Clearpoint Neuro Inc Stock Price, News & Analysis

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%.

ClearPoint Neuro (NASDAQ:CLPT), a global device, cell, and gene therapy-enabling company focused on brain and spine navigation, has scheduled its Q4 and full-year 2024 financial results release for February 26, 2025, after market close.

The company will host a live conference call at 4:30 p.m. Eastern time on the same day to review the results. Investors and analysts can participate via telephone at (877) 407-9034 (U.S./Canada) or (201) 493-6737 (International). A replay will be available until March 25th, 2025, accessible by calling (877) 660-6853 (U.S./Canada) 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 received European Medical Device Regulation (EU MDR) approval for its SmartFlow Neuro Cannula, well ahead of the 2027 deadline for Class III devices. The device, previously cleared under MDD 93/42/EEC, has now achieved extended shelf life of 48 months in the EU, doubled from the previous 24 months.

The SmartFlow Cannula has CE mark approval for delivering approved fluids into the brain during intracranial procedures and for Cytarabine injection or CSF removal from ventricles (14 gauge cannulas). Notably, it is included in PTC Therapeutics' Upstaza, the first approved gene therapy for direct brain infusion.

The company supports over 50 biopharma partners, with the approval reinforcing their ability to support clinical trials and commercialization globally. The certification was facilitated by the device's extensive clinical trial history, meeting EU MDR's enhanced requirements for safety measures, risk management, and post-market surveillance.

ClearPoint Neuro (NASDAQ:CLPT) has received FDA 510(k) clearance for its ClearPoint Navigation Software Version 3.0, expanding its navigation capabilities from exclusively MRI-guided workflows to include intraoperative CT and Conebeam CT imaging in operating rooms. This enhancement allows precision-guided neurosurgery in facilities without intraoperative MRI capabilities.

The software, used with SmartFrame® XG stereotactic frame, provides precise guidance for neurosurgical procedures including biopsies, catheter and electrode insertion, and deep brain stimulation lead placement. Currently, over 95% of U.S. stereotactic procedures occur in operating rooms using CT imaging.

The company plans a market release in Q1 2025, followed by a full market release in the second half of 2025. This development aims to standardize cell and gene therapy delivery globally, supporting ClearPoint's 50+ global biopharma partners.

ClearPoint Neuro (Nasdaq:CLPT) has received FDA De Novo marketing authorization for its SmartFlow Neuro Cannula, marking the first-ever FDA approval for a device delivering gene therapy directly to the brain. The device is specifically approved for intraputaminal administration of PTC Therapeutics' gene therapy KEBILIDI™ to treat aromatic L-amino acid decarboxylase (AADC) deficiency. This milestone represents the first commercially available neuro gene therapy in the United States. The company offers comprehensive medical device solutions for pharma partners, including surgical strategy, testing, clinical trial support, and navigation systems.