ClearPoint Neuro, Inc. Congratulates Voyager Therapeutics on FDA Clearance of IND Application for Gene Therapy Candidate VY-HTT01 for Treatment of…

SOLANA BEACH, Calif., April 28, 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 Voyager Therapeutics on receiving FDA clearance of the IND application for their gene therapy candidate VY-HTT01 for the treatment of Huntingtons disease.

Huntingtons disease is a rare inherited neurodegenerative disorder impacting approximately 30,0001 people in the United States alone, with symptom onset commonly appearing between 30 and 50 years of age. Voyagers anticipated VYTAL Phase 1/2 clinical trial is a dose escalation study to evaluate the safety and tolerability of VY-HTT01 in patients with early manifest Huntingtons disease. The investigational gene therapy has been designed to be delivered throughout the brain via a one-time MRI-guided neurosurgical delivery.

The ClearPoint team is thrilled to continue supporting Voyagers clinical program development with products and clinical services for this important planned Phase 1/2 trial, stated Jeremy Stigall, Vice President, Biologics and Drug Delivery. We look forward to playing our part in providing hope to the Huntingtons disease community through our continued innovation and customer centric approach including patients, physicians and our biologics and drug delivery partners.

About ClearPoint Neuro

ClearPoint Neuros 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 Companys 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 clinical sites in the United States, Canada, and Europe. The Companys SmartFlow cannula is being used in partnership or evaluation with over 25 individual biologics and drug delivery companies in various stages from preclinical research, to late-stage regulatory trials. To date, more than 4,000 cases have been performed and supported by the Companys field-based clinical specialist team, which offers support and services for our partners. For more information, please visit http://www.clearpointneuro.com.

Forward-Looking Statements

Statements herein concerning the Companys plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of COVID-19 and the measures adopted to contain its spread; future revenues from sales of the Companys ClearPoint Neuro Navigation System products; and the Companys ability to market, commercialize and achieve broader market acceptance for the Companys ClearPoint Neuro Navigation System products. More detailed information on these and additional factors that could affect the Companys actual results are described in the Risk Factors section in the Companys Annual Report on Form 10-K for the year ended December 31, 2020, which has been filed with the Securities and Exchange Commission, and in the Companys Quarterly Report on Form 10-Q for the three months ended March 31, 2021, which the Company intends to file with the Securities and Exchange Commission on or before May 17, 2021.

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1https://ir.voyagertherapeutics.com/news-releases/news-release-details/voyager-therapeutics-receives-fda-clearance-ind-application-gene

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ClearPoint Neuro, Inc. Congratulates Voyager Therapeutics on FDA Clearance of IND Application for Gene Therapy Candidate VY-HTT01 for Treatment of...