Clinical Laserthermia Systems

What Clinical Laserthermia Systems does

Clinical Laserthermia Systems AB (CLS) is a Swedish public medical device company founded in 2006 and listed on Nasdaq First North Growth Market under the ticker CLS B, headquartered in Lund, Sweden, with wholly-owned sales subsidiaries in Germany (Berlin), the United States (Irvine, California), and Singapore. The company develops and commercializes image-guided laser ablation systems for minimally invasive treatment of localized prostate cancer, brain lesions (including glioblastoma and drug-resistant epilepsy), and other soft tissue tumors. Its core product portfolio consists of the TRANBERG Thermal Therapy System for urology/oncology applications and the ClearPoint Prism Neuro Laser Therapy System for neurosurgery, both centered on a 1064nm wavelength laser, proprietary non-cooled laser applicators, and the Thermoguide Workstation software that performs real-time MRI thermometry using proton resonance-frequency (PRF) shift analysis to visualize tissue temperature and ablation extent during procedures. The systems integrate with major MRI scanner brands (Siemens Healthineers and GE Healthcare) and can also operate with ultrasound-fusion guidance.

CLS makes money through a hybrid capital-and-consumables model: one-time sales of the TRANBERG and ClearPoint Prism laser units, accessories, and workstations to hospitals and clinics, paired with recurring per-procedure sales of sterile disposable laser applicators and temperature probes that the company states generate gross margins above 60%. Go-to-market is also hybrid: an exclusive global distribution partnership with ClearPoint Neuro Inc. handles the neurosurgery product line worldwide; regional distributors (including Tecnogamma in Italy) cover parts of the European urology market; and direct sales operations through CLS GmbH, CLS Americas Inc., and CLS Asia Pacific Pte Ltd. handle key hospital and academic medical center accounts. The company pursues clinical evidence generation through partnerships with sites such as Skåne University Hospital, Radboudumc, the NIH Clinical Center, University Health Network Toronto, and Urological Research Network to support regulatory clearances (FDA 510(k) and CE marking) and adoption. As of FY2025, CLS reported revenue of SEK 17.5 million with a 67% gross margin and a 38% reduction in operating expenses alongside SEK 37 million of capital raised during the year.

Name

Clinical Laserthermia Systems

Legal name

Clinical Laserthermia Systems AB

Website

https://clinicallaser.se

Company type

Public

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Image-guided laser ablation medical devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Energy-Based Surgical Devices (Electrosurgery, RF, Ultrasonic, Laser) (HLAHADAC)

akta.pro secondary industry

Interventional Radiology & Image-Guided Therapy Systems (HLAHABAG)

Keywords

• Image-guided laser ablation
• Interstitial thermal therapy
• MRI-guided neurosurgery systems
• Focal prostate therapy
• Laser ablation disposables

Headquarters

HQ city

Lund

HQ country

Sweden

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Personnel, Marketing or Sales, Supply Chain, Others

Revenue model

1. System Sales: Revenue from sale of TRANBERG Thermal Therapy Systems and ClearPoint Prism Neuro Laser Therapy Systems to hospitals and clinics. Systems include desktop mobile laser units, accessories, and software workstations.
2. Procedure-based Disposables: Recurring revenue from sterile disposable laser applicators and temperature probes used in each procedure. Generates >60% gross margin with recurring revenue stream from procedure volume.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

Clinical Laserthermia Systems (CLS) designs, manufactures and commercializes image-guided laser ablation systems for minimally invasive treatment of cancer and neurological disease. Its two flagship offerings are the TRANBERG Thermal Therapy System (for MRI- or ultrasound-fusion-guided focal laser ablation of localized prostate cancer and other soft-tissue tumors) and the ClearPoint Prism Neuro Laser Therapy System (for neurosurgical laser interstitial thermal therapy of brain lesions such as glioblastoma and epileptogenic foci), each supported by the Thermoguide Workstation software for real-time MRI thermometry. The company also sells sterile, single-use laser applicators and temperature probes as recurring procedure-based disposables.

Product overview

Clinical Laserthermia Systems (CLS) offers a unified product portfolio centered on image-guided laser ablation systems for minimally invasive treatment of cancer and neurological conditions. The core portfolio consists of two main product lines: the TRANBERG Thermal Therapy System (for urology/oncology applications including prostate cancer focal therapy) and the ClearPoint Prism Neuro Laser Therapy System (for neurosurgery, distributed by ClearPoint Neuro). Both systems share key enabling technology including the Thermoguide Workstation for MRI-based thermometry and temperature monitoring, non-cooled laser applicators, and integration with MRI scanners from Siemens Healthineers and GE Healthcare. The company is also developing imILT (immunostimulating interstitial laser thermotherapy) as an expansion of its technology platform with potential abscopal treatment effects. All TRANBERG components have received EU-wide CE-marking (class II) for soft tissue lesion treatment.

Differentiator

Problem solved

Functional benefit

Brands

• TRANBERG Thermal Therapy System: Integrated therapy systems for high precision laser ablation with real-time monitoring and control, used for prostate cancer and other soft tissue treatments.
• ClearPoint Prism Neuro Laser Therapy System
• Thermoguide Workstation

Products and services

• TRANBERG Thermal Therapy System

Quantifiable outcome

• 23 of 26 sites of prostate cancer were free of disease at treatment site on 6-month biopsy and 19 of 26 sites at 24 months in Phase II trial participants
• +2 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration7 records

Feature4 records

Partnerships

Ten partnerships are on record, tiered minor and core.

