CLS has filed its 510 (k) application with the U.S. Food and Drug Administration (FDA) for the second generation of TRANBERG® | Thermal Therapy System with Thermoguide ™ Workstation.
Clinical Laserthermia Systems AB (publ) (CLS) announces today that the company has submitted its application for 510 (k) approval to the U.S. Food and Drug Administration (U.S. FDA) for the second generation of TRANBERG® | Thermal Therapy System with Thermoguide ™ Workstation
As a result of very extensive work, carried out in close collaboration with our partner Clearpoint Neuro Inc. (formerly MRI Interventions), which included generation of complex ex-vivo and in-vivo data from bench and animal studies performed in accredited laboratories in USA, CLS has submitted its 510 (k) application to the US Food and Drug Administration for the second generation of TRANBERG® | Thermal Therapy System with Thermoguide ™ Workstation for use in ablation of brain lesions.
- The submission of our application to the US FDA today is a very important milestone for CLS and a positive result of the intensive work carried out by CLS in close collaboration with Clearpoint Neuro Inc. in the U.S. Our goal has been to provide the FDA with an application that meets their requirements for information and data in the best possible way. This application takes us one step closer to launching products in the important U.S market for minimally invasive neurosurgery, says Dan J. Mogren, Acting CEO of CLS
With CLS 'new Thermoguide ™ Workstation, MRI-guided laser ablation is made possible. MR offers superior imaging for high precision navigation and positioning as well as ablation monitoring and control. CLS Thermoguide™ Workstation features state-of-the art MR based monitoring and control of the ablative treatment by continuously providing real-time 2D temperature mapping and tissue damage estimates in and around the target lesion. This means that the operator can follow the ablation in real time and optimize the treatment according each patient’s needs, with little risk of complications.
In Europe, CLS has TRANBERG® | Thermal Therapy System with Thermoguide ™ Workstation, approved since April 2020. CLS also has previous FDA clearance for TRANBERG® | Thermal Therapy System in USA, without Thermoguide ™ Workstation.
This press release has been translated from Swedish. The Swedish text shall govern for all purposes and prevail in case of any discrepancy with the English version.
Contact information:
Dan J. Mogren, acting CEO Clinical Laserthermia Systems AB (publ)
Tel: +46 – (0)705 – 90 11 40 E-mail: dan.mogren@clinicallaser.com
Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG®|Thermal Therapy System, 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 for treatment with imILT®, the Company's interstitial laser thermotherapy with potential immunostimulatory effects. CLS is headquartered in Lund and has subsidiaries in Germany, the U.S. 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, Phone: +46 8 528 00 399. E-mail: info@fnca.se.
For more information about CLS, please visit the Company's website: www.clinicallaser.se
This disclosure contains information that CLS is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 31-12-2021 09:50 CET.