Justification for Brand Name word doc summary.docx

Justifications for Brand Name Restrictions Applied BioPhysics is the only company that make the ECIS ZTheta system (“ECIS”). This ECIS ZTheta system is the most advanced all-in-one instrument with a distinct method of accurately measuring cellular behaviors including proliferation, migration, barrier function, attachment, inflammation, etc. The ECIS Z-Theta is capable of a multitude of assays done in real time and is capable of detecting and quantifying morphology changes in the sub-nanometer to micrometer range – all of which gives it unique capabilities and significant advantage in impedance-based assays. In ECIS systems, a small alternating current is applied across the electrode pattern at the bottom of the ECIS arrays (direct current cannot be used). This results in a potential across the electrodes which is measured by the ECIS instrument. When cells are added to the ECIS arrays and attach to the electrodes, they act as insulators increasing the impedance. As cells grow and cover the electrodes, the current is impeded in a manner related to the number of cells covering the electrode, the morphology of the cells and the nature of the cell attachment. When cells are stimulated to change their function, the accompanying changes in cell morphology alter the impedance. The data generated is impedance versus time. No other system that Program is aware of can provide all the needed requirements that allows Program fully understanding the endothelial cell behavior at this level. Other systems such as the Transwell system can be used, but those do not distinguish between cellular movement, invasion, fluid egress and thus cannot truly assess barrier functions. These additional features and capabilities of the ECIS system is crucial to Program’s work in assessing barrier functions.

Furthermore, ECIS use “Barrier Function Assays” that include a modeling function that allows scientists to look at 3 parameters of barrier integrity. This is unique to the ECIS Z-theta and is not available with any of the traditional methods or impedance-based methods. Finally, ECIS systems use “Wound Healing Assays” that use electrical currents to wound the cells while still in the incubator. This is unique to ECIS, and part of this assay technology has been patented and is only available with the ECIS Z-Theta System (Patent No.: US7,332,313 B2).

Thus, only the ECIS branded systems manufactured by Applied BioPhysics are suitable for Program’s intended research because only ECIS-branded systems have particular unique patented features that are not available to other equipment from other brands and manufacturers.