Understanding Sharklet™ Surface Protection Products

A novel approach to improving cleanliness

of high-touch environmental surfaces

Using surface skins featuring the Sharklet™ pattern to decrease

bacterial attachment, survival and surface-to-hand transference
on environmental surfaces

May 2011

© Sharklet Technologies, Inc.

All rights reserved
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Understanding the Sharklet Surface Protection Technology

About Sharklet™ – A New Approach in Bacterial Control.................................................................................. 3

Technology History ............................................................................................................................................ 4
The Role of Environmental Surfaces in Hospital-Acquired Infection Rates ....................................................... 4
Sharklet Technology and Test Results ............................................................................................................... 5
The Sharklet Surface Inhibits Bacterial Attachment, Survival and Touch Transfer ....................................... 7
MRSA and MSSA – Smooth vs. Sharklet™ .................................................................................................. 7
Pseudomonas aeruginosa – Smooth vs. Sharklet ..................................................................................... 7
Vancomycin-resistant Enterococcus faecalis – Smooth vs. Sharklet ......................................................... 8
Touch Transfer Test of Methicillin-Susceptible Staphylococcus aureus (MSSA) ....................................... 8
The Next Generation in Surfaces ....................................................................................................................... 9
Contact Sharklet Technologies, Inc. ................................................................................................................... 9
References ....................................................................................................................................................... 10

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About Sharklet™ – A New Approach in Bacterial Control

Sharklet Technologies, Inc. is a United States company based in Aurora, Colorado. The biotechnology company
develops a revolutionary surface product called Sharklet™. Unlike anything in the marketplace today, Sharklet is the
only non-toxic, biocide-free and no-kill surface pattern used to inhibit bacterial attachment, survival and touch
transference. The Sharklet pattern is manufactured into surfaces of products to create bacterial inhibition and to
reduce surface-to person transfer of
bacteria.

Sharklet is a patented surface technology

comprising millions of raised, microscopic
features arranged in distinct diamond
shapes to form a continuous
micropattern (note the Sharklet pattern
at right). Each Sharklet diamond
measures 22 microns wide (left to right),
16 microns tall (top to bottom of a
diamond), and each feature is about 3 Scanning electron micrographs of the Sharklet micro-pattern with
microns in height. When manufactured recessed grooves of varying lengths in silicone elastomer on the left
into the surface of products, the pattern and the alternate version of the Sharklet pattern with raised features
cannot be seen with the naked eye or felt on the right. Scale bars in both micrographs are 20 µm.
to the touch. For reference purposes, each
th
Sharklet diamond is about 1/50 the width of a human hair.

Of note, the Sharklet pattern provides bacterial inhibition through pattern alone – there are no chemicals, biocides,
disinfectants or antibiotics eluted from the surface. In tests simulating an ambient hospital environment, the Sharklet
patterned surface has shown to significantly reduce survival and touch transference of bacteria.

The Sharklet pattern is manufactured (imprinted) into the surfaces of products to create bacterial inhibition. While
multiple products that feature the Sharklet pattern are in development, Sharklet Technologies, Inc. today offers
Sharklet™ Surface Protection Products marketed under several brands including Tactivex® and SafeZone Media. The
Surface Protection Products are film-based products or “skins” that feature the Sharklet pattern imprinted into the
surface. The skins, via a variety of constructions including adhesively-backed films, are directly applied to high-traffic
touch points that harbor bacteria and serve as vectors for bacterial transfer.

Until the advent of Sharklet, kill strategies including antibiotics, disinfectants and biocides have been the primary
weapons to control bacterial growth. These kill strategies and their overuse has led to increased bacterial resistance,
causing harm to people and the environment. The World Health Organization in 2009 named resistant bacteria as a
top human health threat.

The applications and opportunities for Sharklet are numerous and the benefits are measurable:

• No risk for antimicrobial resistance. It is the shape and pattern of the surface alone that disrupts bacteria’s
ability to survive, not the use of antimicrobial agents that contribute to the development of “superbugs.”
• Defense against multiple strains of bacteria. Sharklet has shown to be effective against many Gram-
negative and Gram-positive strains, including clinical isolates, in different media and flow conditions (e.g.
Staph a., MRSA, VRE, Pseudomonas aeruginosa and E. coli).
• Cleaner surfaces between cleanings. The Sharklet pattern is always at work and serves as a safety net when
hand washing and cleaning protocols fail.

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• Ability to reduce costs with improved hygiene. In the healthcare sector, hospital-acquired infections account
for $30.5 billion in excess healthcare costs each year. The cost of these infections is estimated between
$8,000 and $15,000 per patient. Sharklet may reduce the risk of exposure to disease-causing bacteria.

Sharklet Technologies offers an effective new approach to microorganism control. The deployment of Sharklet-
patterned surface products provides an opportunity to address challenges with infection control, enhance cleaning
protocols and protect bacteria-prone surfaces between cleanings.

