ClearPoint Neuro Announces FDA Clearance for ClearPoint

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SOLANA BEACH, Calif., Sept. 22, 2022 (GLOBE NEWSWIRE) — ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a world therapy-enabling platform firm offering navigation and supply to the mind, right this moment introduced its Swedish companion, Clinical Laserthermia Systems (CLS), has obtained 510(ok) clearance for its laser which the Company plans to commercialize because the ClearPoint Prism™ Neuro Laser Therapy System.

ClearPoint Prism™ Neuro Laser Therapy System

The ClearPoint Prism Neuro Laser Therapy System is indicated for use to necrotize or coagulate tender tissue by way of interstitial irradiation or thermal remedy below 3.0T magnetic resonance imaging (MRI) steerage. Full indications for use could be discovered right here: https://www.clearpointneuro.com/terms-of-service/label-indications/

ClearPoint Neuro has unique world rights to commercialize the CLS magnetic resonance (MR) guided laser interstitial thermal remedy (MRgLITT) system for neuro functions. The system includes a medical answer combining the ClearPoint navigation platform, the laser know-how from CLS, and a thermal ablation monitoring software program known as Thermoguide from France-based medical machine firm Image Guided Therapy SA (IGT).

“It’s wonderful to see new innovation in the space of laser interstitial thermal therapy. Laser ablation is an important and growing part of our surgical armamentarium and offers minimally invasive and powerful treatments for a variety of neurological diseases,” acknowledged John Rolston, MD, PhD, Director of the Mapping & Engineering Neural Dynamics (MEND) Laboratory at Brigham & Women’s Hospital and Harvard Medical School. “The new laser system offered by ClearPoint has several exciting technical innovations that are expected to make this therapy simpler and more accessible to surgeons and their patients.”

“Over the past decade, the ClearPoint Neuro Navigation System has offered an efficient one-room solution to assist neurosurgeons in the United States and Europe to accurately place laser fibers and help treat brain tumors, radiation necrosis and epileptic foci in thousands of patients,” commented Joe Burnett, President and CEO of ClearPoint Neuro. “We look forward to leading the expansion of laser therapy treatment options for patients and neurosurgeons in the United States and beyond in the coming years. This is another example of the innovation that ClearPoint is delivering to the neurosurgery and spine community through our team and our expert partners.”

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The ClearPoint Prism Neuro Laser Therapy System is presently in restricted market launch at choose tutorial medical facilities throughout the United States.

About ClearPoint Neuro

ClearPoint Neuro’s mission is to enhance and restore high quality of life to sufferers and their households by enabling therapies for probably the most advanced neurological issues with pinpoint accuracy. Applications of the Company’s present product portfolio embrace deep mind stimulation, laser ablation, biopsy, neuro-aspiration, and supply of medication, biologics, and gene remedy to the mind. The ClearPoint® Neuro Navigation System has FDA clearance, is CE-marked, and is put in in over 60 energetic websites within the United States, Canada, and Europe. ClearPoint Neuro is partnered with greater than 45 pharmaceutical and biotech corporations, tutorial establishments, and contract analysis organizations offering options for direct CNS supply of therapeutics in pre-clinical research and medical trials worldwide. To date, greater than 5,000 circumstances have been carried out and supported by the Company’s field-based medical specialist workforce, which affords help and companies to our clients and companions worldwide. For extra info, please go to www.clearpointneuro.com.

Forward-Looking Statements

Statements on this press launch in regards to the Company’s plans, progress and methods might embrace forward-looking statements throughout the context of the federal securities legal guidelines. Statements relating to the Company’s future occasions, developments and future efficiency, in addition to administration’s expectations, beliefs, plans, estimates or projections referring to the longer term, are forward-looking statements throughout the that means of those legal guidelines. Uncertainties and dangers might trigger the Company’s precise outcomes to vary materially from these expressed in or implied by forward-looking statements. Particular uncertainties and dangers embrace these referring to: the influence of the COVID-19 pandemic and world instability, provide chain disruptions, labor shortages, and inflationary circumstances; future income from gross sales of the Company’s ClearPoint Neuro Navigation System and different new merchandise provided by the Company; the Company’s capability to market, commercialize and obtain broader market acceptance for the Company’s ClearPoint Neuro Navigation System and different new merchandise provided by the Company; the power of our biologics and drug supply companions to realize industrial success, together with their use of our services and products of their supply of therapies; and dangers inherent within the analysis and improvement of latest merchandise. More detailed info on these and extra components that would have an effect on the Company’s precise outcomes are described within the “Risk Factors” part of the Company’s Annual Report on Form 10-Okay for the yr ended December 31, 2021, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2022, each of which have been filed with the Securities and Exchange Commission.

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Contact:

Jacqueline Keller, Vice President, Marketing
1 (888) 287-9109
data@clearpointneuro.com

Caroline Corner, Investor Relations
ir@clearpointneuro.com

A photograph accompanying this announcement is obtainable at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/66f919ac-c17e-402e-a88e-1211e8044e7c
The photograph can also be obtainable by way of AP PhotoExpress.



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