Company Updates Timeline for 510(k) Filing in the U.S.
IRVINE, Calif. and LUND, Sweden, May 22, 2020 (GLOBE NEWSWIRE) — Clinical Laserthermia Systems AB (publ) (CLS) today announced it is conducting new in-vivo precision laser ablation treatment studies for neuro and prostate using its TRANBERG Thermal Therapy System with Thermoguide thermometry software. The company is also currently preparing its application for 510(k) clearance from the American Food and Drug Administration (FDA) for the U.S. market.
Recent dialog between CLS and the FDA has brought about new information. Most notably, the demand for preclinical data is now more extensive than the company initially expected, primarily for products to be used in neuro applications, but also for use in other indications. This quarter, CLS will initiate preclinical studies in neuro and prostate scheduled to last throughout the year.
In April 2020, CLS obtained EU approval and an EC Certificate for the TRANBERG System, Thermoguide software and related products to be marketed and sold in Europe for indications such as prostate cancer, brain tumors, and epilepsy.
CLS’s current expected timeline for filing its application for 510(k) clearance with the FDA is estimated to take place during the first half of 2021. The timeline and plan could be affected by the ongoing Covid 19 pandemic and travel restrictions within the U.S. and EU.
“We now have a detailed overview of the FDA’s latest requirements, which have been previously difficult to foresee. This enables us to recalibrate and align our resources towards the access and organisations necessary for carrying out the work with, among other things, the preclinical studies,” says Stephan Dymling, CTO at CLS. “Our goal is to begin executing the new plan at the highest pace and productivity the current situation and the prerequisites allow.”
“CLS has current FDA clearance and several North American hospital customers for its current portfolio of TRANBERG products. We will continue to market and sell our existing products while finalizing the application for the new TRANBERG Thermal Therapy System with Thermoguide Workstation,” says Dan Mogren, Chief Commercial Officer at CLS. “In Europe, where we now have approval to market and sell also the Thermoguide Workstation, we will increase our sales resources and market activities during the upcoming period. We are also ready to meet with potential customers as soon as countries open up after the pandemic.”
The TRANBERG® Thermal Therapy System includes a small, user-friendly mobile laser unit with unique monitoring capabilities and tailored single-use products specifically developed to enable safe, efficient, precision laser ablation procedures using all types of image guidance. The system is optimized for controlling and monitoring tissue temperatures within the ablation volume and the surrounding tissue.
CLS’s MRI-integrated Thermoguide software is intended to provide real-time tissue temperature measurements and cell damage calculations by accessing scanner sequences in real time with minimum latency. Software guides the user in achieving targeted treatment size and margin and assists in minimizing risk of damage to adjacent sensitive structures. This enables physicians to optimize each treatment procedure for the patient.
About Clinical Laserthermia Systems AB
Clinical Laserthermia Systems AB (publ), develops and sells the TRANBERG® |Thermal Therapy System including specially designed sterile disposable products minimally invasive treatment of cancerous tumors, in accordance with regulatory approvals in EU and USA. The products are marketed for image-guided laser ablation (FLA, LITT) and for treatment with imILT®, the company’s interstitial thermotherapy with a potentially immune stimulating effect. CLS is headquartered in Lund, Sweden and has subsidiaries in Germany and Irvine, CA. CLS is listed Nasdaq First North Growth Market under the ticker CLS B. Certified Adviser (CA) is FNCA Sweden AB, Ph: +46 8 528 00 399. E-mail: firstname.lastname@example.org. Further information is available on www.clinicallaser.se.
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: Clinical Laserthermia Systems AB: Company Contacts Lars-Erik Eriksson, CEO P: +46 70 290 33 00, E: email@example.com Dan Mogren, Chief Commercial Officer P: +46 70-590 11 40 E: Dan.Mogren@clinicallaser.com Media Contact: TopSpin Communications Joe Waldygo, President P: +1 480-363-8774 E: firstname.lastname@example.org