NovelMethodsofCapturing AirborneContaminationand

InactivatingAirbornePathogens

ClinicalandExperimentalEvidence

MarkH.Ereth,MDDonH.Hess,CTO

FrankStamatatos,CEO

Affiliation&

Disclosure

• MarkH.Ereth,MD• EmeritusProfessorofAnesthesiology• MayoClinicCollegeofMedicine• FounderandCEO,APRIHealth,Inc.

• DonH.Hess• ChiefTechnicalOfficer• SecureAire,LLC.

• FrankStamatatos• ChiefExecutiveOfficer• SecureAire,LLC.

Objectives

l IndoorAir-PollutionandDiseasel Hospital-AcquiredInfectionl ExistingAir-CleansingTechnologyl AirborneParticleMovementandCapturel NovelTechnicalApproachesl LaboratoryandHospitalExperimentsl SummaryandConclusion

Context

l IndoorAir-Pollution>OutdoorAirPollutionl 90%PopulationSpend>90%TimeIndoorsl InnovationinAir-CleansingMethodsLimitedl HEPAFiltration-- AncientStandardl ParticleControl>TraditionalFilteringl ParticleControlPreventsInfection

1µ

Influenza 0.098µ

Pneumonia0.707µ

Anthrax1.12µ

H1N1Measles 0.12µ

Whooping Cough0.25µ

Typhoid Fever1.5µ

Staphylococcus0.95µ

Cold Virus0.08µ

Smallpox 0.22µ

Meningitis0.8µ

Tuberculosis0.637

Bacteria Viruses

Reasons for Concern: Mean Diameters of “Small Particles”

5

ParticulateAirPollution&

Atherosclerosis

• Atherosclerosis-- LipidandFibrousplaque• AirborneFineParticulateMatter(PM2.5)promotesAtherosclerosis

• ParticulateMatter(PM2.5)MediatedAtherosclerosis

• Pro-oxidantmechanisms• Pro-inflammatorymechanisms• Multiplecelltypes• Multipleorgans• Molecularmediators

Biochem Biophys ACTA,2014

TheTerrifyingTruthAbout

AirPollution&Dementia

MotherJones2015

CognitiveFunctionand

OfficeAirQuality

• Conventional(NormalIAQ)HighVOCvs. Green(ConventionalOffice)LowVOCvs. Green+(GreenBuilding)+HighOutdoorAirVentilationRate

• 61%and101%ImprovedforGreenandGreen+

EpidemicofAlzheimer’s

Disease

HarvardGazette,April4,2017

PathophysiologyofAlzheimer’s

Disease

HarvardGazette,April4,2017

Naturevs

Nurture

Naturevs

Nurture

EnvironmentalAirExposure

APOEGeneticAlleles

&Alzheimer’s

Disease

l APOE2 -- APOE3 – APOE4l APOE2 – Rare,ProtectiveagainstAlzheimer’sl APOE3 – Common,Doesnotinfluenceriskl APOE4 – 20%,Increasesrisk,Lowersonsetagel APOE4 – 1Copy2-3xRisk,2Copies12xRiskl Structurecorrectors– DrugsAimtoModify

APOE4 tobemoreAPOE2 like

ParticulateAirPollutants&Alzheimer’s

Disease

l Neurodegenerativeeffectsofambientparticulateair

l Women’sHealthInitiativeMemoryStudy(WHIMS)

l Reside- PM>EPAstandardsIncreasedAlzheimer’sDiseaseby81-92%(EvenGreaterinAPOE4 Carriers)

2017

ParticulateAirPollutants&Alzheimer’s

Disease

l ExperimentalMouseModelsl 225hourexposuretourbannanosized PM(nPM)l Over15weekperiodl IncreasedBeta-amyloid,increasedwithAPOE4l SelectiveatrophyofhippocampalCA1neuritesl Increasedpro-amyloidogenic processingamyloid

precurser protein(APP)

2017

Smoking(Particulate

AirPollution):Responsiblefor14%ofDementia

WorldHealthOrganization2015

ParticulateAirPollution

(LikeTobacco):ThereisNo

SafeThreshold

• Epidemiologicalstudiesonlargepopulationshavenotidentifieda thresholdbelowwhich ambientParticulateMatter hasnoeffectonhealth.

