Periodic Reporting for period 1 - SAFE-ON (SAFE-ON Technology for Smart Antimicrobial Coatings)
Reporting period: 2022-05-01 to 2023-10-31
Infectious diseases are a rapidly growing threat to humanity. For instance, the current COVID-19 pandemic, caused by the virus SARS-CoV-2, has already killed over 4.5 million people since 2019 and is taking a devastating socioeconomic toll around the world. Similarly, nosocomial infections are among the major causes of death and increased morbidity, causing thousands of deaths every year in Europe. Recently, the use of antimicrobial coatings has garnered increasing interest as a simple prophylactic strategy to combat these infectious diseases. In this PoC project, we aim advancing a new patented antimicrobial coating technology called SAFE-ON, into the pre-commercial stage, with the aim of demonstrating its breakthrough innovation potential and approaching its arrival to market.
This project encompasses optimization of SAFE-ON technology as highly efficient, smart antimicrobial coatings. This entails the preparation of two antimicrobial SAFE-ON prototypes, a coated catheter and one door-handle cover coatings, and subsequent testing of their antimicrobial capacity. This project will also be dedicated to intellectual property (IP) and market aspects needed for the pre-commercialization of this new technology for antimicrobial coatings. This study will include a freedom-to-operate analysis and a market study to identify the antimicrobial coating producers that could ultimately serve as manufacturing partners.
Overall, in this project, we will design, fabricate and evaluate two innovative prototypes incorporating our iodine delivery platform, with the aim to assess the commercial viability of with antimicrobial SAFE-ON coatings, accelerate their market entry and ultimately, commercialize and further develop antimicrobial coatings and other biocide products based on our technology.
This project encompasses optimization of SAFE-ON technology as highly efficient, smart antimicrobial coatings. This entails the preparation of two antimicrobial SAFE-ON prototypes, a coated catheter and one door-handle cover coatings, and subsequent testing of their antimicrobial capacity. This project will also be dedicated to intellectual property (IP) and market aspects needed for the pre-commercialization of this new technology for antimicrobial coatings. This study will include a freedom-to-operate analysis and a market study to identify the antimicrobial coating producers that could ultimately serve as manufacturing partners.
Overall, in this project, we will design, fabricate and evaluate two innovative prototypes incorporating our iodine delivery platform, with the aim to assess the commercial viability of with antimicrobial SAFE-ON coatings, accelerate their market entry and ultimately, commercialize and further develop antimicrobial coatings and other biocide products based on our technology.
In this PoC project, we have successfully developed antimicrobial catheter and door-handle prototypes, both made with coatings of the polymer polyurethane that incorporates the porous MOF loaded with iodine (hereafter named I2@UiO-66). Initially, we optimized the formulation of the antimicrobial coatings using a biocompatible, non-porous polyurethane-based polymer for incorporating spherical I2@UiO-66 composites. Cross-sectional analysis of the coatings revealed two distinct regions. In the first region, I2@UiO-66 composites were almost uniformly dispersed within the polyurethane-based polymer, constituting the active region. In the second region, identified as the polymeric region, I2@UiO-66 composites were sparce. This polymeric region is presumed to impart the required adhesiveness and elasticity characteristics for effective coatings utilization.
The resulting coatings were experimentally observed to have low brittleness and high adhesiveness, making them highly suitable for coating applications. The release of iodine from the coatings was characterized as burst biphasic, exhibiting an initial burst release followed by a controlled release through hindered Fickian diffusion. This controlled release was well-described by the semiempirical Korsmeyer-Peppas model. According to this model, the calculated lifetime of the coatings is 147 days.
Subsequently, we evaluated the antimicrobial activity of both catheter and door-handle SAFE-ON prototypes. All the films were assessed 12 h after preparation to avoid testing during the initial burst release phase. The prototypes underwent consistent testing against Gram-positive bacterial species (Staphylococcus aureus, and Enterococcus faecalis), Gram-negative bacterial species (Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii), and yeast (Candida albicans). These prototypes demonstrated effective inhibition against all the tested microorganisms.
