Technology – Nano Safe Coating

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Our Technology

Nano Safe Coatings

Antimicrobial Surface Protection Designed For Medical Devices

Nano Safe has developed proprietary thermal, UV and hybrid cure antimicrobial formulations that covalently bond to surfaces and create a uniform polymeric-coating for lasting antimicrobial protection. Nano Safe utilizes modified organofunctional silane antimicrobial technology to create an invisible, non-toxic antimicrobial coating to effectively lyse or disintegrate the microbe’s cell membrane, preventing the attachment of microorganisms and subsequent growth of biofilms.

Since bacteria and fungi are ubiquitous, even with judicious cleaning, packaging and use protocols, microbes can find their way to devices ex-vivo and in-vivo. Prevention of microbial attachment and biofilm development can help in addressing the challenges with device-related infection and its impact on device performance and outcomes.

Nano Safe Coatings’ technologies do not use heavy metals as their active agents, therefore mitigating the risk of toxicity associated with traditional approaches that use heavy metals.

Advanced Antimicrobial Technology

Nano Safe Coatings’ antimicrobial technologies function in ways that enhance the overall performance of the treated surfaces against microorganism attachment and biofilm formation. Uniform, covalent bonding occurs via the unique molecular design and anchored using UV for plastics and heat catalysis for metals. This produces: [1]

A durable coating of microbe killing nano-networks, that provides mechanical microbial-killing control that meet the needs of this evolving marketplace.
Avoids the potential negative effects experienced by leaching with other microbe-killing technologies that are available.

Above image illustrates..

The image illustrates the antimicrobial surface cross-section containing Nano Safe Coatings’ surface bound antimicrobial treatment (VACT™) on the right and an untreated surface on the left. The functionalized surface depicted shows hills representing long chains of stacked Nano Safe Coatings’ antimicrobial coating molecules with an average thickness of 350nm measured with a surface profilometer. (Used with permission from Toronto Metropolitan University, Toronto Canada)

FDA Device Master File

Nano Safe Coatings holds an FDA Device Master File (also knows as a Master Allowance File). This file is on record for medical device manufacturers to utilize in their development and registration of the application of Nano Safe’s technologies on their devices. This Master File helps inform, simplify, expedite and support our partners’ filings, if needed, for use of Nano Safe’s antimicrobial surface coatings under the 510(k) or de novo provisions of the Medical Devices Act. This file is available from Nano Safe Coatings, LLC under license and authorized use by a medical device manufacturer for their development process to create an antimicrobial surface on their device.

Permanent Coating

Permanently immobilized biocidal coating [1]

Contact Killing

Kills bacteria on contact, avoids biofilm formation [1]

Non-Leaching

Has shown to not leach or migrate from the surface once cured [1]

Bespoke

Specifically designed for medical device substrates (metals, plastics, textiles) [1]

Addressing Key Challenges

Infections Are Common and Costly

Device-related infection is responsible for a quarter of all health care-associated infections and can even compromise device function. These infections are caused by the colonization of microorganisms during the implantation processes. [2]

Of the nearly 2 million healthcare-associated infections reported by the Centers for Disease Control, 50–70% can be attributed to indwelling medical devices. Attributable mortality is highly device dependent but can range from <5% for devices such as dental implants and foley catheters to >25% for mechanical heart valves. Barring revolutionary advances in material sciences and despite process improvements at the time of implantation, this number is likely to increase over time. [2]

Biofilm Formation:

Once biofilms are established, they can be very difficult to treat with conventional antibiotics since the bacteria in the biofilm are metabolically inactive, rendering the biofilms less responsive to antibiotics. Under these circumstances, the infected device often fails and must be removed to eradicate the infection. [3]

Leaching with traditional and current coatings:

Historical and currently used unbound (release or leachable) technologies such as bi-chlorinated phenols (Triclosan), copper, various forms of silver salts, zinc oxide and antibiotics may have issues related to the “leaching” of the active antimicrobial moiety. Some of these problems include:

acute and chronic toxicity (legacy poisons),
lack of broad-spectrum activity,
inactivation by many body materials and metabolites,
linkage to microbial adaptation, antimicrobial resistance and cellular dysfunction,
difficulties in application, durability, and product and process compatibility. These flaws are mostly because of their chemical nature and their mode of antimicrobial action. [3, 4]

Cost Shifting:

Recent changes in healthcare reimbursement (Patient Protection and Affordable Care Act 2010) have shifted the cost of device related infections back to the original service provider as a “preventable infection” generating an urgent need for devices that are better able to prevent bacterial and fungal infections. [5]

Examples of Antimicrobial Testing

Materials and Microbial Challenges Tested

This image shows types of textile and plastic materials and microorganisms used in testing with the Nano Safe Coatings’ antimicrobial technologies. [1]

Measurement of Antibacterial Activity on Metal Coupons

(Control vs Treated with Nano Safe’s Antimicrobial Coating Over Time) [1]

The graph illustrates the change in colony forming units (cfu) from the initial inoculum load through intervals over a 24-hour period upon exposure of the untreated control (“C” – gray bars) vs the Nano Safe Coatings’ antimicrobial coating treated (“T” – color bars) on titanium, stainless steel and aluminum coupons with Pseudomonas aeruginosa. The blue line in the graph represents the limit of detection (LOD) calculated at 1.69 log cfu/carrier meaning < 1 colony was present in undiluted samples.

Survivability of Arthrobacter sp. on Various Plastic Surfaces

(Control vs Treated with Nano Safe’s Antimicrobial Coating) [1], [6]

The graph illustrates the average survival of Arthrobacter sp. when inoculated onto a variety of Nano Safe’s antimicrobial treated and control sample materials. The measurement at 0hrs (Load) indicated the initial number of bacterial cells being inoculated onto the surface material and was determined concurrently to inoculation. The organism controls at 3hrs and 24hrs demonstrating tolerance to drying are shown for comparison. The blue line in the graph represents the limit of detection (LOD) calculated at 1.69 log cfu/carrier meaning < 1 colony was present in undiluted samples.