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Metrika

This article was originally published in The Gray Sheet

Executive Summary

Commercial availability of single-use A1cNow diabetes monitor for measuring gold standard indicator hemoglobin A1c (HbA1c) is announced Feb. 19. The disposable, pager-sized, finger-stick device provides results in eight minutes, allowing prescription use by diabetes patients between physician visits. Launch of the CLIA-waived test, 510(k)-cleared in July 2000 for in-office use and in September 2000 for prescription home-use, was supported by a $26 mil. mezzanine round of financing completed in April 2001 (1"The Gray Sheet" April 23, 2001, In Brief)...

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Metrika

Diabetes diagnostic test developer completes $26 mil. mezzanine round of financing in early April. Funds will be used for ramping up manufacturing of the AlcNOW HbAlc monitoring device (previously known as the DRx HbAlc), and preparing for a full-scale launch. The device was 510(k)-cleared in July 2000 for in-office use and September 2000 for prescription home-use; at the time, the privately held Sunnyvale, California firm said it would wait for additional financing to help build the infrastructure for a product launch (1"The Gray Sheet" Aug. 7, 2000, p. 13). To run the test, a single drop of blood from a finger prick is collected in a supplied pipette; the sample is then mixed with a reagent and inserted into the pager-sized monitor, which displays the level of HbAlc - the amount of hemoglobin bound to glucose - within eight minutes. Funds will also be used for development and marketing of the firm's upcoming microalbumin and cholesterol tests. The transaction was led by Oak Hill Capital Partners, with additional funding provided by Sutter Hill Ventures

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