Technology History
While the Sharklet pattern holds great promise to improve the way humans co-exist with microorganisms, the pattern
was developed far outside of a laboratory. Sharklet was discovered via a seemingly unrelated problem: how to keep
algae from coating the hulls of submarines and ships. In 2002, Dr. Anthony Brennan, a materials science and
engineering professor at the University of Florida, was visiting the United States naval base at Pearl Harbor in Oahu as
part of Navy-sponsored research. The U.S. Office of Naval Research solicited Dr. Brennan to find new antifouling
strategies to reduce use of toxic antifouling paints and trim costs associated with dry dock and drag.

Dr. Brennan was convinced that using an engineered topography could be a key to new antifouling technologies.
Clarity struck as he and several colleagues watched an algae-coated nuclear submarine leave port. Dr. Brennan
remarked that the submarine looked like a whale lumbering out of the harbor. In turn, he asked which slow moving
marine animals don’t foul. The only one? The shark.

Dr. Brennan was inspired to take an actual impression of shark skin, or more specifically, its dermal denticles.
Examining the impression with scanning electron microscopy, Dr. Brennan confirmed his theory. Shark skin denticles
are arranged in a distinct diamond pattern with tiny riblets. Dr. Brennan measured the ribs’ width-to-height ratios
which corresponded to his mathematical model for roughness – one that would discourage microorganisms from
settling. The first test of Sharklet yielded impressive results. Sharklet reduced green algae settlement by 85 percent
compared to smooth surfaces.

While the U.S. Office of Naval Research continued to fund Dr. Brennan’s work for antifouling strategies, new
applications for the pattern emerged. Brennan evaluated Sharklet’s ability to inhibit the growth of other
microorganisms. Sharklet proved to be a mighty defense against bacteria.

Similar to algae, bacteria take root singly or in small groups with the intent to establish large colonies, or biofilms. Also
similar to other organisms, bacteria seek the path of least energy resistance. Research results suggest that Sharklet
keeps biofilms from forming because the pattern requires too much energy for bacteria to colonize. The consequence
is that organisms find another place to grow or simply die from inability to signal to other bacteria. In addition to
Sharklet’s ability to inhibit biofilm formation, the technology also proved to inhibit bacteria’s ability to attach and
survive on the pattern as well as reduce the amount of bacteria transferred when touched.

The Role of Environmental Surfaces in Hospital-Acquired Infection Rates

Despite improved knowledge and greater focus on prevention, incidences of healthcare-acquired infections (HAIs)
have continued to rise in recent decades. HAIs are now among the top six leading causes of death in the United States
1
with 98,987 recorded deaths in 2002 . The medical impact of these infections has been matched in magnitude by the
economic impact, which includes the costs of the treatment as well as the measures taken by the healthcare
community to control and limit the spread of infections. Efforts such as patient monitoring, active surveillance
protocols, screening-based isolation protocols, hand hygiene protocols and cleaning and disinfection procedures have
2,3,4
become ubiquitous to present-day healthcare epidemiology practice .

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The root of the challenge is in preventing the spread of HAI pathogens that lead to these infections. The most difficult
infections to treat are those that include antibiotic-resistant pathogens such as methicillin-resistant Staphylococcus
3, 5
aureus (MRSA) and vancomycin-resistant Enterococcus (VRE), as well as spore-forming Clostridium difficile . The
Health Care Infection Control Practices Advisory Committee (HICPAC) defines contact transmission of pathogens as
occurring with a contaminated intermediate object or person (“indirect transmission”) or without an intermediate
6
object or person involved (“direct transmission”) . It is well documented that pathogens readily contaminate
environmental surfaces near patients and can survive and persist on these inanimate surfaces for weeks to
7,8,9,10
months . Examples of frequently touched surfaces include bed rails, tray tables, telephones, bedside tables,
9, 11, 12, 13
patient chairs nurse call buttons/handsets . Indirect transmission in the hospital environment occurs when
these contaminated surfaces are touched; pathogens are transferred from environmental surfaces to healthcare
14,15,16.
workers’ hands and objects, where they can then be transported elsewhere In addition, recent scientific
evidence confirms that patients admitted to rooms previously occupied by patients infected or colonized with MRSA,
VRE, C. difficile and Acinetobacter baumannii have, on average, a 73 percent increased risk of acquiring the same
17,18,19,20,21,22
pathogen from environmental surfaces contaminated by the prior room occupants .

In the past decade, numerous guidelines, recommendations, and standards have been introduced that relate to
improving environmental hygiene practices in healthcare settings. Healthcare infection control guidelines from the
Centers for Disease Control and Prevention (CDC) now emphasize the importance of cleaning and disinfecting “high-
6
touch surfaces” and monitoring these activities to maintain a sanitary environment in the hospital . These guidelines
reflect an evolving mindset that patient area environmental cleanliness in healthcare settings plays a significant role in
infection prevention and control.

