ClearPoint Neuro Inc. (CLPT) Announces FDA Clearance for ClearPoint Maestro Brain Model


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ClearPoint Neuro, Inc. (Nasdaq: CLPT) today announced that it has received 510(k) clearance for its ClearPoint Maestro™ brain model. Maestro is intended for the automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images. This software is intended to automate the process of identifying, labeling and quantifying the volume and shape of brain structures visible on MRI images.

This first-generation anatomical segment analysis tool was born over 10 years ago from research aimed at detecting subtle volumetric and shape abnormalities in patients with mild traumatic brain injury. This first publication was presented on the cover of the Journal of Neurotrauma. Maestro Brain Model’s unique methodology combines deformable surfaces with active shape models and machine learning. More importantly, it provides one-time correspondence longitudinally and between patients. Cross-validation on over 1,000 scans demonstrates highly reproducible results with sub-millimeter accuracy and normative values ​​from 560 healthy subjects provide reference ranges for patient-specific assessments.

“This is an important milestone for ClearPoint and our collaboration with Philips, as we are excited to introduce this new business tool to our portfolio,” commented Joe Burnett, President and CEO of ClearPoint Neuro. “This is a critical first step in our journey to make the Maestro Brain Model the ‘engine’ of our navigation system supporting multiple new applications in the future. Now that the standalone patient analysis tool is validated, our development team will work to integrate this software directly into the ClearPoint navigation platform and add new features based on business priorities. We are very proud of the ClearPoint and Philips co-development team who delivered another innovative product and further demonstrated our focus and commitment to being an innovative leader in neurosurgery.

“Having spent more than 10 years developing Maestro software at Philips and now here at ClearPoint, I know firsthand the capability and potential of this software within the ClearPoint platform,” commented Lyubomir Zagorchev, Vice President of Clinical and Applications Sciences at ClearPoint Neuro. “The current version will enable reproducible analysis of patient data, which will bring immediate value to our current and future biologics and drug delivery partners as they study volumetric infusion characteristics and longitudinal comparisons of patients.” as part of their pivotal and safety trials. However, the focus of our future applications, when integrated with ClearPoint Navigation software, will enable more advanced patient-specific target identification and path planning in all ClearPoint applications. Our plan is to quantify drug delivery using intraoperative imaging and simulate patient-specific infusions into targeted brain regions. The unique shape representation in Maestro will provide reproducible lead placement for deep brain stimulation and microelectrode recording. Surface meshes of segmented anatomical regions will define safe zones and optimal trajectories for patient-specific laser ablations. This is really just the beginning of what is possible and we are excited to execute the limited release of this product through the end of 2022.”

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, neuroaspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint® Neuro Navigation System is FDA cleared, CE marked, and installed at more than 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro partners with approximately 45 pharmaceutical and biotechnology companies, academic institutions, and contract research organizations that provide solutions for the direct delivery of therapeutics to the CNS in preclinical studies and trials. clinics around the world. To date, more than 5,000 cases have been treated and supported by the company’s team of field clinical specialists, who provide support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.

Forward-looking statements

Statements in this press release and the aforementioned conference call regarding the Company’s plans, growth and strategies may include forward-looking statements within the context of federal securities laws. Statements regarding future events, developments and future 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 such laws. Uncertainties and risks may cause the Company’s actual results to differ materially from those expressed or implied by the forward-looking statements. Particular risks and uncertainties 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; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in the delivery of therapies; and the risks inherent in the research and development of new products. More detailed information about these and other factors that could affect the Company’s actual results is described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021. , and in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022, both of which have been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2022, which the company intends to file with the Securities and Exchange Commission on or before August 15, 2022.

Contact:

Jacqueline Keller, VP of Marketing
(949) 900-6833
[email protected]

Caroline Corner, Investor Relations
[email protected]

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Source: ClearPoint Neuro, Inc.

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