Commercial readiness of kidney stone repositioning - The SonoMotion solution

ABSTRACT There is an unmet clinical need for a non invasive approach to manipulate stones within the kidney and ureterSignificanceThe prevalence of kidney stones is steadily rising and currently affectsinAmericans at a cost of $B annuallyA significant portion of this economic burden stems from athe half a million emergency department visits for an acute obstructed stoneand bsecondary visits and procedures related to residual fragments left after surgeryMultiple studies have shown that these residual fragments often do not pass on their own and lead to symptomatic stone events in up toand secondary surgery inof theprocedures performed yearlyTechnologyStone ClearTM is a non invasive ultrasound based tool to move stones using acoustic radiation forceThe technology is integrated with an ultrasound imager to provide real time monitoring of stone motionThere is no pain associated with the procedure and no anesthetic is requiredThe technology has the potential to aid in the passage of small stones and fragments in an office settingimprove stone free rates following lithotripsy proceduresand to be used in a point of care environment to relieve pain by moving a stone blocking the ureterPreliminary DataInvestigational results from a feasibility trial show the technology to be safe and effective in humans achieving stone repositioning inofsubjectsincluding stones up tommand an aggregate ofstone fragments passed byofpost lithotripsy subjectsAdvancements in the system design since this trial have resulted in overimprovement in in our ability to move a single large stone or clusters of fragmentsSpecific AimsThe first three aims of this proposal focus on tasks required for FDA and CE Mark regulatory submissionas well as future commercializationAimbrings Stone ClearTM development under Design and Quality Systems ControlAimconducts verification and validation testing of the Stone ClearTM therapy probe and acoustic generator under the Quality Systems established in AimAimconfirms the planned regulatory path through a de novo petition submissionFinallyAimfocuses on conducting a reimbursement analysis for Stone ClearTMwhich is an essential component of commercial successThe outcome from this proposal will be a verified and validated Stone ClearTM device with a clear regulatory pathwaybeing developed under a proper Quality System and with a reimbursement strategy in place to guide future commercialization activities