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We noted that none of the studies the applicant included reference another single-use, disposable device as a comparator against which to evaluate and assess the VersaVue TM Single-Use Flexible Cystoscope

FAHMY, et al

The same body of work has identified outgrowth of the FAK-paxillin pathway, a signaling cascade involved in cell migration, as one plausible mechanism [Chang et al., 2011]