This article was originally published in The Gray Sheet
Initial sales of the firm's first product, the INVOS 3100 cerebral oximeter with the SomaSensor disposable sensor, generated revenues of $570,781 in the second quarter ended May 31; shipments began in "mid-May." The system was cleared by FDA via 510(k) last year ("The Gray Sheet" July 13, 1992, p. 13). The Troy, Michigan firm recorded a loss for the period of $1.6 mil., but predicts that it "could achieve break-even on a monthly basis in our fourth quarter" given "current order backlog and customer demand." Based on a July 1 price hike for the Invos from $10,000 to $13,500 in the U.S. and $15,400 abroad, the company estimates that break-even is "achievable at approximately 80 oximeters per month." The price for the disposable sensors was also raised from approximately $30 to $35.
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