Elekta receives FDA clearance for Elekta Synergy (TM)

PRESS RELEASEStockholm, 28 October 2003 Images available - see below!ELEKTA RECEIVES FDA CLEARANCE FOR ELEKTA SYNERGY(TM)The revolutionary new radiotherapy system from Elekta is first tocombine x-ray volume imaging and treatment in a single platformOn Monday the 27 October, the U.S. Food and Drug Administration (FDA),granted 510(k) pre-market clearance to the Elekta Synergy(TM) Systemfrom Elekta. This means that Elekta can now market and sell the systemalso in the U.S. In Europe, Elekta Synergy(TM) is already marketed,following CE marking in July 2003.In research and development over the last five years, this newradiotherapy treatment platform directly addresses the two mostpersistent and significant problems in modern radiation therapy:internal organ motion and errors in patient set-up.Elekta was the first vendor to start research on image-guided radiationtherapy, the first to have systems in clinical use, and the first tobring these solutions to the market."With the introduction of Elekta Synergy(TM), Elekta is leading theefforts to increase the precision of radiotherapy delivery by limitingor even eliminating the impact of the patient's internal organ motionand how the patient is set up for treatment from day to day", says PeterJ. Gaccione, vice president Oncology Sales and Service Operations forElekta North America.Elekta Synergy(TM) does this by using innovative x-ray volume imagingtechnology that is integrated directly onto the treatment system itself.This means that routine pre-treatment imaging of a tumor can now beperformed immediately prior to treatment, decreasing the risk that atumor or internal organs will change position. In addition, since thepatient doesn't have to be moved from an imaging device (e.g. MR, CT) tothe radiotherapy treatment machine, the problem of errors from patientre-setup are eliminated.The first use of this new class of Image Guided Radiation Therapy (IGRT)technology took place at the Netherlands Cancer Institute (NKI) in July2003, when three cancer patients were treated using the ElektaSynergy(TM) system. In addition to NKI, three other leading cancerclinics in Great Britain, Canada and USA have research installations ofElekta Synergy(TM).Clinical data presented both at the recent ASTRO annual meeting in theU.S. and the European ESTRO meeting, demonstrate the enormous potentialfor the new Elekta Synergy(TM) system to significantly advanceradiotherapy treatment for cancer patients.It has been shown that by combining an X-ray volume imaging system andradiotherapy equipment (a medical accelerator) to provide 'real time'images of the tumour during treatment, the image quality and treatmentaccuracy is significantly improved. (ref:1,2)Volker Stieber, Elekta's Executive Vice President - TechnologyDevelopment & Operations, acknowledged the aptness of the new product'sname, "Synergy is defined as two or more entities working together,wherein the sum is greater than each individual's contribution. ElektaSynergy(TM) adds dedicated imaging technology to a proven treatmentplatform, creating a system that is truly more than the sum of itsparts." ******Investor inquiries:International: Peter Ejemyr, Group VP Corporate Communications, ElektaAB (publ), Phone: +46 8 587 254 00, e-mail: [email protected] States: Lars Jonsteg, VP Investor Relations North America,Elekta, USA Phone: +1 770-670-2419, e-mail: [email protected] contact U.S:Michelle Lee, PR and Advertising [email protected]: +1 770-300-9725 x 277, Fax: +1 770-448-6338Notes to editors:· For further information regarding Elekta Synergy(TM) and other Elekta products, please visit www.elekta.com· Images of Elekta Synergy(TM) can be accessed at the following website address: www.elekta.com/investors *****About Elekta:Elekta is a world-leading supplier of advanced and innovative radiationoncology and neurosurgery solutions and services for precise treatmentof cancer and brain disorders. Elekta's solutions are clinicallyeffective, cost efficient and gentle to the patient.References:1. Oldham M, et al. Online volumetric CT-guided radiation therapy.Abstract 101. American Society for Therapeutic Radiology and OncologyAnnual Meeting, October 2003.2. Letourneau D, et al. Implementation of an on-board kilovoltage cone-beam CT imaging system for clinical applications. Abstract 102. AmericanSociety for Therapeutic Radiology and Oncology Annual Meeting 2003.------------------------------------------------------------This information was brought to you by Waymaker http://www.waymaker.netThe following files are available for download:http://www.waymaker.net/bitonline/2003/10/28/20031028BIT01180/wkr0001.doc http://www.waymaker.net/bitonline/2003/10/28/20031028BIT01180/wkr0002.pdf