Clearpoint Neuro Inc Stock Price, News & Analysis

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.

ClearPoint Neuro (CLPT) reported strong Q3 2024 results with record revenue of $8.1 million, representing 41% year-over-year growth. The company saw significant expansion in navigation and device revenue, reaching $2.9 million (53% increase), while overall product revenue more than doubled to $5.5 million. Notable achievements include activating five new global centers, reducing quarterly operational cash burn to $1.2 million, and fully repaying a $10 million convertible note. The company maintains its 2024 revenue guidance of $30.0-$33.0 million and reported cash and cash equivalents of $21.6 million as of September 30, 2024.

ClearPoint Neuro (NASDAQ:CLPT), a global device, cell, and gene therapy-enabling company focused on brain and spine navigation, has announced its participation in several major healthcare conferences during Q4 2024. The company's management will attend five significant events, including the UBS Global Healthcare Conference, Stifel Healthcare Conference, Canaccord Genuity Forum, Piper Sandler Healthcare Conference, and Stifel MedTech Madness West Coast Bus Tour. Additionally, President and CEO Joe Burnett's interview is featured on the Bloomberg Intelligence Vanguards of Healthcare Podcast, released on October 31, 2024.

ClearPoint Neuro, Inc. (NASDAQ: CLPT), a global device, cell, and gene therapy-enabling company focused on precise navigation to the brain and spine, has announced its plans to release financial results for the third quarter of 2024 on Thursday, November 7th, after market close. The company will host a live broadcast review of the Q3 2024 results on the same day at 4:30 p.m. Eastern time.

Investors and analysts can participate in the conference call via telephone or listen to the live broadcast online. For those unable to attend the live event, a replay will be available until December 7, 2024. An online archive of the broadcast will also be accessible on the company's Investor website.

ClearPoint Neuro (Nasdaq: CLPT) has announced the early repayment of a $10 million convertible note held by PTC Therapeutics Inc., originally due in January 2025. This strategic move, completed on August 23, 2024, demonstrates the company's financial strength and commitment to reducing debt without diluting shareholder value. Joe Burnett, President and CEO of ClearPoint Neuro, emphasized the importance of this repayment in removing all debt from the balance sheet while maintaining a strong partnership with PTC Therapeutics.

ClearPoint Neuro continues to support PTC's Biologics License Application submission to the FDA for Upstaza™, an investigational treatment for AADC Deficiency currently under priority review. The company reaffirms its position as a global device, cell, and gene therapy-enabling company, offering precise navigation solutions for the brain and spine.

ClearPoint Neuro (Nasdaq: CLPT) reported record Q2 2024 revenue of $7.9 million, a 32% year-over-year increase. Key highlights include:

- Product revenue across all segments more than doubled, growing 112% to $4.9 million
- Biologics and Drug Delivery revenue increased 28% to $4.3 million
- Navigation and device revenue grew 34% to $2.6 million
- Gross margin improved to 63% from 53% in Q2 2023
- Operating cash burn reduced by 47% to $2.7 million
- Cash and cash equivalents totaled $32.8 million as of June 30, 2024

The company raised its full-year 2024 revenue guidance to $30.0-$33.0 million. ClearPoint Neuro continues to expand its biologics and drug delivery services, add strategic agreements with pharmaceutical partners, and grow its installed base of navigation and therapy systems globally.

ClearPoint Neuro (NASDAQ: CLPT), a global device, cell, and gene therapy-enabling company, has announced it will release its 2024 second quarter financial results on August 7, 2024, after market close. The company will host a live broadcast review of the results at 4:30 p.m. Eastern time on the same day.

Investors and analysts can participate in the conference call via telephone or listen to the live broadcast online. For those unable to attend the live event, a replay will be available until September 7, 2024. An online archive of the broadcast will also be accessible on the company's Investor website.