Despite the increased attention to environmental hygiene, recent studies evaluating the effectiveness of
environmental cleaning have shown that only 40 percent of near-patient surfaces are cleaned in accordance with
2,12,13,18
existing hospital policies . Furthermore, certain multi-drug resistant organisms require specific cleaning
4
regimens and products, reflecting a dynamic situation that relies upon ever-changing guidelines and compliance . In
contrast to the abundance of hand sanitizers and cleansers that have been introduced for hospital use to improve
hand hygiene, there are surprisingly few technological improvements for reducing environmental surface
23
contamination .

The need for improved measures to keep environmental surfaces clean and prevent transmission of pathogens may
be addressed in the following ways:

1. Technologies / procedures to improve cleaning and disinfection of environmental surfaces

2. Surface technologies that reduce microbial presence on the surface.

Ideally, these two approaches would be implemented concurrently, where proper cleaning practices would be
complemented by a surface technology that reduces the risk of pathogen transmission between cleanings.

To address this need, Sharklet Technologies has developed and tested Sharklet – a novel, microscopic surface texture
to reduce bacterial attachment, survival time, and surface-to-hand transference compared to un-textured control
surfaces.

Sharklet Technology and Test Results

Sharklet Surface Protection Products focus on a key unaddressed area of healthcare – surfaces. Today, much attention
is given to improving hand washing that reduces transfer of bacteria between people. Surface cleanliness is addressed
through the use of standard cleaning techniques including disinfection or through biocidal agents. Reliance on humans
to adhere to these protocols, however, begs the question of whether they are fully effective.

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Sharklet Surface Protection Products fill a gap in the hygiene continuum. A Sharklet-patterned surface is always at
work and provides a cleaner surface between cleanings. Sharklet surfaces also serve as a safety net when hand
washing and cleaning protocols aren’t enough. Further, the technology helps break the infection loop by protecting
surfaces that are most often touched.

Testing data demonstrates Sharklet’s three general effects on bacteria.

1. Bacteria find it difficult to attach to the Sharklet pattern

2. Bacteria do not survive on Sharklet
3. Bacteria are less likely to transfer from Sharklet to hands

It is worth noting that other surface

protection strategies rely mainly on
chemical coatings to inhibit bacterial
adherence. The antimicrobial coating
strategy is hampered by the development
of antimicrobial resistant strains of bacteria
and by the harmful toxicity that many of
these agents depend on for their biocidal
effect. By comparison, the Sharklet pattern
adds no chemical coatings or biocidal
agents. This purely physical approach to
inhibiting microbial attachment does not
rely on the incorporation of antimicrobial
agents, thus not contributing to the growing
problem of multi-drug resistant ‘superbugs.’ The photos above show colonies of S. aureus after one hour of
drying on surfaces. The RODAC plates were touched to surfaces
The development of antimicrobial coating methods that were populated with S. aureus. The Sharklet surface in the
stem from the commonly held belief that cell two top RODAC plates show significantly less attachment and
attachment is primarily influenced by the chemical bacterial growth.
composition and activity of the surface. While this
is an important factor, the influence of surface topography can be a significant factor in affecting cell attachment.

It has long been known that surface roughness is an important property affecting surface energy, and this has
24,25,26
motivated the study of using micro-patterned surfaces to control cell attachment . While surface micro-patterns
have been studied in a trial-and-order fashion for randomly roughened surfaces and some ordered patterns, only
27
recently has the interrelationship of micro-pattern structure, surface energy and cell attachment been investigated .
These studies have indicated that geometries of ordered features designed with unique roughness properties can
elicit specific, predictable biological responses. This strategy for controlling bioadhesion represents a paradigm shift
from the current methods utilizing antimicrobial agents. Applying a surface topography, such as Sharklet, instead of
using antimicrobial agents relies upon controllably changing the surface energy so as to affect bioadhesion. Studies
have shown that the Sharklet micro-pattern is the most effective pattern of a variety of patterns studied for
28
inhibiting bioadhesion .

Sharklet Technologies has performed bacterial testing in a number of environments. Testing has been performed by
numerous third parties including University of Florida, NASA (United States National Aeronautical Space
Administration), several leading U.S. medical device manufacturers and others. Numerous strains of Gram positive
and Gram negative bacteria have been tested including S. aureus, P. aeruginosa, S. epidermidis, E. coli, MRSA, and VRE
and others. Testing has spanned 3 to 48 hours and between 7 and 21 days. Environments include Static (TSB,
TSB+BSA, TSB+FBS), Centers for Disease Control reactor, and Static/Aerobic (no media, simulating typical room
conditions, 20% relative humidity, 25-30°C).

