ClearPoint Neuro's new surgical accessory receives FDA approval



SOLANA BEACH, Calif. – ClearPoint Neuro, Inc. (Nasdaq: CLPT), a company specializing in precision navigation for brain and spine surgery, today announced that it has received 510 ( k) Approval of its Prismatic Bone Anchor Accessories. The device is designed for use with the ClearPoint Prism neurolaser therapy system, allowing placement of laser fibers in the operating room.

Prism Bone Anchor Accessories are designed for use with stereotaxic systems for intracranial and neurosurgery procedures to provide short-term fixation and positioning of neurosurgical instruments under image guidance. The latest approval is ClearPoint Neuro's second product launch within the first four months of 2024, following the launch of its SmartFrame OR platform.

Chris Osswald, M.D., director, Global Division Head, Laser Therapeutics at ClearPoint Neuro, said the new product enhances the company's laser portfolio and is a step toward expansion beyond MRI-based procedures. Osswald also noted that the company is preparing to begin limited market launches in the second quarter, with a full market launch expected in the second half of this year.

ClearPoint Neuro's flagship product, the ClearPoint Neuro Navigation System, is FDA approved and CE marked, and the company supports thousands of procedures worldwide. They collaborate with various healthcare and research centers as well as pharmaceutical and biotechnology companies to provide solutions for direct CNS delivery of therapeutics in preclinical research and clinical trials.

This press release also contains forward-looking statements regarding the Company's expectations regarding the performance and market acceptance of its products. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected.

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This announcement is based on a press release from ClearPoint Neuro, Inc. Surgery offers more options.

Investment Professional Insights

ClearPoint Neuro, Inc. (NASDAQ: CLPT ) continues to make strides in neurosurgery with its recent FDA approval, which could fuel investor interest in the company's financial performance. The latest indicators from InvestingPro show Market value Approximately $142.39 millionshowing that the market value of the medical equipment industry is relatively small.

Although the company's revenue growth Growth in the trailing 12 months to Q4 2023 was positive 16.56%strong signs of sales growth, price/book The ratio is 6.72showing that the stock is trading at a premium relative to the company's book value.

Despite positive news about product clearances, ClearPoint Neuro doesn't expect to be profitable this year, as reflected in a report Investment Expert Tips Analysts expect the company to remain in the red.This is related to P/E ratio is a negative value -6.45, further highlighting the current lack of profitability. Additionally, the stock has experienced significant declines over the past month, 1 month total price return of -22.65%which may cause concern among some investors.

There are additional benefits for those considering investing in ClearPoint Neuro, Inc. Investment Professional Tips Can provide further insights into a company's financial health and stock performance.Currently, there are 9 bonus tips Listed on InvestingPro, accessible at: https://www.investing.com/pro/CLPT.For those looking for a more in-depth analysis, use the coupon code PRONEWS24 Annual or biennial Pro and Pro+ subscriptions receive an additional 10% discount.

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