ClearPoint Neuro (Nasdaq:CLPT) today announced preclinical results highlighting the accuracy of its Prism neuro laser therapy system.
The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator technology eliminates the need for external cooling. This simplifies setup, reduces power and ablation time and lessens imaging artifact for more efficient workflows.
ClearPoint Neuro currently has the Prism laser in a limited market release at select academic medical centers in the U.S. The company also recently used Prism with its recently FDA-cleared Array software version 1.2 to improve the practicality of neurolaser therapy.
Investigators published their latest results from evaluations of Prism in the Journal of Neurosurgery. Data demonstrated accurate, near-real-time brain tissue temperature readings with a mean absolute error of <1°C from Prism. Morphology of the lesion, visualized by the Thermoguide MR-thermometry software, also correlated well with histopathology.
ClearPoint Neuro conducted the research with its Swedish partner, Clinical Laserthermia Systems AB (CLS). Dr. John Rolston served as principal investigator. Investigators set out to evaluate Prism’s safety, accuracy and efficacy.
According to a news release, the study achieved all three, demonstrating a predicted safety margin via survival histology, determining thermal damage thresholds that best predict irreversible tissue damage based on said histology and evaluating the accuracy of temperature prediction compared to actual temperature changes in vivo.
“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,” said Chris Osswald, director, global segment leader for laser therapy at ClearPoint Neuro.