• Tecnogamma (Italy)minorChannel Partner/ Reseller/ Distributor · 19 April 2024Italian distributor co-hosting CLS training camp in Turin for European distributors within urology. Provides local market access and clinical support for TRANBERG product portfolio.
• Genesis Research, LLC (Unio Health Partners)coreStrategic or Co-development Partner · 5 May 2023Phase I clinical study: Micro Ultra-Sound Guided, Transperineal Focal Laser Ablation of Low-to-Intermediate Risk Prostate Cancer. Affiliate of Unio Health Partners conducting clinical research.
• NIH Clinical CentercoreStrategic or Co-development Partner · 13 April 2023Research collaboration to access clinical utility of TRANBERG system for MRI/Ultrasound fusion-guided focal laser ablation of prostate tissue and prostate cancer in male patients.
• HALO Diagnostics (HALO Dx)minorStrategic or Co-development Partner · 21 March 2023Post-market study to evaluate safety and short-term efficacy of TRANBERG system for treating low-to-medium risk prostate cancer patients.
• ClearPoint Neuro Inc.coreChannel Partner/ Reseller/ Distributor · 26 September 2022Exclusive global distribution partnership for neurosurgery. ClearPoint Neuro commercializes the ClearPoint Prism Neuro Laser Therapy System powered by CLS technology. Combines ClearPoint's navigation system with CLS's laser ablation system for complete MR-guided stereotactic laser ablation procedures.
• Quadia Diagnostic Imaging CenterminorStrategic or Co-development Partner · 11 May 2022Commercial evaluation agreement for second-generation TRANBERG system with Thermoguide Workstation in MR-guided stereotactic focal laser ablation of localized prostate cancer. Leading Polish MRI diagnostics site.
• Urological Research Network (URN)coreStrategic or Co-development Partner · 5 April 2022Phase I clinical study partnership with Dr. Fernando J. Bianco for Targeted MRI/US Fusion Transperineal Laser Ablation of Low-to-Intermediate Risk Prostate Cancer using TRANBERG system with Focalyx Fusion device.
• Focalyx TechnologiescoreTechnology or Integration · 5 April 2022Product integration partnership for image-guided fusion devices. Focalyx Fusion medical device used with TRANBERG system for treatment planning, image fusion, and real-time image guidance during focal laser ablation procedures.
• Radboud University Medical CentercoreStrategic or Co-development Partner · 18 February 2022Investigator Initiated Trial evaluating MR-guided focused laser ablation as focal therapy for localized prostate cancer using TRANBERG system with Thermoguide Workstation. Integrates with MR-scanner and robotic system for procedure navigation.
• Skåne University HospitalcoreStrategic or Co-development Partner · 16 February 2022Clinical trial sponsorship for MR-guided laser interstitial thermal therapy (MRgLITT) for glioblastoma ablation using TRANBERG system. Single-center prospective trial evaluating safety and feasibility in five patients. Provides clinical data for CE marking expansion.

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Medtronic (Visualase): Medtronic acquired Visualase in 2014 and markets the Visualase MRI-guided laser ablation system for neurosurgery. Direct competitor to CLS's ClearPoint Prism system in LITT (laser interstitial thermal therapy) procedures, with much larger commercial reach but a water-cooled applicator design.
• Monteris Medical: Monteris Medical markets the NeuroBlate system, a minimally invasive MRI-guided laser ablation platform for neurosurgery. Direct competitor in MR-guided LITT with CO2-cooled laser probe technology and established US clinical footprint in brain tumor and epilepsy procedures.

Emerging players

• Profound Medical: Profound Medical develops the TULSA-PRO system for MRI-guided transurethral ultrasound ablation of prostate tissue. Comparable technology approach (MR-guided focal therapy for prostate cancer) but uses ultrasound rather than laser, with a similar commercial-stage profile targeting the same urology customer base.
• EDAP TMS: EDAP TMS markets Ablatherm and Focal One high-intensity focused ultrasound (HIFU) systems for prostate cancer and other urological applications. Targets a similar urology customer base with a different energy modality but competing for the same focal therapy market position.
• Insightec: Insightec develops Exablate, a MR-guided focused ultrasound platform used for both neurosurgery (essential tremor, Parkinson's) and other soft tissue ablation. Competes in the same image-guided minimally invasive therapy category but uses focused ultrasound rather than laser energy.
• IceCure Medical: IceCure Medical develops cryoablation systems (ProSense) for breast, kidney, lung, and prostate tumors. Competes in the percutaneous tumor ablation category with a different energy modality but targets similar minimally invasive oncology indications.
• SonaCare Medical: SonaCare Medical markets Sonablate high-intensity focused ultrasound (HIFU) systems for prostate tissue ablation. Comparable small-cap profile targeting focal prostate cancer therapy using ultrasound rather than laser energy.
• HistoSonics: HistoSonics is developing histotripsy platforms using focused ultrasound for non-thermal tissue destruction in liver and kidney applications. Emerging competitor in the broader image-guided ablation space with similar minimally invasive oncology positioning.

Broad incumbents

• Boston Scientific: Boston Scientific is a large incumbent medical device company with significant urology franchise and prostate treatment offerings (including cryoablation and HIFU via acquired Galil Medical). Could enter the focal laser ablation market or compete indirectly via alternative energy modalities.
• AngioDynamics: AngioDynamics markets medical devices for vascular access, tumor ablation (NanoKnife irreversible electroporation), and surgical specialties. Competes in the broader percutaneous tumor ablation market with overlapping oncology applications but uses electrical rather than thermal energy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCcqWsdxXFjgVfRASAjGEkbw
• LinkedInlinkedin.com/company/clinical-laserthermia-systems-ab-clsb-

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries3 records

Funding overview

Funding rounds5 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Clinical Laserthermia Systems