Welcome to our dedicated page for Clearpoint Neuro news (Ticker: CLPT), a resource for investors and traders seeking the latest updates and insights on Clearpoint Neuro stock.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) is a medical device company focused on device, cell, and gene therapy-enabling technologies for precise navigation to the brain and spine. This news page aggregates company-issued updates and market-moving announcements related to ClearPoint Neuro’s neurosurgical navigation systems, laser therapy platforms, intracranial fluid management technologies, and central nervous system drug delivery services.
Readers can follow earnings and financial updates, such as preliminary unaudited revenue results and quarterly reports furnished via Form 8-K, which outline trends in biologics and drug delivery revenue, neurosurgery navigation and therapy revenue, and capital equipment and software sales. News items also cover strategic transactions, including the completed acquisition of IRRAS Holdings, Inc., which adds the IRRAflow active fluid-exchange system and expands ClearPoint Neuro’s presence in neurocritical care and intracranial bleeding management.
ClearPoint Neuro’s news flow frequently highlights regulatory milestones like FDA 510(k) clearances, including expanded MRI compatibility for the ClearPoint Prism Neuro Laser Therapy System, and international regulatory approvals that extend product use to additional countries. The company also reports on clinical and scientific developments, such as Phase I–II study results in glioblastoma and grade 4 astrocytoma using ClearPoint Prism, as well as the development and demonstration of its proprietary Robotic Neuro-Navigation System.
Investors and observers can also track partnership and conference activity, including updates on more than 60 active biopharma partners, participation in global healthcare conferences, and progress at ClearPoint Advanced Laboratories. Bookmark this page to review historical and ongoing CLPT news related to neurosurgical devices, therapy delivery platforms, and the company’s role in enabling cell and gene therapy programs.
ClearPoint Neuro (NASDAQ:CLPT) has received FDA 510(k) clearance for its ClearPoint Prism Neuro Laser Therapy System to include 1.5T MRI guidance, expanding from the previously cleared 3T MRI guidance. This expansion is significant as 1.5T MRI systems represent approximately 60% of clinical use in the US and over 70% of the global installed MRI base.
The company's Functional Neurosurgery disposable products, including ClearPoint Prism laser applicators, demonstrated strong growth with 70% increase in Q1 and 33% in Q2 2025. The expanded compatibility positions ClearPoint Prism for immediate full market release on 1.5T systems, potentially accelerating the company's growth initiatives.
ClearPoint Neuro (Nasdaq:CLPT) reported strong Q2 2025 results with record quarterly revenue of $9.2 million, representing a 17% year-over-year increase. The company secured significant financing through a $105 million note arrangement with Oberland Capital Management, with $30 million funded at closing, plus an additional $3.5 million stock purchase agreement.
Key performance metrics include 33% growth in neurosurgery navigation and therapy revenue to $3.4 million, driven by SmartFrame and PRISM Laser Therapy products. The company maintained a 60% gross margin and ended the quarter with $41.5 million in cash. ClearPoint reaffirmed its full-year 2025 revenue guidance of $36-41 million.
Operating expenses increased 16% to $11.2 million, resulting in a net loss of $5.8 million or $0.21 per share, compared to a loss of $4.4 million in Q2 2024.
ClearPoint Neuro (NASDAQ:CLPT) has achieved significant milestones in its Biologics and Drug Delivery Portfolio. The company announced the first commercial gene therapy treatments in the US using their SmartFlow® Neuro Cannula for KEBILIDI™, a therapy for AADC deficiency. These groundbreaking procedures were performed at hospitals in Texas and Boston.
Key achievements include: 17 global patients treated across 11 drug platforms in July, two additional partners accepted for FDA expedited review (bringing total to nine), and new ICD-10 codes creation for neuro infusion procedures effective October 1, 2025. The company currently supports over 60 active biopharma partners in clinical trials and preclinical studies.
