Two additional ClearPoint™ Prism systems installed in the U.S.
Lund, Sweden – Clinical Laserthermia Systems AB (publ) (“CLS” or “the Company”) today announces that its global distributor within neurosurgery ClearPoint Neuro Inc. installed two additional ClearPoint Prism™ Neuro Laser Therapy Systems in the U.S. In total, there are now three of the company’s system for MR-guided laser ablation installed on the American neurosurgery market.
CLS’s global distributor ClearPoint Neuro Inc, continues the limited market release in the U.S. of ClearPoint Prism Neuro Laser Therapy System, which is the new brand name for the laser ablation system for MR-guided procedures in the brain. During the first quarter, ClearPoint Neuro Inc. installed two additional systems on the American market, which makes a total of three established systems at leading neurosurgery centers in the U.S.
“We expect to remain in limited market release throughout 2023 as we gain experience with the system across multiple sites and surgeons, but also with different scanners and different patient indications such as brain tumors and drug resistant epilepsy. These cases will help build our educational tools ahead of the upcoming, broader release in 2024,” said Joseph Burnett, President & CEO, ClearPoint Neuro, Inc.
“We are very pleased with the team at ClearPoint Neuro and with their achievements establishing the Prism Neuro Laser Therapy System for MR-guided NeuroLITT procedures on the American market. The team at CLS is also very much involved providing on-site product training and technical support, as well as collecting user feedback towards the upcoming broader release next year.” said Dan J. Mogren, CEO, Clinical Laserthermia Systems AB.
In addition to the commercial launch in the US, there is an ongoing clinical trial with ClearPoint Prism Neuro Laser Therapy System at Skåne university hospital in Lund, Sweden. The primary purpose is to collect clinical data which is to be used for submission of market approval in Europe. The clinical study was recently extended and an additional up to 10 glioblastoma patients will be treated.
The information was submitted for publication, through the agency of the contact person set out below on May 16, 2023.
For more information, please contact:
Dan J. Mogren, CEO, Clinical Laserthermia Systems AB (publ)
Phone: +46 (0) 70-590 11 40
E-mail: dan.mogren@clinicallaser.com
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 65 active sites in North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 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, more than 6,000 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.
About CLS
Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG®|Thermal Therapy Systems, including Thermoguide Workstation and sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy, according to regulatory approvals in the EU and the US. The products are marketed for image-guided laser ablation and used in studies for treatment with imILT®, the Company's interstitial laser thermotherapy for immunostimulant ablation with potential abscopal effects. CLS is headquartered in Lund and has subsidiaries in Germany, the US and Singapore. CLS is listed on the Nasdaq First North Growth Market under the symbol CLS B. The Certified Advisor (CA) is FNCA Sweden AB, Tel: +46 8 528 00 399. E-mail: info@fnca.se.
For more information about CLS, please visit the Company's website: clinicallaser.se