During the start of 2021, Clinical Laserthermia Systems (CLS) has had an active newsflow. The company announced, among other things, that it has strengthened its organisation with three new employees, and that it has received another order from American Immunophotonics within the framework of an ongoing study. Thus, in line with its strategy, CLS has started 2021 by preparing the company to establish itself on the global market.
Lund-based CLS develops innovative products for image-guided laser ablation treatment with high precision. The CLS TRANBERG Thermal Therapy System is approved in the EU for the treatment of the soft tissue, and CLS has chosen to initially focus on the treatment of metastatic prostate cancer, pancreatic cancer, brain tumours, and epilepsy. In the United States, the TRANBERG system is used to treat soft tissue metastases, such as those from prostate cancer. The system is optimised for treatment with the imILT protocol, a protocol developed by CLS that is used in metastatic cancer and has the potential to stimulate the immune system.
New order from Immunophotonics
CLS started the year with the announcement of another order in its collaboration with American Immunophotonics. The two companies have an ongoing collaboration where Immunophotonics conducts a clinical phase Ib/IIa study in patients with solid cancer tumours. The study combines the CLS TRANBERG Thermal Therapy System with Immunophotonics drug IP-001,and the new order concerns single-use instruments for patient treatment.
In a press release, acting CEO Dan Mogren expressed his satisfaction with the news:
»It is a very positive signal that the study is progressing, despite the limitations that Covid-19 has placed on the entire healthcare system. In terms of revenue, it is not a big order, but I think we can all agree that it is gratifying to see that planned clinical studies can continue to recruit patients. I am also pleased that the treating physicians in the study consider the TRANBERG Thermal Therapy System to meet expectations and that they choose to proceed after they have treated the first patients« — Dan Mogren, acting CEO, CLS
Strengthening the organisation
In its latest quarterly reports, CLS has outlined the milestones that the company has ahead of it. The company needs clinical data from treatment with the TRANBERG system, partly as a basis for market approval, and partly as support when selling the system. These are important for the company’s continued establishment on the European, American, and Asian markets.
CLS now complements the resources required in these areas and strengthens its organisation with three new recruits in the form of Lotta Ljungberg, Hoda Tawfik, and Perjan Pleunis. Ljungberg takes on the role of VP Regulatory Affairs & Quality Assurance and her most recent position was at Biora where she was quality manager. Tawfik, who was previously CMO/COO at Magforce Nanomedicine, will be CLS’ new VP Clinical Affairs. These additions will strengthen CLS in its continued global establishment by laying a solid foundation within regulatory approvals and clinical data.
Perjan Pleunis takes the position as new VP Marketing and Sales Europe. The recruitment of Pleunis represents an important step in the launch of CLS ’new generation of products for image-guided ablation treatment, primarily in the brain and prostate, on the European market. According to the company, Pleunis, who has previously had leading roles in e.g., Brainlab and Mevion Medical Systems, is to play a key role as CLS now expands its product range on the European market.
During 2021, CLS has also moved its US office to Irvine Office Plaza, Irvine, California. The company has a distribution collaboration with American ClearPoint Neuro as well as clinical collaborations with, among others, the University of Texas Medical Branch, which uses CLS single-use instruments in laser ablation treatment of localised prostate cancer.
»As everyone knows, the United States was hit hard by the pandemic during 2020. My hope is that as the vaccination programs are implemented, we will be able to meet with potential customers again and demonstrate the product hands-on« — Michael Magnani, managing director, CLS Americas.
EU-patent for product developed by CLS
January ended with good news when the company received a new patent in the EU. The patent is valid until 2036 and goes under the name Apparatus and Method for Controlling Laser Thermotherapy. It protects the technology and methods that CLS use in the new sterile single-use introducer developed in-house with integrated tissue temperature measurement, a so-called Tissue Temp Introducer.
CLS develops the product in collaboration with physicians who have experience of treatment with the TRANBERG Thermal Therapy System. One of the advantages of the product is that it reduces the need for separate temperature probes during treatment. This will not only make it easier for the treating physicians, but the product is also a proof of CLS’ ongoing work to develop new and improved products.
The stock market has received the news flow during the first weeks of the year well, and CLS stock is up by approximately 10 per cent. The next update for the market will be on February 26, when the year-end report for 2020 is published.
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