Measuring brain vascular status at the time of precision ... · Measuring brain vascular status at...
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Measuringbrainvascularstatusatthetimeofprecisionmedicine
CompanyPresentation
Feb2018
WeareLuciole Medical…
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Wearescientists,engineersanddoctors
ETHistheleadingscienceinstitutewhereAlbertEinsteinstudied
Oneplatform,twoproducts
Weprovidephysicianswithinformationtoact
Theplatformhasoneproduct(minimallyinvasiveprobe)withCEmarkinEuropeandanticipatetoobtaintheCEmarkforthesecondproduct(patch)inthecomingyear.
Aswellrecognizedtheacuteinsufficientoxygenavailabilityinthebraincanhavesevereconsequences.Thechronicalortemporaryreduced/sub-acuteoxygenationisoftenundetectedandhasseriousconsequencesonthebrainsuchascognitionimpairment.
Wewantourtechnologyandproductstohelpdoctorsandsavepatients!!and…weareonamission!
Luciole MedicalisaSwissmedicaltechnologycompanydevelopingbrainoxygenationmonitoringsystems.WearelocatedinZürich.
Thecompanyhasdevelopedauniqueproprietarytechnologymakingthemeasurementofthetrueoxygencontentandbloodflowofthebraintissuepossible.
Whyisitimportanttomeasuretheoxygenationofthebrain?
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Thehumanbrainrepresents2%ofthebodyweight…consumes15%to20%oftheoxygenofthebody
3%ofthepopulationhaveananeurismintheirbrain
25%ofpatientsundergoingcardiacsurgeryhavepostop.cognitivedysfunction
Itisproventhatimpairmentofcirculation(andthusoxygenation)playsaroleindegenerativedisease:CVDisCerebralVascularDementia
Thebrainisacomplexandhighlyregulatedorgan,oneparameterisnotsufficienttocapturethewholepictureofwhatisgoingonandtoinitiatethebesttreatment
PrecisionMedicineandA.I.
Importantmedicalneed andcommercialopportunity
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Traumaticandacutecompromisedoxygensupply
§ TraumaticBrainInjury: 1.7mio intheUSperyear,55’000deaths,USD60bn incosts
§ Brainbleeding(aneurism) 9to20per100’000people§ SecondaryVasospasm
Hospitalconditions:surgery
§ RoleofthelowbloodperfusioninthedevelopmentofVasculardementia
§ Monitoringofvariousdegenerativebrainconditions§ Newparameters:watercontentandICP
Emergingopportunities
§ Deaths,coma§ Neurological:paralysis, speaking
impairment§ Cognitiveissues
§ Cardiacanesthesia§ Anesthesiamonitoring
§ 25%ofcardiacsurgerypatientshaveseriouspostoperativecognitiveissues
LuciolePatch
LucioleProbe
Increaseddemandfrommedicalcommunity
Auniqueversatilemultimodalmonitoringsystem
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RheoSens RheoPatch RheoControl UnitandMonitor
§ Implantable singleuseprobe
§ IntensiveCareUnit
§ Forpatientincomaafterhaemorrhageorseveretrauma
§ Oneprobereplacinguptothreeconventionalprobes
§ Adhesivepatchappliedtotheskinontheskull
§ Deliversbrainbloodflow,brainbloodvolumeandoxygen
§ Forpatientduringsurgeryorconscious.
§ Canbeusedtogetherwithprobe
§ PocketsizedNIRS1) controlunitemitter
§ RheoControl Unitallowsformodularexpansionupto6devicesperpatient
§ USBPluggedinmedicalmonitors
1) NearInfraredSpectroscopy
1)Near-InfraRedSpectroscopy
Theplatformistheonlyoneabletomeasurethecontentinoxygenatedanddeoxygenatedhaemoglobinallowingthedoctorsto:
- Rapidlyidentifytheischemia- Understandtheorigin(flow,anaemia,..)- Design,implementandfollowthebesttreatment
OurUSP
Twolargegrowingmarketsegmentsrepresentamultibillionopportunity
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Millioncriticalcarepatientsannually
Milliongeneralanaesthesia
patientsannually
Millioncardio-anaesthesia
patientsannually
Anaesthesia AdditionalapplicationsCriticalcare
§ ValidationmarketforRheoSens andRheoPatch:§ Subarachnoidhaemorrhage§ Traumaticbraininjury§ Severestroke
§ Criticalcaremarketrepresents3millionpatientsannually
§ Currently,2millionofcriticalcarepatientsqualifyforRheoPatch and0.5millionforRheoSens
§ InitialfocusmarketforRheoPatch isthecardiacanaesthesiamarket,representing4millionpatientsannually:§ Cardiopulmonarybypasssurgery§ Othercardiacsurgery
§ Generalanaesthesiainhighriskandelderlypatientswillfollow,representing14millionpatientsannually
§ Currently,1millionofallcardiacanaesthesia patientsqualifyformonitoringwithRheoPatch
§ RheoPatch:§ Sleepapnea
(30mpatientsintheEU,US,Japan)§ Transientischemicattack
(1meligiblepatientsannually)§ Traditionalpulseoximetrymarket
(over$2bnmarket)§ Telemedicine/e-health§ Predictionsoftware§ Asthma/chronicobstructive
