ClearPoint Neuro Expands Software License and Research Agreement with Philips to Power Expansion of the ClearPoint Platform into the Operating Room

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SOLANA BEACH, Calif., April 27, 2022 (GLOBE NEWSWIRE) — ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced expansion of their worldwide license and research agreement with Philips, a global leader in health technology, to include access to technology to enable surgical navigation using Computed Tomography (CT). The design goal of the ClearPoint Maestro™ Brain Model for the Operating Room (OR) is to enable highly accurate procedures with the ClearPoint platform, using CT for live navigation instead of MRI, while maintaining procedural step continuity to facilitate training and adoption.

“A visible part of our strategy at ClearPoint is to offer advanced neurosurgery navigation and delivery tools to surgeons around the world, regardless of the arena in which the procedure is performed,” commented Joe Burnett, President and CEO of ClearPoint Neuro. “Physicians routinely choose the location and technique based on the needs of each individual patient and their disease presentation. There are procedures like drug delivery and laser ablation which are more commonly performed in the MRI because the live MRI images provide important feedback on the success of the procedure. There are other procedures like biopsy, deep brain stimulation (DBS) and brain-computer interface (BCI) implantation which take place primarily in the Operating Room today and use ancillary imaging and navigation tools to get important feedback along the way. By expanding into the OR, we can leverage more than a decade of experience in Neuro MRI navigation and apply those principles to CT and Optical Navigation using the ClearPoint platform, partnerships, and the same clinical specialist support team. This, in-turn, builds centers of excellence and delivers scale.”

The Philips Brain Model, which is integrated into Maestro, emerged over 10 years ago from research aimed at detecting subtle volumetric and shape abnormalities in patients with mild traumatic brain injury. The cover of the Journal of Neurotrauma featured Maestro’s first study. The unique methodology of the brain model combines deformable surfaces with active shape models and machine learning. More importantly, it provides point-based correspondence longitudinally and across patients. Cross-validation on more than 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.

“Extending our licensing relationship with Philips to allow access to ClearPoint technology in the MRI and CT is key to our planned expansion into the Operating Room,” continued Mr. Burnett. “By having a common Maestro software platform that can accommodate fusion with both MRI and CT scans, we will have a common software language in the ClearPoint platform that can deliver meaningful information in the MRI and OR environments. Further, the workflows will be very similar, so every procedure that is done in the OR helps train the physician and surgical team for procedures in the MRI, and vice versa. These results prove that the more familiarity hospitals have with ClearPoint, the more efficient future procedures will be. This enables sites to do multiple procedures in the same day in the same room, therefore increasing capacity to prepare for new DBS, BCI and drug delivery indications in the future.”

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 approximately 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with approximately 40 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 5,000 cases have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. 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 the COVID-19 pandemic and the measures adopted to contain its spread; future revenue from sales of the Company’s ClearPoint Neuro Navigation System products; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System products; and risks inherent in the research and development of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022, which the Company intends to file with the Securities and Exchange Commission on or before May 16, 2022.

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