RaySearch receives FDA clearance for RayStation 4.5 featuring ultrafast and robust optimization

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.

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

For further information, please contact:
Johan Löf, President and CEO, RaySearch Laboratories AB (publ)
Telephone: +46 (0)8-545 061 30
johan.lof@raysearchlabs.com