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CLS updates time plan regarding FDA application for Thermoguide

CLS updates time plan regarding FDA application for Thermoguide

5 July, 2021
During 2020, Clinical Laserthermia Systems has received market approval in Europe for its MR-led minimally invasive soft tissue treatment product, the TRANBERG Thermal Therapy System, as well as  for its new Thermoguide thermometry software, for of which are used for treatment in organs such as the prostate and the brain. At the end of last week, the company also issued an update regarding the corresponding application for approval in the US. BioStock has talked to CEO Lars-Erik Eriksson about what this means and what next step is for CLS.

Lund-based Clinical Laserthermia Systems (CLS) works with image-guided laser ablation treatment of soft tissue, such as cancer tumours. In short, laser ablation means that laser light is led into the tumour, which causes the temperature of the cancer cells to rise and them to be destroyed. The treatment procedure is guided by ultrasound or magnetic resonance imaging (MRI). Thermoguide, CLS’s new thermometry software, is adapted for MRI and allows the physician, with high precision, to control the temperature and see the treated area of ​​the tumour throughout the procedure.

CLS’s products can be used for both focal laser ablation (FLA / LITT), as well as for the company’s proprietary immune-stimulating interstitial thermotherapy (imILT) method, which not only kills the tumour but also has the potential to affect the immune system so that any metastases shrink or are completely eliminated.

Approval in Europe

So far this year, CLS has taken several steps forward with both the TRANBERG Thermal Therapy System and Thermoguide. In April this year, the company received EU approval for Thermoguide as well as a renewed EC certificate for the TRANBERG Thermal Therapy System, including the associated software. This means that CLS’s products can now be sold in Europe for use in treatment indications such as prostate cancer, brain tumours and epilepsy.

Evaluation in Germany

More good news regarding the TRANBERG Thermal Therapy System came in March when CLS announced that the University Hospital in Magdeburg, Germany is evaluating the system for the treatment of small liver metastases. So far, the treatment has worked well and no side effects have been noted in the patients. At the end of April, the university hospital placed another order for disposable materials within the framework of the collaboration, which means that CLS has now invoiced the hospital a total of 220,000 SEK.

Read more about the collaboration with the University Hospital in Magdeburg here and here.

Further preclinical studies required for FDA approval

While working on the European approval, CLS has also filed an application to the FDA to obtain the corresponding approval for the TRANBERG Thermal Therapy System including Thermoguide for the US market. With regards to the TRANBERG Thermal Therapy System, the product already has FDA approval. The company has had a continuous dialogue with the FDA, during which it emerged that the FDA has more extensive requirements for preclinical studies than expected, especially for products to be used in the neuro-field.

So, at the end of last week, CLS announced that it will launch preclinical in vivo studies in both neuro and prostate treatment. The studies will start during the current quarter, and the company expects the studies to continue during the rest of 2020.

BioStock had the opportunity to ask a few questions of CLS’s CEO Lars-Erik Eriksson about the FDA application.

Lars-Erik, the FDA has decided that preclinical in vivo studies are needed for your application. Can you tell us a bit more about why the FDA makes this assessment?

Lars-Erik Eriksson, CEO at CLS

– Laser ablation is an established treatment alternative for the treatment of, among other indications, brain tumours and epilepsy. In recent years, the FDA has tightened the requirements for ablation products for use in the brain. The reason for this is that there were systems on the market that did not work well enough, even though they formally met the FDA’s requirements. Now the requirements have been tightened and since the TRANBERG system has not been used in this area before, it is natural for the FDA to be meticulous. The brain structures are very sensitive and therefore we must show that the product meets all the requirements and behaves in the same way as equivalent products in the area. It is about patient safety and that is just as important to us as it is to the FDA.

More specifically, what is it that the in vivo studies will examine?

– In the in vivo studies, treatment of brain and prostate tumours is performed in living tissue. This means that you can follow up on the treatment and ensure that no side effects occur after the end of treatment, which is of course essential. The FDA has also requested that the tissue destruction, which Thermoguide continuously calculates during a treatment, be correlated with other established methods, e.g. MRI contrast measurements and tissue histology. These types of evaluations will also be included in the preclinical study.

You expect to start the studies during this quarter, which of course places high demands on CLS’s internal organisation and resources. Do you have all the parameters in place to be able to start this venture so quickly?

– On the one hand, it places demands on our internal organisation but also on the external parties that will carry out parts of the work. We have hired a research institute in the US that meets current FDA requirements for preclinical studies, and we have a close collaboration with ClearPoint Neuro, who will conduct the studies with us.

When do you expect to be able to submit a complete application to the FDA?

– According to the plan, we should be ready to submit an application during the first half of 2021, when all analyses and compilations of the pre-clinical studies are ready. 

You have FDA approval for the TRANBERG Thermal Therapy System, and a number of hospitals in the US are already using the system. How, if at all, does this delay in approval for Thermoguide affect your work with marketing and sales of the TRANBERG Thermal Therapy System in the US?

– We will market the system in the US for prostate treatment, just as we are doing today, and we can also present Thermoguide and talk about the work that is being done to obtain approval for the product. We will continue to market and sell our disposable patient care instruments as we are currently doing now. However, we cannot sell the system integrated with Thermoguide in the US as we can Europe. Given how the coronavirus pandemic seems to be evolving, we see great opportunities to work with our hospital contacts in Germany, France and Iberia where we have already established contacts. In the US, we have sales resources locally through our own staff and through ClearPoint Neuro. We will be as effective as we can based on the conditions provided.

CLS products offer laser treatment with high precision

The CLS TRANBERG Thermal Therapy System includes a laser unit specially developed to be user-friendly, a system for monitoring and controlling tissue temperature as well as sterile disposable products that are replaced for each treatment session. The system measures and displays the temperature at various points in the tumour tissue and can be used in conjunction with all available image control techniques.

In addition, CLS has also developed a new software, Thermoguide, which, in combination with CLS laser systems, provides doctors with information on both temperature development and tissue destruction in real time. The fact that ablation can be monitored in real time enables the treatment to be optimised for each individual patient.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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