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Our expanding portfolio of innovative, image-guided laser ablation solutions is designed to meet the new and challenging medical treatment requirements in the growing field of minimally invasive, interventional MR procedures.
Lars-Erik Eriksson, CEO of CLS
The Access-i software and the agreement with Siemens Healthineers is yet another step towards CLS’s goal to build the next generation of integrated, workflow-optimized solutions for precision ablation.
Dan Mogren, CCO at CLS
The Access-i software and the agreement with Siemens Healthineers is yet another step towards CLS’s goal to build the next generation of integrated, workflow-optimized solutions for precision ablation.
Dan Mogren, CCO at CLS
We are pleased and excited to continue our association with DMI as it demonstrates our relevance and effectiveness, in this area, compared with other leading products in the field of urology.
Dan Mogren, CCO
UTMB continues to choose our products for treatment of patients with early stage prostate cancer, or other tumor disease, in the prostate. UTMB has become an important reference for us in the USA-market and the collaboration with the hospital continues to develop in a positive way.
Dan Mogren, CCO
I am very pleased that Toronto General Hospital has chosen our products for its clinical study. We will in a systematic way get access to important data on how our products perform when used in MRI guided focal laser ablation treatment.
Lars-Erik Eriksson, CEO
It is very gratifying that UTMB choses to purchase our system and continue to use our products. Dr. Eric Walser has so far treated about 20 patients, with early stage prostate cancer, using CLS’ accessories for MR-guided focal laser ablation and the products are performing very well.
Dan Mogren, CCO
CLS’ goal for 2017, to initiate sales in the US market, has now been accomplished. We receive repeat orders from demanding customers. This indicates good marks for our products. In the long term I see huge opportunities for us to build a successful business in the US.
Dan Mogren, CCO
As previously announced two patients have received treatment. An image guided laser treatment procedure was carried out, aiming at reducing pain and decreasing /eliminating the vascular malformation, with an immediate positive outcome.
Dan Mogren, CCO at CLS
The relationship with UTMB and Dr. Eric Walser is important to us also in other ongoing discussions in the US. We believe that we are seeing the beginning of a commercial acceptance for our products’ features and pricing, and that we thereby are able to compete with bigger and more established suppliers within our market segment.
Dan Mogren, CCO at CLS
This is the first time we are part of this conference, targeting one of our main user groups, interventional oncologists. WCIO 2017 is an excellent forum for us to showcase our products and further expand our presence in the US market.
Dan Mogren, CCO at CLS
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Clinical Laserthermia Systems publishes annual report for 2025

Lund, Sverige – Clinical Laserthermia Systems AB (publ) (“CLS” or “the company”) today published its annual report for fiscal year 2025.Clinical Laserthermia Systems AB (publ) (“CLS” or “the company”) today published its annual report for fiscal year 2025. The report is available in Swedish on the company’s website https://clinicallaser.se/. It is also attached to this press release.     For more information, please contact: Dan J. Mogren, CEO Clinical Laserthermia Systems AB (publ) Phone: +46 (0)705 90 11 40 E-mail: dan.mogren@clinicallaser.com     About CLS

CLS enters research agreement with the U.S. National Cancer Institute

Clinical Laserthermia Systems AB (“CLS” or the “Company”) today announced that it has extended its research collaboration with the U.S. National Institutes of Health (“NIH”) through a new agreement with the National Cancer Institute (“NCI”), the largest institute within NIH focused on cancer research. The agreement extends CLS non-sponsored collaboration through 2029 and builds on the collaboration originally initiated in 2023.The purpose of the collaboration is to continue building clinical understanding and evaluating the clinical use of CLS’ Tranberg[® ]Thermal Therapy System in a non-

Notice of Annual General Meeting of Clinical Laserthermia Systems AB June 29, 2026

The shareholders of Clinical Laserthermia Systems AB, 556705-8903, are hereby invited to an Annual General Meeting on Monday June 29, 2026, at 16:00 CET, in the building Inspira at Scheelevägen 2, Medicon Village, Lund.Right to participate and registration Shareholders who wish to participate in the Meeting must: · be entered in the share register maintained by Euroclear Sweden AB on Thursday June 18, 2026, and · register with the company no later than Tuesday June 23, 2026, in writing to Clinical Laserthermia Systems AB, Scheelevägen 2, 223 81 Lund. Registration can also be made

