provides support to wound healing
NEW CLASS OF WOUND CARE PRODUCTS
designed for infected wounds and wounds at risk of infection
current advanced
non-antibacterial
wound care products
current advanced
antibacterial
wound care products
THE CHALLENGE
There are about 100 million people in the world who live with chronic wounds that won't heal, and diabetic foot ulcers are among the most challenging of them.
Diabetic Foot Ulcers
Among chronic wounds, diabetic foot ulcers (DFUs) are the number one reason for infection and leg amputation. After every 20 seconds, someone in the world with diabetes loses their leg because of amputation.
DFU is called “a silent killer”, because the five-year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer (Armstrong et al., 2017). 30.5% of patients with diabetic foot ulcer will die in 5 years, and more than half of these patients who go under major amputation will die in 5 years.
PRODUCT
Nanordica advanced antibacterial wound dressing is a sterile single-use dressing, in which wound contact layer is made of natural silk nanofibers containing Premotiv nanotechnology.
TM
Silk nanofibers have outstanding mechanical properties, biocompatibility, biodegradability, flexibility, water vapor permeability and hydrophobic properties
Premotiv nanotechnology is designed to prevent infection and promote wound closure simultaneously. The aim is to provide efficient management of infected wounds and wounds at risk of infection.
TM
TM
Nanordica advanced antibacterial wound dressings are available in different sizes:
TM
Non-adhesive
3 x 4 cm
4 x 5 cm
10 x 10 cm
20 x 20 cm
40 x 40 cm
Adhesive
7 x 8 cm
8 x 8 cm
8 x 9 cm
11 x 11 cm
Indications
All types of wounds including infected wounds:
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Diabetic foot and foot ulcers
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Surgical wounds
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Dirty traumatic wounds
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Inflammed wounds
Properties:
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Unique patented composition of nanofibers and nanoparticles
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Significantly improves wound healing
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Does not contain traditional antibiotics
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Cost-effective and long-lasting
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Breathable hypoallergenic
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Available in different sized and with or without adherence
CLINICAL DATA
The randomized controlled clinical study (RCT) was conducted at the North Estonian Medical Centre and enrolled 30 patients with diabetic foot ulcers (DFUs). The patients were divided into two groups: in group 1, DFUs were managed with silver-based wound dressing, and in group 2 with Nanordica advanced antibacterial wound dressing, in both cases for 1 week with 3 dressing changes. The patients were monitored for wound surface area and other parameters. As a result, almost two times faster reduction in wound area size was observed, when Nanordica wound dressing was used, compared to the silver-based wound dressing. This indicates that the Premotiv concept works.
SCIENCE
Silver (Ag) has been used as an antimicrobial for thousands of years. Ag outperforms other metals as well as chitosan, iodine, honey, and polyhexanide (PHMB) (Du et al., 2009, Kumar et al., 2022, Shoukat et al., 2015, Bondarenko et la., 2016). However, at high concentrations, Ag delays the growth of skin cells and thus, wound healing.
The use of silver nanoparticles (Ag NPs) instead of Ag ions provides a controlled and prolonged release of Ag in the close vicinity of bacterial cells with no adverse effects on skin cells (Bondarenko et al., 2013; Kubo et al., 2018)
Nanordica Medical has developed a method to enhance the beneficial properties of Ag NPs with copper (Cu) NPs. It enables to use 30 - 10,000 times less Ag while achieving superior antibacterial and wound healing effects. We discovered that certain combinations of Cu and Ag NPs are up to 6 times more efficient than Cu or Ag (NPs) alone against a wide range of bacteria, including antibiotic-resistant strains such as gram-negative Escherichia coli and Pseudomonas aeruginosa as well as gram-positive Staphylococcus aureus, Enterococcus faecalis and Streptococcus dysgalactiae (Vasiliev et al., 2023). Thus, the wound care materials with combinations of Cu and Ag NPs will have superior antibacterial properties and safety, leading to faster re-epithelialization of wounds. The randomized controlled clinical study (RCT) on 30 patients with infected diabetic foot ulcers confirmed that the wound dressing with copper and silver nanoparticles led to 2 times faster wound area size reduction compared to Ag ion-based wound dressing.
Besides its antimicrobial properties, Cu is published to be essential for all stages of the wound healing process.
Copper regulates the activity and expression of key proteins in the extracellular matrix (ECM), such as collagen, integrins, and fibrinogen. Copper promotes angiogenesis by enhancing the expression of vascular endothelial growth factor (VEGF), leading to the formation of new blood vessels that supply nutrients to healing tissues. Copper influences metalloproteinases (MMPs), which help remodel the ECM by breaking down damaged tissue and facilitating new tissue formation. Additionally, copper-dependent enzymes like lysyl oxidase are responsible for cross-linking collagen and elastin, strengthening the ECM and improving tissue resilience (Kornblatt et al., 2016).
To achieve even more beneficial effects on wound healing, Cu and Ag NP combinations may be incorporated into advanced
materials such as nanofibers that serve a scaffold for skin cells, improving wound healing.
