Koning Breast Scanner Receives European Regulatory Approval

A University of Rochester Medical Center startup company that developed an imaging system to detect breast cancer, announced that it has obtained a key approval from the European Union signaling that it is in compliance with legislation and medical device regulation. This will allow the system to be marketed and sold throughout the EU.

Koning Corporation received the required CE marking, which means “European conformity,” for its cone beam computed tomography system, known commercially as the Koning Breast CT (KBCT) scanner. The technology combines the advantages of digital x-ray with computed tomography to produce three-dimensional pictures without having to compress the breast tissue.

Ruola Ning, Ph.D., a professor of Radiology at URMC, invented the imaging system. The University of Rochester holds several patents on the cone beam scanner, and the UR licensed the technology to Koning Corporation to make, use and sell the devices. In addition, the University holds a small equity share in the company. Ning serves as president of Koning and also holds an equity share.

“This CE mark approval represents a major step for breast imaging and women’s health care,” said Ning, who founded the privately held Koning Corporation in 2002. “The KBCT is the latest advancement in true 3D breast imaging technology. We are very proud to be able to bring this revolutionary technology to benefit women throughout the world.”

The company is also seeking approval from the U.S. Food and Drug Administration, and from the appropriate regulatory authorities in Canada and China, where Ning has launched an expansion (Koning (Tianjin) Medical Equipment Co. LTD). The development of the KBCT was achieved in part through grants from the National Institutes of Health (NIH), the Small Business Innovation Research (SBIR) program, and the Department of Defense (DOD). (See funding notes below.)

Koning’s breast scanner is another example of the URMC’s push to translate federally funded medical science into useful patient care innovations. After years of basic research and rigorous development, under the direction of URMC Imaging Sciences Chair David L. Waldman, M.D., Ph.D., the first patient scans were obtained in July of 2006. A few months later the URMC unveiled the technology to the medical community at the Radiological Society of North America annual meeting and scientific symposium.

During the past five years, Avice O’Connell, M.D., director of women’s imaging at URMC and professor of Clinical Imaging Sciences, has been the principal investigator on several studies of the new technology, showing that breast coverage and radiation dose is comparable to diagnostic mammography. However, the KBCT was designed to go a step beyond conventional mammography by providing full 3D images of the breast. One application of the new system would be to use the KBCT as an additional tool to diagnose difficult cases.

The KBCT system acquires an extensive set of images in 10 seconds, while the patient lies on her stomach on a cushioned exam table. Koning officials said the KBCT virtually eliminates tissue overlap and superimposition of structures, which are two factors often responsible for failure to diagnose breast cancer early, when it is more treatable.

U.S. Representative Louise M. Slaughter (D-Fairport) supported the company’s efforts in 2008 by securing approximately $3 million from the DOD to fund ongoing research and development. Slaughter’s commitment to early detection of breast cancer as well as the opportunity for economic growth in Rochester were key reasons for her support of the Koning project.

The company has also received significant venture R&D funding from private investors, to improve the technology and build four additional scanners: one is located at Elizabeth Wende Breast Care, LLC, in Rochester; one is at Emory University in Atlanta; and two are in China. Each scanner is being used for further clinical studies. Additional prototypes are being built at Koning’s plant at the Lennox Tech Enterprise Center in Henrietta, N.Y., which is a business incubator supported by High Tech Rochester Inc., a not-for-profit economic development organization.

Please note: The Koning breast CT technology and system has been funded in part by NIH/National Cancer Institute SBIR grant 1R44CA103236 and SBIR bridge grant 2R44CA103236-05. These grants benefitted from the patents licensed from and developed by the University of Rochester under NIH/NCI grant 1R01CA085904, which developed the concept for cone beam CT, and grant 1R21/R33CA094300 that explored the cone beam CT concept’s potential for improved breast imaging. The DOD contract was awarded and administered by the U.S. Army Medical Research & Material Command (USAMRMC) and the Telemedicine & Advanced Technology Research Center (TATRC), under contract number W81XWH-09-1-0441.

# # #