RYTEK MEDICAL INC — Department of Health and Human Services STTR Phase I: NIDCR

Description

PROJECT SUMMARY ABSTRACT Clinical ImportanceAlmostmillion dental implants were placed worldwide inwithmillion of these procedures taking place in the United StatesThe worldwide market for these implants is expected to increase to $$billion in revenue byas more patients opt for this procedure to regain chewing function and improve cosmetic appearanceThe procedure itself requires an osteotomy be drilled into the mandible or maxilladepending on site of implantso that the implant can be seated within the boney structures of the jawA significant challenge to creating the initial osteotomy is ensuring that no critical structures near to the bone are breached leading to severe post procedure morbiditiesClinical LimitationsThe surgeonandapos s objective is to drill into the boneandapos s cancellous structure without breaching the cortical bone protecting critical anatomic structuresIn the case of a mandibular implantthe inferior alveolar nerveIANruns through the cancellous bone and innervates the teeth of the lower jawlipsgumsand skin overlying the chinThe IAN is protected by a conduit of cortical or dense cancellous boneif breached during a drilling procedureirreversible nerve injury is possibleIn the case of maxillary implantsa cortical bone interface separates the cancellous bone of the maxilla from the maxillary sinusBreaching the cortical bone in this case can lead to severe sinus complicationsState of the art guidance systems have accuracies on the order ofmmwhile current guidelines suggest amm margin of safety is needed around these critical interfacesCurrentlyno existing technology is available to providereal timeguidance during drilling that alerts surgeons to an approaching critical anatomic structureOur ProductThe OsteoSmartSense Drill System is a device that integrates with a standard dental drillcan be used with any current guidance systemand provides real time electrical impedance sensing capabilitiesThe electrical impedance of cortical bone is significantly greater than that of the cancellous bone found within the mandible and maxillaWe hypothesize that electrical bioimpedance signatures recorded at the tip of the drill bit with OsteoSmartSense will be sufficiently sensitive and specific to detect when cortical bone structuresor nerve or blood vesselare being approachedprior to breachingSpecific ObjectivesWe specifically propose to optimize the design of our OsteoSmartSense Drill System with controlled manufacturing processes and facilities in order to meet Current Good Manufacturing PracticesCGMPsas is required for submitting a device application to the FDASecondlywe aim to optimize our detection algorithms and evaluate safety and efficacy in an in vivo animal modelFuture DirectionsRyTek Medical is a small company developing bioimpedance sensing devices for a variety of clinical applicationsThis specific device will compliment our existing effortsBy the end of this program we will have demonstrated that the smart sensing drill is functional in an in vivo modelThis will position us to submit akor IDE application to the FDA in order to conduct first inhuman trialsAdditional uses of this technology might include identifying cracks in teethimpedance of air is much greater that of dental tissueidentifying alveolar bone lossor use in orthopedic drilling applications PROJECT NARRATIVE Dental implantation currently relies on pre operative imaging technologies to help guide dental surgeons in safely drilling into the jaw to accurately position an implantunfortunatelythese pre operative images do not provide realtime feedback during the drilling process resulting in the potential for serious post surgical complications associated with drill penetration into critical anatomic structuresincluding nerve bundles and sinus cavitiesWe propose to optimize and commercialize our OsteoSmartSense Drill Systema smart sensing dental drill add on that is capable of gauging tissue bioimpedance at the tip of the drill bitThis novel technology will provide real time feedback regarding the position of the drill during the procedure and help dental surgeons to potentially avoid surgicallyrelated patient injuries