• Withinlargehumanpopulations,thereisawiderangeinsusceptibilitysuchthatsomesubjectsareatriskevenatthelowestconcentrationsofPM

WorldHealthOrganization2015

HospitalAcquiredInfection

$10BillionAnnually

• Viral,Bacterial,&FungalPathogens• BloodstreamInfection• Pneumonia($3Billion)• UrinaryTractInfection• SurgicalSiteInfection• 2MillionPatientsAnnually• 75,000DeathsAnnually

KowalskiandWHO,2006

MostDangerous

HospitalAcquired

Pathogens

• AirborneSpread• MethicillinResistantStaphylococcusaureus(MRSA)• Acinetobactor &Pseudomonas• Superbugs invincibletostandarddrugtreatment• Airbornediseasetransmissionrising

KowalskiandWHO,2006,Healthcarefacilitiestoday.com,2015

HVACDesignManualfor

HospitalsandClinics:HVACandInfection

Control

• “Thescienceofcontrollinginfectionscausedbyairbornemicroorganismsisacomplexmixtureofengineering,particlephysics,microbiology,andmedicine.Theratesatwhichparticlessettleareafunctionoftheirsize,shape,densityandofcourse,airmovement.Turbulencewithinaroomincreasestheresidencetimeoflargerparticlesintheair,hencethedesireforlaminarairflowsinoperatingrooms.Particlesoraerosolsbelowabout1uminsizearevirtuallyunaffectedbygravityandstayinsuspensionbecauseofBrownianmotion.

• Aerosolsgeneratedbycoughsandsneezesgenerallyaffectotherpersons“only” within3to6ft.(0.9to1.8m).ItisvirtuallyimpossibleforHVACsystemstoexertcontrolatthiscloseexposure;therefore,transfermustbecontrolledusingpersonnelprotectionandorisolation.”

SOURCE: ASHRAE 2013, HVAC Design Manual for Hospitals & Clinics, 2nd Edition,*Journal of Fluid Mechanics, April 2014

*MIT Research Suggests that Cough and Sneeze Aerosols can actually travel up to 200 feet!

MitigatingAirborne

Pathogens

• Dilution• Filtration• Pressurization• Disinfection• UV-C• UpperAir/Room

ConventionalAirFiltrationMethods• PREandHighEfficiencyFilters(MERV14(85%),MERV15(95%),HEPA,ULPA,etc.)• MediaFiltersareextremelyimportant astheyprovidethecapturemechanismforairbornecontaminants.• MediaFiltershaveaMajorFlaw.

Conventional Methods of Air Filtration in Healthcare and Cleanrooms

HEPAModuleAHUPre&FinalFilters

AllFiltrationMediadependupononefact:“Particlesmustgettothemedia!”

Conventional Design in Healthcare and Cleanrooms

23

ParticleControlTechnologyMayDisruptExistingCleanMethods!

§ ConventionalStandardsinHealthcareDesignhavenot producedaneffectiveenoughreductioninHAI’s.Thesedesignstandardsinclude:§ Higherairchangerates(15,20,25ACH)§ AirCurtains§ Laminarflowceilings§ HEPAFiltration§ 100%“fresh”/outsideair!Is“fresh”/outsideaircleaner?§ Howabout“solutionbydilution?”

§ CleanroomsutilizemultipleHEPAfiltrationbanksandhighairchangeratestoachieve“Contaminationfreespaces”,whichpeoplearerarelyallowedtoenter.(Class1Cleanroomsusebetween650-900ACH!)

!

LikesRepel

ElectricalPropertiesofaParticle

SecureAireConfidential 24

UnlikesAttract

Particle Behavior of “Critical Size” Airborne Contaminants

+ –

1.SecureAireconditionsparticlestowanttocometogether.

+

2.SecureAireforcestheconditionedparticlestocollide.

25

Particle Behavior of “Critical Size” Airborne Contaminants

Once together the particles do not separate!

26

Particle Size Distribution in Air

18280000

1352000

214000 50000 35000 10000

5000000

10000000

15000000

20000000

0-0.5 0.5-1 1-3 3-5 5-10 10-30Particle Size (u)

Nu

mb

er

of

Pa

rtic

les

ElectromagneticFields

Airflow

Particle Control Technology makes the Dominant

Transport Mechanism: Airflow

Particle Behavior of “Critical Size” Airborne Contaminants

The ACS is the only Particle Control and Pathogen Inactivation Device Available

Particle Control Dominant Transport Process

27

The SecureAire ACS System

Ø Particles are Conditioned and Charged

Ø Charged Particles CollideØ Particles Gain Mass are “Net

Neutral”Ø Particles are CapturedØ Captured Particles/Viable

Pathogens are Killed By INACTIVATETM Technology

Ø Particles Escaping Capture are Conditioned to Remove Additional Critical Contaminants from Treated Spaces

ExperimentalApproachLaboratoryBasedStudyOut-PatientSurgeryCenterHospitalClientFeedbackObjectiveIn-PatientStudy

