Regulatory Filings • Sep 23, 2013
Regulatory Filings
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IBA reached another milestone on its compact Proton Therapy solution, Proteus®ONE
Louvain-la-Neuve, Belgium September 23rd, 2013 - IBA (Ion Beam Applications SA), the world's leading provider of proton therapy solutions for the treatment of cancer, announces that it has submitted all necessary documentation on IBA's first compact proton therapy gantry to the U.S. Food and Drug Administration (FDA) for Marketing Authorization.
The submission includes full documentation from the recently completed in factory performance and safety tests on its compact gantry beam line.
The compact gantry beam line has also already been shipped to Willis-Knighton Cancer Center (WKCC) as an element of the first Proteus®ONE solution.
Three Proteus®ONE solutions have been ordered to date, with patient treatment expected to start in 2014.
Olivier Legrain, Chief Executive Officer of IBA commented: "This is an important milestone in the development of our compact proton therapy solution and making Proteus®ONE a reality for our customers such as the Willis-Knighton Cancer Centre. It is the talent and determination of our team at IBA that makes it possible to achieve these milestones in the development of Proteus®ONE and ensures that we maintain our leading edge in innovation and our position as the world's leader in the delivery of proton therapy."
Lane R. Rosen, MD, Director of Radiation Oncology at WKCC, added: "IBA and Willis-Knighton Cancer Center are showing once again that a strong partnership can help bringing advanced cancer care to our community. We are looking forward to start treating patients next year on the first Proteus®ONE solution."
-ENDS-
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Proton Therapy is considered the most advanced and targeted cancer treatment due to its superior dose distribution and reduced side effects. Protons deposit the majority of their effective energy within a precisely controlled range within a tumour, sparing healthy surrounding tissue. Higher doses can be delivered to the tumour without increasing the risk of side effects and long-term complications, improving patient outcomes and quality of life.
Today, more than half of proton therapy clinical facilities worldwide utilize IBA solutions. This includes 15 proton therapy centres in operation and 11 centres under development. Over 25,000 patients have been treated on IBA equipment – more than all competitor installations combined.
IBA Proteus®ONE is a compact single-room proton therapy solution. It benefits from the latest technologies of Proteus®PLUS, developed with top clinical institutions worldwide. Proteus®ONE is the safest way to compact Intensity Modulated Proton Therapy (IMPT), the most advanced radiotherapy modality. Proteus®ONE is smaller, more affordable, easier to install, easier to operate and ultimately to finance. With Proteus®ONE, protons are possible for more patients worldwide.
*Proteus®ONE is the brand name of a new configuration of the Proteus® 235, including some new developments subject to review by Competent Authorities (FDA, European Notified Bodies, et al.) before marketing.
IBA (Ion Beam Applications S.A.) is a cancer diagnostics and treatment equipment company, and the worldwide technology leader in the field of proton therapy, the most advanced form of radiotherapy available today.
The Company's primary expertise lies in the development of next generation proton therapy technologies that provide oncology care providers with premium quality services and equipment. IBA's proton therapy solutions are scalable and adaptable, offering universal full scale proton therapy centers as well as next generation compact, single room solutions. IBA also focuses on the development and supply of dosimetry solutions for Quality Assurance of
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medical equipment and increased patient safety as well as particle accelerators for medical and industrial applications.
Headquartered in Belgium and employing more than 1,200 people worldwide, IBA currently has installed systems across Europe and the US and is expanding into emerging markets. The Company is focused on building sustainable global growth for investors, providing solutions in the fight against cancer.
IBA is listed on the pan-European stock exchange EURONEXT. (IBA: Reuters IBAB.BR and Bloomberg IBAB.BB) and more information can be found at: www.iba-worldwide.com
Located in Shreveport Louisiana, the Willis-Knighton Cancer Center is the region's premier cancer treatment facility. WKCC provides a wide range of treatment options for cancer patients including radiation oncology, medical oncology and hematology, surgical oncology and gynecologic oncology. The Cancer Center provides diagnostic services such as PET, Xray, CT and laboratory. It also offers support groups, counselling, nutritional and educational resources, and community education programs.
Olivier de Sadeleer Marketing Manager PT +32 10 475 890 [email protected]
Thomas Ralet Vice-President Corporate Communication +32 10 475 890 [email protected]
For media and investor enquiries: Consilium Strategic Communications Amber Bielecka, Mary-Jane Elliott, Matthew Neal +44 (0) 207 920 2333 [email protected]
Lucy Medvec Public Relations Manager +1 318 212 4422 [email protected]
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