CLS Publishes Interim Report January – March 2026

Lund, Sweden – Clinical Laserthermia Systems AB (publ) ("CLS" or the "Company") today publishes its interim report for January – March 2026.Highlights of First Quarter Interim Report 2026 During the first quarter, CLS continued to produce and deliver products, development, and support services to its partners, supporting the expansion of the installed base and adoption of its product portfolio. · Through its partner in neurosurgery, CLS saw continued ClearPoint Prism® System installations and procedure growth in the U.S., reflecting underlying clinical and commercial momentum. ·

CLS Receives Largest Purchase Order Worth SEK 23 Million for Prism[®] Business

Clinical Laserthermia Systems AB (“CLS” or the “Company”) today announced that it has received purchase orders totaling approximately SEK 23 million (€2.1 million) for its neurosurgery Prism® business from its strategic partner in neurosurgery. The orders represent the largest purchase order received to date for the Prism business and form part of the previously communicated agreement between the parties to accelerate the growth of the Prism® business beginning in 2026.The purchase orders support the planned expansion of commercial activities, including increased market penetration,

CLS Strengthens its Strategic Partnership in Neurosurgery and Aims to Become Market Leader in Neuro LITT

Clinical Laserthermia Systems AB (CLS) today announced it has reached an agreement with its strategic partner on an alignment to accelerate the growth of the ClearPoint Prism® business. The plan includes market expansion, product development and revenue growth with strengthened long-term outlook. The partnership runs through 2030, with an option for further extension, supporting CLS aim to become market leader in minimally invasive Laser Interstitial Thermal Therapy (LITT) within neurosurgery.The agreement follows extensive discussions during recent quarters and establishes a shared plan to

Clinical Laserthermia Systems AB publishes Year-end report January – December 2025

Lund, Sweden – Clinical Laserthermia Systems AB (publ) ("CLS" or the "Company") today publishes its Year-end report for January – December 2025.Highlights of the Year-end report 2025   The year 2025 represents the continued and disciplined execution of the strategic change initiated in 2024. During the year, CLS further strengthened its position as a commercially focused, partnership-driven company with a clear priority on neurosurgery. As previously communicated to the market, CLS has established the following financial targets:       Positive cash flow in the fourth quarter

TRANBERG[®] Thermal Therapy System installed at Andros Clinics for Launch of Ultrasound-Guided Focal Laser Ablation Program in The Netherlands

Clinical Laserthermia Systems AB (CLS) today announced the installation of the TRANBERG Thermal Therapy System at Andros Clinics in Amsterdam, through its distribution partner MTEC Company. The system is intended for ultrasound-guided focal laser ablation (FLA), a minimally invasive treatment option to radical prostatectomy for patients with localized prostate cancer.The first three patients have also been successfully treated at Andros Clinics, marking an important clinical milestone in CLS’s strategy to expand the adoption of FLA across Europe.   Treatment of prostate cancer with

CLS initiates recruitment process for permanent Chief Financial Officer

Clinical Laserthermia Systems AB (publ) (“CLS”) today announces that the company has decided to transition from its current interim, part-time consulting CFO arrangement to a permanent and fully employed Chief Financial Officer. The recruitment process for this position has now been initiated.The decision reflects CLS’s ambition to strengthen its financial leadership and establish a more cost efficient, long-term, scalable structure that supports the company’s continued growth, operational focus, and international expansion. “Our business is entering a stage where a full-time CFO is

Clinical Laserthermia Systems Submits CE-Marking Application for its ClearPoint Prism[®][ ]branded Neuro Laser Therapy System seeking European Regulatory Approval for use in Neurosurgery

Lund, Sweden – Clinical Laserthermia Systems AB (publ) (CLS) today announces that it has formally applied for CE marking of its ClearPoint Prism branded Neuro Laser Therapy System, seeking regulatory approval in Europe for use with 1.5T and 3.0T magnetic resonance imaging (MRI) guidance in neurosurgical procedures.Seeking regulatory approval in EU follows on CLS’s 2024 ISO‑certification in accordance with the European Medical Device Regulation (MDR), and the successful completion of the sponsored clinical study at Skåne University Hospital, which assessed safety and feasibility of MRI‑

