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First patient treated with TRANBERG Thermal Therapy System in nationwide French study evaluating MRI together with biopsies to detect residual prostate cancer after focal therapy

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Lund, Sweden – Clinical Laserthermia Systems AB (publ) (“CLS” or “the Company”) today announced its participation in a national French study together with Urolib (urological team of the Medical Center Chateau Galland (MCCG)) in Besançon, France, and that the first patient was safely treated with CLS TRANBERG® Thermal Therapy system for laser ablation of prostate cancer.

 

The multicenter study, named the IRMPROFT Study, aims to investigate the “Performance of Prostate MRI and targeted biopsy to detect residual Prostate cancer following focal therapy”. Various focal therapy technologies are being used at the different study sites, and Urolib in Besançon has selected the CE-marked and FDA 510(k) cleared CLS TRANBERG® Thermal Therapy system as its focal therapy of choice.

 

According to the agreement, Urolib purchases the accessories and disposables needed for treatment and CLS provides technical and clinical support.

 

“We are pleased to have safely treated the first localized prostate cancer patient in France with the CLS TRANBERG system providing temperature controlled focal laser ablation (FLA). Using Ultrasound-fusion for image guidance, we were able to position the Laser Applicator of the TRANBERG system exactly as planned”, says Dr Pierre-Charles Henry, one of the principal investigators for Urolib.

 

“During the laser ablation procedure, the Temperature Probes of the TRANBERG System allowed us to continuously monitor the tissue temperature in real-time, providing important information to optimize the treatment while sparing surrounding tissue. We look forward to enrolling more patients in this nationwide clinical study investigating the accuracy of biopsies after treatment with focal therapy”, says Dr Henry.

 

“Urolib has impressive experience in focal therapy, including FLA, and we are very proud that this centre has chosen to use the CLS TRANBERG system for treatment in this study”, says Perjan Pleunis, VP Sales Europe, CLS. “The principal investigators of Urolib, urologists Dr. Vincent Bailly and Dr. Pierre-Charles Henry, also have an extensive experience in MRI-Ultrasound fused biopsy techniques that work well together with the CLS products”, says Perjan Pleunis.

 

About localized prostate cancer

About 1.400.000 new cases per year of prostate cancer are reported worldwide with approximately 350.000 of them within EU. Although there are many prostate cancer treatment options, there is still an important unmet need for patients with localized prostate cancer who progress to intermediate risk stage. The currently available surgical options show significant risks and side effects related to urinary and erectile functions and quality of life.

 

About Urolib

Urolib is located at the Medical Center Chateau Galland in Besançon that works in close relationship with the Clinique Saint Vincent, part of ELSAN Groupe which is the largest group of private clinics in France which even has its own university.

 

Urolib is one of the biggest private urological team in France (10 urologist). They are also a reference site in France for Philips (Uronav platform for targeted biopsies), and a reference site in France for focal treatments of prostate cancer (one of the major sites for the training in hifu).

 

For more information about Urolib, please contact:

Dr Pierre Charles Henry

E-mail: henrypc2311@gmail.com

 

Dr Vincent Bailly

E-mail: docteur.bailly.urolgie@gmail.com

 

Or visits the websites: www.urolib.org and Château Galland Medical Center, Medical practice in Besançon www.doctolib.fr .

 

About ELSAN and clinic Saint Vincent

ELSAN, a leader in private hospitalization in France, is present in all hospitalization professions and in all regions of France to offer quality, innovative and humane care to everyone and everywhere. ELSAN has 28 000 employees and 7 500 private doctors who work in the group's 140 establishments. They care for more than 4,2 million patients per year. Two out of three French people live less than 50 km from an ELSAN establishment. Acting and innovating for the health of all in the heart of the regions is the group’s “raison d’être”. www.elsan.care.fr

 

For more information about ELSAN and clinic Saint Vincent, please contact:

Brigitte Lemarquis

E-mail: brigitte.lemarquis@elsan.care

Or visit the hospital´s website: www.elsan.care/clinique-saint-vincent

 

 

 

 

For more information, please contact:

Dan J. Mogren, CEO Clinical Laserthermia Systems AB (publ)

Phone: +46 70-590 11 40

E-mail: dan.mogren@clinicallaser.com

 

 

About CLS

Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG®|Thermal Therapy Systems, including Thermoguide Workstation and sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy, according to regulatory approvals in the EU and the US. The products are marketed for image-guided laser ablation and used in studies for treatment with imILT®, the Company’s interstitial laser thermotherapy for immunostimulant ablation with potential abscopal effects. 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

 

For more information about CLS, please visit the Company's website: www.clinicallaser.se

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