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Nanordica, a six-year-old medical technology company based in Tallinn, Estonia, is preparing to commence a trial of its advanced antibacterial wound dressing product with partners in Spain this year. The firm is gathering data as it prepares to submit its wound care product for clearance under the European Medical Device Regulation, or MDR, also in 2025.
For Anna-Liisa Kubo, Nanordica’s chief innovation officer, the planned trial and MDR submission will be milestones for the company she helped found as part of a personal goal to apply her research into a real-world setting where it could have a direct effect on patient healthcare.
“I like to do applied research,” she says, “research that has practical value.”
Kubo has a PhD in biotechnology from Tallinn University of Technology. She helped to develop Nanordica’s underlying technology while as a researcher at the Estonian National Institute of Chemical Physics and Biophysics (KBFI). There, she worked on characterizing antimicrobial agents and conducted in vitro toxicity testing of chemicals and nanoparticles.
Specifically, she was looking at ways to replace or reduce the use of silver in wound care. While silver has antibacterial properties, it can also negatively affect wound healing if used to excess. During her studies though, she found that the use of silver and copper nanoparticles had a synergistic effect. When included in a silk-based nanofiber scaffold, they created a dual-use wound dressing, one that could both cure an infection and improve healing at the same time.
Less silver, more healing
They dubbed the new technology Premotiv, and Kubo established Nanordica in 2019 with company CEO Olesja Bondarenko, Chief Clinical Officer Grigory Vasiliev, and Chief Business Officer Meelis Kadaja. The company now consists of 12 people. It has also received Cross-Sectoral Mobility Measure (SekMo) support from the Estonian Research Council, which has funded the research of staffers Andres Valkna, the company’s chief technology officer, and Jekaterina Krištal, Nanordica’s principal scientist.
“Both SekMos have been milestones for the development of the company,” says Kubo. They have also helped to move it towards its goal of commercializing their innovative technology.
“This is something that has not been done before in wound care,” says Kubo. “Usually, you have a variety of materials and one is for infection management and another is for healing. Nobody has tried to incorporate these dual effects in one possible product.”
Nanordica’s Premotiv technology offers a reduction in silver content and associated toxicity combined with an improvement in outcome. “We can vastly reduce silver content compared to the best products in the market and sustain the efficacy of the products,” Kubo claimed. She said that Nanordica’s dressings contain on average about 40 times less silver than the conventional wound dressings used today. “We have achieved our goal to produce a material that has high efficacy and safety, prevents infection and promotes wound healing,” she said.
A focus on diabetic foot ulcers
While they had developed an innovative technology, Nanordica’s team — currently 12 people — was looking for a use case where there was an unmet clinical need. Through consultations with partners at the North Estonia Medical Centre (PERH), they determined that patients suffering with diabetic foot ulcers stood to benefit greatly from the availability of new woundcare products.
According to Kubo, the risk of infection in diabetic foot ulcers is high. About half of all wounds result in infection, and about 20 percent of those infections lead to amputation, the removal of the limb. Amputation in turn is a major cause of mortality in diabetic patients. While Estonia does not have a high prevalence of diabetes, it is climbing, as diabetes is more common in wealthier countries.
“Diabetes is a disease of modern society,” says Kubo. “In countries with a higher GDP, the prevalence is higher.” She provided Spain, Germany, and Saudi Arabia as countries with particularly acute problems. Patients with diabetic foot ulcers are typically older and suffering from chronic diseases. These patients are the most likely to suffer from a microbial infection.
As Nanordica’s technology can prevent infection and promote wound healing at the same time, its management sees the application of its wound dressings in treating diabetic foot ulcers as a “sweet spot.” Its wound dressings can also be used for weeks at a time, longer than conventional, silver-based dressings.
Together with its partners at PERH, Nanordica recently carried out a randomized controlled trial involving 30 patients with diabetic foot ulcers. One group received silver-based wound dressings, while the second received Nanordica’s advanced antibacterial dressings. Both groups were treated for a week with the dressings changed three times. As part of the study, wound surface area was measured, as well as other attributes. In general, the researchers found that the Nanordica dressings helped wounds to heal in half the time as conventional ones.
“This was beyond our expectations,” says Kubo. “We started the study not knowing how well it would work, as we just had in vitro data. She adds that Nanordica is going through the study data and soon intends to publish its findings.
A randomized, double-blind trial in Spain
The company is now eager to run a randomized, double-blind trial in a larger market and at the end of 2024 announced a collaboration with José Luis Lázaro-Martínez, a professor at Complutense University of Madrid and a leading international expert on diabetic foot ulcers. The trial will involve five clinical centers in Madrid, León, and Cádiz in Spain and will recruit 170 patients over the next year, with an anticipated end date in March 2026.
The investigators in the study will compare the safety and performance of Nanordica’s product with conventional wound dressings. The study is being co-financed through a €2.4 million European Innovation Council (EIC) Accelerator grant. Nanordica’s Chief Clinical Officer Grigory Vasiliev is responsible for the study design.
“We will collect data about wound response, including microbiological data and surface area data,” says Kubo. Following the end of the study in March 2026, the researchers will analyze and publish the data, she adds.
“I believe this technology is of significant importance as it explores innovative therapies in the field of prevention and management of diabetic foot infections,” said Lázaro-Martínez of his interest in the technology. Lázaro-Martínez said that most existing treatments for diabetic foot ulcers have shown limited effectiveness and demonstrated no preventative benefits, especially silver dressings.
“Investigating the effects and potential benefits of this new technology could greatly assist both patients and healthcare professionals involved in diabetic foot care,” he said.
One challenge Nanordica faces is commercialization, Kubo notes, and it is here where its collaboration in Spain could pay off. As it is coming to market with a novel technology, it has to introduce the product to the market, raise awareness of its existence, and prove its utility over other products that have long been entrenched for use in wound care. The partnership withLázaro-Martínez could support Nanordica’s ambition to do so.
“We are coming to the market with a new product that nobody has known before,” says Kubo. “It needs to gain trust among clients and end users.” As Nanordica commences its trial in Spain and prepares for market approval in Europe, it is also working on new wound indications. One area of interest is pressure ulcers or bed sores. Another is deeper wounds, such as traumatic wounds. Kubo says that widening the product portfolio is certainly in the cards for the company.