ClearPoint Neuro (NASDAQ:CLPT), a global device, cell, and gene therapy-enabling company focused on brain and spine navigation, has scheduled its 2025 second quarter financial results announcement for August 12, 2025, after market close.
The company will host a conference call at 4:30 p.m. Eastern time on the same day to discuss the results. Investors can join via webcast or telephone, with replay access available until September 11, 2025.
- Biologics and drug delivery revenue increased 9% to $4.7 million
- Neurosurgery navigation and therapy revenue grew 70% to $3.3 million
- Capital equipment revenue decreased 63% to $0.5 million
- Gross margin improved to 60% from 59% year-over-year
ClearPoint Neuro (NASDAQ:CLPT) has secured a significant financing arrangement with Oberland Capital, totaling up to $110 million. The deal includes a note financing of up to $105 million, with $30 million funded at closing and additional tranches available until December 31, 2026. Additionally, Oberland Capital purchased 275,808 shares at $12.69 per share in a registered direct offering, providing $3.5 million in gross proceeds.
The company, which specializes in precise navigation technology for brain and spine procedures, plans to use the funds for general corporate purposes, including capital expenditures and working capital. The financing will support ClearPoint's expansion efforts to meet the growing demands of its 60+ pharmaceutical partners in cell and gene therapy delivery partnerships.
ClearPoint Neuro (NASDAQ:CLPT) and its partner Clinical Laserthermia Systems (CLS) have submitted a 510(k) application to the FDA to expand the labeling of ClearPoint Prism Neuro Laser Therapy System to include 1.5 T MRI guidance. The system, which has shown rapid adoption in functional and oncological neurosurgical LITT procedures, is currently only approved for use under 3.0 T MRI guidance.
The company expects to receive clearance in the second half of 2025, which would unlock access to over 50% of the neuro LITT market in the United States that is currently inaccessible. The ClearPoint Prism system is indicated for necrotizing or coagulating soft tissue through interstitial irradiation or thermal therapy under MRI guidance in neurosurgery at a wavelength of 1064nm.
ClearPoint Neuro (NASDAQ:CLPT), a global device, cell, and gene therapy-enabling company specializing in brain and spine navigation, has scheduled its 2025 first quarter financial results announcement for May 13, 2025, after market close.
The company will host a live conference call at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) for investors and analysts to review the quarterly results. Participants can join via telephone at (877) 407-9034 for domestic calls or (201) 493-6737 for international calls.
A replay will be available until June 12, 2025, accessible by calling (877) 660-6853 (domestic) or (201) 612-7415 (international) with conference ID 413671. An online archive will also be available on the company's investor website.
ClearPoint Neuro (NASDAQ:CLPT) has announced the full market release of ClearPoint Navigation Software Version 3.0, introducing an iCT image-guidance workflow option for traditional operating rooms. The new version builds on their decade of MRI-guided procedure experience, offering the same precision with enhanced accessibility and efficiency.
The software is compatible with standard iCT scanners in any operating room, with early adoption reported during market release. The platform will be showcased at the American Academy of Neurological Surgeons Annual Meeting in Boston (April 25-28, 2025).
Dr. Ellen Air from Henry Ford Health confirms the software achieves equivalent placement accuracy as MRI-guidance without requiring MRI infrastructure. The system supports various procedures including biopsies, catheter and electrode insertion, and deep brain stimulation lead placement.
ClearPoint Neuro (NASDAQ:CLPT) reported strong financial results for Q4 and full-year 2024, achieving record revenue of $31.4 million, representing 31% year-over-year growth. The company's Q4 revenue reached $7.8 million, up 14% from Q4 2023.
Key highlights include:
- Product revenue growth of 76% to $18.6 million
- Activation of 25 new global centers in 2024
- Reduced operational cash burn by 35% to $9.0 million
- Full repayment of $10 million convertible note
- Cash position of $20.1 million as of December 31, 2024
The company's gross margin improved to 61% in 2024 from 57% in 2023. For 2025, ClearPoint projects revenue between $36.0-$41.0 million, indicating potential growth of 15-31%.
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