We have been developing our own needle administration sets for subcutaneous immune globulin, called the Daisy Set which incorporates many enhanced features that we believe will address many of the issues faced by current offerings. The current devices are available with a number of needles from one to six, in three different lengths, and in some cases two different diameters, thus creating a logistical problem for providers to store 38 different kinds of needle sets. Our new Daisy needle sets contain an adjustable needle depth setting, and have the ability to connect to each other to create any number of joined needles, thus reducing all the offerings from 38 to only one type of needle set. In addition, since we have pioneered the fluidics for these administrations, we have designed the Daisy set for very rapid administrations with improved safety. An FDA 510(k) has been submitted for the new set and updated performance features of the Freedom60.
There can be no assurance that we will be able to enter the market during the summer of YE 2010 as planned, that we will be able to deliver the Daisy set at a competitive price point, or that the Daisy set will end up being accepted by the industry.