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ClearPoint Neuro Congratulates Neurona Therapeutics on IND Clearance for Neural Cell Therapy NRTX-1001 in Chronic Focal Epilepsy Patients
SOLANA BEACH, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company
About this update from Clearpoint Neuro Inc.
[{"type":"text","content":"SOLANA BEACH, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today congratulates partner Neurona Therapeutics on clearance by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application to initiate its first-in-human Phase 1/2 clinical trial evaluating the safety and efficacy of NRTX-1001 in patients with drug-resistant mesial temporal lobe epilepsy (MTLE). Epilepsy is one of the most common neurological disorders affecting over three million people in the U.S. and approximately one-third have drug-resistant disease1. In the first stage of this multi-center, Phase 1/2 clinical trial, Neurona plans to enroll up to 10 patients with MTLE to evaluate the safety, tolerability, and efficacy of a single administration of NRTX-1001. In a subsequent study phase, Neurona plans to enroll up to 30 patients with MTLE in a randomized blinded investigation of NRTX-1001, compared to a control group to determine safety and efficacy. “We are very excited to be working with Neurona on potentially the first human cell therapy candidate to enter clinical trials for epilepsy,” stated Jeremy Stigall, Vice President, Biologics and Drug Delivery. “Every day our clinical specialist team supports laser ablation procedures to treat chronic focal epilepsy. The potential of an expanded treatment option will provide additional hope for millions of patients worldwide.” About ClearPoint Neuro ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with over 35 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 4,500 cases have been performed and s...