DIASENSE'S DIASENSOR NON-INVASIVE BLOOD GLUCOSE MONITOR CLINICALS

DIASENSE'S DIASENSOR NON-INVASIVE BLOOD GLUCOSE MONITOR CLINICALS will begin in February at five sites, the company says in a Dec. 31 prospectus for an initial public offering. In preparation for the start of the clinical studies, the firm is refining prototypes of the light-based device and seeking institutional review board clearance from the five sites. The firm already has gained IRB approval from two sites, according to the prospectus. The Diasensor determines blood glucose levels by measuring the amount of near-infrared light that is reflected by the blood. The device shines the light through the skin, and depending on glucose level, variable amounts of the light are absorbed. The system's spectrum analyzer then measures the intensity of the light reflected back to the device, and an algorithm converts the measurement to a glucose level. According to Diasense, the clinical trials will be conducted with a prototype that is larger than the desktop model the company intends to market. The firm estimates that it will take eight to 10 weeks to complete trials, after which a 510(k) will be submitted to FDA. Allowing time for the review of the 510(k), Diasense predicts that the device is not likely to come to market before the second half of 1993. The IPO seeks to raise $10.5 mil. through the sale of 3 mil. shares of common stock at $3.50 per share. The firm estimates that an additional $4.7 mil. could be raised through the sale of 6.9 mil. shares of stock that are issuable upon the exercise of warrants. However, the company believes "a substantial number of the warrants may not be exercised prior to 1994." Diasense plans to use the IPO's proceeds to continue development of the Diasensor and cover general working capital expenditures. Biocontrol Technology (BICO), which currently owns 44.7% of Diasense's common stock and is not selling any shares in the offering, will own 28.5% of Diasense after completion of the IPO. BICO formed Pittsburgh-based Diasense in 1989 and transferred the technology and patent related to the glucose sensor to the new firm in 1991. Under an August 1989 pact, Diasense was provided with exclusive worldwide distribution rights to the Diasensor in exchange for 8 mil. shares of Diasense common stock. The firms entered additional agreements in January 1992 under which BICO was given responsibility for research, development and manufacturing of the device, as well as for obtaining FDA clearance for it. In exchange, Diasense pays BICO $100,000 per month plus direct costs. The prospectus notes that there are three other firms developing noninvasive blood glucose monitors. Sandia National Laboratories, in collaboration with the University of New Mexico and the U.S. Department of Energy, currently is seeking an industry sponsor to provide capital for the continued commercial development of its technology. In addition, the firms Futrex and Boston Advanced Technologies hold patents related to the noninvasive detection of glucose and other blood constituents. Diasense hired its first full-time employees in January 1992 and currently has five. The firm intends to add between 10 and 20 full- or part-time employees during the first half of 1993. The firm's management includes Chairman and Chief Scientist David Purdy. He has also been chairman of the board of BICO since its inception in 1972.