CTI To Own Thermal Imaging Processor Outright Following Bales Acquisition

Computerized Thermal Imaging's acquisition of infrared imaging system manufacturer Bales Scientific includes Bales' thermal imaging processor, an adjunctive diagnostic tool that CTI already uses as part of its own thermal imaging system for breast cancer.

Bales has been supplying the processor since CTI began developing the breast cancer diagnostic in 1996. The device, which gained 510(k) clearance in 1985, represents the most obvious synergy between the two companies, according to CTI officials.

Announced April 18, the combined cash and stock deal gives Layton, Utah-based CTI 100% ownership of Bales, including order backlog and intellectual property. Specific financial terms were not disclosed. "The expertise [of Bales Scientific] will help us meet equipment supply demands as well as foster the technological advances needed to build and maintain our momentum," CTI President David Packer noted in a press release.

Maurice Bales, MD, founder of Walnut Creek, California-based Bales Scientific, will take on the position of director of research and chief scientist at CTI. "This move will help us all realize our long-term potential and business goals," Bales commented.

In particular, Bales likely will look to CTI for help in securing FDA approval for additional indications of the Photonic Stimulator infrared-based pain management system. The device was cleared via 510(k) in June 1998 for general pain relief, but the clearance did not mention specific medical conditions.

The company was cited in a March 14 warning letter for promoting the system for specific uses, including diabetic neuropathy and radiculopathy (¹ (Also see "Bales Scientific FDA Warning Cites Website Promotion Of Unapproved Uses" - Medtech Insight, 3 Apr, 2000.)).

Meanwhile, CTI has completed two modules in its five-part modular premarket approval application for the breast cancer imaging system. The final module should be submitted late this summer, and FDA approval is expected by year-end. While the company is initially pursuing approval as an adjunct to mammography in differentiating between benign and malignant breast abnormalities, it ultimately seeks to perform clinical trials to demonstrate its use as a stand-alone primary screening device (² (Also see "TMI Pursuing Modular PMA For Thermal Breast Imaging System" - Medtech Insight, 19 Apr, 1999.)).