According to Prostate Cancer UK “Focal therapy means removing the cancer, while leaving the rest of the organ intact. This is done to retain as much normal function as possible, and so attempt to reduce the side effects, and recovery times, associated with radical treatment options”.
Today, CLS offers focal therapy systems for both US-fusion and MR-guided focal laser ablation. Below our CTO Cristina Pantaleone and VP Medical Affairs Hoda Tawfik, explain how the TRANBERG® Thermal Therapy Systems have been designed for precise and safe focal therapy of soft tissue, such as the prostate gland, and what kind of research CLS is now supporting.
Cristina, you have been working with the development of CLS´s products since 2012 and is now Chief Technical Officer of the company. What are the benefits of using laser as the energy source for focal therapy?
Laser light is a unique energy source. Although it is technically an electromagnetic wave, which applies also for other energy sources used for focal ablation, it interacts with the tissue in a different way. By changing the properties of the laser beam, as well as the kind of laser applicator used, it is possible to optimize the treatment to the target tissue.
In addition, laser light passes through glass and plastic and does not require metallic delivery systems as microwave- and radiofrequency-based systems for focal therapy do. These properties of laser light make it well suited for use also in the MRI environment. So, for CLS it has been a natural step to develop applications for MR-guided focal therapy.
What does this mean for the physician and the patient?
From a therapy point of view, the size of a tissue ablation that can be achieved in one single shot is limited, when compared to for example microwave systems, but this can be compensated for by using the pull-back technique. It is also a factor that can be used to increase precision rather than a downside, and we believe this is the reason why focal laser ablation has demonstrated low risk of side effects, such as erectile dysfunction and urinary incontinence.
In addition, laser light radiation is not ionizing, which means that laser ablation can be safely repeated without cumulative risks if an extensive area needs treatment, or if repeated sessions are required.
How have the laser applicators been designed to ensure precise and safe treatment of patients?
Our proprietary unique production technique allows us to easily adapt the tip design of our laser applicators. We now offer laser applicators with three different tip variations. The current product portfolio was accurately developed and selected together with experienced urologists and radiologists to enable the physician to choose the most optimal tool for each patient case and, when needed, combine different tools during one treatment session.
Our non-cooled technology allows easier to use setup and no risks for leakages of coolant, which may be both an environmental risk and a risk for the patient, for example causing infections. The non-cooled technology also shows smaller artifacts when MR is used.
Hoda, you started working as VP Medical Affairs at CLS in 2021. What was it that attracted you to the company?
What attracted me was the innovative design of CLS´s technology and the opportunity for development in many different clinical areas, including prostate cancer, with a large unmet medical need.
What is your view of the potential of laser ablation and the TRANBERG® Thermal Therapy Systems in this area and how does the clinical program assist CLS in establishing its products in the market?
Both our systems for focal laser ablation have European CE marking for certain indications, including prostate cancer which represents a huge market. In the US our system for fusion-guided laser ablation is FDA cleared and it is already gaining a lot of interest. It is designed for use at the doctor’s office, which are common in the US, and the patient can generally go home within a few hours after treatment.
We promote the implementation of investigator-initiated studies, as well as registration of data for our focus therapy areas, including, prostate cancer. As a result, we can introduce TRANBERG® Thermal Therapy Systems for focal ablation in the medical networks, gain the confidence of treating physicians and establish the technology in the market.
What progress has been made in the clinical program and what are the current objectives?
We support the commencement of several investigator-initiated studies for prostate cancer at renowned clinical centers in Europe such as the university hospital in Magdeburg and the university hospital in Nijmegen and we are supporting a study being conducted by Urological Research Network, LLC, in Miami, US. We are planning for other investigator-initiated studies with prostate cancer patients in and outside Europe.
The clinical objectives right now are to obtain first results from the investigator-initiated studies in prostate cancer to establish the TRANBERG® Thermal Therapy System in the urology market and continue marketing and commercializing our products, both in Europe and in the US.
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Please note that all our products and indications are not yet approved in all markets. Don’t hesitate to contact us for up-to-date market approvals in your area!
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