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Clinical Laserthermia Systems AB - A medical device star on the rise on the fast-growing Cancer Immunotherapy Market

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As the world’s first device-based laser immunotherapy, imILT® will curve its own market niche on the fast-growing Cancer Immunotherapy Market and therefore have a significant disruptive effect on this market.

Clinical Laserthermia Systems AB ($CLSB).

 imILT® – immune stimulating Interstitial Laser Thermotherapy

A novel therapy developed through the research of Swedish Professor Karl-Göran Tranberg and marketed by CLS.

EU Horizon 2020 SME instrument Champion

The INTHER project will bring the groundbreaking immune stimulating Interstitial Laser Thermotherapy (imILT®) to the market and clinical practice. This minimally invasive therapy is designed to achieve local tumor destruction and stimulate specific antitumor immunity in a patient’s body.

In recent years, anti-cancer therapies based on activation of the immune system have grown in significance and popularity. This approach is especially viable for patients who previously had very few treatment options. However, only approx. 20 % of all patients respond to drug-based immunotherapies of today. The key need of medical oncologists is to increase those response rates and thus decrease cancer-related suffering, increase life expectancy and survival rates for the patients. The project will meet those needs by delivering a novel device-based cancer immunotherapy method that destroys the tumor locally and induces long-lasting, vaccination-like, systemic immunity against the treated form of cancer.

As the world’s first device-based laser immunotherapy, imILT® will curve its own market niche on the fast-growing Cancer Immunotherapy Market and therefore have a significant disruptive effect on this market.

The studies performed to date have confirmed the therapeutic capability of the new method. In the project, the method will be further validated for the two chosen solid tumor types: pancreatic cancer and breast cancer. This will enable CLS to shorten the time to full commercialization, obtain the clinical acceptance and fully exploit the commercial potential of the new treatment method.

The clinical uptake of imILT® in Europe will lead to reduction of costs associated with the treatment of solid tumors, especially surgeries, and reduction of costs related to the activation of immunotherapies.

CLS’ strategy is based on intensive efforts towards validating imILT® and bringing it to the market. The project is a key step towards realizing this business strategy.

The imILT® procedure

The principle behind the immune stimulating interstitial thermotherapy (imILT®) is simple, but the procedure requires great precision and control.

imILT® is developed for metastatic cancer, meaning cancer that has spread from the part in the body where it started (the primary site). When cancer cells break away from a tumor, they can travel to other areas of the body through the bloodstream or the lymph system (which contains a collection of vessels that carry fluid and immune system cells). With imILT® treatment activated cytotoxic T-cells home in on and kill tumor tissue throughout the body and set an immunological memory.

An optical laser fiber is inserted into the tumor. Laser light is then used to heat the tumor, in a gentle and controlled way, causing a process where the tumor then dies within a few days and antigens start leaking out of the tumor cells. The antigens activate the body's immune system, which then also attacks other tumors and metastases in the body.

This immunological effect is generated by treating the tumor with a temperature that is so low that the tumor's antigenic proteins are preserved. These proteins come into contact with the immune system and stimulate an immunological defense against tumor disease. The method can be used for both curative and palliative treatment. Curative treatment aims to cure the patient of cancer.

Indications for which treatment with imILT® is suitable include breast, skin, lung, prostate, kidney, liver and pancreas tumors. Globally, it is estimated that over 5 million patients could potentially benefit from curative or palliative treatment with imILT® per year.

The user groups that CLS focuses on for this product include medical specialists in surgical oncology and oncologic interventional radiology at both publicly financed and private cancer treatment centers around the world. The market also includes important groups such as other specialists involved in the decision-making process for the individual cancer patient’s treatment plan.

For patients, imILT® could provide extensive medical benefits since the treatment is expected to produce lasting immunity (comparable to vaccination) against the treated form of cancer. In addition, the number of side effects associated with traditional therapy such as surgery, radiotherapy and chemotherapy can be reduced if some of these procedures are replaced by imILT®. In summary, imILT® entails decreased cancer-related suffering and socioeconomic savings through more effective therapy, with lower expenses for both inpatient care and outpatient follow-up care.

Focal Laser Ablation (FLA)

An evaluation of CLS’ products for treatment with Focal Laser Ablation (FLA) was initiated in the beginning of 2017 and the first treatments of early stage prostate cancer (PCA) and enlarged prostate (BPH) has been performed at UTMB Texas under the supervision of Dr. Eric Walser with satisfying results.

See video with Eric Walser,

The first tests performed at the University of Texas Medical Branch (UTMB) in the United States, has the objective to introduce CLS's single-use materials more broadly to interventional radiologists and urologists for the treatment of early neoplastic disease of the prostate. Every year 400,000 cases of prostate cancer suitable for FLA are reported in Europe and the United States.

Image-guided FLA is a method primarily used today for treatment of early localized prostate cancer (PCA). While imILT® is aimed at activating the immune system, FLA is intended to kill the parent tumor, which is done by using a higher temperature and shorter treatment time compared to imILT®. The treatment is performed by a urologist or an interventional radiologist using MRI or CT images and ultrasound.

Clinical studies

The imILT® treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes.

Today CLS focuses a large part of its efforts on clinical evaluation of imILT® and the TRANBERG® | Cancer Immunotherapy System. Given their regulatory approval, the mechanism of action and the technology used in their device, imILT® can be performed in all types of solid malignant tumors, with the exception of those located in hollow organs. Investigating the clinical outcome of imILT® is the obvious goal for their clinical studies which is carried out in cooperation with European KOLs (Key-Opinion-Leaders). imILT® treatment in the clinical studies include cancer in: breast, liver, lung, pancreas, prostate and skin.

Combined therapies

Focus of the development of new cancer therapies has recently centered significantly around combinations of proven therapies. Previous studies of the imILT® method have shown that it works satisfactory in conjunction with surgical excision. However, based on the experience with similar local ablative techniques, there is reason to believe that imILT® will work well together with conventional treatments and novel immune stimulating pharmacutical drugs. Therefore, the company currently evaluates several combination strategies both pre-clinically as well as through evaluation of data gathered in the ongoing clinical trials.

BEST CEO in the Medical Devices Industry 2016 was awarded to CLS, CEO Lars Erik Eriksson

CEO Lars-Erik Eriksson explains how the technology works. By putting a fibre into a solid tumour and heating it with a laser, CLS can kill the tumour and trigger an immune response to tackle metastasis. He also discusses focal laser ablation for prostate cancer, and the future view of combining cancer treatments to personalise patient care.

Recent developments in CLS market penetration abroad

First repeat-order from UTMB,c2393496

The Tranberg system has been evaulated with great results for treatment of vascular malformations in the US.,c2378000

Portuguese television highlights the imILT treatment method.,c2394255

CLS launches US website focusing on MRI guided laser ablation.,c2397180

CLS expands it´s product portfolio with new diffuserfiber adressing larger tumors.,c2403492

CLS receives strong method and technology patent i China.,c2405188

CLS signs supplier agreement with yet another hospital in the US,c2377990

CLS signs supplier agreement with University of Texas Medical Branch,c2377980

CLS presents preclinical work at SITC 2017,c2352740

CLS obtains it´s first order for MRI guided laser ablation in the US,c2281827



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