pulmonarydisease§ Post-cardiacarrestcare
§ RheoSens:§ Osteosynthesis§ Muscularcompartmentsyndrome§ Reconstructivesurgery§ Oralsurgery§ Organtransplantation
JapanUSEurope
1.9
6.61.5
5.3
2.1
Generalanastheasia
14.0
Cardio-anastheasia
4.00.6
Europe JapanUS
1.6
1.0
0.4
3.0
Criticalcare
1)#ofpatientsperyearinmillions
1)
1) 1)
Basisforsuccess
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Firstclassuniqueproductwithclearpathtomarket
Largegrowingmarketwithundisputedmedicalneed
Largelyde-risked
Attractivevaluationandlowcashburn
Luciole MedicalsolvedscientificproblemsinNIRS andmadethetechnologyfitforuse
clinically,regulatorypathway,industryconfirmation,partiallycommercially
- Twodifferentiatedmarketsegments- Potentialforcompetitivepricingandlowreimbursementhurdle
Turnaroundopportunitywithnoliability:executionplay
Keydatapointstogenerateconcreteshorttermvaluecreationandexitopportunities
Shorttermvaluegeneration
Attractiveaccelerationopportunity
Luciole MedicalhasanexperiencedleadershipteamwithstrongexecutionskillsNewtalentswilljoinuponfinancing
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Luciole Medicalisanawardwinningcompany
Luciole MedicalhasreceivedtheCertificateforaQualityManagementSysteminOct2014
Strongscientificposition:- 18peerreviewed
publicationsinrenownedjournals
§ Prof. Emanuela Keller,MD,FounderHeadoftheNeurocritical CareUnit,Dep.ofNeurosurgery,UniversityofZϋrich
§ Prof. JavierFandino,MDDivisionofNeurosurgery,Kantonsspital Aarau
Advisors
§ Prof.DanielA.Rüfenacht,MDProf.ofNeuroradiology,KlinikHirslanden,Zϋrich
§ Prof.JoseI.Suarez,MDBaylorCollegeofMedicine,NeurosensoryCentreofHouston
§ PhilippeDro,PhD,MBACEO&ChairmanoftheBoard§ FormerCEOofGlycoVaxyn§ FormerCEOofEndoArt§ Co-FounderofAxovan
§ MarkusH.Muser,PhDMemberoftheBoard§ Over25yearsexperienceinengineeringandmedicine,
medicine,inventorofseveralpatents§ Co-founderandco-ownerofAGUZϋrich
§ BrunoReihl,PhDMemberoftheBoard§ FormerCTOanddeputyCEOatDisetronic§ FormerCEOofRaumedic§ Founderofseveralcompanies
§ JürgFröhlich,PhD,CSOElectromagneticsinbiomedicalapplicationsandBiomedicalPhotonics§ FormerAssociateDirector,IT’ISFoundation,Zurich§ FormerGroupleaderElectromagneticsinMedicineandBiology,ETH§ VisitingSeniorResearchFellowNUS,Singapore§ Co-FounderofFieldsatWorkGmbH,Zurich(Spin-OffETHZurich)§ Co-FounderofPiomic MedicalAG,Zurich
• DirkBaumann,PhD,HeadDevelopmentmanagesthedevelopmentofsoftware,algorithmsandhardware§ InternshipattheUniversityofFairbanks,Alaska§ ResearchAssistant/Phd StudentETHZurich§ FormerResearchEngineeratA*STAR,Singapore§ PostDoc BiomedicalPhotonicsETHZurich
§ MedIdee SAMedidee isaQA/regulatoryboutiquewithexpertisebothinEUandUSThecompanyisactivelyinvolvedwithsupportingLuciole Medical.AQAmanagerwillbehireduponclosingofSeriesA
Board KeyTeamMembers
Investmentcase:Cuttingedgetechnologyatprecommercialstagewithlargeupsidepotential
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Technology&Products Uniquenewgenerationplatformprovidingvascularandmetabolicinformationfordiagnostic,treatmentandmonitoring
Medical Need&Market Verylargeunmetmedicalneed:monitoringofcerebraloxygenationinvariousmedicalconditions:- ICUmarket:USD500millionperyear- Anesthesia:USD1+bn- Emergingnewindicationsandmarkets
Stage ofDevelopment With humandata,CEmarkandearlymanufacturingcapabilities,thecompanyislargelyde-risked.Buildingofrelationshipwithindustryalreadystarted,interestconfirmed.Ready forcommercialization(EU)andregulatoryactivityinlargeterritory(US)
FinancingneedandTerms Financingroundinpreparationforearly2018TargetisatotalofCHF 5to8 millionInvestedsofar:CHF10million(7 inequity/3grants)
Clear valuecreationpath Shapethecompany assolidinnovativeplaybecominganattractiveacquisitiontarget:- SaleandPipeline- 2010AcquisitionofSomanetics byCovidienforUSD250mio
AdditionalInformation:
ClinicalCase*ManagementofaPatientinHypoxiaconsecutivetoaSubarachnoidHemorrhageduetoAneurysmRupture
*CasewashandledinZürichUniversityHospital,dept.ofNeuroIntensiveCarebyPr.E.Keller,founder
Clinicalcase:subarachnoidhemorrhage
1. Lowoxygensupply(O2 ↓)
2. Lowoxygencarrier(hemoglobin;anemia)
3. Lowbloodflow(CBF)
4. Highoxygendemandofbraincells
• Only 1/3of patients survive with mildor nodisabilities
• 1/3of patients develop cerebral vasospasmleading to ischemia &secondary infarctions
• Deathor severe disability inallpatientswith vasospam refractory to treatment
Vasospasmè ischemiaè infarctions dueto:
IschemiainIntensiveCareUnit:Whatdoesitmean?
