ClearPoint Neuro

CLPT

Market cap $719M

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 7, 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, today announced results from a Phase I-II clinical study at Skåne University Hospital in Lund, Sweden evaluating the ClearPoint Prism Neuro Laser Therapy System's safety, feasibility, and efficacy. The study cohort comprised fourteen patients ages 18-80years with primary and recurrent glioblastoma and grade 4 astrocytoma, tumors which are among the most challenging to treat.

The clearly established history across global regulatory bodies is expected to de-risk BioPharma partners' pathways towards achieving global scale and standardization. SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 6, 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, today announced several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan.

ClearPoint's new Robotic Neuro-Navigation System merges proven software with KUKA robotics to boost precision in cell and gene therapy delivery.

ClearPoint's stock surged after uniQure announced strong Huntington's data, highlighting the value of its drug delivery platform. CLPT's technology has been validated by the AMT-130 data, positioning the company for improved deal economics in future partnerships. Beyond Huntington's, CLPT's pipeline includes promising programs in Parkinson's and epilepsy.

New Product Category Will Enable Added Flexibility to Support Commercial Launches of Cell and Gene Therapy SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 1, 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, today formally announced the development and demonstration of the Company's proprietary Robotic Neuro-Navigation System. This new product category will enable the ClearPoint Neuro Navigation software to operate the KUKA LBR Med Robotic Arm to support all minimally invasive cranial surgical procedures including cell and gene therapy infusions, laser catheter placement, biopsy workflows and deep brain stimulation and stereotactic EEG lead placements.

ClearPoint Neuro surged over 100% following positive Huntington's Disease data from partner uniQure, highlighting its drug delivery device's role in AMT-130 trials. CLPT's SmartFlow cannula is already FDA-labeled with Kebilidi, and AMT-130's larger market could make it a meaningful revenue driver if approved. Financially, CLPT expects margin expansion and cash flow breakeven by 2027, with a solid cash runway and manageable debt structure supporting growth.

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / September 25, 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, today announced that Dr. Paul Larson will be joining the company as Chief Medical Officer starting in January 2026. Dr. Larson has a long history of working with ClearPoint Neuro as an advisor, especially supporting education and product development efforts related to cell and gene therapy delivery.

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / September 4, 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, today announced that the ClearPoint Prism® Neuro Laser Therapy System ("ClearPoint Prism") received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include 1.5T MRI guidance in addition to the previously cleared 3T MRI guidance. This expanded labeling could significantly increase ClearPoint Prism's market opportunity within the United States, where 1.5T MRI systems account for approximately 60% of clinical use.1 As the Company considers future development within key markets, 1.5T systems represent over 70% of the global installed MRI base,2 well-positioning ClearPoint Prism for future growth as the company continues to expand internationally.

ClearPoint Neuro's Q2 results were solid; although real upside is likely to be more apparent from 2026 onward. Key catalysts include the launch of GLP services and partner program commercialization, particularly uniQure's Huntington's therapy. Positive partner data and strong system placements could drive ClearPoint's stock higher in 2025.

ClearPoint Neuro, Inc. (NASDAQ:CLPT ) Q2 2025 Earnings Conference Call August 12, 2025 4:30 PM ET Company Participants Joseph Michael Burnett - President, CEO & Director Danilo D'Alessandro - Chief Financial Officer Conference Call Participants Frank James Takkinen - Lake Street Capital Markets, LLC, Research Division Anderson Schock - B. Riley Securities, Inc., Research Division Operator Greetings, and welcome to the ClearPoint Neuro, Inc.'s Second Quarter 2025 Financial Results Conference Call.