SecondHeartMinimallyInvasiveCirculatoryAssistDevices

ProductSummarySecondHeartisdevelopingaminimallyinvasivecirculatorysupportplatformbasedonproprietaryaorticstentpumptechnology.Theplatformwillbedeployedusinglowprofilecatheter-basedtechniquesandwillprovideeithertemporaryorchroniccirculatorysupport,dependingonthespecificneedsofthepatient.SecondHeart'sinitialproductwillbeacatheter-basedtemporaryassistpumptotreatpatientswithacutedecompensatedheartfailureandtoprovidecirculatorysupporttothoseundergoinghigh-riskpercutaneouscoronaryintervention(PCI).Thesecondapplicationwillbeawirelesslypoweredcirculatoryassistpumpthatwillprovidechroniccirculatorysupportforheartfailurepatients.

KeyfeaturesofSecondHeart'splatforminclude:

  Ahigherflow(withlowerRPMs)ratethanothersystemsatover7litersperminute.

  Pumpplacementjustabovetherenalarterieswillprovideadditionalbenefitforheartfailurepatientswithkidneydysfunction.

  Achoiceofpulsatileorcontinuousflowtooptimizehemodynamicsandlessentheriskofthrombosis.

  Theonlysystemtousethefullinnerdiameteroftheaortatoincreasepumpstabilityandreducepumpmigration.

  Lowerriskofmechanicalfailureduetosimpleimpellerdeploymentmechanism,improvedbearings,andliquidcooleddriveshaft.

FAQ

Isheartfailureasignificantproblem?IntheU.S.over6millionpeoplesufferfromheartfailurewithupto20%sufferingfromanadvancedformofthedisease(Class3and4).Thisresultsinover1millionhospitalizationseachyearthatcostthehealthcaresystemover$30billion.AccordingtotheAmericanHeartAssociation,theprevalenceofheartfailureisexpectedtoincreaseby46%through2030,resultinginover8millionpatients.

WhatistheregulatorystatusofSecondHeart'sproducts?SecondHeartiscurrentlyconductingpreclinicalstudiesandhasidentifiedthesitesthatwillbeusedfortheclinicaltrialsthatwillbenecessaryforFDAandCEMarkapproval.

WhatisSecondHeart'sintellectualproperty?SecondHearthasaformidableintellectualpropertyportfoliothatincludespatentsfromleadingcardiovascularphysiciansandCalTech.

HowdoesSecondHeartcomparetothecompetition?Competingproductsaremoredifficulttoplace,havelowerflowrates,anddonotprovidetheimprovementsinrenalfunctionthatareanticipatedwithSecondHeart'splatform.

Market ThetargetmarketsforSecondHeart'stemporarycirculatoryassistpumpinclude:

  Acutedecompensatedheartfailure―Oftheestimated1millionannualhospitalizationsfordecompensatedheartfailure,roughly10%arecomplicatedbyreducedkidneyfunction.Duetoitsplacement,justabovetherenalarteries,patientswithreducedkidneyfunctionstandtosignificantlybenefitandrepresent100,000potentialpatientsperyear.

  High-riskPCI―TheestimatednumberofPCIsthatoccureachyearintheU.S.rangesfrom650,000to1.2million(basedonthespecificsource).Currentestimatesarethatatleast10%ofPCIsareconsideredhighriskandcouldpotentiallybenefitfromasupportdevicesuchasSecondHeart’s.Asaresult,thismarketsegmentincludes65,000to120,000patients.

Combined,thesesegmentsencompass165,000to220,000heartfailurepatientseveryyearandresultinanannualprojectedmarketofover$4.6billion.AcomparablethatconfirmsthemarketpotentialisAbiomed,amanufacturerofcatheter-basedtemporarycirculatoryassistdevicesindicatedforhigh-riskPCIandcardiogenicshock.Overthepast5yearstheyhaveseen36%annualgrowthwithImpellasalesgenerating$570millionofrevenuein2018.Evenwithlessthan15%oftheirprojectedmarket,Abiomedhasachievedamarketcapitalizationofover$18billion.

ThemarketforSecondHeart’schronicaorticimplantwillbeheartfailurepatientswhorequirelong-termcirculatorysupport.Sincemanyofthesepatientsareunabletoreceiveahearttransplant(duetoorganshortage,contraindications,etc.),theycurrentlyrelyoncardiacassistdevicessuchasventricularassistdevices(VADs).TheLVADmarketisexpectedtogrowat7.9%annuallyoverthenext3yearstoreachatotalrevenueofroughly$900millionin2021.

ProblemCurrentlyavailablecirculatoryassistdevicesfaceanumberofsignificantlimitationsanddrawbacks,including:Lowflowratesthatdonotprovidethefullassistancepatientsneed.Device-associatedthrombosisthatcanblockbloodflowtovitalorgans,potentiallyresultinginastroke,myocardialinfarction,etc.Highimpellerspeedsthatcancausehemolysisandpumpmigration.Risksandcomplicationsassociatedwithinvasiveimplantationproceduresthatarerequiredtodeploymanycirculatoryassistdevices.Externalequipmentcandecreasepatientcomfortandqualityoflifewhilelimitingtherangeofactivitiesapatientcanparticipatein(swimming,etc.).

