Tuesday 2 September 2008

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

�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 win an effective complement to helical TomoTherapySM, one that enables firm treatment provision and delivery, while broadening the spectrum of patients that lavatory be optimally treated with the industry's most advanced platform for cancer precaution.


"This is a major milestone for TomoTherapy and, in change by reversal, 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 gauntry technology, and sharing a simple, consistent treatment provision and rescue process. The choice of which sensory system to use for a given case will depend on the nature of the neoplasm volume and surrounding organs at jeopardy. TomoDirect allows clinicians to choose respective discrete angles as well as the optimal modulation level needed for delivery. It is expected to provide significant time nest egg in both the planning and delivery phases for several clinical scenarios, including whole chest 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 gain to the added capabilities offered by TomoDirect, the Hi�Art system's treatment modes are beingness expanded to include 3D conformal bringing, 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 discourse of a wide variety of cancers. The Hi�Art treatment system combines integrated CT imagery with conformal radiation therapy to give birth sophisticated radiation treatments with speed and precision patch reducing radiation exposure to surrounding hefty 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 former similar matters, including just not limited to statements using the terms "volition", "can", "is expected to", or "should" constitute forward-looking statements inside the substance of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements contained in this exhort release are subject to risks and uncertainties that could case actual results to differ materially from those hoped-for, including simply not limited to factors such as our ability to gain ground customer acceptance, ability to complete exploitation in a timely way, ability to protect intellectual property, risks of break due to events beyond the company's control, and the early risks listed from time to time in TomoTherapy's filings with the U.S. Securities and Exchange Commission, which by this book of facts 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 logotype and Hi�Art are among trademarks, service marks or registered trademarks of TomoTherapy Incorporated.

http://www.TomoTherapy.com


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