CLINICAL LASERTHERMIA Aktie

 

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...

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...

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...

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‑...

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...

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...

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...

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...

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...

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 sheet The 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...

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...

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....

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...

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...

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...

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 handled Read the full article at biostock.se (https://www.biostock.se/en/): https://www.biostock.se/en/2025/04/cls-not-significantly-affected-by-...

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...