A. Science Overview_Masks_Nexera

“Next Generation Respiratory Protection”

Masks

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THE FIRST GLOBAL LINE OF ANTIMICROBIAL RESPIRATOR MASKS

• N95, N99, and FFP2 RD & FFP3RD • Reusable up to 14 days** • Single Use for extended wear up

to 12 hours* • Adult (large) and children’s

(small) sizes

• Superior Respiratory Protection • Self Sanitizing • Universal Fit for all facial shapes and

sizes • Safe, natural & non toxic • PVC Free, Latex Free, Non-allergenic • Prevents cross-contamination

GUARDIAN FFP2 DEFENDER PROFESSIONAL PROTECTOR GUARDIAN FFP3

* N95 for United States, N99 for Canada, FFP3 for European Union

** For European Union, South America, & Canada only

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Revolutionary New FDA Cleared SpectraShield™ N95 Surgical

Respirator Mask

DEEMED “SAFE AND EFFECTIVE” BY THE FDA

FIRST TO USE ANTIMICROBIAL TEXTILE

Simultaneous clearance by FDA & NIOSH.

Tested and proven for extended wear up to 12 hours

The technology eliminated “breathing zone” concerns of the FDA

Patented technology – proven performance

Meets CDC & WHO guidelines for infections disease exposure control

Effective against certain bio-terrorism illnesses such as Tuberculosis

SpectraShield™ receives clearance for

a new class of Antimicrobial Medical Devices called “OUK”

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The SpectraShield Series of Antimicrobial Masks offer:

SUPERIOR RESPIRATORY PROTECTION

PROTECTION DURING A HEALTH CRISIS

REDUCED CROSS CONTAMINATION

EASY BREATHING AND COMFORT

KILLS TUBERCULOSIS, MRSA, BIRD FLU, SWINE FLU AND MORE

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The SpectraShield™ Mask filters over 3,500% better than an ASTM F2100-07 high barrier mask

No Filtration Capability

No Snug Fit – Loose Ear Straps

Causes Air Leakage

Gaps Around Nose Causes Air Leakage

Superior Filtration Filters out up to

99% of particulates

Tight Fit Around Nose No Air

Leakage

Snug Fit Dual Elastic Straps

No Air Leakage

ASTM F2100-07 High Barrier Surgical Mask

SpectraShield™ Antimicrobial N95, N99, FFP3 Respirator

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BE PROTECTED

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A powerful sneeze can produce nearly 40,000 aerosol droplets which are propelled

through the air at great force. The most common estimates for the speed these droplets travel is around 95 mph, but some people may be able to reach 650 mph

for their sneezes. This is the main reason that airborne diseases can be so easily spread throughout the

population.

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THIS IS HOW IT PROTECTS The SpectraShield™ Mask, captures microbes, then inactivates or kills them*

*Antimicrobial performance inactivates viruses and kills bacteria

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No other natural, nontoxic, safe, and effective antimicrobial agent works as effectively as Fosshield.

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Fosshield inhibits microbial survival in three ways:

Suffocation: Inhibits membrane transport

processes

Sterilization: Prevents cell reproduction

Starvation: Interrupts cell metabolism

&

THIS IS HOW IT KILLS MICROBES

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Aspergillus niger

The SpectraShield™ Mask’s proven Antimicrobial technology performance

SpectraShield Mask Material

which has long-lasting and

continuous kill capability

Most Other Mask Material

Kills Harmful Pathogens

Including H1N1, Swine Flu, TB, &

MRSA*

*Antimicrobial claims applicable to the E.U.,

Canada, & South America. Antibacterial

claims applicable to the United States

30 Day Inoculum Test

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Ag+ /Cu+ active elements are

released through a proprietary

ion exchange process at a

steady rate that effectively

maintains an antimicrobial

surface

Moisture in the environment

causes a controlled release of

copper & silver (Cu+ & Ag+)

The Silver & Copper nanoparticle killing agent of the SpectraShield™ Mask

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Copper-Silver zeolite nanoparticles are permanently embedded into the fiber

strands as illustrated under magnification.

