ClearPoint Neuro Announces FDA Clearance for SmartFrame OR™ Stereotactic System
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The 510(k) clearance of ClearPoint Neuro's SmartFrame OR™ Stereotactic System represents a significant regulatory milestone in the medical device sector. This clearance indicates that the device is considered as safe and effective as legally marketed devices and can now be commercially distributed in the United States. The SmartFrame OR system's compatibility with pre-existing capital hardware and software in neurosurgical operating rooms is a strategic move that could facilitate rapid adoption and integration into current hospital workflows, potentially reducing barriers to entry and accelerating market penetration.
From a financial perspective, the system's ability to operate without the need for MRI during procedures can be a cost-saving factor for hospitals, reducing the total cost of ownership and operation. This could make the product attractive to a broader range of healthcare facilities, including those that may not have the infrastructure to support MRI-guided procedures. Moreover, the system's flexibility and compatibility with various imaging modalities, such as intraoperative CT (iCT), may offer a competitive advantage in terms of precision and workflow optimization, leading to potential market share gains within the neuro-navigation space.
ClearPoint Neuro's strategy to expand its portfolio into the operating room (OR) addresses a significant portion of the market, as the majority of stereotactic neuro-navigation procedures occur in this setting. The anticipated increase in addressable market size due to this expansion could have a positive impact on the company's revenue growth and market valuation. The ability to support a wider range of procedures, such as Deep Brain Stimulation (DBS), Laser Ablation and biopsies, suggests a diversification of the company's product offerings, which is often viewed favorably by investors seeking to mitigate risk.
Furthermore, the claim of submillimetric accuracy provided by the SmartFrame OR system could enhance clinical outcomes, which is a critical factor in the adoption of new medical technologies. Better clinical outcomes can lead to increased demand from surgeons and healthcare providers, as well as higher patient preference for facilities utilizing advanced technologies. This could result in a positive feedback loop, enhancing the company's brand reputation and driving long-term growth.
The integration of the SmartFrame OR Stereotactic System with existing optical stereotaxic navigation systems leverages the trend towards interoperability in healthcare technology. This approach aligns with the current healthcare IT infrastructure, which is increasingly favoring seamless integration across different platforms and devices. By ensuring compatibility with other systems, ClearPoint Neuro is not only expanding its market reach but also aligning with the broader industry move towards connected healthcare ecosystems.
Additionally, the mention of flexible workflows and iCT forward projection technology implies that the system is designed to enhance the user experience for surgeons, potentially improving procedure efficiency and outcomes. This user-centric design philosophy is crucial in driving technology adoption and can lead to a stronger competitive position in the market. The emphasis on precision and accuracy through image-based corrections could also contribute to improved patient safety and reduced rates of complications, which are key factors in technology selection by healthcare institutions.
Limited Market Release of First Purpose-Built OR Product to Begin in First Half of 2024
SOLANA BEACH, Calif., Jan. 16, 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 it has received 510(k) clearance for its SmartFrame OR™ Stereotactic System.
The SmartFrame OR Stereotactic System is composed of two main components: the SmartFrame OR, and the ClearPointer™ Optical Navigation Wand. The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The ClearPointer is intended to be used in conjunction with the SmartFrame OR and a compatible stereotactic optical navigation system for patient registration and navigation. SmartFrame OR may be used with or without available bone screw fiducials. The Company plans to commence limited market release in the first half of 2024, with a planned full market release in the second half of 2024.
“Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the Company in 2024 and beyond,” stated Joe Burnett, President and CEO at ClearPoint Neuro. “More than
“SmartFrame OR embodies over a decade of accumulated expertise in MRI-guided navigation, now enhanced with the latest OR imaging technology,” said Rob Rubio, Segment Leader for Neuromodulation at ClearPoint Neuro. “It offers surgeons flexible workflows, including iCT forward projection, enabling precise image-based corrections to achieve submillimetric accuracy.”
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, including the Company’s expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.
A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a2ebbab0-b838-4d64-b33f-d57fdb80a9a6
FAQ
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