Nine Continents Medical Inc — Department of Health and Human Services SBIR Phase I: 400

Description

ABSTRACT Overactive bladderOABaffects approximatelypercent of U Sadultsmen and women alikeStewartet alOAB can profoundly impact quality of life and can even have psychological repercussions including depressionGormleyet alMore thanmillion Americans with OAB are likely to fail or discontinue firstand second line therapybut only aboutpursue third line therapyThusthere is a large untapped market for an innovative third line therapyIn response to this significant unmet needthe Project DirectorMrPeter Jacobsonand his colleagues at Nine Continents MedicalInchave developed an implantable tibial nerve stimulatorITNSThis patent protectedminiaturizedself powered neurostimulator is designed for permanent implant in the medial lower calfvia a percutaneous procedure with a singlemm incisionThe pulse generator is subcutaneousand a short integrated electrode lead delivers electrical pulses to the posterior tibial nerveITNS uniquely provides diagnostic data via telemetry andyear nominal longevity without requiring any external device for charging or operationWhile leveraging several aspects of currentlyapproved third line therapies that have demonstrated effectivenessITNS is likely to have a better safety profile than current third line solutionsand its user friendly features are designed to improve patient and caregiver compliance compared to externally powered conceptsTo advance the ITNS to commercializationthis Fast Track proposal seeksin Phase Ito refine the innovative programming system by designing and testingaan integrated neurostimulator for the programmerban ergonomic user interfaceandcan ergonomic programming wandWith this work completedwe aim to obtain FDA and IRB approval to initiate a clinical feasibility study to be completed in Phase IIThis prospectiveobservationallongitudinal single site study will enrollsubjects with OAB who have failed firstand secondline therapy and who meet at least one of four severity criteria for OABThey will not have potentially confounding conditions such as predominant stress incontinenceadditional risks such as other active implantsconcurrent medications with urinary side effects such as anti muscarinicsor planned or current pregnancySubjects will be monitored forweeks following ITNS implantation to collect objective safety and effectiveness data as well as self reported quality of lifeThe FDA has reviewed this feasibility study and does not require hypothesis testingResults from this first human use of the ITNS will support an IDE application for a pivotal clinical trial and inform the design of that trialThusPhase I and II activities in this Fast Track proposal are key steps for positioning the ITNS for commercialization byNARRATIVE Overactive bladderOABprofoundly impairs the ability to engage in social and occupational activitiesand overmillion Americans with OAB may benefit from a novel approach that is more patient friendlyeffective and safe than current solutionsThis project will develop a self powered implantable tibial nerve stimulatorITNSthat provides symptom relief automatically without any action by the patient or caregiverand will evaluate its safety and effectiveness in a small group of OAB patientsThe findings will help guide the path to ITNS commercializationand thus this proposal is directly responsive to the mission of the NIDDK to improve health and quality of life for OAB sufferers