CLPT

ClearPoint Neuro remains a speculative Buy, offering leveraged exposure to gene therapy commercialization and neurosurgery navigation growth. Recent FDA feedback on uniQure's AMT-130 renews optimism for near-term revenue, but regulatory and partner execution risks persist. CLPT's Q1 organic growth slowed, cash burn accelerated, and full-year 2026 revenue guidance ($52–$56M) disappointed versus expectations.

ClearPoint Neuro (CLPT) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

Announcement is made after successful proof-of-concept trial in a preclinical model of intravenous delivery of large molecule tracers across the blood-brain barrier guided by prototype systems, including both focused ultrasound hardware and ClearPoint Navigation Software and Robotics SOLANA BEACH, CA / ACCESS Newswire / May 27, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) ("Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced plans to enter the focused ultrasound market, and demonstrated successful intravenous delivery of tracers across the blood-brain barrier in a preclinical model using the ClearPoint prototype system. This device was built in partnership with the SONOCARELAB, at Sungkyunkwan University in Suwon, South Korea on the Natural Science Campus.

Record Revenue Achieved Including 25% Organic Growth in Devices and 43% Overall Growth SOLANA BEACH, CA / ACCESS Newswire / May 13, 2026 / 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 financial results for its first quarter ended March 31, 2026. First Quarter 2026 Highlights Reported first quarter revenue of $12.1 million, including $2.3 million of IRRAflow revenue, representing 43% overall growth and 16% year-over-year total organic growth compared with the first quarter of 2025; The activated installed base across all ClearPoint technology including IRRAflow systems now includes over 175 global centers; Achievement of measurable revenue and cost synergies through the continuing integration of the IRRAflow product portfolio and team; Continued clinical trial and regulatory progress across more than 60 active biopharma partners; FDA clearance and successful completion of the first clinical procedure utilizing the Velocity Alpha MR High Speed Surgical Drill System; Received Medical Device License (MDL) from Health Canada for the ClearPoint Neuro Navigation System, covering both MRI-guidance and iCT guidance workflows with first cases now scheduled; Completion of the first commercial drug delivery case utilizing ClearPoint technology in the Asia-Pacific region; Gross margin expanded to 64%; and Reported cash and cash equivalents totaling $35.6 million as of March 31, 2026.

SOLANA BEACH, CA / ACCESS Newswire / May 13, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) ("Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that the Velocity Alpha ® MR High Speed Surgical Drill System has received CE Marking in addition to the existing FDA 510(k) clearance in the United States. The Velocity Alpha MR High Speed Surgical Drill System is manufactured by German-based surgical equipment leader Adeor Medical AG.

SOLANA BEACH, CA / ACCESS Newswire / April 29, 2026 / 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 it will release financial results for its 2026 first quarter on Wednesday, May 13th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2026 first quarter results on Wednesday, May 13th, at 4:30 p.m.

ClearPoint's stock has come under significant pressure in recent months following weaker 2026 revenue guidance and further regulatory uncertainty. Despite near-term headwinds, a step change in revenue remains likely as partner therapies are commercialized over the next few years. Independent of this, ClearPoint's forward revenue multiple looks increasingly reasonable given the company's strong competitive positioning and solid growth.

SOLANA BEACH, CA / ACCESS Newswire / April 22, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) ("Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced the successful completion of the first clinical procedure utilizing the 510(k)-cleared Velocity Alpha MR High Speed Surgical Drill System. Utilized in a four-trajectory clinical trial procedure, the system highlights its scalability and potential to support a broader range of programs within the Company's partnered biologics portfolio.

Combined clearance of the navigation and drug delivery technologies enables Canadian neurosurgery centers to leverage the Company's flagship image-guidance workflow and advances ClearPoint Neuro's overall global infrastructure in support of its strategy to enable 20,000 cell and gene therapy procedures annually. SOLANA BEACH, CA / ACCESS Newswire / April 20, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) ("Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced receipt of a Medical Device License (MDL) from Health Canada for its Neuro Navigation System, further expanding our Drug Delivery ecosystem and global footprint.