iotaMotion, Inc. — Department of Health and Human Services SBIR Phase II: Y

Description

AbstractSince their clinical introduction overyears agocochlear implantsCIshave had a remarkable impact on patients experiencing moderate to profound hearing lossRecent advances in technology have driven the development ofhearing preservationimplants and procedures designed to preserve the residual acoustic hearing of patients while treating the damaged areas of the ear with an electrically stimulated CIDespite these advancesover half of patients undergoing this procedure will eventually lose residual hearing months to years after surgery likely due to cochlear trauma sustained during the surgeryAdditionallybecause current techniques do not allow the electrode to be inserted farther into the cochlea to reach now dysfunctional regionspatients either require additional surgery or live with suboptimal hearing once againiotaMotion is developing an implantable robotic assisted positioning system to enable precise control of intracochlear electrodes both intraand post operatively to reduce the effects of post surgical hearing lossThe anticipated impact of this technology will be to improve the long term outcomes of patients undergoinghearing preservationcochlear implantation as well as increase the candidacy range for this procedureThe overall goal of this Direct to Phase II SBIR project is to further develop and ultimately commercialize iotaMotion s proprietary technologyDuringPhase I equivalent SBIRstudiesiotaMotion developed and characterized an initial prototype to establish proof of concept and feasibility in cadaveric modelsFollowing that successPhase II will continue to develop the technology toward commercialization with the following specific aimsVerify device compatibility andopenplatform with commercially available cochlear implantsUsingclinically available electrodeswe will establish the procedureinstructionsand ease of use for integrating each electrode within the devicethen determine the maximum stall force that can occur with each device electrode combinationEstablish that the iotaMotion pilot line system meets functionalqualitysafetyand biocompatibility requirements in a GLP environmentUsing a combination of international standards and in house experimentswe will demonstrate that the device can be sterilizedis biocompatibleand can remain functional in the body for up tomonthsQuality standards will be implemented to ensure valid data are collected for eventual regulatory submissionEvaluate the efficacy of the iotaMotion robotic assisted surgical system in a long term large animal modelPhase II will conclude with an evaluation of the device efficacy in an established sheep model overmonthsCompleting these aims will set the stage for our system development and production in a GMP environment with private sector partnering and execution of a prospective clinical trial designed to establish safety and efficacy in humansThe phase II project enables iotaMotion to achieve significant commercialization milestonesdriving the company forward toward improving the hearing and quality of life for millions worldwide