IDE version of the technology is intended to improve performance and ease of use for the company’s robotic platform to further assist physicians in managing patients with suspected stroke. The FDA cleared the first generation of the Lucid robotic system in 2018.
As the first to clinically evaluate the new investigational version of the Lucid robotic system, Dr. Iwuchukwu and the Ochsner Clinic have been using the device within the CODEX study to explore the technical feasibility of the novel technology in a wide range of patients and neurological pathologies where the monitoring of CBFV would be of benefit to stroke clinicians.
Dr. Iwuchukwu commented in the company’s announcement, “We are honored to be the first in the world to evaluate the performance of Neural Analytics’ next-generation robotic technology. So far, we have been impressed with the improved simplicity, and ease of use of the new Lucid robotic system.” He added, “Over the past 9 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.”