CLS focuses on the Neurosurgery business area to optimize capital allocation, secure profitability targets and implement associated cost savings

Lund, Sverige - Clinical Laserthermia Systems AB (publ) ("CLS" or "the Company") today announces that the Company has decided to revise its strategy to increase the possibility to achieve the Company's prioritized goal of reaching a positive cash flow in 2026. The revised strategy means the Company prioritizes and increases its investment in the neurosurgery business area, which is expected to result in significantly improved profitability during the period 2024-2026. The focus on neurosurgery also enables significant cost savings for the Company of approximately SEK 65 million during the same period.

The background to announced changes to the business is the strength of the ClearPoint Prism® product offering, a strength that has become increasingly clear in the spring of 2024 through the initial market launch in the US carried out by CLS commercial partner, ClearPoint Neuro, based in California, USA. As a result, CLS has decided to reallocate resources to the Neurosurgery business area and the full market launch of the Prism® Neuro Laser Therapy System that ClearPoint Neuro initiates in the US in the second half of 2024. During the spring, the companies have jointly taken several decisive steps to, among other things, further strengthen the product offering and expand the market in the US, steps that include ClearPoint Neuro's FDA 510(k) approval for Prism® Bone Anchor Accessory and the addition of CLS MR-introducer to the ClearPoint Prism® product portfolio. All things considered; this means that the Company is expected to achieve double the number of installations in the business area by the end of 2026 compared to what was predicted at the beginning of this year.

 

Consequently, within the Urology business area, CLS will focus its operations on ensuring that negotiations, agreements and clinical collaborations entered in the US and European markets are fulfilled. The company plans to re-accelerate its commercial efforts in urology with its TRANBERG® product portfolio and related services towards the end of 2025. This means that the ambition for 2026, which was communicated in January 2024 of 20 active customers in the US, is reduced by half and with a priority on large annual treatment volumes. CLS operations in Singapore are not affected.

 

The reprioritization and change in the direction of operations that CLS has now decided on also entails an expected reduction in the company's costs, which are expected to decrease by approximately SEK 65 million during the period 2024-2026.

 

CLS target of achieving a positive operating profit (EBITDA) for the financial year 2026 remains, while the possibility of achieving this target is expected to increase through decided changes to the business. To achieve a positive operating profit, CLS currently estimates that slightly smaller sales of approximately SEK 70 million are required during the same year.

 

"After stress-testing our forecasts during the spring, it is reassuring that, with the news presented today, we are reducing the risk in the business and strengthening our ability to be cash flow positive in 2026. With these changes, CLS and ClearPoint Neuro create the right conditions to fully benefit from the potential in neurosurgery while not compromising our potential in the field of urology," says Dan J. Mogren, CEO of CLS.

 

In connection with this, CLS will shortly carry out a business update where this announcement will be presented in more detail.

 

 

For further information, please contact:

Dan J Mogren, VD
Phone: [phone]

E-mail: [e-mail]

 

This press release has been translated from Swedish. The Swedish text shall govern for all purposes and prevail in case of any discrepancy with the English version.

 

About CLS

Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG®|Thermal Therapy Systems, including Thermoguide Workstation and sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy, according to regulatory approvals in the EU and the US. The products are marketed for image-guided laser ablation and used in studies for treatment with imILT®, the Company's interstitial laser thermotherapy for immunostimulant ablation with potential abscopal effects. CLS is headquartered in Lund and has subsidiaries in Germany, the US and Singapore. CLS is listed on the Nasdaq First North Growth Market under the symbol CLS B. The Certified Advisor (CA) is FNCA Sweden AB.

 

For more information about CLS, please visit the Company's website: www.clinicallaser.se

This disclosure contains information that CLS is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 21-05-2024 08:50 CET.

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