CLS Again Releases TRANBERG® Sterile Disposable Products into the US Market
LUND, Sweden, Nov. 18, 2021 (GLOBE NEWSWIRE) — Clinical Laserthermia Systems AB (publ) (CLS), developer of high precision, image-guided focal laser ablation (FLA) systems, today announced the company is once again releasing its complete range of TRANBERG sterile disposable products into the US market via its subsidiary CLS Americas Inc.
As a result of the intensive work of recent months to develop a new solution for sterilizing the company’s disposable products, CLS is now releasing its complete range of TRANBERG® sterile disposable products into the US market through its subsidiary CLS Americas Inc. In April 2021, the company recalled all its sterile disposable products as a result of the company’s previous supplier of these services being deprived of its certificate due to poor quality in its processes.
“It is with great satisfaction that I can now state that we again have sterile disposable products on the market. This has been achieved after intensive work landing a new supplier solution for our sterilization
that includes the German sterilization company Rose GmbH. In a next step, we will also release the complete range of our sterile disposable products for the European market. We expect to do so in the coming weeks,” says Dan Mogren, acting CEO of CLS.
Release and resumption of deliveries of sterile disposable products in Europe will take place after final approval by CLS’s notified body, TüV Süd.
A new solution for sterilization of the company’s disposable products also includes a build-up of redundancy to help ensure access to a validated sterilization process and capacity at more than one supplier. Such a solution provides the necessary flexibility and prevents future interruptions in the company’s product delivery to the market.
CLS develops and sells TRANBERG® products for minimally invasive, high precision, image-guided laser ablation. In the EU, the products are approved for the treatment of soft tissue and malignant tumor disease. CLS initially focuses here on the treatment of malignant tumor disease in the prostate in the early stages, treatment of pancreatic cancer, and treatment in the brain of malignant tumor disease and drug-resistant epilepsy.
In the US, CLS’s product portfolio has a market approval for soft tissue ablation and is sold mainly for image-guided, minimally invasive treatment in the prostate of malignant tumor disease in the early stage. Image-guided treatment means that the doctor uses magnetic resonance (MR) or ultrasound (US) image guidance during the treatment to identify the treatment area, determine the placement of instruments, and to monitor the ablation procedure with high precision and accuracy.
About Clinical Laserthermia Systems
Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG® Thermal Therapy System, including sterile disposables, for minimally invasive treatment of soft tissue such as cancer tumours and drug-resistant epilepsy, according to regulatory approvals in the EU and the US. 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: www.clinicallaser.se.
This press release has been translated and adapted from Swedish. The Swedish text shall govern for all purposes and prevail in case of any discrepancy with the English version.
This information is such that CLS AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the care of the contact person below, for publication on November 17, 2021 at 13:00 PM CET.
CONTACT: Company contact: Clinical Laserthermia Systems AB Dan J. Mogren, Acting CEO T: +46 – (0)705 – 90 11 40 E: dan.mogren@clinicallaser.com