0

2000000

4000000

6000000

8000000

10000000

12000000

14000000

16000000

1 2 3 4 5 6 7 8 9 1011121314151617181920212223242526272829303132

Baseline

Drift Recovery

NewBaseline Baseline

Drift Recovery

NewBaselineRecoveryTime

t

Measurement and Verification (M&V) of Filtration Performance

Baseline,DriftandRecoveryaretheRealTimeMetricsforFiltrationPerformance

0

100000000

200000000

300000000

400000000

500000000

600000000

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32

ACSOff

Time(min)

Coun

ts@

0.4uandlarger/Ft3

ACSOn

Particle Control Technology Filtration Performance

ParticleControlSystemPerformance:• ReducedParticleBaselineandDriftby98.7%• ReducestheBaselinetoitslowestlevel• Reduces/EliminatesRecoveryTimeandDrift

AQMCou

ntsa

t0.4u/Ft

3

TimeofDay

Same TimeofDay SmallCounts(0.4microns)Average6-12-13 319010

Average6-13-13 76131

%Improvement 76

Particle Control Technology Results

31

0

200000

400000

600000

800000

1000000

1200000

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1600000

1 20 39 58 77 96 115

134

153

172

191

210

229

248

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305

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457

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571

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609

628

647

666

685

704

723

742

761

780

799

818

6/12/13APSOff

6/13/13APSOn

Cleanup Rate = 76%

ReductionofParticlesbyParticleControlTechnologyFollowingHEPAFiltration

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

6:32

12:25

18:17

0:10

6:02

11:55

17:47

23:40

5:32

11:25

17:17

23:10

5:02

10:55

16:48

22:40

4:33

10:25

16:18

22:11

4:03

9:56

15:48

21:41

3:34

9:26

15:19

21:12

7:56

13:49

1:34

10:23

16:16

23:07

13:48

19:41

3:31

10:22

19:11

1:03

6:56

13:47

21:37

3:30

11:20

8-17

-16

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-16

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-16

8-23

-16

9-1-16

9-2-16

9-3-16

9-4-16

9-5-16

9-6-16

Average=93,351 Average=3,820

OperatingRoomP-4(PreFilter/SecureAireM15)

OperatingRoomOR-3(PreFilter/Merv14/HEPA)

Date

Time

Coun

tsat0

.4uan

dLarger/Ft3

SecureAireConfidential

ParticleDifference=96%

Particle Control Technology Operating Room Results

ReductionofAirborneContaminantsbyParticleControlTechnology

INACTIVATETM Technology

ViablePathogenscapturedintheFilterMediaareInactivated/KilledbySecureAire’sINACTIVATETechnology:

• TheIonfieldgeneratedbythePCUcausesoxidativestressonthepathogen.

• TheHighVoltageChargeDensitythatexiststhroughouttheCollectormedia.

• “Kill”TestingResultsperformedonBacillus subtilis (Anthrax Surrogate)

33

ViableAirbornePathogenTrappedintheACSAreInactivated

Particle Control Technology Reduces Hospital Acquired Infection

Lake Tahoe Surgical Center Data

0

100000

200000

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600000

700000

12:0

0 A

M12

:47

AM

1:34

AM

2:21

AM

3:08

AM

3:55

AM

4:42

AM

5:29

AM

6:16

AM

7:03

AM

7:50

AM

8:37

AM

9:24

AM

10:1

1 A

M10

:58

AM

11:4

5 A

M12

:32

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1:19

PM

2:06

PM

2:53

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3:40

PM

4:27

PM

5:14

PM

6:01

PM

6:48

PM

7:35

PM

8:22

PM

9:09

PM

9:56

PM

10:4

3 P

M11

:30

PM

12:1

7 A

M1:

04 A

M1:

51 A

M2:

38 A

M3:

25 A

M

Time

2.5

mic

ron

coun

ts/C

FM

Without Secure Air System With Secure Air System

Lake Tahoe Surgury Center Data

0

50

100

150

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12:0

0 AM

12:4

8 AM

1:36

AM

2:24

AM

3:12

AM

4:00

AM

4:48

AM

5:36

AM

6:24

AM

7:12

AM

8:00

AM

8:48

AM

9:36

AM

10:2

4 AM

11:1

2 AM

12:0

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12:4

8 PM

1:36

PM

2:24

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3:12

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4:00

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4:48

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7:12

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8:48

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9:36

PM

10:2

4 PM

11:1

2 PM

12:0

0 AM

12:4

8 AM

1:36

AM

2:24

AM

Time

TVO

C Co

unts

Without Secure Air SystemWith Secure Air System

Lake Tahoe Surgery Center

Particles TVOCs

Zero Hospital Acquired Infections (HAI) since PCT installation in January 2006.

34

ExperimentalDesign

Particlesa

t0.4uan

dLarger/Ft3

PinkColumns=Surgerytimes.

