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SOLANA BEACH, CA - ClearPoint Neuro, Inc. (NASDAQ:CLPT), a company specializing in navigation systems for brain and spine therapy, has announced the completion of a 510(k) application submission to the FDA by its partner, Clinical Laserthermia Systems AB (CLS), today. The application seeks to expand the use of the ClearPoint Prism Neuro Laser Therapy System for guidance under 1.5 T MRI. The announcement comes as the company’s stock has shown significant momentum, with InvestingPro data showing a 23% return over the past week and impressive revenue growth of 31% over the last twelve months.
The ClearPoint Prism system is currently approved for use with 3.0 T MRI guidance to necrotize or coagulate soft tissue in neurosurgical procedures. The proposed expansion could potentially open up over half of the neuro Laser Interstitial Thermal Therapy (LITT) market in the United States, which is currently inaccessible to the company. With a market capitalization of $406 million and analyst price targets ranging from $25 to $30, InvestingPro subscribers can access detailed analysis and 8 additional key insights about CLPT’s growth potential through the comprehensive Pro Research Report.
President and CEO of ClearPoint Neuro, Joe Burnett, expressed optimism about the FDA clearance, anticipated in the second half of this year. He emphasized the significance of the expansion in accessing a larger portion of the market. Dan J. Mogren, CEO of CLS, highlighted the collaborative effort between the two companies and the role of ClearPoint Prism in advancing the global neuro LITT market. The company maintains a strong financial position with a current ratio of 3.22, indicating healthy liquidity to support its growth initiatives.
ClearPoint Neuro’s technology is utilized in various medical centers across North America, Europe, Asia, and South America, providing clinical and preclinical navigation systems for drug and device delivery in the central nervous system. The company’s products are supported by FDA clearance and CE marking, and their clinical specialist team has supported thousands of procedures worldwide.
The press release also contained forward-looking statements regarding the company’s expectations for market growth and regulatory outcomes. These statements were accompanied by a cautionary note on the risks and uncertainties that could impact the company’s future results, including economic conditions, regulatory changes, and the success of partnerships. Investors should note that the company’s next earnings report is scheduled for May 13, 2025, which could provide additional insights into its growth trajectory and market expansion efforts.
This expansion application is part of ClearPoint Neuro’s ongoing efforts to enhance its product offerings and increase its footprint in the neurosurgical market. The information in this article is based on a press release statement from ClearPoint Neuro, Inc.
In other recent news, Clearpoint Neuro Inc. reported its fourth-quarter 2024 earnings, revealing a 31% increase in revenue to $31.4 million and an improved gross margin of 61%. The company also reduced its operational cash burn by 35% to $9 million. Looking ahead, Clearpoint Neuro has set its revenue guidance for 2025 between $36 million and $41 million. Meanwhile, Stifel analysts have raised the company’s stock target to $25, citing Clearpoint Neuro’s growth potential in its biologics and drug delivery business. The company’s biologics franchise, which includes over 60 clinical partners, is seen as a significant growth driver with potential total addressable markets around $10 billion. Clearpoint Neuro’s strategy of integrating MedTech with a biologics and drug delivery franchise is gaining attention within the industry. The company is also focusing on expanding its global presence and preparing for potential drug approvals in the next two years.
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