PitchBook-器官移植技術(shù)（英）

(pitchBooK

EMERGINGTECHRESEARCH

OrganTransplantTech

Exploringkeyinnovationsandstartupopportunities

PitchBookData,Inc.

JohnGabbertFounder,CEO

NizarTarhuniVicePresident,Institutional

ResearchandEditorial

PaulCondraHeadofEmerging

TechnologyResearch

PitchBookisaMorningstarcompanyprovidingthemostcomprehensive,most

accurate,andhard-to-finddataforprofessionalsdoingbusinessintheprivatemarkets.

InstitutionalResearchGroup

Analysis

AaronDeGagne,CFA

Keytakeaways

?Coreareasofinnovationintheorgantransplantmarket—includingtransplantdiagnostics,organtransport,andAI-basedtransplantmatching—havean

estimatedcombinedmarketopportunityofatleast$7billion.

?Thetransplanttechnologymarketisinaperiodoftransitionfromgrowingmodernizationeffortsandevolvingincentivesforimprovedorganmatching,whicharepositivefactorsformarketgrowthandstartupopportunities.

?Overthepastdecade,theorgantransportmarkethasdevelopedfroma

nicheservicetoonewithseveralmajormarketplayers;thegrowthtrajectoryremainsstrongastransplantcentersconverttousingadvancedorgan

preservationtechnology.

?AIcanprovidesolutionsforrejectionriskandcrossmatching,andgreaterpublicaccesstoorgantransplantdatahaspotentialtoformthebuildingblocksfor

novelAI-basedtransplantmodels.

?AnupcomingreviewofthegovernmentcontractfortheOrganProcurementandTransplantationNetworkmayleadtoadditionaldisruptionwithopportunityfortransplantstartupstogainafootholdastechnologypartners.

SeniorAnalyst,Healthcare

aaron.degagne@

pbinstitutionalresearch@

Publishing

DesignedbyJennaO’Malley

PublishedonMarch28,2024

Contents

Keytakeaways

1

Introduction

2

Regulatoryoverview

3

Futureoftransplanttesting

5

Innovationsinorgantransport

6

Conclusion

7

Appendix

8

1

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PitchBookAnalystNote:OrganTransplantTech

Introduction

Despitethebroadsuccessofthenationalorgantransplantsystem,asmeasured

bythenumberoflivessavedorsignificantlyimprovedthroughsuccessful

transplants(over800,000intheUSsince1988),1thesystemstillfacessignificantbarrierstooperateefficiently.Thereareover100,000Americansontheorgan

transplantwaitlist,2andadifficult-to-understandwaitingprocess,challenges

withtransportation,andpossibilityoforganrejectionallcontributetoless-than-

perfectresults.Inthisnote,wehaveidentifiedcoreareasofinnovationintheorgantransplantmarketwithanestimatedcombinedmarketopportunityofatleast$7

billion:transplantdiagnostics,organtransport,andAI-basedtransplantmatching.

Whilenotexploredindepthhereduetothisnote’sfocusondurablemedical

technologies,anotherpotentiallylargeopportunityisbiotech-enabledefforts

tocreateorregenerateartificialorgans.FullybioengineeredorgansaretheHoly

Grailforthetransplantmarket,astheycouldbeapowerfulsolutiontoovercome

transplantwaitlists—thoughmeaningfultechnologicalchallengesremain,3andlivepatientapplicationsarelikelymanyyears,ifnotdecades,away.Beyondfullorgangeneration,startupsdevelopingotherbiotechalternativesincludeIVIVAMedical(implantableartificialkidney),Cella?on(stem-cellorganregeneration),andOssiumHealth(stem-celltransplanttoleranceinfusions).

Thegraphiconthefollowingpageprovidesaframeworkforevaluatingkey

innovationopportunitiesinorgantransplantationandhighlightswhereinnovativetechnologiesmighttakeholdalongdifferentpointsofthesupplychain.Major

decision-makersareidentifiedtoshowthecomplexityoftheorgantransplant

processandpinpointdifferentcustomertypesfororgantransplantproduct-makers.

1:“TheHistoryofOrganTransplantation,”NationalLibraryofMedicine,BaylorUniversityMedicalCenterProceedings,KristenD.NordhamandScott

Ninokawa,October19,2021.

2:“OrganDonationStatistics,”HealthResources&ServicesAdministration,February2024.