U.S. Patent # 6,723,428, issued for Fosshield Antimicrobial Fiber System on April 20, 2004

Same Zeolite Nanoparticle Super Magnified

Permanent EMBEDDING of the nanoparticle killing agent makes the difference

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Antiviral Testing

Tested at Independent Laboratories

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Bacterial Reduction- 1 Hour

(Continuous & Improved Performance)

Antibacterial Testing

Tested at Independent Laboratories

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Short-term bacterial testing shows an immediate reduction in bacterial

concentrations.

Tested at Independent Laboratories

Immediate Antibacterial Testing

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“The fiber technology featured in Fosshield works against the types of airborne bacteria we are most concerned about. This type of 'capture and kill' technology is ideal. It's the silver bullet against bacteria!”

• Good Morning America • MSNBC • New York Times • Fox News

• CBS News • Washington Post • ABC News • USA Today

Dr. Gerba featured in the media:

Dr. Charles Gerba Professor, Adjunct Professor, Department

of Microbiology and Immunology, The University of Arizona, Tucson, Arizona

What the experts are saying…

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The SpectraShield™ Mask is safe and effective

Test Outcome

Dermal Sensitivity Scored “0” on test -No sensitivity

Primary Skin Irritation Scored “0” on test –No irritation

Systemic Toxicity Test showed “No toxicity”

Gas-Off/Leach-Off No measureable amounts

Cytotoxicity Not toxic to human cells

Fluid Resistant Highly fluid resistant

B IOCOMPAT IB I L ITY

All Biocompatibility Tests were performed in FDA Certified Independent Laboratories

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The SpectraShield™ mask is superior to other antimicrobial or antibacterial* masks

SpectraShield BioMask ActiProtect

NIOSH Cleared as a Respirator YES NO NO

Long Lasting – Continuous Kill Antimicrobial Agent

YES NO NO

Approved for Extended Wear up to 12 Hours in the US by the FDA

YES NO NO

REUSABLE Certified by E.U. with a CE Mark

YES NO NO

Use of Silver, a known natural effective antimicrobial for centuries

YES NO NO

Multiple Respirator Mask Designs including Molded and Flat Fold, valve and non-valve

YES NO NO

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The SpectraShield™ Mask is FDA Cleared

With Long-lasting and Continuous Kill performance, the SpectraShield Mask:

• Cleared as an N95 Antibacterial Surgical Respirator • Meets requirements for surgical respirator as a Class

II Medical Device • Tested and proven for “Extended Wear” with

performance up to 12 hours when exposed to sweat and saliva

• Passed all safety related testing including, toxicity, biocompatibility, gas-off / leach–off, fluid resistance, and dermal sensitivity

Only N95 Antibacterial Masks are available in the United States.

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The SpectraShield™ Mask is CE Certified as a REUSABLE ANTIMICROBIAL

FFP2 & FFP3 MASK

CE EN149:2001 & A1:2009

With Long-lasting and Continuous Kill performance, the SpectraShield™ Mask:

• CE Cleared as a REUSABLE Antimicrobial Respirator Mask • CE Cleared FFP2 & FFP3 RD • Tested and proven for “Extended Wear” performance for

reusability up to 14 days • Complies with European Communities Medical Device

Directive 93/42/EEC • All tests conducted at ISO Certified independent testing

facilities in the European Union

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With Long-lasting and Continuous Kill performance, the SpectraShield Mask:

• Cleared as an N99 Reusable Antimicrobial Respirator • Reusable for 14 day minimum and up to 28 days • Meets requirements for respirator mask as a Class I

Medical Device • Tested and proven for “Extended Wear” with

performance up to 12 hours when exposed to sweat and saliva

• Passed all safety related testing including, toxicity, biocompatibility, gas-off / leach–off, fluid resistance, and dermal sensitivity

The SpectraShield™ Mask is Canadian Cleared as a N99 Reusable Antimicrobial Respirator