Nano Safe Coating – Antimicrobial Surface Protection for Medical Devices

Patented Formulations

Advanced Antimicrobial

Coatings

designed for medical devices

The Antimicrobial Mission

Nano Safe's Technology

Nano Safe Coatings 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.

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)

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]

Patented Antimicrobial Surface Protection For Medical Devices

Nano Safe Coatings addresses the industry needs of patented, effective and biocompatible antimicrobial surface protection for medical devices without the problems of legacy toxicity, leaching, non-target bio-interactions, risks of microbial adaptation and resistance, and where the proven unique bonding and performance has been demonstrated.

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.

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]

Device related infections

1/4

All healthcare associated infections [2]

Of the over 2M HAIs reported to CDC

50-70%

are related to indwelling medical devices [3]

Attributable mortality [3]

<5%

Devices such as dental implants and foley catheters

>25%

Mechanical heart valves

SARs-Cov-2 RNA Detected on PPE

5-30 Days

Transmissible for [4]

5-7 Days

^[1]As demonstrated through extensive internal development and testing and as part of the information included in Nano Safe Coating’s FDA Device Master File.

^[2] Device-Related Infections. Racing for the Surface. (2020) (https://doi.org/10.1007/978-3-030-34475-7_7)

^[3] Implantable Device Related Infection, Shock (2016) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5110396/)

^[4] Persistence of SARS-CoV-2 infection on personal protective equipment (PPE), BMC Infectious disease (2021) (https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06861-7)

^[5]Hospital-Acquired Infections Under Pay-for-Performance Systems: an Administrative Perspective on Management and Change. Vokes, R.A., Bearman, G. & Bazzoli, G.J., Curr Infect Dis Rep 20, 35 (2018). (https://doi.org/10.1007/s11908-018-0638-5 )

Experienced Application & Development Partner

Nano Safe Coatings has Established a Strategic Alliance with Applied Medical Coatings. With Over 25 Years and 100 Million Medical Devices Coated, Applied Medical Coatings Brings A Powerful Expertise to Nano Safe Coatings and the Medical Device Industry.