Home News CLS’ partner initiates full market release in the US

CLS’ partner initiates full market release in the US


CLS’ partner initiates full market release in the US

5 June, 2024

CLS’ commercial partner ClearPoint Neuro has initiated its full market release of the ClearPoint Prism 3T Neuro Laser Therapy System, which is based on CLS’ technology. The launch took place June 1-4 at the 2024 American Society for Stereotactic and Functional Neurosurgery Biennial Meeting in Nashville. 

Two years ago, Clinical Laserthermia Systems (CLS) received FDA 510(k) clearance in the USA for its laser ablation system for use with MR imaging in neurosurgery. Since then, the company’s partner ClearPoint Neuro has been planning for commercialisation under the brand name ClearPoint Prism Neuro Laser Therapy System. 

This is an integrated system for laser ablation in the brain with high precision through MR guidance and a stereotactic system. The system is used to identify target tissue, position the laser applicator, and monitor the laser ablation in real-time. The system enables targeted and minimally invasive laser therapy for lesions in the brain, such as brain tumours or epileptogenic foci. 

Commercial launch in the US

In recent months, ClearPoint Neuro has focused on carrying out an initial market launch of ClearPoint Prism, and the company has begun the full market launch in the US, according to this press release. 

–  The full market release of our joint neurosurgery offering is fruit of an intense joint collaboration during the last couple of months, says CLS’ CEO Dan J Mogren.  

Joe Burnett, President and CEO of ClearPoint Neuro, also comments on the market launch: 

– This is a truly exciting milestone for ClearPoint, and one that has been years in the making. We set out to prove that we are one of the most innovative and focused companies in the Neurosurgery space.  

Increased focus on neurosurgery

The market launch in the US is part of CLS’s increased focus on the neurosurgery segment. CLS’ and ClearPoint Neuro’s joint offering has been expanded to reach a larger share of the market for Laser Interstitial Thermal Therapy (LITT). 

– 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 Mogren. 

To finance the market establishment, CLS is carrying out a rights issue of SEK 59 million with a subscription period running from June 12 – 26, 2024. 

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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