CLS obtains extended EC-certificate for Europe, expanded to include FLA, for the TRANBERG® system
Clinical Laserthermia Systems AB (publ) has obtained an extended EC certificate for the TRANBERG®|Thermal Therapy System. When applying for the renewed certificate CLS also applied for, and got approved, an expansion, in order for the certificate to also include focal laser ablation treatment (FLA) in Europe.
The FLA approval is wide and allows treatment of most organ. It has no limitations as to type and stadium when it comes to treated cancer tumors. The extension means that the system continues to be approved for sale and use on the European market in the area of ”Medical laser system for immunostimulating treatment of solid cancer tumors and for other surgical applications”.
CLS received the original EC approval for the product in 2013. The certificate is valid for five years and in order to get it extended a new application has to be filed. This includes a new product review. The expansion, to also cover FLA, was fully reviewed according to the requirements for a new indication for an existing product.
- To get a product EC approved is a comprehensive work. In order to keep the certificate we need to constantly live up to the quality demands for the product, with regards to the specific applications stated in the certificate, said Lars-Erik Eriksson, CEO of CLS. During the years that we have had the certificate we have received feedback from the market and implemented a few technical changes in the product. These changes must be reported to the authorities. Our certificate is now extended and we can continue our marketing activities as planned. We can also fully market use for FLA in Europe, in the same way that we already do on the U.S., said Lars-Erik Eriksson.
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.
Lars-Erik Eriksson, CEO, Clinical Laserthermia Systems AB (publ)
Tel: +46 – (0)702 – 90 33 00 E-mail: lee@clinicallaser.se
Clinical Laserthermia Systems AB (publ), develops and sells the TRANBERG®|Thermal Therapy System and specially designed sterile disposable products for safe, gentle and effective treatment of cancerous tumors. The products are marketed for image-guided laser ablation and for treatment with immunostimulating interstitial laser thermotherapy, imILT®. The company, which is headquartered in Lund Sweden and have subsidiaries in Berlin, Germany and Boston, MA,USA, is listed Nasdaq First North under the ticker CLS B. Certified Adviser is Västra Hamnen Corporate Finance. Further information is available on the company’s website: www.clinicallaser.se