LOS ANGELES, Sept. 23, 2022 (GLOBE NEWSWIRE) — CLS Americasa subsidiary of Clinical Laserthermia Systems AB, and Focalyx Technologiesdeveloper of image-guided fusion target devices, today announced that the companies will exhibit and demonstrate their TRANBERG™ Heat Therapy System for focal laser ablation and Focalyx® Fusion medical device at FOCAL 2022 Conference will be held September 22-24, 2022 in Los Angeles. The theme of the conference is, ”Frontiers of prostate cancer care and local ablative therapy.
The TRANBERG™ System is designed to work with multiple MR/US fusion image guidance systems for accurate and precise tumor ablation in a minimally invasive ambulatory setting. Compared to other focal therapies, focal laser ablation therapy has demonstrated higher levels of precision and accuracy with a lower risk of side effects, such as erectile dysfunction and urinary incontinence.
“CLS Americas is excited to introduce its new desktop-based fusion-guided focal laser ablation solution to FOCAL 2022 attendees in collaboration with Focalyx Technologies and the Urology Research Network,” said Michael Magnani, President of CLS Americas. . “The treatment process and workflow is very similar to the workflow for fusion-guided transperineal prostate biopsies and cryoablations. This reduces the learning curve for urologists already familiar with these procedures.
In the United States, more than one million prostate biopsies are performed each year, leading to the diagnosis of prostate cancer in nearly 250,000 men. These patients are asking for emerging therapies as alternatives to standard treatments that have shown harmful long-term side effects.
“Some current treatment options for prostate cancer tumors expose patients to unacceptable complication rates for erectile dysfunction or urinary incontinence,” said Dr. Fernando J. Bianco, chief investigator of the Urologic Research Network . “Based on my clinical trial experience with CLS’s TRANBERG laser, I believe that focal laser ablation by partial gland fusion provides the precision needed to successfully treat cancerous lesions while providing patients with a profile higher side effects.
Lunch Presentation CLS Americas & Focalyx Technology
Dr. Fernando J. Bianco, chief researcher for the Urology Research Networka Florida-based nonprofit clinical research organization, will talk about their experience conducting their ongoing Phase I clinical study of 20 patients using the TRANBERG and Focalyx systems titled, “Targeted MRI/US fusion transperineal laser ablation of low-to-intermediate risk prostate cancer.”
Dr. Fernando Bianco is widely recognized as a pioneer of in-office fusion targeted therapies under local anesthesia and respected throughout the international medical community as an innovative urological oncologist. He started his full MRI/US program, Transperineal Fusion in 2013 and has since performed over 2,500 biopsies and 1,000 fusion targeted cryoablations in one office.
History and Experience of CLS – Image Guided Focal Laser Ablation of Prostate Tumors
CLS’s TRANBERG™ Thermal Therapy System has been used in hundreds of tumor laser ablation procedures in patients with localized prostate cancer in the US and EU using an MRI-guided procedure in the borehole. The safety and diagnostic accuracy of transperineal prostate biopsy guided by MRI/US fusion being well documented, this procedure and this technology in the outpatient setting are experiencing strong worldwide adoption. CLS takes its experience in intramuscular MRI and applies it to MRI/US, fusion-guided transperineal procedures and technology to perform focal laser ablation of prostate tumors with the TRANBERG® thermal therapy. CLS helps reduce the “focal therapy learning curve” to provide more patients with the added benefit of a safe, fast, and precise tumor ablation procedure.
High precision heat therapy system
The TRANBERG™ Thermal Therapy System was developed for image-guided, high-precision thermal therapy and soft tissue ablation procedures. The system can be configured for MR or MR/US fusion guided procedures utilizing tissue temperature feedback for precise therapy and ablation control. It includes a mobile desktop laser unit, innovative uncooled laser applicators, external tissue temperature probe sensors, and procedure-specific accessories. The TRANBERG System can be deployed in a transperineal or transrectal approach. Its uncooled fiber laser technology optimizes heat distribution, eliminates the need for external cooling, and helps reduce procedure times.
Focalyx® Fusion
Focalyx®Fusion is an innovative image fusion medical device. It originated from the Computational Biology program at the University College of London and was developed by Focalyx® Technologies, a Miami-based medical device manufacturing company. The Focalyx® Fusion allows the integration of an MRI diagnosis and a treatment plan from magnetic resonance imaging with real-time ultrasound. The contour of the prostate is introduced, and the two silhouettes are superimposed. The result is a very precise 3D image of the patient’s gland, in which it is possible to locate suspicious lesions with great precision using a GPS-like system. The diagnosed lesion is then safely ablated while preserving the prostate without compromising sexual and urinary functions. Thus, patients can maintain their quality of life.
About CLS and the TRANBERG® product portfolio
Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG® thermal therapy systems, including the ThermoguideTM workstation and sterile disposable items, for the minimally invasive treatment of cancerous tumors and drug-resistant epilepsy, in accordance regulatory approvals in the EU and the US. All components of TRANBERG® Thermal Therapy Systems have received EU-wide regulatory approval as medical devices (CE Marked Class II) for the treatment of soft tissue injuries. CLS is developing its systems to achieve Class III CE Marking for TRANBERG Disposable Laser Applicators for use in the brain, as well as extending the current CE Marking for treatment with imILT®, the company’s interstitial laser thermotherapy for ablation immunostimulatory with potential abscopal treatment effect. CLS is headquartered in Lund and has subsidiaries in Germany, the United States 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. Email: info@fnca.se.
For more information about CLS, please visit the company’s website for the US market:www.clinicallaser.com.
Corporate Contact: CLS Americas: Michael Magnani, President T: +1 (949) 504-5440 E: michael.magnani@clinicallaser.com Media Contact: CLS Americas TopSpin Communications Joe Waldygo, President T: +1 (480)363-8774 E: joe@topspinpr.com