Devices Oncology

 News Release - August 7, 2008

TomoTherapy to Introduce TomoDirect(TM) at ESTRO, ASTRO Annual Meetings

New, Discrete-Angle Radiation Delivery Mode Extends Hi-Art(R) System Capabilities, Offering Faster Planning and Treatment for a Wide Range of Cancer Cases

MADISON, Wis.--(HSMN NewsFeed)--TomoTherapy Incorporated (NASDAQ: TOMO ) today announced that it will introduce the TomoDirect™ discrete-angle delivery mode1 for the TomoTherapy® Hi·Art® treatment system at two upcoming radiation oncology conferences. This innovative new technology allows Hi·Art system users to quickly plan and deliver advanced TomoTherapySM radiation treatments with a series of linear beam paths, rather than the existing helical path. With TomoDirect, clinicians can choose several discrete angles and the optimal modulation level required for delivery, based on specific patient therapy goals. 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.

“We are excited about TomoDirect because it will greatly increase the overall flexibility and efficiency of the Hi·Art treatment system,” said Fred Robertson, CEO of TomoTherapy. “Along with helical TomoTherapy delivery, TomoDirect will enhance our customers’ revenue-generating opportunities, and strengthen their ability to deliver the highest quality radiation therapy to the broadest patient population.”

TomoDirect was developed as a complement to helical TomoTherapy, with both utilizing the same binary multi-leaf collimator and CT-style gantry technology. 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 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.

Said TomoDirect research partner Paul Read, M.D., Ph.D., assistant professor of Radiation Oncology, University of Virginia: “TomoDirect will expand the spectrum of external beam radiation therapy patients who can be optimally treated with TomoTherapy’s unique image-guided, intensity-modulated radiation therapy (IG-IMRT). Now, we will have an option to deliver dose via two unique and complementary delivery modes, choosing whichever provides the optimal dose distribution. Clearly, breast cancer patients will benefit from TomoDirect, and other disease sites will likely be developed for which there is clinical benefit.”

Added research partner Prof. Guy Storme, M.D., Ph.D., director of the Oncologic Center at UZ Brussel, Brussels, Belgium: “Certainly, with the combination of helical and direct deliveries, TomoTherapy should offer significant benefit for a majority of breast cancer treatments. It will provide the ability to choose and apply the right modality for the best treatment. Our research is focused on providing comprehensive usage guidelines as we study and validate this new mode combination.”

The TomoDirect delivery mode leverages the Hi·Art treatment system’s unique design, componentry and capabilities. According to TomoTherapy co-founder Thomas “Rock” Mackie, Ph.D., Hi·Art system integration facilitates a simple, consistent treatment planning and delivery process across both modes of delivery.

“TomoDirect will use all the power of the platform that makes helical TomoTherapy the gold standard in radiation therapy,” said Mackie. “The difference is that we expect treatment planning times will be dramatically reduced due to the much smaller number of beam directions used. Furthermore, for certain geometries, the ability to use only the most beneficial angles will cut delivery times significantly. With TomoDirect, routine cases can now be planned in under 10 minutes. And, importantly, users can deliver from up to 12 discrete angles, with a single turn of the key.”

In addition to the added capabilities offered by TomoDirect, the Hi·Art system’s treatment modes are being expanded to include a 3D conformal option, thereby meeting the full range of options needed for all clinical cases.

Concluded Robertson: “TomoTherapy has already been embraced for its superior treatment quality, especially for complex cases. The introduction of TomoDirect will fully open the door for the Hi·Art system to have a significant presence in all settings, from large academic centers to single linac centers where high patient throughput is paramount. TomoDirect will effectively increase our access to a larger percentage of the radiation therapy market opportunities.”

1 TomoTherapy is planning to make TomoDirect available to radiation clinics in summer 2009. As a product pending FDA 510(k) clearance, TomoDirect is not yet available for sale in the United States.

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. To learn more about TomoTherapy, please visit 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 integrate acquired assets, 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.

Source: TomoTherapy

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