CLS Publishes Interim Report January – September 2025

Lund, Sweden – Clinical Laserthermia Systems AB (publ) ("CLS" or the "Company") today publishes its interim report for January – September 2025.Highlights of the Third Quarter Interim Report   During the third quarter, CLS continued to strengthen its operational and financial position while producing and delivering products, development, and support services for growing the adoption and installed base of its product portfolio. · The company achieved a key regulatory milestone in the US-FDA clearance of the expanded labeling of CLS ClearPoint Prism® branded Neuro Laser Therapy

CLS-sponsored neuro LITT study in patients with malignant brain tumor shows positive results

Lund, Sweden, October 7th, 2025 – Clinical Laserthermia Systems AB (publ) (“CLS”) today announces positive results from a clinical safety study on laser ablation, performed using CLS proprietary LITT platform in patients with malignant brain tumor, conducted at Skåne University Hospital.Patients with recurrent malignant brain tumor that were treated with Laser Interstitial Thermal Therapy (LITT) had increased median survival compared to a matched control group treated with open surgery. The study’s primary objective – to investigate whether the CLS proprietary LITT platform was safe and

Clinical Laserthermia Systems AB Raises SEK 20.9 Million Through Full Subscription of Warrants of Series TO 8 B

NOT FOR RELEASE, DISTRIBUTION, OR PUBLICATION, WHETHER DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SWITZERLAND, SINGAPORE, SOUTH AFRICA, RUSSIA, BELARUS, OR ANY OTHER JURISDICTION WHERE THE RELEASE, DISTRIBUTION, OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE ADDITIONAL REGISTRATION OR OTHER MEASURES. SEE THE SECTION "IMPORTANT INFORMATION" AT THE END OF THIS PRESS RELEASE. Lund, Sweden, 30 September 2025, Clinical Laserthermia Systems AB (publ) (“CLS” or the “Company”) today announces that all 5,500,000

Clinical Laserthermia Systems Receives FDA Clearance for Expanded Labeling of the ClearPoint Prism[®] Neuro Laser Therapy System, doubling the addressable U.S market for Neuro LITT

Lund, Sweden – September 4th, 2025 – Clinical Laserthermia Systems AB (publ) (“CLS” or “the Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for expansion of the labeling of ClearPoint Prism[®] Neuro Laser Therapy System. In addition to the existing clearance for use with 3.0 Tesla (3.0T) magnetic resonance imaging (MRI) guidance, the system is now also cleared for use with 1.5T MRI guidance.The expanded clearance significantly broadens the accessibility of the Prism Neuro Laser Therapy System for U.S. hospitals and patients, as

CLS publishes half-year report January – June 2025

Lund, Sweden – Clinical Laserthermia Systems AB (publ) ("CLS" or the "Company") today publishes its half year report January – June 2025. Second Quarter Highlights · Record sales revenue of SEK 9,4M, a 67% year-over-year increase compared with the second quarter 2024 · Minimal short-term impact from U.S.–EU tariffs · US-FDA review underway for expanded labeling of ClearPoint Prism® to include 1.5T MRI compatibility, doubling the TAM in U.S · Strong team and partner performance, continued market expansion, and a structurally lower cost base · Board of directors strenghted

Communique from the Annual General Meeting on Friday June 27th in Clinical Laserthermia Systems A

Today, 27 June 2025, the Annual General Meeting of Clinical Laserthermia Systems AB ("CLS" or the "Company") was held. Below is a summary of the resolutions that were passed. The resolutions were passed with the required majority.Resolution regarding appropriation of the company's profit according to the adopted balance sheetThe Board of Directors resolved at the Annual General Meeting to allocate the Company's earnings in accordance with the Board's proposal in the annual report. The meeting resolved in accordance with the Board's proposal that no dividend be paid for the financial

