HumaScan receives warning letter

June 10, 1998

HumaScan's marketing efforts for its BreastAlert Differential Temperature Sensor (DTS) system have drawn the attention of the Food and Drug Administration. In an April 24 warning letter to the Cranford, NJ-based company, the agency's Center for Devices

HumaScan's marketing efforts for its BreastAlert Differential Temperature Sensor (DTS) system have drawn the attention of the Food and Drug Administration. In an April 24 warning letter to the Cranford, NJ-based company, the agency's Center for Devices and Radiological Health took issue with advertisements, physician labeling, comments by celebrity spokespersons, and press releases associated with BreastAlert, a noninvasive adjunctive screening device for breast cancer (SCAN 7/9/97). HumaScan holds U.S. and Canadian marketing rights from Scantek Medical, which developed the product.

In particular, the CDRH's warning letter stated that the company has misrepresented the intended use of the device, making both implicit and explicit claims that the device can detect breast disease, including breast cancer. The device was cleared as an adjunct to routine physical examination, including palpation, mammography, and other established procedures for the detection of breast disease. HumaScan officials were not immediately available for comment.

In other company news, HumaScan and BreastAlert's developer, Scantek Medical of Denville, NJ, have restructured their licensing agreement. The move, which was made to provide HumaScan with additional time and financing to pursue its marketing and distribution plans, waives certain HumaScan royalty payments in exchange for HumaScan stock warrants.

HumaScan has also restructured its contract with Zigmed, which provides production equipment for BreastAlert. The purchase price for the equipment has been reduced by approximately $200,000 in exchange for the issuance of warrants to purchase 30,000 shares of HumaScan's common stock at $4.725 per share.