GlobeNewswire Inc | Jun 8, 2021 07:30AM EDT

June 08, 2021

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 BayerAG, 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 Parkinsons 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 Companys 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.

Parkinsons 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). Parkinsons 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 BlueRocks efforts to explore authentic cell treatments and routes of administration under live-image guidance for patients with advanced Parkinsons 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 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 sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with over 30biologics/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 Companys 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 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, and the Companys 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

Contact:

Jacqueline Keller, Vice President, Marketing1 (888) 287-9109info@clearpointneuro.com

Caroline Corner, Investor Relationsir@clearpointneuro.com