SolutionsSecondHeart'stechnologyisaminimallyinvasivesolutionthatprovidescirculatoryassistancetopatientswhileovercomingmanyofthelimitationsofcurrentoptions:Collapsiblestentpumpdesignallowsforlowprofilecatheter-basedintroductionforeasyandsecureplacementintheaorta.Mechanicaldesignprovideshighflowrates(over7litersperminute)whileminimizingtheriskofmechanicalbreakdownandreducesdamagetobloodcells(hemolysis).Thrombosis-resistantmaterial,harmonicvibrationalenergytechnology,andpulsatileflowallhelptopreventbloodclottingthatcanleadtostrokeormyocardialinfarction.Ourpatent-pendingremovable(andwirelesslypowered)pulsatingcuffstentissituatedabovetheimpellerpumpprovidingatwopump"in-series"system.Thiswirelesspowersourceeliminatestheneedforpercutaneousequipmentthatcanserveasasiteofinfectionandlimitapatient'squalityoflife.

KeyMilestones

CompletedMilestones

• 2016-2018-3ExpertPanelmeetingswith20U.S.heartfailuredepartmentchairs• Spring2017-CompletedfirstwirelesspowertestatQueenslandUniversity• Spring2017-Licensed5+PatentsfromCaltech• Fall2017-Completed4LargeAnimalFeasibilityStudyatTuftsMedicalCenter• Winter2018-FDAPre-submeetingEarlyFeasibilityStudy• Spring2018-CompletedMockLoopTestingatUniversityofLouisville• Spring2018-9daychallengetestingatBiomericsMinneapolis• Spring2018-FilingofSecondHeartpatentsforthrombosisandhemolysisreduction• Summer2018-Completed2RoundsofComputationalFluidDynamicsTestingwithenModesinGermany• Summer2018-FilingofSecondHeartpatentsforflowoptimization,autoadjust,andpowermanagement• Summer2018-NewmotorcontrollerbuildfromDeviceLabinTustin,CA• Summer2018-Completedfirstof5largeanimalQTestOhioStateUniversity

UpcomingMilestones

• September2018-HemolysistestingatUniversityofLouisville• September2018-WirelesspowertestingSecondHeartdevice• September2018-Completionof4largeanimalstudiesincluding3GLPaswithQTest• September2018-First-In-ManStudiesinAustraliafor1stgenerationcatheter• Fall2018-USAEarlyFeasibilityStudyfor1stgenerationcatheter• Winter2018-Exit1stgenerationcathetertostrategicpartner• 1Q-3Q2019-Wirelesspowerchronicimplantpre-clinicalstudies• Fall2019-WirelesspowerchronicimplantFIMstudies• Winter2019-Exitchronicimplantandwholecompany

4LargeAnimal

FeasibilityStudies

Fall2017

MockLoopTestingatLouisville

Spring2018

FirstinMan

Studies

Fall2018

USAEarlyFeasibilityStudy

Fall2018

Exit1stGenerationCatheter

Winter2018

ExitChronicImpant&Company

Winter2019

CurrentPrice$4/Share

$37.1MNValuation

CoreTeam

TeamMembers

HowardLeonhardt

Chairman,CEO

HowardisahighlysuccessfulserialentrepreneurwhohasdevelopedmultiplecardiovasculardevicesthatcontinuetoleadthemarketincludingtheTALENTstentgraftandpercutaneousheartvalves.

LeslieMiller,MD

ChiefMedicalOfficer

Dr.Millerisaboard-certifiedcardiologistandoneoftheworld'sleadingexpertsinthedevelopmentandevaluationofcirculatoryassistdevices.Hehasbeeninvolvedinover100clinicaltrialsandhaspublishedmorethan250manuscripts.

JeffDonofrio

President

Jeffhasover30yearsofmedicalsales,managementandbusinessdevelopmentexperience(with16ofthoseyearsspecifictocardiovasculardevices).HehasworkedforWorldHeart,ATSHeartValves,EdwardsLifeSciences,andCardiacAssist,Inc.

ToddSeiger-ChiefAdvisorReimbursementLarryStevens-ChiefAdvisorRegulatoryAffairsJaneReedy-ChiefAdvisorClinicalAffairsStephenKann-ChiefFinancialOfficerAlexRichardson-VPEngineering&ProductDevelopmentDr.NicChronos-ChiefAdvisorResearchDr.MarkCunningham-ChiefAdvisorCardioThoracicSurgery

Dr.WilliamAbraham-ChiefAdvisorHeartFailureKenEvans-VPCorporateDevelopmentDr.BarryGreenberg-ClinicalAdvisoryBoardMemberDr.DineshPatel-BoardDirectorDr.SamerBanihani-ChiefNephrologyAdvisorRyanStanfield-CirculatoryAssistDeviceDesignAdvisor