Day0:ruptured aneurysm:bleeding inthe brain
brain vessels constrictedè imminentischemia
Consequences:Afterseveraldaysthepatientisdevelopingvasospasmsthatcanleadtoseveredamages.
Thisischemiacan’tbedetectedasthepatientisin
coma.
Clinicalcase:treatmentcascadeofSAHwithvasospam
1. Correctanemia è increase of oxygen carrier (hemoglobine)concentration
2. Treatfever è decrease oxygen demand
3. Artificialhypertensionè increase blood flow
4. Balloondilatationoflargecerebralvesselsè increase blood flow
5. Intraarterialvasodilatorsè increase blood flow
6. Therapeutichypothermiaè decrease metabolism(“hibernating”)
Ø Precisionmedicine:TheORIGINof ischemia is to be identified to decide
which treatment(s)is specifically adapted to the each patient
Paradigmshift:precisionandpersonalizedmedicine
https://www.whitehouse.gov/precision-medicine
Clearneedforneuromonitoring
O2–delivery O2–consumption
given by:• O2 content (~Hboxy)• hemoglobin (carrier of O2)• blood flow (CBF)
ischemia = dysbalance
Luciole Systemmeasures• CBF• Hboxy
Luciole Systemmeasures• Hbdeoxy
given by:• cell metabolism• O2 need (~Hbdeoxy)
Luciole Systemmeasures• SbtO2
Sbto2:agoodindicatorofhypoxia
ischemia with ptiO2 <15-20mmHg
Reasonforischemia?
1. Lowhemoglobin?
2. LowO2 content/delivery?
3. LowCBF?
4. HighO2 need?
Thesystemcandetectischemiaearlierthanothermeasures
SbtO2is the earlier indicator for ischemia(>1min.)than ptiO2
è Starttreatment earlier with Luciole System
CerebralBloodFlowmeasuresgivesoriginofischemia
CBF↓
ContinuousmeasureofHboxy,Hbdeoxy indicatescauseofischemia
Hbdeoxy↑è O2 need↑
Hboxy↓è O2 delivery ↓dueto CBF↓
SbtO2=Hboxy/Hbtotal
dueto blood pressure drop↓
Initiateandmonitorthebesttherapeuticaction(s)
Hbdeoxy↑è O2 need↑
Hboxy↓è O2 delivery ↓dueto CBF↓
SbtO2=Hboxy/Hbtotal
dueto blood pressure↓
è Treatment:1.Increase blood pressure to increase bloodflow &O2 delivery (monitor impact onCBF&Hboxy)
è Treatment:2.induce hypothermia to decrease O2need(monitor impact onCBF&Hbdeoxy)
Induction of hypothermia
Hbdeoxy↓è O2 need↓
Controleffectivenessoftreatment:reductionofmetabolism
Induction of hypothermiaArtificial increase of blood pressure
Hboxy↑è O2 delivery↑
Controleffectivenessoftreatment:increaseofO2delivery
Conclusions
• Oximetryvalues obtained with the Luciole Systemare valuable
• SbtO2 values behave similarly to ptiO2 values
• Hboxy andHbdeoxy values are inclose relationship with clinical events
• Luciole Systemallows detection of brain ischemia earlier
(SbtO2 reacts earlier than ptiO2)
• Multiparametermonitoring with the Luciole System,
delivering CBF,SbtO2,Hboxy andHbdeoxy allows
• to identify the exact cause of ischemia
• to enable causal treatment of ischemia
• to control the effectiveness of treatment
• to explore new neuroprotectivetherapies
Thankyou!
Luciole: pronounced:lysjɔl (“Lüssiol”)FrenchwordforFirefly(Eng.);Glühwurm (Ger.),Lucciola (Ita.)
FlyinginsectofthefamilyofLampyridae havingtheproperty toemitfluorescentlightbetween510and640nmwavelengthandshowingamovinggreendotinthenight.
Similartothetechnologyusedbythecompany(NIRS)tomeasureoxygensaturationofbraintissue.
Contact:PhilippeDro,CEOemail:[email protected]
Luciole MedicalisthesuccessorcompanyofNemoDevices AG