ClearPoint Neuro Congratulates Neurona Therapeutics on Authorization of IND for NRTX-1001 Neural Cell Therapy in Patients with Chronic Focal Epilepsy



SOLANA BEACH, Calif., November 08, 2021 (GLOBE NEWSWIRE) – ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy platform company providing navigation and delivery to the brain, today hui congratulates its partner Neurona Therapeutics on the approval by the United States Food and Drug Administration (FDA) of its new investigational drug (IND) application to launch its first phase 1/2 clinical trial in humans 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 more than three million people in the United States, and about one-third have drug-resistant disease.1. In the first phase of this multicentre phase 1/2 clinical trial, Neurona plans to enroll up to 10 patients with MTLE to assess 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 study of NRTX-1001, compared to a control group to determine safety and efficacy.

“We are very pleased to be working with Neurona on potentially the first human cell therapy candidate to enter clinical trials for epilepsy,” said Jeremy Stigall, vice president, Biologics and Drug Delivery. “Every day, our team of clinical specialists support laser ablation procedures to treat chronic focal epilepsy. The potential for an expanded treatment option will bring additional hope to millions of patients around the world. “

About ClearPoint Neuro

ClearPoint Neuro’s mission is to improve and restore the quality of life for patients and their families by enabling therapies for the most complex neurological disorders with pinpoint precision. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neurosuction, 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 at over 60 active sites in the United States, Canada and Europe. ClearPoint Neuro partners with more than 35 biologic / pharmaceutical companies and academic centers, providing solutions for the direct delivery of therapeutics to the CNS in preclinical studies and clinical trials around the world. To date, more than 4,500 cases have been completed and supported by the company’s team of clinical specialists in the field, which provides support and services to our customers and partners around the world. For more information, please visit www.clearpointneuro.com.

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1 https://www.neuronatherapeutics.com/wp-content/uploads/2021/11/2021_11_01_-INDClearance_FINALVersion.pdf

Forward-looking statements

Statements contained herein concerning the plans, growth and strategies of the Company may include forward-looking statements in the context of federal securities laws. Statements regarding future events, future developments and performance of the Company, as well as management’s expectations, beliefs, plans, estimates or projections regarding the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the actual results of the Company to differ materially from those expressed or implied by forward-looking statements. Uncertainties and particular risks include those related to: the impact of the COVID-19 pandemic and the measures adopted to contain its spread; future revenues from sales of the Company’s ClearPoint Neuro Navigation System products; the Company’s ability to market, market and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System products; and the risks inherent in the research and development of new products. More detailed information on these and other factors that may affect the actual results of the Company is described in the “Risk Factors” section of the Company’s annual report on Form 10-K for the year ended 31 December 2020, and in the Company’s quarterly report on form. 10-Q for the quarter ended June 30, 2021, both filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, which the Company has intends to file with the Securities and Exchange Commission no later than November 15, 2021.

CONTACT: Contact: Jacqueline Keller, Vice President, Marketing (949) 900-6833 [email protected] Caroline Corner, Investor Relations [email protected]


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