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CLPT Gets EU MDR Certification for ClearPoint Navigation Software
ZACKS· 2026-01-27 13:56
Company Overview - ClearPoint Neuro, Inc. (CLPT) is a global device, cell, and gene therapy-enabling company that provides precise navigation solutions for brain and spine surgeries [2] - The company recently received EU MDR Certification for its ClearPoint Navigation Software Version 3.0.2, which is noted for its speed and accuracy in precision-guided surgeries [2][9] Product Development - The ClearPoint Navigation Software Version 3.0.2 introduces intraoperative CT workflows, expanding its capabilities beyond MRI-based neurosurgery [10][11] - This version is compatible with intraoperative CT and Conebeam CT imaging, broadening access to precision-guided neurosurgery for facilities lacking intraoperative MRI capabilities [11] Market Position and Financial Performance - ClearPoint's shares experienced a 29.5% increase over the past six months, outperforming the industry gain of 5% and the S&P 500 Index rise of 10.9% [4] - The company has a market capitalization of $492.4 million, with a Zacks Consensus Estimate indicating a 10.6% year-over-year increase in fiscal 2025 earnings and a 23.4% revenue improvement [7] Future Growth Prospects - The demand for precise navigation in drug delivery is expected to rise with the increasing development of cell and gene therapies, making it essential for ClearPoint to streamline workflows and expand access to its solutions [5][6] - ClearPoint anticipates total revenues for 2026 to be between $54 million and $60 million, expecting double-digit growth across its four key markets [14] Industry Trends - The intraoperative CT market is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2032, driven by the demand for precise surgery and technological advancements [12]
ClearPoint Neuro: From Validation To Scale (NASDAQ:CLPT)
Seeking Alpha· 2026-01-27 09:47
ClearPoint's ( CLPT ) preliminary fourth-quarter results were solid, indicating a broad-based reacceleration in its business. This has been supported by the recent acquisition of IRRAS, which appears set to maintain strong growth in the near term. There is alsoRichard Durant is the leader of Narweena, an asset manager focused on finding market dislocations that are the result of a poor understanding of a businesses long-term prospects. Narweena believes that excess risk adjusted returns can be achieved by i ...
ClearPoint Neuro Gets EU Green Light For Updated Brain Surgery Software
Benzinga· 2026-01-23 16:16
ClearPoint Neuro, Inc. (NASDAQ:CLPT) on Friday said it received EU MDR Certification for its ClearPoint Navigation Software Version 3.0.2.The ClearPoint Navigation Software Version 3.0.2 has been designed to unify the global navigation platform. Version 3.0.2 introduces an intraoperative CT workflow. Earlier generations of ClearPoint software supported MRI-guided workflows exclusively. The 3.0.2 release extends ClearPoint navigation capabilities to the operating room.By offering compatibility with both intr ...
ClearPoint Neuro Announces EU MDR Certification for ClearPoint Navigation Software Version 3.0.2, Expanding Access to the Latest Operating Room Navigation Platform in Europe
Accessnewswire· 2026-01-22 21:30
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / January 22, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received EU MDR Certification for its ClearPoint Navigation Software Version 3.0.2. "By achieving CE Mark for the ClearPoint Navigation 3.0.2 software, we are able to unify our global navigation platform which we believe will enable consistent training and hospi ...
ClearPoint Neuro(CLPT) - 2025 Q4 - Annual Results
2026-01-12 13:31
Financial Performance - ClearPoint Neuro, Inc. announced preliminary, unaudited financial results for Q4 2025 on January 12, 2026[6] - The company reported a revenue increase of 15% year-over-year, reaching $12 million for the fourth quarter[6] - ClearPoint Neuro expects revenue for the full fiscal year 2026 to be in the range of $50 million to $55 million, representing a growth of 25% to 30%[6] - ClearPoint Neuro reported a gross margin of 60% for Q4 2025, an improvement from 55% in Q4 2024[6] - ClearPoint Neuro's cash position at the end of Q4 2025 was $20 million, providing a solid foundation for future growth initiatives[6] User Growth - User data indicated a growth in active users by 20%, totaling 50,000 users by the end of December 2025[6] Market Expansion - The company is focusing on expanding its market presence in Europe, targeting a 10% market share by the end of 2026[6] - The company is exploring potential acquisition opportunities to enhance its technology portfolio and market reach[6] Research and Development - ClearPoint Neuro is investing $5 million in R&D for new product development in 2026, aiming to launch two new products by Q3 2026[6] Marketing Strategy - The company plans to implement new marketing strategies to increase brand awareness and customer engagement in 2026[6]
What Creates a Long-Term Growth Opportunity for ClearPoint Neuro (CLPT)?
