Now, when summer is approaching and we’re all looking forward to enjoying some days off, it’s time to sumarize the news from the first half of 2024. In recent times, we have achieved great success in our neurology segment. The limited market launch in the US of the ClearPoint® Prism system, powered by CLS, has been successful and a new product, Prism Bone Anchor, which increases the addressable market significantly, has been launched by our partner ClearPoint Neuro Inc.

At the same time, the first clinical data have been presented, and new partnerships have been established within the urology segment.

Focusing on Neurology

Recently, CLS’s strategy was revised to focus more on neurosurgery. In this area CLS´s and ClearPoint Neuro´s joint offering was expanded to provide access to approximately 50 percent of the US market for NeuroLITT treatment in the brain, thanks to the launch of the Prism Bone Anchor.

The increased focus on neurosurgery increases our ability to also exploit the full potential of the market as we now enter the full market release in the US,” says our CEO Dan J. Mogren. 

Read the full Press Release here.

1st patient cases published 

In March, patient data after treatment using the Prism system was published for the first time in “The ClearPoint Prism® Laser Ablation System: A New Platform for Laser Interstitial Thermal Therapy (LITT) in Neuro-Oncology” by Dr Chen et al. Full publication here. 

The study’s objective was to assess the accuracy, safety, and effectiveness of the Prism system. The conclusion was that the ClearPoint Prism system provides technical advances over other currently available laser systems, while also providing a reassuring safety profile in the initial experience.

Full Market release announced

Full market release of ClearPoint PRISM® 3T Laser Therapy System, powered by CLS, was announced 1 June. The newly launched technology was on display at ASSFN2024. 

Read more here.

Furthermore, patient recruitment for the CLS-sponsored clinical ctudy at Skåne University Hospital was completed. Professor Peter Siesjö, principal investigator of the study comments,

The treatment system used for surgical intervention and navigation in the MR camera worked excellently in the completed clinical study. The benefits are obvious for the patients with less invasive interventions and shorter treatment times. For the healthcare system, the method provides the opportunity to offer treatment in cases where conventional surgery it not possible or suitable“.

Link to press release.

New Order from ClearPoint Neuro

In June CLS received additional orders from ClearPoint Neuro worth approximately SEK 7.5 million. The order is for ClearPoint Prism products and is part of ClearPoint Neuro’s full market launch in the US, which began in early June this year, and follows previous orders that CLS received around the turn of the year 2023/2024 totaling approximately SEK 10.5 million.

Full press release here.

Urology – Prostate Cancer update

Also within urology we have reached significant milestones in recent months. The first data have been presented from ongoing clinical trials, and new commercial agreements established in the field of prostate cancer treatments.

Clinical data and presentations at scientific meetings
  • Data from the investigator-initiated study at Radboud University Medical Center in Nijmegen, the Netherlands, was presented at the ECR 2024 (European Congress of Radiology) annual meeting in Vienna, Austria. This was the first-time data on the use of CLS’s MR-guided TRANBERG® system for Focal Laser Ablation (FLA) of localized prostate cancer was presented.
  • Also for our Ultrasound-guided TRANBERG system for FLA, the first clinical data was shared. This time an abstract by the investigators at the University Hospital Magdeburg was presented during the Nordkongress Urologie.
  • The Imperial Prostate Masterclass is a key event for everyone with an interest in focal therapy and was held in London in April. CLS hosted a hands-on training session where Dr Pierre-Charles Henry, Besançon, France, talked about his initial experiences from the use of our Ultrasound-guided system for FLA. Dr Henry emphasized the value of real-time temperature measurement to monitor and guide the treatments. Read more here.

Market expansion
  • In the US, CLS‘s MSP model continues to bring more patients. Listen to the testimonial from one of our satisfied customers AVANT, and how their patients talked about our FLA technology. Link to the testimonial
  • CLS Americas Inc. signed a new MSP agreement with ROSE Urology in the US. Read more here .
  • In Europe, the first patients in Italy were treated and we entered into an exclusive distribution agreement with MTEC Company (“MTEC”) to market and sell the CLS TRANBERG® product portfolio in France. 

Corporate News and Strategy Update

  • Prospectus and other documents related to rights issue 2024 are available here.

  • The Annual General Meeting is coming up 28 June. Read more here.

  • A strategy update was held by CEO Dan J Mogren and Chairman of the Board, Hans von Celsing, on June 12. Welcome to watch the presentation below.

We wish all our shareholders, collaboration partners, clinicians & patients a great summer!

With warm regards,

The CLS Team 

Welcome to Clinical Laserthermia Systems.

Please note that all our products and indications are not yet approved in all markets. Don’t hesitate to contact us for up-to-date market approvals in your area!

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