CLS: Receives FDA Clearance

Research Note

2022-09-23

15:07

Redeye endorses that CLS has received FDA clearance for its MR-guided laser ablation system in neurosurgery. We believe this is an essential milestone for the company and crucial for its commercialization in the US. We make no valuation changes on the back of today's news, owing to our valuation already taking height for a launch in the US. However, during the fall, we will provide an update where we review the case and our forecasts.

GM

Gustaf Meyer

This morning, CLS announced the positive news that it has received FDA clearance (510k) for its MR-guided laser ablation system (2nd Gen TRANBERG Thermal Therapy System with Thermoguide Workstation) in neurosurgery.

During the fourth quarter of 2021, CLS filed the 510(k) application for the 2nd generation of TRANBERG with Thermoguide Workstation. Earlier, CLS received EU approval for the Thermoguide Workstation and obtained an updated EC certification for the TRANBERG Thermal Therapy System, including the software. CLS has previously received FDA clearance for TRANBERG Thermal Therapy System without Thermoguide Workstation.

However, with Thermoguide Workstation in the neurosurgery segment, MRI-guided laser ablation is possible, and the user can monitor the ablation in real time, which provides treatment according to the patient’s individual needs.

The clearance is a result of a great collaboration with Clearpoint Neuro. The system will be commercialized under the brand name ClearPoint Prism Neuro Laser Therapy System by ClearPoint Neuro, which also is the exclusive global distributor of the system within the neurosurgery segment, and we expect a limited launch to start during the first half of 2023.

We are positive about the news as this is an essential milestone for CLS and also want to highlight how the clearance validates the great performance and potential of the solution. We look forward to receiving more news about CLS and ClearPoint’s collaboration and are excited about a US launch. We make no valuation changes on the back of today's news, owing to our valuation already taking height for a launch in the US. However, during the fall, we will provide an update where we review the case and our forecasts.

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