3:“OrganRegenerationThroughStemCellsandTissueEngineering,”NationalLibraryofMedicine,Cureus,LaibaAjmal,etal.,January29,2023.

2

Organprocurementorganizations

Accept/declineoffer

Organtransport

Transplantcenter

PitchBookAnalystNote:OrganTransplantTech

Organtransplantprocess

OrganProcurementandTransplantationNetwork

Bidsavailablefor

third-partycontractors

UnitedNetworkforOrganSharing(administrator)

AI-basedmatching

Organmatching

Matchingoffer

Organdonor

InnovationopportunityNonprofitorganization

Patient/donor

Healthsystem

Matchingprocess

Pre-andpost-

diagnostics

Patienttechservices

Patientseeking

transplant

Stem-celland

regenerativetherapies

Source:PitchBookEmergingTechResearch?Geography:US

Regulatoryoverview

Theprocessforinitiatingandperformingorgantransplantsinvolvescoordination

betweenacomplexwebofsystemsandproviders.Importantparticipantsin

theprocessareorganprocurementorganizations(OPOs),whicharenonprofit

entitiesthatrecoverorgansfromdeceaseddonorsandaidwiththerecoveryand

transportationoforgansfortransplantation.Thereare56OPOsintheUS,andwhilemanyperformwellwithintheirdesignatedservicearea,therehasbeenrecognitionofsignificantissuesstemmingfromlowsuccessratesinreachingdonorsand

matchingthemtopotentialrecipients.4Thiscanbeattributed,inpart,tothe

self-regulativenatureofOPOsandthehistoricallackofmeaningfulenforcementofmetrics.Todate,noOPOhaslostitscontractwiththeCentersforMedicare&MedicaidServices(CMS)despitesomeachievingobjectivelypoorresults.5

Inrecentyears,andasaresultofgreaterrecognitionofOPOunderperformance,explicitgovernmentaloversightandscrutinyhasrisen,andCMShasputforwardaconcreteprocesstopotentiallydecertifyunderperformingOPOsbeginning

in2026.6AndinSeptember2023,PresidentJoeBidensignedintolawanew

4:“TheTransplantEco-System:TheRoleofDatainCMSOversightoftheOrganProcurementOrganizations,”CentersforMedicare&MedicaidServices,

LeeA.Fleisher,JeanD.Moody-Williams,andJonathanBlum,April28,2023.

5:“ACrucialLinkintheNation’sOrganDonationProcessIsFailing,”TheMarkup,MalenaCarollo,April28,2023.

6:“TheTransplantEco-System:TheRoleofDatainCMSOversightoftheOrganProcurementOrganizations,”CentersforMedicare&MedicaidServices,

LeeA.Fleisher,JeanD.Moody-Williams,andJonathanBlum,April28,2023.

3

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PitchBookAnalystNote:OrganTransplantTech

regulationthatwillintroducecontractorcompetitionintotheOrganProcurement

andTransplantationNetwork(OPTN),whichisresponsibleforthenationalorgan

transplantwaitlistthathasbeenmanagedfordecadesbyasoleentity,theUnitedNetworkforOrganSharing(UNO).7Consideringthemulti-yearleadtimefor

potentialOPOdecertificationandstrengthenedincentivesforOPOstoimprove

performance,thereisclearopportunityfortheadoptiontoolsandtechnologiesthatcanassistwithorganprocurementandmatching.

Meaningfulstartupinvolvementdepends,inpart,onthewillingnessofUNOto

sharegovernmentdatatothirdpartiesviaAPIs.Recentmodernizationefforts

havesetthestageforgreaterdatasharingandthepotentialarrivalofstartup-

drivensolutions;andbeginningin2023,morecomprehensivedatadashboardsontransplantsbecamepubliclyavailable.Inthefuture,itcouldbepossibleforstartupstoemergewithnovelAI-basedsolutionspoweredbythisnewlypublicdata.

NonprofitstartupValeoshasbeguntoleveragetransplantdatatoprovidesolutionsacrosstheecosystem,andotherscouldfollowinitsfootstepsinthecomingyearsthroughanalysisofpublicdataandpartnershipswithtransplantcentersand

OPOs.However,itmaytakemoredirectgovernmentactionforUNOandOPOstoimplementthird-partysolutions,giventheseincumbententitiesoperateasfull-serviceorganizationswithlimitedtiestoexternalcompanies.