Nanofibers produced from silk mimic the structure and function of extracellular matrix (ECM) protein fibers, which are essential for regulating cellular processes such as adhesion, spreading, proliferation, migration of keratinocytes (Lu et al., 2014, Ferraris et al., 2020). It has been demonstrated in animal models that the nanofibrous wound dressings enhance the wound healing rate as compared to the healing rate of traditional clinical grade gauze (Sapru et al., 2018). The hydrophobic interaction is a key non-specific binding parameter for bacterial adhesion (Pace 2006). It has been observed that microbes adhere to extracellular matrix (ECM) components either through hydrophobic, electrostatic interactions, or via receptor-like cell surface proteins known as hydrophobins (Wessels, 1997). Silk fibroin is insoluble in water (hydrophobic) and in a humid environment silk fibroin nanofibers exert an electrostatic action against hydrophobic microorganisms.
By combining Cu and Ag nanoparticle combinations and nanofibers, it is possible to develop materials that do both, prevent infection and support wound healing, setting a new standard in wound care and beyond.
REFERENCES: Armstrong DG, Swerdlow MA, Armstrong AA, Conte MS, Padula WV, Bus SA. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. J Foot Ankle Res. 2020 Mar 24;13(1):16. Bondarenko, O. M. et al. Multilaboratory evaluation of 15 bioassays for (eco)toxicity screening and hazard ranking of engineered nanomaterials: FP7 project NANOVALID. Nanotoxicology 10, 1229–1242 (2016). Du, W. L., Niu, S. S., Xu, Y. L., Xu, Z. R. & Fan, C. L. Antibacterial activity of chitosan tripolyphosphate nanoparticles loaded with various metal ions. Carbohydr Polym 75, (2009). Ferraris S, Spriano S, Scalia AC, Cochis A, Rimondini L, Cruz-Maya I, Guarino V, Varesano A, Vineis C. Topographical and Biomechanical Guidance of Electrospun Fibers for Biomedical Applications. Polymers (Basel). 2020 Dec 3;12(12):2896. doi: 10.3390/polym12122896. PMID: 33287236; PMCID: PMC7761715. Kornblatt, A. P., Nicoletti, V. G., & Travaglia, A. (2016). The neglected role of copper ions in wound healing. Journal of Inorganic Biochemistry, 161, 1–8. Kubo, A.L.; Capjak, I.; Vrček, I.V.; Bondarenko, O.M.; Kurvet, I.; Vija, H.; Ivask, A.; Kasemets, K.; Kahru, A. Antimicrobial Potency of Differently Coated 10 and 50 nm Silver Nanoparticles against Clinically Relevant Bacteria Escherichia Coli and Staphylococcus Aureus. Colloids Surfaces B Biointerfaces 2018, 170, 401–410, doi:10.1016/j.colsurfb.2018.06.027. Kubo, A.L.; Vasiliev, G.; Vija, H.; Krishtal, J.; Tõugu, V.; Visnapuu, M.; Kisand, V.; Kahru, A.; Bondarenko, O.M. Surface Carboxylation or PEGylation Decreases CuO Nanoparticles’ Cytotoxicity to Human Cells in Vitro without Compromising Their Antibacterial Properties. Arch. Toxicol. 2020, 94, 1561–1573, doi:10.1007/s00204-020-02720-7. Kumar, A., Bajaj, S. S. & Bajaj, J. K. A comparative study of efficacy of silver stream versus povidone iodine in healing the diabetic ulcers. International Surgery Journal 9, (2022). Lu G, Liu S, Lin S, Kaplan DL, Lu Q. Silk porous scaffolds with nanofibrous microstructures and tunable properties. Colloids Surf B Biointerfaces. 2014 Aug 1;120:28-37 Pace JL. Biofilms, infection and antimicrobial therapy. 2006 Sapru S, Das S, Mandal M, Ghosh AK, Kundu SC. Prospects of nonmulberry silk protein sericin-based nanofibrous matrices for wound healing - In vitro and in vivo investigations. Acta Biomater. 2018 Sep 15;78:137-150. doi: 10.1016/j.actbio.2018.07.047. Epub 2018 Jul 29. PMID: 30059800. Shoukat, K., Pilling, S., Rout, S., Bradbury, J. & Humphreys, P. N. A systematic comparison of antimicrobial wound dressings using a planktonic cell and an immobilized cell model. J Appl Microbiol 119, (2015). Vasiliev, G., Kubo, A.-L., Vija, H., Kahru, A., Bondar, D., Karpichev, Y., & Bondarenko, O. (2023). Synergistic antibacterial effect of copper and silver nanoparticles and their mechanism of action. Scientific Reports, 13(1), 9202. https://doi.org/10.1038/s41598-023-36460-2 Wessels, J.G. Hydrophobins: proteins that change the nature of a fungal surface. Adv Microb Physiol 1997; 38: 1-45.
MISSION
We improve wound management, reduce healthcare costs, and help hundreds of millions of people with wounds by developing innovative products that prevent infection and promote wound closure simultaneously.
TEAM
Nanordica Medical is an Estonian medtech company established by scientists and medical doctors with the purpose of taking innovations from the lab to improve medical practice. Nanordica Medical is a spin-off of the National Institute of Chemical Physics and Biophysics (Estonia).
COLLABORATIONS & FUNDING
May 16, 2024
Nanordica Medical OÜ
Register code: 14710113
Mäealuse 2/1, Tallinn, Harjumaa 12618, Estonia