ClearPoint Neuro, Inc. (CLPT) recently announced the publication of preclinical results of an in vivo validation study in the Journal of Neurosurgery. The aim of the research, which was conducted by the company and its Swedish partner, Clinical Laserthermia Systems AB, was to assess the safety, accuracy and efficacy of the Prism System.The data demonstrated that the ClearPoint Prism Neuro Laser Therapy System provides accurate and near real-time temperature of the brain tissue. Additionally, the morphology ...

Supply Chain and Operational Risks - The company reported a significant reliance on single-source suppliers, which poses risks to its ability to meet product demand and could lead to increased costs and operational disruptions[40] - The company is aware that disruptions in the global supply chain could adversely affect its ability to meet product demand and maintain customer satisfaction[40] - The company relies on single-source suppliers for many components, which poses risks related to pricing, availability, and quality, potentially affecting operating results[40] Product Development and Regulatory Challenges - The SmartFlow Cannula has received 510(k) clearance from the FDA for use in the U.S. and is being utilized in clinical studies, indicating potential growth in the drug delivery and biologics business[41] - Regulatory approvals for new products are uncertain, and failures could adversely impact the company's ability to maintain and grow its business[46] - The company’s ability to maintain and grow its business is uncertain due to various risks, including regulatory challenges and market acceptance of new products[46] - Failure to obtain necessary clearances for new products could harm the company's global growth potential[75] - The company is subject to ongoing regulatory requirements, including safety submissions and compliance with Good Manufacturing Practice regulations[73] - The company is subject to extensive government regulations, and failure to comply could result in fines and penalties[1] Financial Performance and Profitability - The company has incurred losses since inception and may continue to do so, with no assurance of achieving profitability in the future[54] - The company expects to continue consuming cash in operations over at least the next twelve months despite anticipated revenue increases[56] - The company may need additional funding and may not be able to raise capital on acceptable terms, which could lead to dilution or operational restrictions[1] - The company has incurred losses since inception and may continue to do so, raising concerns about achieving profitability[75] - The company’s financial condition could be adversely affected by declines in the value of its investments due to market risks[59] Market Competition and Growth Strategies - Future business growth is dependent on the successful marketing and sales of the ClearPoint system and other new products in operating rooms[31] - The competitive landscape for medical devices is highly challenging, with risks from larger established companies and emerging innovators[47] - The company operates in a highly competitive medical device market and may struggle to compete against larger, established competitors[1] - The markets for medical devices are highly competitive, posing challenges against larger and emerging competitors[75] - Future growth is contingent upon the success of clinical trials and regulatory approvals for new products, which are costly and time-consuming[44] - The company anticipates increases in revenues from sales of hardware products and related disposables due to greater utilization at existing sites and new installations, alongside payments from strategic partnerships[56] Human Resources and Management Challenges - The company may face challenges in hiring and retaining qualified personnel, which is critical for business growth[53] - The company may face difficulties in recruiting and retaining qualified personnel, which could hinder business growth[53] Intellectual Property and Legal Risks - The company faces risks related to intellectual property protection, which could harm its competitive position if not adequately secured[1] - The company may incur significant liabilities if found promoting off-label uses of its products, violating regulations[1] - The company may engage in costly disputes over intellectual property infringement claims[75] - There is a risk of dilution to existing stockholders if additional funds are raised, which could restrict operations[58] - The company is at risk of product recalls that could harm its reputation and financial condition[75] Economic and Geopolitical Factors - The ongoing geopolitical tensions and economic instability may negatively impact the company's business and financial condition[27] - The company is subject to various economic, political, and regulatory risks related to international operations, which could impact growth[1]

SOLANA BEACH, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- 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 that preclinical results of an in vivo validation study have been published in the Journal of Neurosurgery.1 These data demonstrate that the ClearPoint Prism Neuro Laser Therapy System provides accurate, near real-time temperature of the brain tissue with a mean absolute erro ...

SOLANA BEACH, Calif., March 01, 2024 (GLOBE NEWSWIRE) -- 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 that it will release financial results for its 2023 fourth quarter and full year on Tuesday, March 12th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company’s 2023 fourth quarter and full year results on Tuesday, M ...

SOLANA BEACH, Calif., March 01, 2024 (GLOBE NEWSWIRE) -- 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 that it will release financial results for its 2023 fourth quarter and full year on Tuesday, March 12th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2023 fourth quarter and full year results on Tuesday, Ma ...

SOLANA BEACH, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, announced today the commencement of a proposed underwritten public offering of its shares of common stock. All the shares will be offered by the Company. The Company also expects to grant the underwriters a 30-day option to purchase additional shares of common stock in an amount of up to 15% ...

ClearPoint Neuro, Inc. (CLPT) recently announced its receipt of the FDA’s clearance and first-in-human cases using the ClearPoint 2.2 Software with integrated Maestro Brain Modeling. The company also announced the publication of a key validation study for its ClearPoint Maestro Brain Model in the peer-reviewed journal NeuroImage.The first clinical cases using ClearPoint 2.2 were completed successfully in the current quarter. The company expects a full market release in the second half of 2024.The latest reg ...

Healthcare stocks are one of the best sectors to capture long-term innovation and sector strength. After all, healthcare needs are perennial, especially as the global population lives longer and can generally afford more than the bare minimum of care. But finding the strong buy options for healthcare stocks is tough, especially as many press releases and earnings calls are filled with medical and technical jargon that spins finance-minded heads.That’s why using analyst ratings is a useful metric when resear ...

ClearPoint Neuro, Inc. (CLPT) recently announced the installation and completion of an initial procedure with both the ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System at Kaleida Health in Buffalo, NY.These technologies are expected to offer selected minimally invasive neurosurgical procedures to patients.Price PerformanceFor the past six months, CLPT’s shares have gained 5.2% against the industry’s decline of 3.1%. The S&P 500 increased 6.8% in the same time frame.Imag ...

Small-cap healthcare stocks might be the next stock market goldmine, but many investors are overlooking the sector’s potential. Small-cap healthcare stocks tend to be nimbler and more innovative than their blue-chip counterparts (with some exceptions), meaning they’re better equipped to navigate tricky market conditions and changing industry trends.At the same time, many of the best small-cap healthcare stocks capitalize, in one way or another, on global trends that sent stocks like Nvidia (NASDAQ:NVDA) soa ...