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Microsulis launches MEA system

This article was originally published in The Gray Sheet

Executive Summary

U.S. commercial use of minimally invasive microwave endometrial ablation device for uterine lining ablation commences Oct. 6 following PMA approval Sept. 23. Microsulis is training physicians on the device, as was recommended in a June FDA approval condition (1"The Gray Sheet" June 16, 2003, p. 28)...

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Microsulis: Firm will use $45 mil. round financing to hire 50 direct sales reps/physician educators to support full launch of Microwave Endometrial Ablation (MEA) system to treat menorrhagia. Approved last September, MEA has been slowly rolled out, awaiting funding for clinical specialists required under FDA clearance (1"The Gray Sheet" Oct. 20, 2003, In Brief). Microsulis currently is evaluating distributors for metropolitan areas. The funds also will go to support separate 510(k) applications for soft tissue ablation and peripheral vascular indications to be submitted by year-end. Existing investors contributed $20 mil. to the round, while the remaining $25 mil. came from venture capital...

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