- CLS is granted approximately SEK 20 million in project funding from the EU program Horizon 2020. The project involves three clinical studies and activities related to these.
- The Company finalizes its first post-market clinical follow-up report. The report is based on eight imILT® treatments with the TRANBERG® System. There have been no serious side effects reported that can be linked to the treatment – the system is safe provided that the treatment instructions are followed.
- CLS signs a letter of intent with the Department of Radiology at the University of Texas Medical Branch (UTMB).
- The US FDA grants CLS approval to market and sell its product, the TRANBERG® | Thermal Therapy System, on the US market.
- In cooperation with the University Hospital of Verona in Italy and the Institut Paoli-Calmettes in Marseille, France, CLS is granted approval to conduct studies of the treatment of pancreatic cancer.
- The Company releases a supplementary treatment kit that enables percutaneous treatment (i.e. treatment via needle stick approach) of tumors that are up to 35 centimeters deep in the body.
- CLS submits a 510(k) application to the US Food and Drug Administration (FDA) to seek approval of the TRANBERG® System for the US market.
- CLS is granted approval for CE marking of the TRANBERG® | Cancer Immunotherapy System.
- CLS initiates clinical studies in cooperation with a European medical center and begins development of additional treatment kits for outpatient use.
- The fourth round of funding is secured, providing SEK 20 million.
- The treatment system is tested and documented in accordance with the Medical Devices Directive 93/42/EEC (MDD).
- The Company’s partner INTERmedic delivers its first product in the “0 series”.
- CLS’ quality assurance system is certified in accordance with ISO 13485.
- A collaboration is established with a US laser fiber supplier.
- The Company enters into a cooperation agreement with Spanish development and production partner INTERmedic.
- The third round of funding is secured, providing SEK 16 million.
- The first prototype is complete.
- The Company is listed on the Aktietorget stock exchange.
- The second round of funding is secured, providing SEK 5 million.
- CLS wins Venture Cup Syd, a business plan competition aimed at promoting the implementation of business ideas.
- Clinical Laserthermia Systems (CLS) is founded by Karl-Göran Tranberg, Pär Henriksson and Lars-Erik Eriksson with the aim of developing a commercial product based on Professor Tranberg’s discovery that will be used by doctors to treat cancer worldwide.
- The first round of funding is secured.
- The Company enters into a cooperation agreement with a Swedish prototype development partner.
- Professor Karl-Göran Tranberg discovers that heat from laser beams can not only destroy cancer locally under the right conditions, but also stimulate the immune system to attack cancer throughout an organism.