Thereisatighttimeperiodforwhenadecisionneedstobemadeforanorgan

transplantfollowingdonordeath—sometimesasshortasfourhours,oronthe

longerend,upto36hours.8AIcanprovidesolutionsforbothrejectionriskand

crossmatching,whichistheprocessfordeterminingtheimmunologicriskofan

organtransplantrecipient.In2023,theMayoClinicpublishedastudyinClinical

TransplantationthatdemonstratedtheeffectivenessofanAI-basedsystemfor

analyzingtransplantedkidneybiopsiesforinflammationlevels,9andotherstudies

haveidentifiedthepotentialforAI-poweredelectrocardiographytopredictthe

riskoflow-gradeorganrejection.10Inanearlyindicationofwhatcouldbepossible

fromastartupperspective,academicresearchersfromboththeMassachusetts

InstituteofTechnologyandtheUniversityofNorthCarolinahaverecentlydevelopedtechnologyforimproveddonormatching.11,12

7:“BigTech,StartupsLooktoRevampTroubledOrganDonationSystem,”BloombergLaw,TonyPugh,November27,2023.

8:“UNCResearchersCreateNewPlatformtoImproveOrganTransplantation,”TheUniversityofNorthCarolinaatChapelHill,April18,2022.

9:“ClinicalImplementationofanArtificialIntelligenceAlgorithmforMagneticResonance–DerivedMeasurementofTotalKidneyVolume,”Mayo

ClinicProceedings,TheodoraA.Potretzke,etal.,March16,2023.

10:“FiveWaysArtificialIntelligencePromisestoTransformOrganTransplant,”MayoClinic,May26,2023.

11:“UNCResearchersCreateNewPlatformtoImproveOrganTransplantation,”TheUniversityofNorthCarolinaatChapelHill,April18,2022.

12:“MITAIAlgorithmsAimtoRevolutionizeOrganTransplantSystem,”HealthcareITNews,BillSiwicki,April12,2023.

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PitchBookAnalystNote:OrganTransplantTech

Futureoftransplanttesting

Transplantdiagnostictestingisanimportantinnovationareawithinthetransplantspace,asorgantransplantrejectioncanbeexpensiveforpayersandleadtoworseoutcomesforrecipients.Adoptionofnoveltestshasbeenrising,supportedby

robustdemandforteststhatcanusebloodorurinesamplesinsteadoftraditional,more-invasive—andmorecostly—tissuebiopsies.Transplanttestshavelongbeenusedaspartofpre-transplantduediligenceoncompatibilityandtocheckfor

signsofrecipientrejectionfollowingthetransplant.However,innovationhasbeenaccelerating,andthemarketappearssetforsignificantgrowthasnewtechnologiesbecomeavailable.Whileexistingtestsworkwell,theyoftenrelyonexpensiveandinvasivetissuebiopsies;recentinnovationhasfocusedonthepotentialforeasier

andcheaperbloodteststoachievesimilarresults.Asanexample,aresearchteamattheNationalInstitutesofHealth’sNationalHeart,Lung,andBloodInstitute

publishedastudyin2021evaluatingtheeffectivenessofcell-freeDNAbloodtestsfordetectingacuterejectionofhearttransplants.Resultsshowedhearttransplantrejectionwasidentifiedassoonas28daysaftertransplantationandaboutthreemonthsbeforeitwasdetectableusingtraditionalhearttissuebiopsies.13

TheuseofbloodtestsfororganrejectiongainedfurthermomentumafterMedicareAdministrativeContractor(MAC)PalmettoadoptedtheMolecularTestingforSolidOrganAllograftRejection(MolDX)LocalCoverageDeterminationinJune2021.ThisenabledbloodteststosupplanttissuebiopsieswhendeemedclinicallyappropriatebyMACs.Whilecertainupdatestobillingandcodingwereimplementedin

2023inresponsetooverutilizationoftransplantbloodtestsinsomecases,thecoveragedeterminationhasremainedinplaceandwasconfirmedinSeptember2023byCMS.14

Globally,themarketopportunityfortransplanttestinganddiagnosticshas

beenestimatedat$5billion,whichincludesbothcompatibilitytestsandpost-

transplantrejectiondiagnostics.15Thisaddressablemarkethasscopetoincreaseaswell,giventheworkbeingdonetoimproveorganmatchingsuccessratesandincreasethenumberofdonors.AriseinthenumberoforgantransplantscouldhaveameaningfulimpactonthemarketopportunityandleadtogrowingstartupinvolvementandVCinterestovertime.

