CTI sells first breast-imaging system to Latin American consortium

Computerized Thermal Imaging has sold 10 breast-imaging systems for $5 million to a Latin American consortium based in Mexico City. The consortium, Computerized Thermal Imaging International, and CTI have a goal of selling 100 breast imaging systems in Latin America.

The CTI system, which has not been approved in the U.S., consists of a patient table and heat-sensitive camera, and can be used in conjunction with traditional x-ray mammography, the firm said. CTI’s technology takes an image based on heat radiating from the body.

The company believes that data generated by the CTI system can assist physicians in detecting the presence of numerous diseases, disorders, and injuries that conventional imaging such as x-ray, CT, or MR may miss.

The approval process in Mexico is less stringent than in the U.S., said John Ott, CTI’s senior vice president of marketing and business development.

“Since there’s no radiation involved, it (the approval process) is easier,” Ott said. “It’s region by region and hospital by hospital. They do their evaluation based on clinical trials and early results.”

David Packer, CTI president and COO, said this is the first sale of his company’s system. CTI is seeking FDA premarket approval for its Computerized Thermal Imaging system in the U.S.

The company announced last week that it had received approval of Module 2 of its application, which was submitted in February. There are five modules, data packages describing how the imaging system works (SCAN, 5/24/00). Module 1 was approved in December 1999 (SCAN, 1/12/00).

“Module 2 contains system design information and is the most technologically complex of all the modules,” Packer said.

The Latin American consortium, CTII, is owned in part by CTI, the imaging company.

“It’s not our endeavor,” Ott said. “We own 15%. The name similarity is a blessing and a curse—it gives us name recognition to the casual observer, but it also looks like we’re selling equipment to ourselves.”