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©Copyright 2024 CLS AB. All rights reserved.
MM-2022-025/Rev2
As our prosperity grows and life expectancy increases, more people are afflicted by difficult to treat illnesses. As an example, currently more than 19 million people are affected by cancer and almost ten million people die of the disease. In the year 2040, it is expected that over 30 million people will suffer from cancer with over 16 million deaths. This development demands new treatment alternatives so an increasing number of patients can be treated more effectively and with fewer and less serious side effects. This is where laser ablation has an important role to play in the future.
CLS’ vision is that laser ablation will be introduced as standard treatment in focal therapy and as an alternative to surgery for several patient groups. Laser ablation is an excellent form of focal therapy where laser technology is used to heat and destroy tissue to remove benign and malignant solid soft tissue tumors, including in the prostate and brain, with minimal impact on adjacent healthy tissue. The method is also used for the treatment of neurological conditions when drugs do not work satisfactorily, such as some patients with epilepsy. Therefore, prostate cancer, brain tumors and epilepsy are the indications on which CLS is primarily focused.
Laser ablation is minimally invasive and well-tolerated by patients. Compared with traditional surgery, the method is safer and more precise, takes less time to perform, and means faster recovery after the procedure. The treatment is also an alternative when tumors cannot be reached by traditional surgery.
For prostate cancer patients, focal therapy carried out with laser ablation is already an alternative to waiting until the disease has deteriorated to a stage where traditional surgery can be justified. For patients with drug-resistant epilepsy, laser ablation is a recognized, but currently underutilized, treatment for reducing or eliminating the number of attacks.
Additional benefits are that laser ablation procedures are carried out in real time with the help of imaging, such as ultrasound or MRI, which makes them more precise with minimal risk of damage to the surrounding tissue. The method is also cost effective and widely available[1] which saves societal and healthcare resources, gives extended survival, and improves patient quality of life. Together, these factors have meant that demand for laser ablation as a treatment alternative to surgery has increased strongly – both from patients and healthcare providers.
CLS’ treatment system is also currently being used in studies for the treatment of the diseased tumor area so that the immune system is stimulated to attack any metastases (immune stimulating interstitial thermo-therapy, imILT), also called systemic immune reaction. This is currently an exciting area of research in immune-oncology and CLS hopes to be able to offer a complement to drugs which currently have significant side effects.
The addressable market for each indication within CLS’ main markets – the USA and the five largest markets in Europe and the Asia-Pacific region – are significant. For example, each year more than 425,000 people in Europe and the USA are diagnosed with localized prostate cancer, which is one of CLS’ focus areas. It is estimated that globally approximately 1,275,000 people have been diagnosed with localized prostate cancer and the number of diagnosed cases is expected to almost double by 2040. Treatment guidelines in the USA and Europe recommend that patients with localized prostate cancer are either placed on active monitoring or undergo radical therapy (radiation or surgery). In those cases where the disease is discovered at an early stage, the risks with radical treatment are often judged as outweighing the benefits and so active monitoring is recommended. Receiving this information can be stressful for the patient due to the anxiety it creates.
This situation leads to an increased demand for treatment alternatives between active monitoring and radical therapy. This is the gap CLS intends to fill. In 2019, the market in Europe and the USA for the minimally invasive treatment of prostate cancer was valued at approx. USD 35 billion. This value is expected to grow by nearly 12 percent annually to 2027[1]. Starting in Europe and the USA, CLS plans to commence commercialization of its treatment system for localized prostate cancer in 2022.
The global drug market for the type of tumor disease in the brain (glioblastoma) CLS is targeting will reach almost USD 1.8 billion in 2027 and have an annual growth rate until then of almost 13 percent[2]. The global market for epilepsy drugs was estimated to be approx. USD 4.6 billion in 2020 and is expected to reach USD 5.8 billion in 2027[3].
CLS’ treatment system for laser ablation can easily be integrated into today’s healthcare processes as they are compatible with two of the leading types of imaging systems used globally in healthcare. The treatment system and the disposable devices are CE-marked and FDA cleared and have strong patent protection. The business model based on selling treatment systems and associated disposable devices creates recurrent revenues for the company.
CLS has its headquarters in Lund, Sweden, local sales operations in Germany, the USA, Singapore and a distributor and collaboration partner in the USA. Based on established partnerships with hospitals, clinics and distributors globally in both oncology and neurology, the objective is to achieve the clinical evidence needed for the fastest possible route to market. The goal is that tomorrow’s cancer and neurology patients will have access to yet another treatment option that is safe, effective and gives an improved quality of life.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4080850/
[2] https://www.medgadget.com/2021/01/north-america-and-europe-minimally-invasive-prostate-cancer-surgery-market-is-accounted-for-us-86187-4-million-in-2019-with-11-9-cagr-by-2027-coherent-market-insights.html
[3] https://www.ihealthcareanalyst.com/global-glioblastoma-multiforme-drugs-market/
[4] https://www.prnewswire.com/news-releases/world-epilepsy-drugs-market-and-global-epilepsy-drugs-competitor-market-share-scenario-2020-2027-301246381.html
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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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©Copyright 2024 CLS AB. All rights reserved.
MM-2022-025/Rev2