Lookingahead,thetransplanttestmarketislikelytoprovideopportunitiesfor

bothstartupsandestablishedincumbents.Selecttransplantdiagnosticstartups

includeNephroSant,BioMAdvancedDiagnostics,andBiohope,whichhaveraised

acombined$24.9millionofVCfunding.Still,thebulkofcurrentmarketshareis

heldbymajorincumbentsThermoFisher,Natera,CareDx,Oncocyte,VericiDx,

andImmucor(acquiredbyWerfen),amongothers.Incumbentsinthespacehold

heavyadvantagesfromstrongdistributionnetworksandexistingrelationshipswithpayersandproviders.Forthisreason,aswellasthestrongdesireforincumbents

tomaintainleadership,themostlikelyoutcomeforrisingstartupsisanacquisitionbyanexistingmarketplayer—incontrastwiththelowerchanceofachievingan

independentpubliclistingthroughsteadyorganicgrowth.

13:“AcuteHeartTransplantRejectionDetectedEarlierWithNewTest,”NationalInstitutesofHealth,January26,2021.

14:“CMSStatementonCurrentStatusofBloodTestsforOrganTransplantRejection,”CentersforMedicare&MedicaidServices,September25,2023.

15:“TransplantDiagnosticsMarketSurgesat7.2%CAGRTowardsUSD8.3Billionby2032,”Yahoo!Finance,Market.Us,October19,2023.

5

PitchBookAnalystNote:OrganTransplantTech

TestsapprovedundertheMolDXreimbursementprogramforsolidorganallograftrejection*

TestTestmanufacturerCompanystatusSpecimensourceOrgan(s)

AlloMapCareDxPubliccompanyBloodHeart

AlloSure

CareDx

Publiccompany

Blood

Kidney,heart,lung

HeartCare

CareDx

Publiccompany

Blood

Heart

Prospera

Natera

Publiccompany

Blood

Kidney,heart,lung

QSant

NephroSant

VC-backedstartup($22.1Mraised)

Urine

Kidney

TruGraf

TransplantGenomics

Acquired(Eurofins)

Blood

Kidney

ViracorTRAC

Eurofins

Publiccompany

Blood

Kidney

VitaGraft

Oncocyte

Publiccompany

Blood

Kidney

Source:

CentersforMedicare&Medicaid

Services?Geography:Global?*AsofMarch18,2024

Innovationsinorgantransport

Amajorpieceofthepuzzletoimprovingsuccessfulorgantransplantsisonthesupplyside,giventhatadonorshortageisasignificanthurdletoincreasingthenumberof

successfultransplants.Traditionalorganpreservationmethods—suchascoldstorage,whichiseffectivelyasecuredcooler—canleadtofrozenanddamagedorgansdue

tothedifficultyofmaintainingprecisetemperatureneedsthroughoutthetransportprocess.Incontrast,severalmarketplayershaveemergedtooffernovelorgan

transportandpreservationmethodstoimprovethereliabilityandeffectivenessofthecriticalandtime-sensitivetransportprocess.

Overthepastdecade,theorgantransportmarkethasdevelopedfromaniche

servicetoonewithseveralmajormarketplayers,whichnowincludepubliccompanyTransmedics;VC-backedstartupsParagonix,OrganOx,ScubaTx,andBridgetoLife;

andpreviouslyVC-backedOrganRecoverySystems(acquiredbyShanghaiGenext

MedicalTechnologyCompany).ParagonixreceivedFoodandDrugAdministration

clearancein2013foritsfirstproduct,theSherpaPakCardiacTransportSystem.The

startupnowholdssignificantshare(approximately50%)inhearttransportanda

double-digitshareinlungtransport,anditalsorecentlylaunchedaproductforliver

transport.Apartfrompuresafetybenefits,novelorgantransportproductshave

shownanabilitytodelivercostsavingsfororganrecipients,asadvancedtransport

technologycanreducethechanceoforganlossandloweraveragehospital-staycosts;astudypublishedinNovember2022identifiedaveragecostsavingsofover$26,000perpatientwhenusingtheSherpaPakCardiacTransportSystem.16WhilesophisticatedtransportsolutionslikethoseofferedbyParagonixarenotinexpensive,theabilitytodeliverbettertransplantoutcomesandcostsavingsislikelytoleadtorisingadoptionbytransplantcenters.Thoughorgantransportmarketplayerscompetewitheach

othertoanextent,theprimarygrowthopportunityremainsinconvertingtransplantcenterstousingadvancedtransporttechnologyinsteadofcoldstorage.Inthelong

term,newtechnologiesnotyetavailable,suchascryopreservation,couldenableevenmorerobustdisruptionoftraditionalorgantransportmethods.

