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

Rhea-AI Summary

ClearPoint Neuro (CLPT) announced its support for Voyager Therapeutics' FDA clearance of the IND application for the gene therapy candidate VY-HTT01, aimed at treating Huntington’s disease, affecting around 30,000 people in the U.S. This gene therapy will undergo a Phase 1/2 clinical trial to assess its safety and tolerability. ClearPoint's navigation and delivery systems play a crucial role in this trial. The company remains committed to innovating and providing clinical services that support complex neurological treatments.

Positive

• ClearPoint's support for Voyager Therapeutics may enhance its reputation in the neurological treatment market.
• FDA clearance for VY-HTT01 could lead to future collaborations in gene therapy.

Negative

• Dependence on third-party developments, such as Voyager's trial outcomes, poses market risks.
• Uncertainties in future revenues due to reliance on the success of external clinical trials.

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 Huntington’s disease.

Huntington’s 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. Voyager’s 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 Huntington’s 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 Voyager’s 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 Huntington’s disease community through our continued innovation and customer centric approach including patients, physicians and our biologics and drug delivery partners.”

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 clinical sites in the United States, Canada, and Europe. The Company’s 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 Company’s field-based clinical specialist team, which offers support and services for our partners. For more information, please visit www.clearpointneuro.com.

Forward-Looking Statements

Statements herein concerning the Company’s 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 Company’s ClearPoint Neuro Navigation System products; and the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section in the Company’s 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 Company’s 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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¹ https://ir.voyagertherapeutics.com/news-releases/news-release-details/voyager-therapeutics-receives-fda-clearance-ind-application-gene

FAQ

What is the significance of the FDA clearance for CLPT related to VY-HTT01?

The FDA clearance allows Voyager Therapeutics to proceed with clinical trials for their gene therapy VY-HTT01, in which ClearPoint Neuro plays a support role.

How does ClearPoint Neuro contribute to the VY-HTT01 clinical trial?

ClearPoint provides navigation and delivery technology essential for the safe administration of the gene therapy during the trial.

What impact does VY-HTT01 have on ClearPoint Neuro's business prospects?

Success in the VY-HTT01 trial could enhance ClearPoint's market position and create new partnership opportunities in gene therapy.

What are the main challenges ClearPoint Neuro faces with its collaborations?

ClearPoint's challenges include reliance on the outcomes of Voyager's trials, which may affect future revenue and market acceptance.

What is the potential market size for Huntington's disease treatments?

Approximately 30,000 individuals in the U.S. are impacted by Huntington’s disease, representing a significant potential market for new treatments like VY-HTT01.