Toronto General Hospital Physicians Presented Interim Clinical Study Results for MR-guided FLA Treatment of Low-intermediate Risk Localized Prostate Cancer at AdMeTech 4thGlobal Summit

Boston, MA, October 7, 2019 - Clinical Laserthermia Systems AB (CLS) today announced that Dr. Sangeet Ghai and other physicians at Toronto General Hospital presented a poster at the AdMeTech 4th Global Summit on Precision Diagnosis and Treatment of Prostate Cancer in Boston, MA on October 3-5, 2019. The poster describes interim clinical study results regarding MR-guided Focal Laser Ablation treatment of low-intermediate risk localized prostate cancer. See results here

The treatments in the study are being performed using CLS’s TRANBERG®|Thermal Therapy System, optimized for high-precision thermal ablation treatment.  

“The short term oncologic and functional outcomes for treatment of this group of patients is encouraging,” stated Dr. Sangeet Ghai, Vice Chief of Research and Abdominal Radiologist with the Toronto Joint Department of Medical Imaging (JDMI). “However, the long-term efficacy will be determined in the coming years.”

“It is very inspiring to see these first interim results from Dr. Sangeet Ghai’s work using our TRANBERG®|Thermal Therapy System. We look forward to continuing our collaboration through the outcome of this clinical study,” says Lars-Erik Eriksson, CEO at Clinical Laserthermia Systems. “Dr. Ghai’s work provides valuable clinical data and extensive user experience from treating early stage prostate cancer with CLS TRANBERG-products and technology.”

 

POSTER OVERVIEW  

Title:”Early Oncological and Functional Outcomes following MR guided Focal Laser Ablation (MRgFLA)” (Click to view full poster and results.) 

BACKGROUND:Men diagnosed with localized low to intermediate risk prostate cancer and a signicant life expectancy are usually offered the choice of two broad therapeutic options, either active treatment with surgery or irradiation with high risk of side effects.

Using its localizing strength, MRI has increased opportunities in management of prostate cancer. Additionally, MR thermometry allows real time peri-procedural monitoring to ensure selective and adequate tumor ablation.

Focal therapy (FT) for prostate cancer (PCa) reduces functional complications with promising oncological results. Magnetic resonance image (MRI)-guided Focal Laser Ablation (MRgFLA) potentially maximizes precision. In this Phase II study, non water cooled 1064nm diode laser bers were used for ablation.

PURPOSE & AIM:This study aims to determine the oncologic and functional outcomes of

MRgFLA in low-intermediate-risk localized PC in the single-center series of patients treated with the 1064nm diode laser fi­bers.

RESULTS: At time of reporting, treatment was successfully completed in 21 patients. Intratreatment parameters are shown in Table 1. 14 patients with 15 lesions completed their 6 month follow up. No adverse events were reported.

CONCLUSION:  MRgFLA shows encouraging short-term oncologic and functional outcomes

for the treatment of low-intermediate-risk prostate cancer. However, the long-term efficacy will be determined in the coming years.

AUTHORS OF THE POSTER: Sangeet Ghai1*, Nathan Perlis2, Masoom Haider1, Guan Hee Tan2, Kateri Corr2, Rosanna Chan1, Mark Gertner1, Alex Zisman2, Anna Konukhova1, Sarah Jokhu1, Theodorus van der Kwast3, Stuart McCluskey4, Antonio Finelli2.  

1 Jt Dept of Medical Imaging, University Health Network – Mt Sinai Hospital, University of Toronto 
2 Division of Urology, Dept of Surgical Oncology, University Health Network, University of Toronto 
3 Laboratory Medicine Department, University Health Network, University of Toronto
4 Dept of Anesthesia, University Health Network, University of Toronto 

The TRANBERG®|Thermal Therapy System has not yet received market clearance for immune stimulating interstitial laser thermotherapy (imILT®) by the Food and Drug Administration (FDA) in the United States of America (USA).

(Note: This press release was published in Swedish on October 4, 2019.) 

Dan Mogren, Chief Commercial Officer
P: +46 70-590 11 40 
E: Dan.Mogren@clinicallaser.com

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 immuno-stimulating interstitial laser thermotherapy, imILT®. The company, which is headquartered in Lund Sweden and has a subsidiary in Germany and USA, is listed Nasdaq First North Growth Market under the ticker CLS B. Certified Adviser: Certified adviser (CA) isFNCA Sweden AB, Ph: +46 8 528 00 399. E-mail: info@fnca.se. Further information is available on www.clinicallaser.se