Finally, we conducted cytotoxicity assays to ensure that the catheter and door-handle SAFE-ON prototypes meet safety requirement and do not pose any issue associated with excessive iodine administration. The results indicated that the prototypes do not raise safety concern.
In conclusion, we have successfully developed catheter and door-handle prototypes based on ptimized SAFE-ON coatings, demonstrating a broad-spectrum antimicrobial activity, a substantial lifetime of up to 147 days, and no secondary safety concern.
The resulting coatings were experimentally observed to have low brittleness and high adhesiveness, making them highly suitable for coating applications. The release of iodine from the coatings was characterized as burst biphasic, exhibiting an initial burst release followed by a controlled release through hindered Fickian diffusion. This controlled release was well-described by the semiempirical Korsmeyer-Peppas model. According to this model, the calculated lifetime of the coatings is 147 days.
Subsequently, we evaluated the antimicrobial activity of both catheter and door-handle SAFE-ON prototypes. All the films were assessed 12 h after preparation to avoid testing during the initial burst release phase. The prototypes underwent consistent testing against Gram-positive bacterial species (Staphylococcus aureus, and Enterococcus faecalis), Gram-negative bacterial species (Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii), and yeast (Candida albicans). These prototypes demonstrated effective inhibition against all the tested microorganisms.
Finally, we conducted cytotoxicity assays to ensure that the catheter and door-handle SAFE-ON prototypes meet safety requirement and do not pose any issue associated with excessive iodine administration. The results indicated that the prototypes do not raise safety concern.
In conclusion, we have successfully developed catheter and door-handle prototypes based on ptimized SAFE-ON coatings, demonstrating a broad-spectrum antimicrobial activity, a substantial lifetime of up to 147 days, and no secondary safety concern.
The results of this PoC project have allowed increasing the TRL of SAFE-ON technology to 4-5, approaching it towards its commercialization. It is expected that, in the future, the wide application of SAFE-ON technology will allow applying it to large markets of medical and protective devices (valued at $512.29 billion in 2022 with a CAGR of 5.9% from 2023-2030), food processing (valued at $134.21 billion in 2021 with a CAGR of 11.82% from 2022-2030), and HVAC systems (valued at $206.3 billion in 2023 with a CAGR of 6.3% from 2023-2028). Furthermore, demand for antimicrobial coatings in general is large (valued at $10.12 billion in 2022) and expects rapid growth with a CAGR of 13.8% from 2023-2030. In terms of commercialization, SAFE-ON technology is well positioned to take advantage of considerable market demand for biocompatible coatings, particularly in the global markets for medical devices and food processing. While the technology's market outlook appears to be very promising, its commercialization may be hindered by steep regulatory barriers for medical devices, food processing, and food packaging. In this context, one of the most important next steps for SAFE-ON technology will be to start the regulatory processes. Moreover, we are planning to fully demonstrate the antimicrobial performance of SAFE-ON technology towards viruses. Finally, we will continue searching and contacting companies to find an industrial partner to ensure further developing and transferring of SAFE-ON technology to the society.
Overall, this PoC project has allowed the fabrication of two antimicrobial SAFE-ON prototypes, a coated catheter and one door-handle cover coatings; the subsequent demonstration of the outstanding antimicrobial performance of these prototypes towards bacteria and fungi; analyse the high potential impact of SAFE-ON technology in the market; demonstrate the freedom-to-operate status of SAFE-ON technology, and start conversation with potential industrial partners. With all these demonstrations, SAFE-ON technology has reached a TRL of 4 to 5, approaching its market entry and ultimately, its commercialization and further development of antimicrobial coatings and other biocide products based on our technology.
Overall, this PoC project has allowed the fabrication of two antimicrobial SAFE-ON prototypes, a coated catheter and one door-handle cover coatings; the subsequent demonstration of the outstanding antimicrobial performance of these prototypes towards bacteria and fungi; analyse the high potential impact of SAFE-ON technology in the market; demonstrate the freedom-to-operate status of SAFE-ON technology, and start conversation with potential industrial partners. With all these demonstrations, SAFE-ON technology has reached a TRL of 4 to 5, approaching its market entry and ultimately, its commercialization and further development of antimicrobial coatings and other biocide products based on our technology.