Neural Analytics said yesterday that it has enrolled the first subjects in a study of its Lucid robotic system for the management of patients suspected of suffering a stroke.
The Codex study is a prospective, single-arm, multi-center, safety and technical feasibility study under an FDA investigational device exemption for the Lucid system. Dr. Ifeanyi Iwuchukwu will be the first to clinically evaluate the new version of the system at the Ochsner Clinical Foundation in New Orleans.
Neural Analytics is actively enrolling patients in the feasibility study. The company intends to activate up to 15 sites, both in the U.S. and around the world.
The Lucid system is a medical ultrasound device designed for adjunct use in measuring and displaying CVBF and the occurrence of transient emboli within the brain. Neural Analytics said the device is not meant to replace other means of evaluating physiological processes.
Lucid won CE Mark approval in January 2017 and added FDA clearance in 2018. Neural Analytics also raised approximately $22 million in a Series C round of financing to support the device in May.
“We are honored to be the first in the world to evaluate the performance of Neural Analytics’ next-generation robotic technology,” Iwuchukwu said in a news release. “So far, we have been impressed with 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.”
“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,” added Neural Analytics co-founder & chief science officer Robert Hamilton. “This milestone represents our continued commitment to providing the clinical community with critical tools to evaluate suspected stroke patients using our robotic, autonomous and non-invasive patient management platform.”
