RaySearch Laboratories: RaySearch receives 510(k) clearance for Pencil Beam Scanning with protons

Regulatory News:

RaySearch Laboratories AB (STO:RAYB):

In December 2013 an extended version of RaySearch’s RayStation® 4.0 treatment planning system was CE-marked and released for clinical use to multiple markets. The new version contained tools for optimization of proton treatments using the pencil beam scanning technique (PBS). RaySearch has now received 510(k) clearance for this new version, which means that this new functionality can be sold and marketed in the US.

Proton therapy is considered the most advanced form of radiation therapy due to its superior dose distribution and fewer side effects. Protons deposit the majority of their energy within a precisely controlled range, thus making it easier to target the tumor and to spare healthy surrounding tissue. PBS is the most sophisticated technique to deliver proton therapy. It enables Intensity Modulated Proton Therapy (IMPT) that allows clinicians to target a cancerous tumor by controlling both the intensity and the spatial distribution with millimeter precision.

The proton module in RayStation® contains all the state-of-the-art tools needed for PBS such as multiple field optimization, single field uniform dose and distal edge tracking techniques.

"We have won several orders and been the most successful supplier of solutions for proton treatment planning over the last year. Our position on the US market becomes even stronger now that we have market clearance for all relevant techniques for proton therapy”, says Johan Löf, CEO of RaySearch.

About RayStation®

RayStation® integrates all RaySearch’s advanced treatment planning solutions into a flexible treatment planning system. It combines unique features such as multi-criteria optimization tools with full support for 4D adaptive radiation therapy. It also includes functionality such as RaySearch’s market-leading algorithms for IMRT and VMAT optimization and highly accurate dose engines for photon, electron and proton therapy. The system is built on the latest software architecture and has a graphical user interface offering state-of-the-art usability.

About RaySearch

RaySearch Laboratories is a medical technology company that develops advanced software solutions for improved radiation therapy of cancer. RaySearch provides the RayStation® treatment planning system to clinics all over the world. In addition, RaySearch’s products are distributed through licensing agreements with leading partners such as Philips, Nucletron, IBA, Varian and Brainlab. To date, 15 products have been launched via partners and RaySearch’s software is used by over 2,500 clinics in more than 65 countries. RaySearch was founded in 2000 as a spin-off from the Karolinska Institute in Stockholm and the company is listed in the Small Cap segment on NASDAQ OMX Stockholm. F

or more information about RaySearch, visit www.raysearchlabs.com

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