Clearpoint Neuro Inc Stock Price, News & Analysis

ClearPoint Neuro (NASDAQ:CLPT) announced expanded regulatory clearances for its therapy delivery products in Canada, Hong Kong, and Taiwan, bringing total cleared countries to 34. The company said these clearances are intended to simplify regional clinical trial design and support BioPharma partners' paths toward global commercialization. ClearPoint noted it works with 60+ BioPharma sponsors and will demonstrate US-cleared products at the CNS Annual Congress, Oct 13–15, 2025. The release also highlights the SmartFlow Neuro Cannula 510(k) FDA clearance for CSF aspiration, intraventricular Cytarabine injection, and delivery of gene therapy KEBILIDI to brain parenchyma.

ClearPoint Neuro (NASDAQ:CLPT) has unveiled its proprietary Robotic Neuro-Navigation System, designed to operate the KUKA LBR Med Robotic Arm for minimally invasive cranial procedures. The system will support cell and gene therapy infusions, laser catheter placement, biopsy workflows, and deep brain stimulation.

The platform offers three deployment options: traditional MRI guidance, new ClearPoint 3.0 iCT guidance, and future robotic-assisted technique, all unified under ClearPoint's software planning module. The company will showcase a prototype at the 75th Annual Congress of Neurological Surgeons in Los Angeles (October 13-15, 2025).

The system, which has not yet received regulatory approval, aims to provide both consistency and flexibility for commercial launches of cell and gene therapies, particularly targeting BioPharma partners preparing for increased commercial case volumes.

ClearPoint Neuro (Nasdaq:CLPT) has appointed Dr. Paul Larson as Chief Medical Officer, effective January 2026. Dr. Larson, who has been a long-time advisor to the company, brings extensive expertise in neuro navigation and drug delivery, having performed or overseen more than 100 cell and gene therapy clinical procedures.

Dr. Larson will maintain his positions at the University of California San Francisco and Banner Hospital, University of Arizona, where he will continue participating in cell and gene therapy clinical trials. His appointment comes at a strategic time as ClearPoint Neuro and its partners prepare for the commercialization of new therapies targeting conditions like Huntington's Disease, Parkinson's Disease, epilepsy, dementias, tumors, and rare childhood genetic disorders.

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.

ClearPoint Neuro (NASDAQ:CLPT) reported record Q1 2025 revenue of $8.5 million, marking an 11% year-over-year increase. The company saw remarkable growth in consumable product revenue, up 104% to $2.6 million. Key highlights include:

• 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

The company secured a long-term credit facility and equity investment from Oberland Capital, maintaining $12.4 million in cash and cash equivalents. ClearPoint reaffirmed its full-year 2025 revenue guidance of $36.0-41.0 million. Operating expenses increased 29% to $11.3 million due to higher personnel costs and product development investments.

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.