Clinical Laserthermia Systems publishes annual report for 2024

Lund, Sweden – Clinical Laserthermia Systems AB (publ) (“CLS” or “the company”) today published its annual report for fiscal year 2024.­ Clinical Laserthermia Systems AB (publ) (“CLS” or “the company”) today published its annual report for fiscal year 2024. The report is available in Swedish on the company’s website https://clinicallaser.se/. It is also attached to this press release.     Contact information: Dan J. Mogren, CEO Clinical Laserthermia Systems AB (publ) Tel: +46 – (0)705 – 90 11 40 E-mail: dan.mogren@clinicallaser.com       About CLS

Notice of Annual General Meeting of Clinical Laserthermia Systems AB June 27, 2025

The shareholders of Clinical Laserthermia Systems AB, 556705-8903, are hereby invited to an Annual General Meeting on Friday June 27, 2025, at 10:00 CET, in the building Inspira at Scheelevägen 2, Medicon Village, Lund.Right to participate and registration   Shareholders who wish to participate in the Meeting must: · be entered in the share register maintained by Euroclear Sweden AB on Wednesday June 18, 2025, and  · register with the company no later than Monday June 23, 2025, in writing to Clinical Laserthermia Systems AB, Medicon Village, Scheelegatan 2, 223 81 Lund.

Clinical Laserthermia Systems AB publishes Interim report for January – March 2025

Summary of the interim report (relates to the Group)   Three months (01/01/2025–03/31/2025) · Net sales totaled SEK 4,496,000 (SEK 3,140,000). · Operating profit totaled SEK -7,868,000 (SEK -16,992,000). · Profit/loss after financial items totaled SEK -15,230,000 (SEK -12,397,000). · Basic and diluted earnings per share totaled SEK -0.68 (SEK -1.89). · The equity ratio on March 31, 2025, was 88% (81%).­   Significant events in the first quarter of 2025 · CLS announced that the outcome of the Investigator Initiated Trial (IIT) in Nijmegen evaluating the

Clinical Laserthermia Systems, together with its partner ClearPoint Neuro, announces FDA submission to expand the labeling of ClearPoint Prism® to include 1.5 T MRI guidance

Lund, Sweden – Clinical Laserthermia Systems AB (publ) (CLS), a leading developer of image-guided laser ablation systems, announces the submission of its 510(k) application to the U.S. Food and Drug Administration (FDA) for expanding the indication of ClearPoint Prism to also include 1.5 T MRI guidance.This submission is a result of and marks a key milestone in CLS’s strategic partnership with ClearPoint Neuro, Inc., and will expand the labeling of ClearPoint Prism to include both 3.0 T and 1.5 T MRI guidance on its labeling.   “The expanded indication of ClearPoint Prism, once

Updated clinical guidelines provide clear recommendations on the use of Laser Interstitial Thermal Therapy (LITT) in patients with metastatic brain tumors and radiation necrosis

Clinical Laserthermia Systems AB (publ) ("CLS or the "Company") today announces that updated clinical guidelines with recommendations supporting the use of Laser Interstitial Thermal Therapy (LITT) has been published by Congress of Neurological Surgeons (CNS).The guidelines named “Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines Update for the Role of Emerging Therapies in the Management of Patients with Metastatic Brain Tumors”, authored by Huntoon K et al are published in the high-impact medical journal Neurosurgery, and the background and importance of

BioStock: CLS not significantly affected by tariffs

Clinical Laserthermia Systems announces that the proposed U.S. tariffs are expected to have minimal impact on the company, despite the fact that its products are manufactured in the EU and shipped to the U.S. The company’s U.S. operations are fully managed by its subsidiary, CLS Americas Inc., which gives CLS control over the import process. Additionally, the company’s agreements with partners already include clear terms on how tariffs are to be handledRead the full article at biostock.se : https://www.biostock.se/en/2025/04/cls-not-significantly-affected-by-

Proposed U.S. tariffs expected to have minimal impact on CLS business

Lund, Sweden – Clinical Laserthermia Systems AB (publ) (“CLS” or “the Company”) clarifies that the proposed U.S. tariffs are expected to have minimal impact on its total business, including operations in the United States.This assessment is based on several key factors:  Established U.S. Presence CLS’s U.S. business is managed entirely through its wholly owned subsidiary, CLS Americas Inc., which oversees all imports and sales within the country. This setup gives CLS full control over its U.S. operations and limits exposure to external disruptions. The proposed U.S. tariffs will

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