Average@0.4uandLarger

167,408/Ft3

629100

203800

194600168400

156200

183000189000

13200

159000

166000

222009100

20600

183009900

21800

15000

17003700 10000

2100

760056003700

12009800

5800

19000

100000

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700000

7:00

8:15

9:30

10:45

12:00

13:15

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17:00

18:15

19:30

20:45

7:45

9:00

10:15

11:30

12:45

14:00

15:15

16:30

17:45

19:00

20:15

7:15

8:30

9:45

11:00

12:15

13:30

14:45

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17:15

18:30

19:45

21:00

8:00

9:15

10:30

11:45

13:00

14:15

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18:00

19:15

20:30

7:30

8:45

10:00

11:15

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16:15

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18:45

20:00

17-Jan 20-Jan 23-Jan 24-Feb 25-Jan

BaselineData(January17-25,2017)

26008500

3700 4300

3800 2800 1200

29600 13800

3900

900 700

16500 14001100 4700

1100

4200 3200

243005700

3300

290010700

33003100

750011100

2680038300

17400

2300 61009400

16200

16000

194009400

22600

0

50000

100000

150000

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7:00

8:30

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7:45

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10:45

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18:15

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7:00

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20:30

7:45

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16:45

18:15

19:45

7:00

8:30

10:00

11:30

13:00

14:30

16:00

17:30

19:00

20:30

13-Feb 14-Feb 15-Feb 16-Feb 17-Feb

Particlesa

t0.4uan

dLarger/Ft3

PinkColumns=Surgerytimes.

Average@0.4uandLarger

9,313/Ft3

SecureAireTechnologyDeployed(February13-17,2017)

107900116700

50600

13900

2700 65008500

6000

20300 540016200

1200 134001800

220011000

8400

4500 17900

310019400 2900

4300

73008400

3300

11100

79600

252200

362300

4700

1700

31004500 3600

6000

0

50000

100000

150000

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7:00

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7:45

9:00

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7:30

8:45

10:00

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12:30

13:45

15:00

16:15

17:30

18:45

20:00

20-Feb 21-Feb 22-Feb 23-Feb 24-Feb

2

Particlesa

t0.4uan

dLarger/Ft3

Average@0.4uandLarger

33,936/Ft3

PinkColumns=Surgerytimes.

SecureAireTechnologyRemoved(February20-24,2017)

APS-1000XOffAPS-1000XOn

ParticleControlTechnologyDataSummary:

%ImprovementItem BaselineData SecureAire

DeployedSecureAireRemoved Improvement(%)

AverageCounts (0.4uandlarger/Ft3) 167,408 9,313 33,936 94.4

PeakCounts 629,100 22,600 362,300 96.4

LowCounts 4,827 700 1,200 85.4

Surgeries 19 12 12

Hours 30:03 24:06 22:97

Pathogen KillRate 0% 99+% 0%

Particle Control Technology Benefits

üIAQBenefitsüMERV13orMERV15ASHRAE52.2üINACTIVATETechnologyforAirbornePathogensüLowerRateofHospitalAcquiredInfectionsüIncreasedRateofDiseaseRecovery

üParticleControlTechnologyüAirborneContaminantsareEffectivelyRemoved

• TVOC’s• CarbonMonoxide/Dioxide• Smoke• Odors• DissolvedGases

40

!

Summary and Conclusions

• Acuteand/orChronicAirborneParticulateExposureCausesorContributestoHealthcareAcquiredInfections,Atherosclerosis,DecliningCognitiveFunction,andDegenerativeDiseasessuchasAlzheimer’sDiseaseandDementia

• ConventionalMethodsofFiltrationlacktheabilitytoTransfertheContaminantforCapture(ACriticalAspectofPerformance)

• ParticleControlScienceandTechnologyProvidestheAbilitytoReduceCriticalAirborneContaminationandcanbeMeasuredandVerified

• ReducingAirborneContaminationcanReduceHealthcareAcquiredInfections• ParticleControlandInactivateTechnology(ACS)isSuperiorinConventionalFiltration• BroadDeploymentofSecureAire’s PCTandINACTIVATETechnologyCould

• SignificantlyImproveClinicalOutcomesinHospitals• Reducethe$9.8BillionAnnualCostofHospitalAcquiredInfections• ImproveCognitiveFunctionatHomeandOffice• ReduceInflammatoryandDegenerativeDIsease 41

ThankYouMarkH.Ereth,MD

ereth.mark@mayo.edu507.254.1425

DonH.Hess,CTOdhess@secureaire.com

813.766.0400

FrankStamatatos,CEOfstamatatos@secureaire.com

631.827.5426