(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 t ...

Company Overview - ClearPoint Neuro Inc. operates in two segments: providing medical devices for neurosurgical applications and focusing on partnerships in the biologics and drug delivery space [2] - The primary product is the ClearPoint system, which targets the insertion of deep brain stimulation electrodes, biopsy needles, and laser catheters, as well as the infusion of pharmaceuticals into the brain [2] Recent Developments - The ClearPoint Prism Neuro Laser Therapy System received FDA clearance to include 1.5T MRI guidance, expanding its market opportunity in the U.S., where 1.5T MRI systems account for approximately 60% of clinical use [3] - The company began commercialization of the ClearPoint Prism Neuro Laser Therapy System in 2022 [2] Financial Performance - For the full year 2024, revenue was reported at $31.4 million, reflecting a 31% increase over 2023 [4] - The company expects revenue for 2025 to range between $36.0 million and $41.0 million, which would mark the 11th consecutive year of annual revenue growth if achieved [4][5] Stock Performance - ClearPoint Neuro's stock has seen significant movement, trading around $5.50 in May 2024 and reaching a high of $19.22 on February 6, 2025, before pulling back [5] - As of the latest trading, the stock is up nearly 40% at $17.01 in premarket trading [1][5]

Company Overview - ClearPoint Neuro enables cell, gene, and device therapies by offering precise navigation to the brain and spine[6] - The company's platform includes clinical products for neurosurgeons and drug development services for BioPharma partners[6] - ClearPoint Neuro has built a complete drug delivery ecosystem over 15+ years, including navigation solutions, predictive modeling, delivery devices, infusion monitoring software, and clinical case support[8] - The company has 100+ active global centers and 60+ partners across 20+ indications[8] Market Opportunity - The company estimates a current portfolio provides access to a ≈$500 million market opportunity[8] - ClearPoint Neuro sees a $10 billion potential diversified market[9, 117] - Neurological diseases cost Americans nearly $800 billion annually[10] Financial Performance and Growth - The company's 2024 revenue was $31.4 million[51] - The company had $12.4 million in cash and cash equivalents as of March 31, 2025, excluding $33.5 million gross proceeds received on May 12, 2025[51, 52] - The gross margin was 61% for the trailing twelve months[51] - The company estimates 2025 revenue between $36 million and $41 million[52]