SOLANA BEACH, Calif. - ClearPoint Neuro, Inc. (NASDAQ:CLPT), a company specializing in precision navigation for brain and spine procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Prism Bone Anchor Accessory. This device is intended for use with the ClearPoint Prism Neuro Laser Therapy System, allowing for the placement of laser fibers in the operating room.
The Prism Bone Anchor Accessory is designed to work with stereotactic systems for intracranial and neurosurgical procedures, providing short-term fixation and positioning of neurosurgical instruments under image guidance. This recent clearance represents the second product introduction by ClearPoint Neuro in the first four months of 2024, following the launch of their SmartFrame OR platform.
Chris Osswald, PhD, Director, Global Segment Leader for Laser Therapy at ClearPoint Neuro, stated that this new product enhances the company's laser portfolio and is a step forward in their expansion beyond MRI-based procedures. Osswald also noted that the company is prepared to begin a limited market release in the second quarter, with a full market release anticipated in the second half of the year.
ClearPoint Neuro's flagship product, the ClearPoint Neuro Navigation System, is already FDA cleared and CE-marked, with the company supporting thousands of procedures worldwide. They collaborate with various healthcare and research centers, as well as pharmaceutical and biotech companies, to provide solutions for direct central nervous system delivery of therapies in both pre-clinical studies and clinical trials.
The press release also contains forward-looking statements regarding the company's expectations for the performance and market reception of its products. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected.
This announcement is based on a press release statement from ClearPoint Neuro, Inc. The company, known for its device, cell, and gene therapy-enabling technology, continues to innovate in the field of neurosurgery with the introduction of the Prism Bone Anchor Accessory, aiming to provide more options for surgical procedures in the brain and nervous system.
InvestingPro Insights
ClearPoint Neuro, Inc. (NASDAQ:CLPT) continues to make strides in the neurosurgical space with its recent FDA clearance, which may spark investor interest in how the company is performing financially. The latest metrics from InvestingPro show a Market Cap of approximately $142.39 million USD, indicating a relatively small cap company in the medical device sector.
While the company's Revenue Growth over the last twelve months as of Q4 2023 is positive at 16.56%, a robust sign of increasing sales, the Price / Book ratio stands at 6.72, suggesting the stock is trading at a premium relative to the company's book value.
Despite the positive news on product clearances, ClearPoint Neuro is not expected to be profitable this year, as reflected by an InvestingPro Tip indicating that analysts foresee the company remaining in the red. This aligns with a P/E Ratio that is negative at -6.45, further underscoring the current lack of profitability. Moreover, the stock has experienced a notable decline over the last month with a 1 Month Price Total Return of -22.65%, which may concern some investors.
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