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Testing in the following graphs was performed by Dr. Kenneth Rand, professor of Pathology and Medicine at the
University of Florida, College of Medicine.

The Sharklet Surface Inhibits Bacterial Attachment, Survival and Touch Transfer
Studies to-date have focused on demonstrating a triple-play effect of the Sharklet surface to inhibit bacterial
attachment, survival and touch transference compared to an un-textured control surface. These three properties are
particularly significant for use of the Sharklet pattern on high-touch environmental surfaces, where cross-
contamination can readily occur. For example, if a high-touch surface is exposed to a contaminated surface such as an
unsterile gloved hand, bacteria will readily attach to the surface and stay alive on the surface until they are picked up
by a receiving surface, such as a piece of clothing or another hand.

MRSA and MSSA – Smooth vs. Sharklet™

Experiments with Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus
(MSSA) show significantly less attachment and survival of MRSA and MSSA on the Sharklet surface compared to a
smooth control surface after exposure to a highly concentrated suspension of the bacteria. See the table below.

Bacterial Strain Time-Point Average percent reduction on

Sharklet-patterned surfaces
relative to smooth control
Attachment (no drying) 76.5 %
MRSA Survival (1 hour drying) 76.5 %

Attachment (no drying) 87.4 %

MSSA Survival (1 hour drying) 88.4 %
Survival (3 hours drying) 80.6 %

Pseudomonas aeruginosa – Smooth vs. Sharklet

Sharklet reduces Pseudomonas aeruginosa by 100 percent versus a smooth surface after one hour of exposure
simulating typical room conditions. Laboratory test performed on Sharklet on silicone elastomer.

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Vancomycin-resistant Enterococcus faecalis – Smooth vs. Sharklet

Sharklet reduces Vancomycin-resistant Enterococcus faecalis by 99 percent versus a smooth surface after one hour of
exposure simulating typical room conditions. Laboratory test performed on Sharklet on silicone elastomer.

These charts provide a graphical representation of Sharklet Surface Protection Product effectiveness against a variety
of bacteria in environments that are reflective of ambient conditions in a healthcare environment.

Touch Transfer Test of Methicillin-Susceptible Staphylococcus aureus (MSSA)

Another experiment with Methicillin-susceptible Staphylococcus aureus (MSSA) demonstrated that if the surfaces are
touched after the bacterial suspension is removed, only 16 percent of the bacteria are removed from a Sharklet
surface while 67 percent of bacteria are removed from a smooth surface. This translates to 77 percent less bacteria
removed from the Sharklet surface compared to a smooth control surface. The Sharklet surface effectively acts a trap
for any surviving bacteria and renders a unique “quarantine-like” effect. Thus, the Sharklet surface not only prevents
attachment and survival of organisms, but it also prevents the possibility of transferring pathogens off of the surface,
offering greater protection for high-touch surfaces.

[Figure at left] Representative photographs of one set of RODAC plates

used for touch transference experiment.

Plates were touched to Sharklet surfaces and smooth surfaces that had
been exposed to MSSA. The top row of plates shows the attached
bacterial colonies prior to touch, with smooth on the left and Sharklet
on the right. The bottom row of plates show bacteria remaining on each
surface after being touched with gloved fingertips. The Sharklet surface
significantly reduces the amount of bacteria transferred off the surface.

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The Next Generation in Surfaces

While disinfectant solutions and regularly-implemented cleaning protocols are important in high-risk environments
such as healthcare facilities, food-preparation facilities, and public high-touch areas, surface protection between
cleanings is equally important. The Sharklet surface not only offers the capability to reduce bacterial burden on
surfaces via reduced bacterial attachment and survival, but also effectively ‘traps’ any remaining bacteria via the
pattern, thereby preventing transference of bacteria from the surface to the next person coming in contact with the
surface.

These three outcomes — reduced bacterial attachment, survival and transference — have a compound effect on
ultimate bacterial cross-contamination: less bacteria attach to a Sharklet surface compared to a smooth un-patterned
surface; of the few bacteria that do attach to a Sharklet surface, even fewer survive over time compared to bacterial
survival on smooth surfaces; of the very few bacteria attaching and surviving on a Sharklet surface, a much smaller
proportion of those are then be transferred off the Sharklet surface to another contacting surface compared to
transference off of a smooth surface.

This compound, sequential effect offers multiple levels of safeguards for the surface and the people coming into
contact with contaminated surfaces. The Sharklet surface thus offers a continuous safeguard for surfaces and people
in a manner that does not expose users to toxic chemical agents and does not actively promote antimicrobial
resistance.

Contact Sharklet Technologies, Inc.

For more information, contact:

Sharklet Technologies, Inc.

12635 E. Montview Blvd., Suite 160
Aurora, Colorado 80045

720-859-4070

info@sharklet.com
www.sharklet.com

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