ClearPoint Neuro, Inc. Congratulates BlueRock Therapeutics on First Patient Dosed with DA01 in Phase 1 Study in Patients with Advanced Parkinson’s Disease

Rhea-AI Summary

ClearPoint Neuro has achieved a significant milestone by treating the first patient using its platform in a Phase 1 clinical trial for advanced Parkinson's disease. Conducted by BlueRock Therapeutics, this trial investigates the safety and efficacy of pluripotent stem cell-derived dopaminergic neurons. The surgery was performed at Memorial Sloan Kettering Cancer Center, utilizing the ClearPoint Neuro Navigation System. This trial aims to enroll ten patients across sites in the U.S. and Canada, highlighting ClearPoint's role in advancing treatments for complex neurological conditions.

Positive

• First patient treated in a Phase 1 trial using ClearPoint technology.
• Collaboration with BlueRock Therapeutics on advanced Parkinson's disease treatment.
• ClearPoint's navigation system used successfully in a live MRI-guided procedure.

Negative

• None.

First Ever Stem Cell Clinical Trial Patient Treated Using Entire ClearPoint Platform

SOLANA BEACH, Calif., June 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 BlueRock Therapeutics, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer AG, on the dose administration for the first patient in a Phase 1, open-label study of pluripotent stem cell-derived dopaminergic neurons in patients with advanced Parkinson’s disease (PD). The clinical trial, designed to evaluate the safety, tolerability, and preliminary efficacy of DA01 in patients with PD, is expected to enroll ten patients at sites in the United States and Canada.

The surgery, which represents the first ever delivery of stem cell-derived dopaminergic neurons using the ClearPoint platform, was performed by Dr. Viviane Tabar, Chair of the Department of Neurosurgery and Theresa Feng Chair in Neurosurgical Oncology at Memorial Sloan Kettering Cancer Center. Dr. Tabar utilized the ClearPoint Neuro Navigation System with two SmartFrames, and six SmartFlow cannulae to surgically transplant dopamine-producing cells into the putamen under live-MRI guidance. The Company’s clinical specialist team provided support during the dose administration and assisted the study team to execute the MRI workflow which ClearPoint helped design for the clinical trial protocol.

Parkinson’s disease is a progressive neurodegenerative disorder caused by nerve cell damage in the brain, leading to decreased dopamine levels. The worsening of motor and non-motor symptoms is caused by the loss of dopamine-producing neurons. At diagnosis, it is estimated that patients have already lost 60-80% of their dopaminergic neurons. Parkinson's disease often starts with a tremor in one hand. Other symptoms are rigidity, cramping and slowness of movement (bradykinesia). Parkinson’s disease is the second most common neurodegenerative disorder, impacting more than 7.5 million people globally, including 1.3 million people in North America.¹ It is estimated that approximately 60,000 Americans are diagnosed with PD each year.²

“ClearPoint is proud to contribute to BlueRock’s efforts to explore authentic cell treatments and routes of administration under live-image guidance for patients with advanced Parkinson’s disease, and beyond,” stated Jeremy Stigall, Vice President, Biologics and Drug Delivery. “We look forward to supporting additional trial patients and activated sites.”

More information about this trial is available at clinicaltrials.gov (NCT#04802733).

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 30 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 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, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2021, both of which have been filed with the Securities and Exchange Commission.

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¹ https://bluerocktx.com/pipeline/
² https://www.parkinson.org/Understanding-Parkinsons/Statistics#:~:text=Approximately%2060%2C000%20Americans%20are%20diagnosed,worldwide%20are%20living%20with%20PD.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d375ef5e-925f-4976-8bb2-63f3e90871a3

FAQ

What is the purpose of the Phase 1 clinical trial involving CLPT?

The trial aims to evaluate the safety, tolerability, and preliminary efficacy of pluripotent stem cell-derived dopaminergic neurons in patients with advanced Parkinson's disease.

Who performed the first patient treatment using the ClearPoint platform?

The treatment was performed by Dr. Viviane Tabar at Memorial Sloan Kettering Cancer Center.

How many patients will be enrolled in the CLPT trial?

The trial is expected to enroll a total of ten patients at sites in the U.S. and Canada.

What technology did ClearPoint utilize during the trial?

ClearPoint used its navigation system with SmartFrames and SmartFlow cannulae for the surgery.

What are the expected outcomes of the trial for CLPT?

The trial seeks to establish safety and preliminary efficacy for a new treatment approach to Parkinson's disease.