RaySearch receives FDA clearance for RayStation 4.5

28 October 2014 – RaySearch Laboratories AB (publ) has received 510(k) clearance from the FDA for version 4.5 of its treatment planning system RayStation®.

The new version includes a wide range of new features that will help cancer centers improve their treatment planning process and also enable them to take adaptive planning a step further. For example RayStation® 4.5 offers ultrafast and robust optimization for proton and photon treatments, boosted dose calculation, automated breast planning and biomechanical deformable registration using the unique MORFEUS technology.

The ultrafast multi-purpose optimization engine in RayStation®, rayOptimizer, can solve virtually any posed optimization problem within radiation therapy using all degrees of freedom of the treatment unit.

In the 4.5 version, the robust algorithm can take density and patient setup uncertainties into account. This gives the clinicians a structured tool to handle safety margins more efficiently in the planning process which has the potential to further increase the plan quality.

RayStation’s unrivalled speed of optimization and dose computation has also been improved even further in the new version. The dose calculation algorithms have been rewritten entirely and every step in the process has been optimized to improve computation speed. The new version also includes support for optimization and dose computation using the GPU which lets the user benefit from the latest developments in computer technology as well. Together these improvements lead to extremely fast computation speeds. Optimization and clinical dose computation for a standard prostate IMRT case is done in less than ten seconds and even for a more complex 9-beam IMRT head and neck case on a high resolution 2mm dose grid, the optimization and dose computation are executed in approximately 30 seconds.

RayStation® 4.5 includes a major step forward in the field of automated treatment planning. The new rayAutoBreast module provides tools for automated generation of tangential breast IMRT plans using heuristic optimization and includes features such as:

• Automatic detection of radio-opaque markers defining the breast
• Automatic contouring of all the relevant target and risk organs
• Automatic setup of beams, including heuristic optimization of gantry and collimator angles
• Automatic creation of objective functions, optimization and segmentation settings and clinical goals

rayAutoBreast was initially developed at the Princess Margaret Hospital (PMH) in Toronto, Canada. Between 2009 and 2012, PMH ran a large-scale clinical study to evaluate the performance of their automated treatment planning methodology for tangential breast intensity modulated radiation therapy (IMRT). Automated planning was used for 97 percent of the patients receiving tangential breast IMRT during the time interval studied i.e. in 1661 patients. The study results showed an increase in clinical acceptance using this fully automated method. PMH concluded that the method can add tremendous efficiency, standardization, and quality to the current treatment planning process and that its use will allow faster adoption of IMRT together with increased access to care improvements for breast cancer patients.

RaySearch and PMH also collaborate in adaptive radiation therapy and a new feature in RayStation® 4.5 is the MORFEUS technology initially developed by PMH. The unique MORFEUS technology contains a set of algorithms for deformable image registration based on biomechanical modeling of anatomical structures. This makes it possible to track how the radiation dose is delivered to the patient taking into account changes occurring in the patient’s anatomy over the course of treatment. This information can be used to further refine the treatment which has the potential to increase tumor control as well as reduce the risk for side effects. The development and extensive validation of MORFEUS has been documented in several publications in renowned scientific journals.

This know-how is now incorporated in RayStation® and enables cancer centers to take adaptive planning a step further. The advanced biomechanical modeling in MORFEUS incorporates not only the material properties of various anatomical structures, but also how they interact and affect each other. Examples include the sliding interface between the lung and the chest, and structural impact of bronchial tree in the lungs.

“RayStation® 4.5 is a big step forward in our quest to provide a tool that lets the clinicians focus all their skill and experience on evaluating and refining plan quality. The number of menial repetitive tasks is minimized with our tools for automated planning, and in this release we have achieved game-changing computation speed that I think will revolutionize the whole treatment planning work process. As the computation time is measured in seconds rather than minutes, the user can efficiently create and refine the treatment plans in one sweep instead of opening a second case or going on a break during computations. This is a huge improvement for the clinics that I believe ultimately will lead to better treatment plans as the clinicians will be able to test more options to further tweak the treatments for higher quality”, 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.
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Mevion and Philips to develop Pinnacle3 proton planning for HYPERSCAN

LITTLETON, MA, 27 October 2014 – Mevion Medical Systems and Philips Radiation Oncology Systems are collaborating to combine the treatment planning capability of Philips’ Pinnacle³radiation therapy planning system with the MEVION S250 solution with HYPERSCAN, Mevion’s new pencil beam scanning technology that is capable of scanning a tumor in seconds.

