FDA Votes Against CTI Breast Imaging System

PORTLAND, Ore., Dec. 13 -- Computerized Thermal Imaging (CTI) announced this week that the FDA's Radiological Devices Panel met yesterday and recommended by a vote of 4-to-3 that the FDA deny approval of CTI's infrared breast imaging system. Panel members said they believe the technology is promising but that they need more information before it can recommend approval. A formal decision will follow from the FDA, CTI said.

"With the solid clinical results and seven years of research and development on our breast imaging system, we are deeply disappointed by the Panel's recommendation," said Richard Secord, chairman and CEO of CTI. "However, we are encouraged by the positive comments of all the panel members and we will proceed to better understand how to ultimately earn FDA approval for this device and decide on the most appropriate course of action."

Secord was among six directors re-elected to CTI at its annual meeting Thursday, held at the American Stock Exchange headquarters in New York City. Each will serve a one-year term until the 2003 annual meeting.

Also re-elected: John M. Brenna, president and COO; Brent Pratley, Audit Committee member; Milton Geilman, Audit Committee member; Harry Aderholt, Audit Committee chairman; and Robert Simmons, Providence Hospital, Washington, D.C.

For more information, visit: www.cti-net