16:“ClinicalEvidenceShowsReducedCostsandImprovedOutcomesinHeartTransplantationWithParagonixSherpaPak,”Paragonix,

November22,2022.

6

PitchBookAnalystNote:OrganTransplantTech

Weestimatetheglobalorgantransportmarkettoberoughly$2billionacross

thefourmajororgansofheart,liver,lung,andkidney.Eachsingle-usetransport

productisgenerallypricedupto$20,000,andthereareapproximately40,000

organtransplantsannuallyacrosstheseorgantypesintheUS,withthemajorityofthese(25,000)beingkidneytransplants.17Thistranslatestoamarketopportunity

ofover$500millionintheUSalone,andtheglobalmarketcanbereasonably

estimatedasamultipleoftheUSfigure.Furthermore,manymarketplayersthat

offertransportproductsasacoreofferinghaveacceleratedtheireffortstoprovideancillarysoftwareservicessuchasprocurementservicesanddigitaltracking,whichincreasesthepotentialforrecurringrevenueaspartoftheoverallbusinessmodel.

Selectorganpreservationstartups*

Company

HQlocation

TotalVC($M)raised

LastdealtypeLastdealdate

Leadinvestor(s)

OrganOxOxford,UK$95.7PEgrowthJuly17,2023LauxeraCapitalPartners,AnjostInvestment,BGF

BridgetoLife

Northbrook,US

$56.7

SeriesA

August18,2021

PerceptiveAdvisors,SCLaunch

Paragonix

Cambridge,US

$39.3

SeriesB

March7,2023

SignetHealthcarePartners

OrganRecoverySystems

Itasca,US

$26.9

Acquisition

January24,2019

N/A

ScubaTx

Royston,UK

$2.2

Early-stageVC

May15,2023

PraeturaVentures,GoldenTrianglePartners,ConduitConnect

Source:PitchBook?Geography:Global?*AsofMarch18,2024

Conclusion

Theorgantransplantmarketishighlycomplexandoftenoperatesinefficiently,

whicharefactorsthathavepotentialtoopendoorsforstartup-fueleddisruption.Organtransplantsserveanimportantfunctioninhealthcare,savingtensof

thousandsofliveseachyear,andincentivesarerisingfortransplantcenters

andOPOstoshowperformanceimprovement.Fromafinancialstandpoint,the

transplantmarketoffersanattractive,recurringsalesopportunityforkeymarketplayers,anddemandfororgantransplantsislikelytoriseovertimefromolder

populationsandgreaterincidenceofchronicdiseasesaffectingmajororganssuchastheliverandkidney.Ultimately,increasingthenumberoforgandonorsisthe

bestsolutiontoresolvingwaitlistandmatchingdifficulties,thoughdemandfor

donatedorgansislikelytoexceedsupplyevenwithhigherdonorrates.Startupsthatoffertechnologyforimproveddonorcrossmatching,transport,andpost-transplanttestingcanmeaningfullycontributetoimprovedtransplantsuccessrates,assumingdonorratesremainstable.

17:“2022OrganTransplantsAgainSetAnnualRecords,”UnitedNetworkforOrganSharing,January10,2023.

7

PitchBookAnalystNote:OrganTransplantTech

Lookingahead,anupcomingreviewoftheexclusivegovernmentcontractforthe

OPTNcouldleadtofurtherdisruption,potentiallywithBigTechinvolvement,as

Microsoft,Google,andOracleareanticipatedtopotentiallyenterabid.18Althoughinvolvementbyamajortechcompanyislikelytoattractscrutiny,thesecompaniesofferadvancedcloudinfrastructuresolutionsthatcouldbenefitthecomplex

technologysystemsoftheOPTN.Thesefuturebids—expectedwithinthenext

yearortwo—couldarriveintheformofapartnershipbetweenstartupcompaniesandestablishedcloudproviders.19Inthisscenario,therewouldbemeaningful

opportunityfortech-focusedstartupstogainaninitialfootholdinapartner

capacity,particularlyintheareasofAI-basedorganmatchingandpatient-facing

techservices.Thoughsignificantchangesinthisma