Journal of Neurosurgery Publication Demonstrates Distinct Advantages of ClearPoint Prism® Neuro Laser Therapy System
ClearPoint Neuro Announces Preclinical Results of ClearPoint Prism Neuro Laser Therapy System, Along with FDA Cleared SmartFrame Array Software 1.2
The publication of preclinical results from an in vivo validation study of the ClearPoint Prism Neuro Laser Therapy System has significant implications for the field of neurosurgery and the treatment of conditions such as epilepsy, movement disorders and brain tumors. The data indicating a mean absolute error of <1°C in temperature predictions during laser therapy suggests a high level of precision, which is crucial for avoiding damage to surrounding healthy brain tissue. This precision could lead to increased adoption of the Prism System in clinical settings, potentially improving patient outcomes and expanding the market for ClearPoint Neuro's technology.
Moreover, the correlation between the Thermoguide™ MR-thermometry software's visualizations and the actual histopathology is a strong indicator of the system's reliability. Such validation could bolster confidence among neurosurgeons and might translate into a competitive advantage for ClearPoint Neuro in the medical device market. The integration of the SmartFrame Array Neuro Navigation System with the new software further enhances the practicality of the system, offering streamlined procedures and more workflow options, which could lead to operational efficiencies in neurosurgical departments.
From a market perspective, the FDA clearance of the Array software version 1.2 and its integration with the Prism System is a strategic move that could enhance ClearPoint Neuro's market positioning. The unique selling proposition of non-cooled neurosurgical laser applicators and the elimination of external cooling requirements address key operational challenges in neurosurgery, potentially reducing procedure times and costs. This innovation may drive market demand and adoption rates, especially within leading academic medical centers that often pioneer the use of cutting-edge technologies.
The limited market release strategy currently employed allows ClearPoint Neuro to gather additional real-world data and refine the system based on feedback from top-tier medical institutions. This approach may not only improve the product but also create buzz in the medical community, potentially leading to wider market acceptance upon full release. As the system gains traction, the company could see an uptick in sales and an enhanced reputation as a leader in precision neurosurgical solutions.
The financial implications for ClearPoint Neuro following the FDA clearance of its software and the publication of positive preclinical study results are multifaceted. Initially, the company may incur increased costs associated with the limited market release, including marketing to select academic medical centers and the collection of additional data. However, these upfront investments are likely to yield long-term benefits. Positive clinical outcomes and surgeon endorsements could lead to broader adoption and potentially justify a premium pricing strategy for the Prism System.
Investors should monitor the rate of clinical adoption and any strategic partnerships or collaborations that may arise as a result of these developments. ClearPoint Neuro's stock valuation could be influenced by the market's perception of the company's growth potential in the neurosurgery device sector. It is essential, however, to balance expectations with the understanding that medical device adoption can be a slow process, influenced by regulatory hurdles, hospital budgets and the need for extensive training and education.
03/11/2024 - 08:00 AM
ClearPoint Prism Now Being Used with Recently FDA Cleared and Launched SmartFrame Array® 1.2 Software
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 error of <1°C. Additionally, the morphology of the lesion, as visualized by Thermoguide™ MR-thermometry software, correlated well with histopathology.
The research was conducted by the Company and its Swedish partner, Clinical Laserthermia Systems AB (CLS), with Dr. John Rolston leading the study as Principal Investigator. The aim of the study was to evaluate the safety, accuracy, and efficacy of the Prism System. This was achieved by 1) demonstrating a predicted safety margin via survival histology; 2) determining the Thermal Damage Thresholds (TDTs) that best predict irreversible tissue damage based on said histology; and 3) evaluating the accuracy of temperature prediction compared to actual temperature changes in vivo .
“Our research presents a comprehensive and meticulously conducted open analysis of the ClearPoint Prism laser system. Prism offers a seamlessly integrated solution for precise and more efficient laser interstitial thermal therapy, advancing new treatment options for patients with intractable epilepsy, movement disorders, and brain tumors,” said John D. Rolston, MD, PhD, Associate Professor of Neurosurgery, Harvard Medical School.
“This robust, peer-reviewed validation clearly demonstrates that the advantages of Prism result in excellent predictability of targeted cell death. Our comparison of histopathology to damage estimation is arguably the most definitive test we could have performed and was part of the dataset that led to FDA clearance,” commented Chris Osswald, PhD, Director, Global Segment Leader for Laser Therapy at ClearPoint Neuro.
Additionally, the Prism System has been used together with the Company’s recently FDA cleared Array software version 1.2 to improve the practicality of neuro laser therapy. The SmartFrame Array Neuro Navigation System combines hardware and software designed to streamline neurosurgical procedures2 and enable more workflow options for both laser ablation and drug delivery procedures. Array’s new “Parallel Trajectory” feature allows for combination biopsy and laser therapy procedures, for example, to be performed in a single setting, through a single frame alignment, without the biopsy void interfering with the accuracy of thermometry.
The Prism System features the only non-cooled neurosurgical laser applicators on the market. ClearPoint’s next-generation laser applicator technology eliminates the need for external cooling, simplifying setup, reducing power and ablation time, lessening imaging artifact, and enabling more efficient workflows. Currently, Prism is in limited market release at select academic medical centers across the United States.
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 preclinical 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, which may include 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.
1 Singh H, Osswald CR, Rossman A, et al. Preclinical assessment of a noncooled MR thermometry–based neurosurgical laser therapy system. Journal of Neurosurgery . Published online March 08, 2024. doi:10.3171/2023.12.JNS232154 2 Sterk B, Taha B, Osswald C, Bell R, Chen L, Chen CC. Initial Clinical Experience With ClearPoint SmartFrame Array-Aided Stereotactic Procedures. World Neurosurg. 2022;162:e120-e130. doi:10.1016/j.wneu.2022.02.095
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What are the results of the in vivo validation study announced by ClearPoint Neuro?
The in vivo validation study demonstrated that the ClearPoint Prism Neuro Laser Therapy System provides accurate brain tissue temperature measurement with a mean absolute error of <1°C.
Who conducted the research study on the Prism System?
The research was conducted by ClearPoint Neuro and its Swedish partner, Clinical Laserthermia Systems AB (CLS), with Dr. John Rolston as the Principal Investigator.
What are the applications of the Prism System according to John D. Rolston, MD, PhD?
John D. Rolston mentioned that Prism offers precise and efficient laser interstitial thermal therapy for patients with intractable epilepsy, movement disorders, and brain tumors.
What is the significance of the Prism System being used with the recently FDA cleared Array software version 1.2?
The Array software version 1.2 enhances the practicality of neuro laser therapy by combining hardware and software to streamline neurosurgical procedures and enable more workflow options.
What are the advantages of the Prism System's next-generation laser applicator technology?
The next-generation laser applicator technology eliminates the need for external cooling, simplifies setup, reduces power and ablation time, lessens imaging artifact, and enables more efficient workflows.
