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Dune MarginProbe™ Reduces Repeat Lumpectomy Surgeries

Business Wire, May 2, 2008

Randomized, Controlled Study Underscores Device's Safety and Effectiveness

CAESAREA, Israel -- The Dune Medical MarginProbe[TM], a novel real-time surgical tissue characterization system, reduced repeat surgeries in breast conserving procedures, according to a study presented here at the American Society of Breast Surgeons Annual Meeting. Currently, the MarginProbe[TM] system is in investigational use in the U.S. It is market-approved in the E.U.

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Using radio frequency spectroscopy technology (RFS), the handheld device intraoperatively assesses the malignancy status of tumors at the resection margin. If lumpectomy margins are identified as positive, physicians often re-shave the excision site during the initial procedure sparing patients the risk, trauma and expense of additional surgeries. The primary objective of breast conservation therapy is to achieve complete excision of tumors surrounded by a margin of healthy tissue. Currently, positive re-section margins must be addressed through additional surgeries.

Selected for oral presentation at the Society meeting, which draws noted surgical oncology medical specialists from around the world, the 300-patient, randomized clinical trial found that use of the Dune device reduced repeat lumpectomies by 56 percent. The double-arm study was recently conducted in 11 Israeli medical centers with 35 surgeons operating with and without use of the device. It compared the surgeons' ability to detect and remove positive margins during the initial lumpectomy and the resulting rate of repeat procedures. In the device group, surgeons applied the probe to the excised lumpectomy specimen and shaved additional tissue according to the device's readings. The volume of tissue removed from patients showed no statistically significant difference between the two study arms.

"The results of the study are extremely encouraging," said Tanir Allweis, MD of Hadassah Hebrew University Medical center in Jerusalem, Israel, an investigator in the study. "The research underscores the accuracy and reliability of MarginProbe[TM] and radio frequency spectroscopy in determining margin status. It suggests that MarginProbe[TM] has the potential to provide physicians with important information that will spare many women the risk and stress of repeat surgeries. The device potentially represents an important breakthrough supporting a higher standard of care."

According to the North American Association of Central Cancer Registries (NAACCR), 240,510 new cases of invasive and non-invasive breast cancer in women were reported in 2007. Nearly all of these women will be recommended for some type of surgical treatment.

"MarginProbe[TM] addresses a significant and longtime clinical need in the surgical treatment of breast cancer that has eluded medical science until now," said Dr. Dan Hashimshony, Dune Medical founder and CEO. "Without any accurate method for determining margin status during surgery, many women have had to endure difficult additional procedures to achieve clear margins. With MarginProbe[TM], many of these procedures will become unnecessary."

The Dune MarginProbe[TM] comprises a sterile hand-held probe and portable console. When the probe tip is applied to an excised lumpectomy segment, radio frequency signals are transmitted into the tissue and reflected back to the console where they are analyzed using a specialized algorithm to determine tissue status. With streamlined operation and instantaneous results, the technology is designed for easy integration into existing surgical workflow. The device is currently undergoing additional studies in the U.S. and Israel.

About Dune Medical Devices, Ltd.

Founded in 2002 and headquartered in Caesarea, Israel, Dune Medical Devices, Ltd. is a privately owned, venture-funded medical device company, backed by Apax Partners. Dune is engaged in the development and commercialization of devices for real-time tissue characterization. Dune Medical's devices facilitate complete, therapeutic excisions in surgical and interventional oncology procedures. The MarginProbe[TM] described above is undergoing extensive clinical trials in Israel and the U.S.

Business Services Industry

Dune MarginProbe™ Reduces Repeat Lumpectomy Surgeries

Business Wire, May 2, 2008

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