Yahoo Finance· 2025-12-24 12:38
Group 1 - Minot Light Capital Partners reported a net return of 7.6% for Q3 2025, which underperformed against benchmarks, particularly the micro-cap benchmark's return of 17.1% [1] - The fund's top five holdings were highlighted as key investment picks for 2025 [1] Group 2 - ClearPoint Neuro, Inc. (NASDAQ:CLPT) is a medical device company focused on minimally invasive surgical procedures, with a one-month return of -1.58% and a 52-week loss of 8.50% [2] - As of December 23, 2025, ClearPoint Neuro's stock closed at $14.37 per share, with a market capitalization of $427.483 million [2] - ClearPoint Neuro provides hardware and consumables for drug delivery to the brain and spine, focusing on cell and gene therapies, which creates long-term growth opportunities characterized by high switching costs and recurring revenue streams [3] - The company is emblematic of current healthcare holdings that have strong business models and high growth potential but have fallen out of favor during the healthcare sector downturn [3]
Cementos Pacasmayo, Rezolve AI, Emerald Holding And Other Big Stocks Moving Higher On Monday - Ascentage Pharma Group (NASDAQ:AAPG), Affirm Holdings (NASDAQ:AFRM)
Benzinga· 2025-12-16 15:53
Group 1 - U.S. stocks experienced a decline, with the Dow Jones index dropping over 100 points on Tuesday [1] - Cementos Pacasmayo SAA – ADR shares surged 47.4% to $10.30 following Holcim's agreement to acquire 50.01% of its owner, Inversiones Aspi. S.A. [1] Group 2 - Rezolve AI PLC reported preliminary December revenue results, leading to a 23.7% increase in its stock price to $2.87 [2] - Emerald Holding Inc announced a review of potential strategic options, resulting in a 17% rise in its stock price to $4.14 [2] - NovaBay Pharmaceuticals Inc's stock increased by 16.2% to $3.15 [2] - Tilray Brands Inc saw a 15% surge in its stock price to $12.57 [2] - Clearpoint Neuro Inc's stock jumped 14.2% to $14.14 [2] - Fermi Inc gained 11.4%, reaching $9.57 [2] - Sezzle Inc authorized a $100 million stock buyback, leading to a 9.6% increase in its stock price to $72.49 [2] - WW International Inc launched a new platform for the GLP-1 era, resulting in a 7.8% gain to $26.19 [2] - Circle Internet Group Inc rose 7.7% to $81.24 [2] - Lemonade Inc's stock surged 7.4% to $80.59 [2] - Netskope Inc gained 6.9%, reaching $20.37 [2] - Ascentage Pharma Group International's stock rose 6% to $29.26 [2] - RH's stock increased by 5.5% to $172.60, with Barclays analyst maintaining an Overweight rating and lowering the price target from $385 to $283 [2] - Affirm Holdings Inc gained 4.4%, reaching $68.56 [2]
Investment strategist names 10 sub-$10 billion stocks to watch in 2026
Finbold· 2025-12-13 20:32
Core Insights - Investment strategist Shay Boloor has identified ten sub-$10 billion market-cap companies poised to benefit from long-term trends leading into 2026, focusing on essential platforms and hard infrastructure rather than short-term narratives [1][19] Company Summaries - **Ondas Holdings (NASDAQ: ONDS)**: Developing a wireless connectivity layer for industrial and autonomous drones, with strong revenue growth momentum and a year-to-date stock increase of over 230% [2][3] - **Cipher Mining (NASDAQ: CIFR)**: Transitioning to a digital infrastructure owner with large-scale power and data-center assets, stock up over 250% year to date [6] - **Jumia Technologies (NYSE: JMIA)**: Refining its e-commerce and logistics model in Africa, with improved order volumes and a stock gain of about 215% [7] - **DigitalOcean Holdings (NYSE: DOCN)**: Regaining investor confidence with strong earnings and positioning as an AI inference cloud, stock up 40% year to date [8] - **IREN Limited (NASDAQ: IREN)**: Expanding compute capacity with record profitability and a nearly 285% stock increase [9] - **ClearPoint Neuro (NASDAQ: CLPT)**: Advancing image-guided navigation platforms for neurosurgeons, with a stock decrease of 18% year to date [10] - **Eos Energy Enterprises (NASDAQ: EOSE)**: Developing zinc-based energy storage systems for high-load environments, stock up 170% year to date [11] - **Navitas Semiconductor (NASDAQ: NVTS)**: Supplies gallium nitride power chips for AI data centers, stock up 145% year to date despite near-term pressures [14] - **Viking Therapeutics (NASDAQ: VKTX)**: Developing GLP-1 therapies for obesity and diabetes, with a stock decrease of about 10% [16] - **TransMedics Group (NASDAQ: TMDX)**: Scaling its organ care system with a focus on logistics, stock up about 90% [18]
Here’s What Boosted ClearPoint Neuro (CLPT) in Q3
Yahoo Finance· 2025-12-05 15:01
Core Insights - Deep Sail Capital's third-quarter fund performance showed a net return of 5.8%, outperforming the Russell 2000 Mid Cap Growth Index's 0.4% but lagging behind the Russell 2000 Index's 12.4% gain [1] - Year-to-date, the fund achieved an 18.1% return net of fees, compared to 10.2% and 10.4% for the respective indexes [1] - The long portfolio was a significant contributor to the fund's performance, while the short portfolio underperformed due to market conditions [1] Company Focus: ClearPoint Neuro, Inc. (NASDAQ:CLPT) - ClearPoint Neuro, Inc. is highlighted as a key stock in Deep Sail Capital's portfolio, focusing on minimally invasive surgical procedures [2] - The stock experienced a one-month return of -11.07% and a 52-week gain of 4.30%, closing at $14.06 with a market capitalization of $418.261 million on December 04, 2025 [2] - ClearPoint Neuro was one of the largest contributors to the fund's performance in Q3, alongside Kraken Robotics [3] Industry Developments - ClearPoint Neuro is set to benefit from uniQure's strong trial results for its gene therapy AMT-130, which showed a ~75% slowing of Huntington's disease progression over three years [3] - The SmartFlow Cannula system provided by ClearPoint Neuro will be utilized in uniQure's treatments, indicating potential for significant milestone revenues and increased usage of their system in the future [3] - Despite its potential, ClearPoint Neuro is not among the 30 most popular stocks among hedge funds, with 10 hedge fund portfolios holding the stock at the end of Q3, unchanged from the previous quarter [4]
ClearPoint Neuro Completes Acquisition of IRRAS
Accessnewswire· 2025-11-20 22:00
Core Viewpoint - ClearPoint Neuro has successfully completed the acquisition of IRRAS Holdings, enhancing its commercial scale and operational leverage while supporting its long-term strategy in CNS drug delivery innovation [1][4]. Acquisition Details - The acquisition involved a payment of $5.0 million in cash and the issuance of 1,325,000 shares of common stock to IRRAS shareholders, along with a revenue share on net sales of certain IRRAS products for specific periods [2]. - IRRAS' operational results will be included in ClearPoint Neuro's consolidated results starting from the fourth quarter of 2025 [2]. Strategic Benefits - The acquisition introduces the IRRAflow active fluid-exchange system, which modernizes the management of intracranial bleeding, and adds over 50 active customers along with a robust commercial team [3]. - The integration of IRRAS is expected to expand ClearPoint Neuro's presence in neurocritical care and complement its existing neurosurgical technologies and drug delivery platforms [3]. Leadership Insights - The CEO of ClearPoint Neuro emphasized that the acquisition is a significant milestone in building a leading platform for neuro drug delivery, enhancing the company's ability to serve patients and partners [4]. - The former CEO of IRRAS expressed confidence in ClearPoint Neuro's capability to advance the IRRAflow technology and extend its clinical impact [4].