| Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
|---|
| Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
|---|
| Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
|---|
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.
Posted In: CLPT
