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. develops and commercializes medical-device and therapy-enabling systems for precise navigation to the brain and spine. Its recurring news includes updates on the FDA-cleared and CE-marked ClearPoint Neuro Navigation System, SmartFrame navigation platform, SmartFlow Neuro Cannula, Velocity Alpha MR High Speed Surgical Drill System, and services that support controlled CNS delivery for cell and gene therapy programs.
Company announcements also cover financial results, product clearances and international regulatory approvals, preclinical development services, biopharma and academic partnerships, and integration of the completed IRRAS Holdings acquisition, which expanded the portfolio into neurocritical care and IRRAflow-related products.
ClearPoint Neuro (Nasdaq: CLPT) reported second quarter 2026 revenue of $10.9 million, up 18% year over year, driven by the acquired IRRAflow portfolio and strong neurosurgery navigation and therapy revenue, which grew 62% to $5.6 million. Biologics and drug delivery revenue declined 15% to $4.0 million, mainly due to a large prior-year customer order that did not repeat.
Gross margin improved to 62%, while operating expenses rose 51% to $17.0 million, expanding the operating loss to $10.2 million and net loss to $11.3 million. Cash and cash equivalents were $29.4 million at June 30, 2026. The company issued 2026 revenue guidance of $48.0–$52.0 million and highlighted regulatory progress by biopharma partners, activation of its ClearPoint Advanced Laboratories preclinical facility, a 10-year focused ultrasound drug delivery partnership with the SONOCARE Lab, and ongoing development of its robotic platform and Harmony 1.0 software.
ClearPoint Neuro (Nasdaq: CLPT) congratulated partner Aspen Neuroscience on receiving U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for sasineprocel (ANPD001), an investigational autologous dopaminergic neuron cell replacement therapy for Parkinson's disease. RMAT status is based on preliminary clinical evidence and does not constitute approval.
According to ClearPoint Neuro, its Navigation System and SmartFlow Cannula are being used for cell transplantation in Aspen's ASPIRO clinical trial in moderate to severe Parkinson's disease. ClearPoint reports supporting 60+ biologics and drug delivery partner programs, with over 10 having received one or more expedited regulatory review designations.
ClearPoint Neuro (NASDAQ: CLPT) will release its second quarter 2026 financial results on Monday, August 3, 2026, after the market close. A live earnings conference call and webcast are scheduled for 4:30 p.m. Eastern time (1:30 p.m. Pacific time).
Investors may join the call by phone at (877) 407-9034 (U.S./Canada) or (201) 493-6737 (international), or via an online webcast. According to ClearPoint Neuro, a telephone replay will be available until September 2, 2026 using conference ID 413671, and an archived webcast will be accessible on the company’s investor website.
ClearPoint Neuro (NASDAQ:CLPT) announced a 10-year focused ultrasound development partnership with Sungkyunkwan University in South Korea. The collaboration supports entry into the focused ultrasound market and expansion of ClearPoint's drug delivery ecosystem.
According to ClearPoint, a prototype system enabled intravenous delivery of large-molecule tracers across the blood-brain barrier in a preclinical model, integrating focused ultrasound hardware with ClearPoint navigation software and planned robotics for use in the operating room outside MRI suites.
ClearPoint Neuro (Nasdaq: CLPT) reported first quarter 2026 revenue of $12.1 million, up 43% year over year, with 16% organic growth and 25% organic device growth. Neurosurgery navigation revenue rose 80% and capital equipment 177%. Gross margin improved to 64%, and cash totaled $35.6 million. 2026 revenue is estimated at $52–56 million.
ClearPoint Neuro (NASDAQ:CLPT) announced that its Velocity Alpha MR High Speed Surgical Drill System has received CE Marking, adding to existing FDA 510(k) clearance in the US.
The Adeor Medical–manufactured drill integrates with ClearPoint’s SmartFrame platform to support multi-trajectory neurosurgical, cell, and gene therapy procedures and broaden the company’s global drug delivery ecosystem.
ClearPoint Neuro (NASDAQ:CLPT) will release first-quarter 2026 financial results on Wednesday, May 13, 2026, after the market close. A live broadcast and conference call will begin at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).
Listeners can join via webcast or telephone; a replay will be available through June 12, 2026, and an online archive will be posted on the company's investor website.
ClearPoint Neuro (NASDAQ:CLPT) announced FDA 510(k) clearance of the Velocity Alpha MR High Speed Surgical Drill and reported the system's first clinical use on April 22, 2026 in a four-trajectory procedure. The drill integrates with ClearPoint's SmartFrame navigation and is manufactured by adeor medical AG.
The device is designed for multi-trajectory, MR and OR workflows, aims to streamline procedures, and is expected to be compatible with ClearPoint's robotic navigation platform now in development.
ClearPoint Neuro (NASDAQ:CLPT) received a Medical Device License from Health Canada on April 20, 2026 for its Neuro Navigation System, covering both MRI-guidance and new iCT-guidance workflows in Canada.
This clearance, which follows the SmartFlow Neuro Cannula delivery clearance in October 2025, allows biopharma partners to run Canadian clinical trial and commercial sites using ClearPoint's integrated navigation and therapy-delivery platform and supports the company's strategy to enable 20,000 cell and gene therapy procedures annually.
ClearPoint Neuro (Nasdaq:CLPT) reported record 2025 results with $37.0M revenue, 18% growth, and Q4 revenue of $10.4M (34% growth). The company completed the November 2025 acquisition of IRRAS, secured $20.0M additional financing access, achieved EU MDR certification, and ended 2025 with $45.9M cash.
Management projects 2026 revenue of $52.0–$56.0M and highlighted product, commercial, and cell/gene therapy expansion initiatives.