Developing Medical Devices for Diagnosing & Monitoring ... · respiratory diagnos8cs market •...
Transcript of Developing Medical Devices for Diagnosing & Monitoring ... · respiratory diagnos8cs market •...
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DevelopingMedicalDevicesforDiagnosing&MonitoringLung
Condi7ons
DrMarkBowmanCEO,PulmonIRLtd
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CompanyHistory• Early-stagemedicaldevicecompanydevelopingproductsfortheglobalrespiratorydiagnos8csmarket• ForecasttoreachUS$7.45billionby2021.Keydiseasesegmentsincludechronicobstruc8vepulmonarydiseaseandlungcancer• Aspin-outfromSwanseaUniversityestablishedinFebruary2016andbasedontheworkofProfessorPaulLewis• Receivedsubstan8alventurecapitalinvestmentfrom:
• £120,000WelshGovernmentgrant:HealthTechnology&TelehealthFund• Winnerofthe2016MediWalesStart-upAwardSource:RespiratoryDiagnos8csMarketbyProduct&Service-GlobalForecastto2021,marketsandmarkets.com,November2016
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Diagnos7cPlaDorm• Usingwell-establishedinfraredspectroscopytechniquestoanalysesputumproducedbypa8entswithrespiratorydiseases• Changesintheconforma8onofmoleculespresentinpa8entsputumcanbedetectedandarecharacteris8cofpar8culardiseasestates• Uniquecombina8onsofabsorp8onatpar8cularwavelengthshavebeeniden8fiedandprotectedviapatentapplica8ons• Thesecombina8onscanbeiden8fiedusingproprietaryalgorithmsthatdeliveradiagnos8cresult• Diagnos8capplica8onsiden8fiedinChronicObstruc8vePulmonaryDisease(COPD)andLungCancer• Userswillincludepa8ents,healthvisitors,generalprac88oners,respiratoryclinics,carehomesandpharmaceu8calcompanies
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COPD–LeadApplica7on• Collec8venameforagroupofcondi8onsincludingemphysemaandchronicbronchi7sthatcauseinflamma8on,makingithardertobreathe• Maincauseissmoking,butlong-termexposuretoharmfulfumesanddustintheenvironmentalsocontributes• Nocure,butthereisthepoten8altomanagethecondi8ontoimprovesymptomsandreduceflare-ups(exacerba8ons)• Thereare1.2millionpeoplelivingwithCOPDintheUKwithafurther115,000peoplebeingdiagnosedeachyear• Accountsfor140,000hospitaladmissionsandover1millionbeddayseachyearacrosstheUK• Nearly30,000peoplediefromCOPDeachyearSource:TheBaaleforBreath-TheImpactofLungDiseaseintheUK,Bri8shLungFounda8on,2016
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LungCancer• Mostlungcancersdevelopintheairways,butcanalsostartinthelung8ssueitself• Over85%ofcasesoccurincurrentorformersmokers,butitcanalsobecausedbypassivesmokingandexposuretoharmfulfumes&dust• 85,000peoplelivingfollowingdiagnosis,butonly50%surviveformorethan6monthsduetolatestagediscovery• Over43,000peoplediagnosedwithlungcancereveryyear,with35,000peopledyingfromthecondi8onperannum• Accountsfor45,000hospitaladmissionsandover450,000beddaysperyear
Source:TheBaaleforBreath-TheImpactofLungDiseaseintheUK,Bri8shLungFounda8on,2016
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COPD-CurrentTechnology
Spirometry
• Well-establishedmethod–BUT:• Inaccurate• Insensi8ve–60%accuracyatbest
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PrototypeforClinicalPOC
PreliminaryClinicalStudies
• Highcost-£5,000perspectrometer• Provediagnos8ccapability• Demonstrateexacerba8onpredic8on
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Case-ControlStudy
LongitudinalStudy
• COPDExacerba8ondetec8on
• Rawsputum
• 50pa8ents
• 5sputumsamplesperweek
• 12months
• COPDdiagnos8cstudy
• Rawsputum&urine
• Collec8on@8meofdiagnosis
• 100newlydiagnosedcases• v• 100non-COPDsmokers
PrinceCharlesHospital,MerthyrTydfil
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Pa8entsrecruitedinrespiratoryclinics
FTIRanalysisSwanseaUniversity
PrinceCharlesHospital
5sputumsamples/pa8ent/week
1xResearchNurse3xHealthcareAssistants
FTIRanalysis
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FuturePlans• Focusonproductdevelopmentworkandonplanningandcommencingregulatoryclinicaltrials• CurrentlyshortlistedforanewInnovateUKInvestmentAcceleratorawardthatwillsupportproductdesignanddemonstratethatasuitablepricepointcanbeachieved• Inparallel,plansforthenextroundofclinicaltrialsarebeingdevelopedthatwillfocusonsecuringCEmarking,USFDAandChineseFDAapprovals• Adop7onandSalesintotheglobalrespiratorydiagnos8csmarket• AimtocreatehighqualityjobsinWalesthatservicebothna8onalandexportmarkets,deliveringsignificantreturnsforourinvestors,andenablingsignificanthealthcarecostsavings
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Next:ProductDevelopment
Designforregulatoryclinicaltrials
• Canpricepointbereached?• Conductfurtherclinicaltrialstoobtainnecessarydata• SecureCEmarking,USFDAandChineseFDAapprovals