CLS Filed 510 (k) Application with the United States Food and Drug Administration (FDA) for the Second Generation of TRANBERG® | Thermal therapy system with Thermoguide ™ workstation.


Laserthermia Systems AB Clinic (publ) (CLS) announces today that the company has submitted its 510 (k) approval request to the United States Food and Drug Administration (we FDA) for the second generation of TRANBERG® | Thermal therapy system with Thermoguide ™ workstation

The result of very thorough work, carried out in close collaboration with our partner Clearpoint Neuro Inc. (formerly MRI Interventions), which included the generation of complex ex-vivo and in-vivo data from bench and animal studies performed in accredited laboratories in the United States, CLS submitted its 510 (k) application to United States Food and Drug Administration for the second generation of TRANBERG® | Thermal therapy system with Thermoguide (TM) workstation for use in the ablation of brain damage.

– The submission of our application to United States FDA today is a very important step for CLS and a positive result of the intensive work carried out by CLS in close collaboration with Clearpoint Neuro Inc. in the we Our goal has been to provide the FDA with an application that best meets its information and data requirements. This app brings us one step closer to launching products in the large US market for minimally invasive neurosurgery, says Dan J. Mogren, Interim CEO of CLS

With the new Thermoguide (TM) workstation from CLS, MRI-guided laser ablation is made possible. MRI offers superior imaging for high precision navigation and positioning as well as ablation monitoring and control. The CLS Thermoguide (TM) Workstation provides state-of-the-art MRI-based monitoring and control of ablative therapy by continuously providing real-time 2D temperature mapping and estimates of tissue damage in and around the lesion target. This means that the operator can follow the ablation in real time and optimize the treatment according to the needs of each patient, with little risk of complications.

In Europe, CLS to TRANBERG® | Thermal therapy system with Thermoguide (TM) workstation, since approved april 2020. CLS Has Also Obtained Prior FDA Clearance For TRANBERG® | Heat therapy system in the United States, without a Thermoguide (TM) workstation.

This press release has been translated from Swedish. The Swedish text shall prevail for all purposes and shall prevail in the event of any discrepancy with the English version.

Contact information:Dan J. Mogren, Interim CEO Laserthermia Systems AB Clinic (published)
Tel: +46 – (0) 705 – 90 11 40 E-mail: [email protected]

Laserthermia Systems AB Clinic (published) develops and markets the TRANBERG®| Heat therapy system, including a Thermoguide workstation and sterile disposables, for the minimally invasive treatment of cancerous tumors and drug-resistant epilepsy, in accordance with EU and US regulatory approvals. The products are marketed for image guided laser ablation and for treatment with imILT®, the Company’s interstitial laser heat therapy with potential immunostimulatory effects. CLS is headquartered at Lund and has subsidiaries in Germany, the we 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, Telephone: +46 8 528 00 399. E-mail: [email protected].

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 in accordance with the EU Market Abuse Regulation (EU No 596/2014). The information has been submitted for publication, through the contact person, on 31-12-2021 9:50 a.m..

https://news.cision.com/cls/r/cls-has-filed-its-510–k–application-with-the-us–food-and-drug-administration–fda–for -the-second, c3480184

https://mb.cision.com/Main/11591/3480184/1516074.pdf

(c) Decision 2021. All rights reserved., source Press Releases – English


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