IRVINE, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems AB (publ) (CLS), today announced the American Medical Association (AMA) has approved its application and issued a Category level III Current Procedural Terminology (CPT®) reimbursement code for “transperineal focal laser ablation of malignant prostate tissue with ultrasound guidance.” The new code is expected to be formally finalized and active from July 1, 2021.
The CPT terminology is the most widely accepted medical nomenclature used across the U.S. to report and reimburse for medical, surgical, and radiology procedures under public and private health insurance programs. CPT code descriptors are clinically focused and utilize common standards so that a diverse set of users can have common understanding across the clinical health care paradigm.
“The new code gives healthcare providers the ability to register treatments and usage of our TRANBERG® Thermal Therapy System. The code registrations, together with collected clinical data, provide information for a future decision on level of reimbursement. An established category level I code with a defined reimbursement is expected to have a positive impact on CLS’ commercial activities. This represents a first and very important step in implementing our commercial strategy in the U.S.,” says Dan Mogren, Chief Commercial Officer at CLS AB.
CLS developed its TRANBERG Thermal Therapy System with Thermoguide thermometry software and single-use accessories for image-guided, high precision soft tissue thermal therapy and laser ablation of tumors and soft tissues. The system’s tight integration with MRI scanners is designed to enable precise monitoring, real-time tissue temperature measurements, and cell damage calculations during treatments for exact therapy, precise guidance, and ablation control. The system includes a desk-top mobile laser unit, thermometry software for real-time temperature mapping of MRI images during treatments, and non-cooled laser applicators and accessories.
Clinical Laserthermia Systems AB (publ), develops and sells the TRANBERG® |Thermal Therapy System including specially designed sterile disposable products for the minimally invasive ablative treatments of soft tissues and 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 on 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: info@fnca.se. Further information is available on www.clinicallaser.se.
The TRANBERG®|Thermal Therapy System has not yet received market clearance for immune stimulating interstitial laser thermotherapy (imILT®) or its Thermoguide thermometry software by the Food and Drug Administration (FDA) in the United States of America (USA).