Pinnacle³ currently supports the MEVION S250, the world’s smallest proton therapy platform. The new collaboration will focus on enabling the Pinnacle³ system to also support HYPERSCAN.

“HYPERSCAN is an advanced form of pencil-beam scanning and is only available on the MEVION S250. Since Pinnacle³ is already being used by certain Mevion S250 users, it’s only fitting that we work together to develop planning for HYPERSCAN,” said Joe Jachinowski, the president and chief executive officer of Mevion Medical Systems.

“We’re really pleased to be collaborating with Mevion as it introduces HYPERSCAN,” said Sue Wallace, PhD, general manager of Philips Radiation Oncology Systems. “At Philips, treatment planning is a critical element of informed therapy guidance, and the integration of Philips imaging and planning with therapy delivery systems is essential.”

The first site to use Pinnacle³ with the MEVION S250 is the UF Health Cancer Center at Orlando Health. Omar Zeidan, PhD, the center’s chief of proton therapy physics, noted, “The collaboration between Philips and Mevion will give world-class cancer centers like ours the ability to offer patients all the benefits of HYPERSCAN combined with the accuracy and reliability of Pinnacle^³.” Zeidan added, “This will help lead to well-planned and well-executed proton therapy sessions that accurately target tumors.”

HYPERSCAN’s patented technology, paired with the direct and efficient proton beam generation of the MEVION S250 platform, allows tumor volumes to be quickly scanned in a matter of seconds. This speed makes HYPERSCAN’s treatment delivery much less sensitive to patient and tumor motion.

The MEVION S250’s revolutionary compact design removes the obstacles of size, complexity and cost that exist with conventional proton therapy systems without compromising beam quality or patient care. It was first installed at Barnes Jewish Hospital in St. Louis. Five other MEVION S250 installations are currently in process.

HYPERSCAN has not been cleared by the USFDA for clinical use.

About Mevion Medical Systems
Mevion Medical Systems, Inc. is a leading provider of proton therapy systems for use in radiation treatment for cancer patients. Mevion’s flagship product, the MEVION S250 proton therapy platform, is the only modular, single room proton therapy system currently on the market. The MEVION S250 integrates with standard radiation therapy workflow and provides a proton therapy treatment environment at a fraction of the cost, footprint and operational complexity of conventional systems.

Mevion is privately held and based in Littleton, Massachusetts, with international offices in the United Kingdom and Japan. For more information, please visit www.mevion.com.
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Particle Therapy Statistics in 2013

Martin Jermann (2014) Particle Therapy Statistics in 2013. International Journal of Particle Therapy: Summer 2014, Vol. 1, No. 1, pp. 40-43.
doi: http://dx.doi.org/10.14338/IJPT.14-editorial-2.1

Martin Jermann, MSc

Particle Therapy Cooperative Group Secretary

From the Paul Scherrer Institute, Villigen, Switzerland

Received: March 28, 2014; Accepted: March 28, 2014 ;Published Online: May 13, 2014

From 1954 through December 2013, more than 120 000 patients across the world have been treated with particle therapy, including more than 13 000 (10.8%) with carbon ions and more than 105 000 (87.5%) with protons (Table). More than 30% of those patients have been treated for ocular melanomas. Global acceptance of particle therapy is growing, with the most rapid increase in facilities occurring in Japan and the United States. Five particle facilities were opened in 2013 in Seattle, Washington; St. Louis, Missouri; Essen, Germany; and Nagoya and Tosu, Japan. The Figure, a and b, shows the rapid rise in patients treated, particularly with proton therapy and particularly in Japan and the United States.

Today, about 10 new facilities are in the phase of technical commissioning, clinical commissioning, or both, and 5 or 6 of them should be ready to treat patients before the end of 2014.

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