DevelopingMedicalDevicesforDiagnosing&MonitoringLung

Condi7ons

DrMarkBowmanCEO,PulmonIRLtd

CompanyHistory•  Early-stagemedicaldevicecompanydevelopingproductsfortheglobalrespiratorydiagnos8csmarket•  ForecasttoreachUS$7.45billionby2021.Keydiseasesegmentsincludechronicobstruc8vepulmonarydiseaseandlungcancer•  Aspin-outfromSwanseaUniversityestablishedinFebruary2016andbasedontheworkofProfessorPaulLewis•  Receivedsubstan8alventurecapitalinvestmentfrom:

•  £120,000WelshGovernmentgrant:HealthTechnology&TelehealthFund• Winnerofthe2016MediWalesStart-upAwardSource:RespiratoryDiagnos8csMarketbyProduct&Service-GlobalForecastto2021,marketsandmarkets.com,November2016

Diagnos7cPlaDorm• Usingwell-establishedinfraredspectroscopytechniquestoanalysesputumproducedbypa8entswithrespiratorydiseases• Changesintheconforma8onofmoleculespresentinpa8entsputumcanbedetectedandarecharacteris8cofpar8culardiseasestates• Uniquecombina8onsofabsorp8onatpar8cularwavelengthshavebeeniden8fiedandprotectedviapatentapplica8ons•  Thesecombina8onscanbeiden8fiedusingproprietaryalgorithmsthatdeliveradiagnos8cresult• Diagnos8capplica8onsiden8fiedinChronicObstruc8vePulmonaryDisease(COPD)andLungCancer• Userswillincludepa8ents,healthvisitors,generalprac88oners,respiratoryclinics,carehomesandpharmaceu8calcompanies

COPD–LeadApplica7on•  Collec8venameforagroupofcondi8onsincludingemphysemaandchronicbronchi7sthatcauseinflamma8on,makingithardertobreathe• Maincauseissmoking,butlong-termexposuretoharmfulfumesanddustintheenvironmentalsocontributes•  Nocure,butthereisthepoten8altomanagethecondi8ontoimprovesymptomsandreduceflare-ups(exacerba8ons)•  Thereare1.2millionpeoplelivingwithCOPDintheUKwithafurther115,000peoplebeingdiagnosedeachyear•  Accountsfor140,000hospitaladmissionsandover1millionbeddayseachyearacrosstheUK•  Nearly30,000peoplediefromCOPDeachyearSource:TheBaaleforBreath-TheImpactofLungDiseaseintheUK,Bri8shLungFounda8on,2016

LungCancer• Mostlungcancersdevelopintheairways,butcanalsostartinthelung8ssueitself•  Over85%ofcasesoccurincurrentorformersmokers,butitcanalsobecausedbypassivesmokingandexposuretoharmfulfumes&dust•  85,000peoplelivingfollowingdiagnosis,butonly50%surviveformorethan6monthsduetolatestagediscovery•  Over43,000peoplediagnosedwithlungcancereveryyear,with35,000peopledyingfromthecondi8onperannum•  Accountsfor45,000hospitaladmissionsandover450,000beddaysperyear

Source:TheBaaleforBreath-TheImpactofLungDiseaseintheUK,Bri8shLungFounda8on,2016

COPD-CurrentTechnology

Spirometry

•  Well-establishedmethod–BUT:•  Inaccurate•  Insensi8ve–60%accuracyatbest

PrototypeforClinicalPOC

PreliminaryClinicalStudies

•  Highcost-£5,000perspectrometer•  Provediagnos8ccapability•  Demonstrateexacerba8onpredic8on

Case-ControlStudy

LongitudinalStudy

•  COPDExacerba8ondetec8on

•  Rawsputum

•  50pa8ents

•  5sputumsamplesperweek

•  12months

•  COPDdiagnos8cstudy

•  Rawsputum&urine

•  Collec8on@8meofdiagnosis

•  100newlydiagnosedcases•  v•  100non-COPDsmokers

PrinceCharlesHospital,MerthyrTydfil

Pa8entsrecruitedinrespiratoryclinics

FTIRanalysisSwanseaUniversity

PrinceCharlesHospital

5sputumsamples/pa8ent/week

1xResearchNurse3xHealthcareAssistants

FTIRanalysis

FuturePlans•  Focusonproductdevelopmentworkandonplanningandcommencingregulatoryclinicaltrials• CurrentlyshortlistedforanewInnovateUKInvestmentAcceleratorawardthatwillsupportproductdesignanddemonstratethatasuitablepricepointcanbeachieved•  Inparallel,plansforthenextroundofclinicaltrialsarebeingdevelopedthatwillfocusonsecuringCEmarking,USFDAandChineseFDAapprovals• Adop7onandSalesintotheglobalrespiratorydiagnos8csmarket• AimtocreatehighqualityjobsinWalesthatservicebothna8onalandexportmarkets,deliveringsignificantreturnsforourinvestors,andenablingsignificanthealthcarecostsavings

Next:ProductDevelopment

Designforregulatoryclinicaltrials

•  Canpricepointbereached?•  Conductfurtherclinicaltrialstoobtainnecessarydata•  SecureCEmarking,USFDAandChineseFDAapprovals

ThankyouforyouraUen7on

mark.bowman@pulmonir.com

07986484898