CEASAREA, Israel--(BUSINESS WIRE)--June 28, 2006--Dune Medical Devices, Ltd. today announced the closing of a $12.5 million Series B investment led by Apax Partners who invested $11.5 million in the round. Apax also led the two tranched $7.5 million Series A round which closed in 2004. This funding, which closed on June 28, will be used to complete pivotal U.S. clinical studies of Dune's BP probe and console system, attain market clearance of the BP system in the U.S. by the Food & Drug Administration (FDA), begin development of Dune's second product and expand the company's infrastructure in the U.S.
Dune also announced that the company has received the European Union CE Marking (Communaute Europeenne) designation for its disposable BP probe and console system. The intended use for the probe and system is to enable intraoperative, on-contact measurement of suspected tissue surfaces during a lumpectomy (partial mastectomy) procedure. The CE mark permits Dune to market its device throughout the European Union.
"Dune Medical Devices is gratified by the continuing strong financial and strategic support received from Apax since their initial investment," said Dr. Dan Hashimshony, founder and CEO of Dune Medical Devices, Ltd. "Having European Union CE Mark certification is an important milestone for Dune Medical. While this regulatory approval positions the BP system for its future commercialization in the European Union, its greatest significance in the short term will be the rapid accrual of investigational sites to expedite our clinical program in the United States, Europe and Israel. The intent of our clinical program is to obtain a rigorous and ample body of data that demonstrates the capacity of our technology to improve surgical oncology practice and outcomes."
Amos Goren from Apax Partners and director of Dune's board said: "Apax is extremely impressed by the very significant progress demonstrated by the team at Dune Medical Devices in developing novel technology and positioning it for commercialization to address unmet needs in surgical oncology worldwide. The Dune BP probe and console system will enable surgical oncology teams to consistently obtain cleaner margins during the initial procedure. This has the potential to drastically reduce the disturbingly high rate of re-excisions, and there is a particularly noteworthy need for this especially in breast cancer."
Published reports indicate that anywhere from 20 to 60 percent of breast-conserving lumpectomies performed each year in the U.S. necessitate re-excision because a clean margin was not obtained in the initial procedure. According to data presented earlier this year at the annual scientific meeting of the American Society of Breast Surgeons, the Dune BP probe would have identified positive margins in 9 out of 12 patients, whose margins were missed during the initial lumpectomy, potentially eliminating the need for additional surgery in those cases. This would be equivalent to a 7.3 percent positive margin rate. When researchers assessed margins without the probe, the positive margin rate was 29.3 percent. In the study, device readings were postoperatively compared to permanent pathology findings.
The BP probe and console system developed by Dune Medical Devices uses patent-protected, proprietary RF spectroscopy that enables intraoperative, on-contact, measurement of suspected tissue surfaces.
Headquartered in Ceasarea, Israel and founded in 2002, Dune Medical Devices, Ltd. is a privately owned venture funded medical device company engaged in the development and commercialization of devices for real time tissue characterization. Dune's devices are designed to facilitate complete, therapeutic excisions in surgical and interventional oncology procedures.
Michele Fox, 781-684-0770
Source: Dune Medical Devices, Ltd.