Business
ClearPoint Neuro, Together with its Partner Clinical Laserthermia Systems, Announces FDA Submission to Expand the Labeling of ClearPoint Prism(R) to Include 1.5 T MRI
SOLANA BEACH, CA / ACCESS Newswire / April 28, 2025 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling
About this update from Clearpoint Neuro Inc.
[{"type":"text","content":"SOLANA BEACH, CA / ACCESS Newswire / April 28, 2025 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the \"Company\"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, announces that today its partner, Clinical Laserthermia Systems AB (publ) (CLS), completed the submission of its 510(k) application to the FDA, expanding the indication of the ClearPoint Prism Neuro Laser Therapy System to include 1.5 T MRI guidance.ClearPoint Prism has already seen rapid adoption across functional and oncological neurosurgical LITT procedures. \"We anticipate that we will achieve clearance for 1.5 T in the second half of this year, unlocking more than 50% of the neuro LITT market in the United States that we do not have access to today,\" commented Joe Burnett, President and CEO.\"This submission is a result of great collaboration between our companies. At CLS, we're proud to support ClearPoint Neuro in expanding access to the neuro LITT Market and driving global adoption of ClearPoint Prism,\" said Dan J. Mogren, CEO of CLS.ClearPoint Prism is currently indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 3.0 T magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery for a wavelength of 1064nm.About ClearPoint NeuroClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct central nervous system delivery of therapeutics in preclinical studies and clinical trials worldwide. To date, thousands of procedures 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.clearp...