TomoTherapy Receives FDA 510(k) Clearance For TomoDirect™ Radiotherapy Technology

Main Category: Radiology / Nuclear Medicine
Also Included In: MRI / PET / Ultrasound;  Cancer / Oncology;  Medical Devices / Diagnostics
Article Date: 29 Aug 2008 - 3:00 PST

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TomoTherapy Incorporated (NASDAQ: TOMO) announced that it has received FDA 510(k) clearance for its TomoDirect™ radiation therapy technology. TomoDirect is an innovative new discrete-angle, sliding-beam delivery mode for the Hi•Art® treatment system. With this capability, clinicians gain an efficient complement to helical TomoTherapySM, one that enables fast treatment planning and delivery, while broadening the spectrum of patients that can be optimally treated with the industry's most advanced platform for cancer care.

"This is a major milestone for TomoTherapy and, in turn, for cancer centers of all sizes," said Fred Robertson, CEO of TomoTherapy. "TomoDirect significantly improves the throughput of our system, and widens the TomoTherapy treatment options available for clinical use. Now, more cancer patients can benefit from true, next-generation treatment technology."

TomoDirect was developed as a complement to helical TomoTherapy, with both modes utilizing the same binary multi-leaf collimator and CT-style gantry technology, and sharing a simple, consistent treatment planning and delivery process. The choice of which modality to use for a given case will depend on the nature of the tumor volume and surrounding organs at risk. TomoDirect allows clinicians to choose several discrete angles as well as the optimal modulation level required for delivery. It is expected to provide significant time savings in both the planning and delivery phases for several clinical scenarios, including whole breast irradiation and palliative treatments.

TomoDirect will be unveiled at the annual meetings of the European Society for Therapeutic Radiology and Oncology (ESTRO) in Gothenburg, Sweden, Sept. 14-18, 2008, and the American Society for Therapeutic Radiology and Oncology (ASTRO) in Boston, Mass., Sept. 21-25, 2008.

In addition to the added capabilities offered by TomoDirect, the Hi•Art system's treatment modes are being expanded to include 3D conformal delivery, thereby providing a comprehensive range of options for all clinical cases.

About TomoTherapy Incorporated

TomoTherapy Incorporated has developed, markets and sells the TomoTherapy® Hi•Art® treatment system, an advanced radiation therapy system for the treatment of a wide variety of cancers. The Hi•Art treatment system combines integrated CT imaging with conformal radiation therapy to deliver sophisticated radiation treatments with speed and precision while reducing radiation exposure to surrounding healthy tissue. The company's stock is traded on the NASDAQ Global Select Market under the symbol TOMO.

http://www.TomoTherapy.com.

Forward-Looking Statements

Statements in this release regarding future products, events, expectations and other similar matters, including but not limited to statements using the terms "will", "can", "is expected to", or "should" constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements contained in this press release are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated, including but not limited to factors such as our ability to gain customer acceptance, ability to complete development in a timely manner, ability to protect intellectual property, risks of interruption due to events beyond the company's control, and the other risks listed from time to time in TomoTherapy's filings with the U.S. Securities and Exchange Commission, which by this reference are incorporated herein. These forward-looking statements represent TomoTherapy's judgments as of the date of this press release. TomoTherapy assumes no obligation to update or revise the forward-looking statements in this release because of new information, future events or otherwise.

©2008 TomoTherapy Incorporated. All rights reserved. TomoTherapy, TomoDirect, the TomoTherapy logo and Hi•Art are among trademarks, service marks or registered trademarks of TomoTherapy Incorporated.

http://www.TomoTherapy.com