Periodic Reporting for period 1 - NEXTNANO (NEXT GENERATION NANOPARTICLE-BASED ANTIBACTERIAL TREATMENT FOR INFECTED WOUNDS)
Periodo di rendicontazione: 2022-06-01 al 2023-05-31
Every 5th patient with diabetes develops chronic wounds, commonly foot ulcers that are frequently infected by bacteria. In 2019, the estimated global prevalence of foot ulcer infection was 6.4% (40-60 million people). Nearly 20% of foot ulcer infections lead to gangrene that requires an amputation, being the most common cause of lower limb amputation. Every year 10 mln amputations occur, demonstrating huge societal challenge and demand for new more effective antibacterial wound treatments.
Our project NEXTNANO aims to develop a proof-of-concept solution to cure wound infections. With our innovative advanced nanotechnology, we aim to reduce the infection-related amputation rates among diabetics.
During NEXTNANO we improved our commercialization strategy, established the quality management system at our company, and conducted pilot clinical case studies of our first prototype, an antibacterial wound dressing. This enabled us to gain a valuable set of data and to move from the R&D stage to the business development stage. Most importantly, by the end of the project, our solution is ready for the scaleup and following testing in a clinical trial to help millions of patients with wounds.
Our project NEXTNANO aims to develop a proof-of-concept solution to cure wound infections. With our innovative advanced nanotechnology, we aim to reduce the infection-related amputation rates among diabetics.
During NEXTNANO we improved our commercialization strategy, established the quality management system at our company, and conducted pilot clinical case studies of our first prototype, an antibacterial wound dressing. This enabled us to gain a valuable set of data and to move from the R&D stage to the business development stage. Most importantly, by the end of the project, our solution is ready for the scaleup and following testing in a clinical trial to help millions of patients with wounds.
NEXTNANO had 4 following objectives:
OBJECTIVE 1. To upgrade the commercialization strategy of Nanordica Medical.
OBJECTIVE 2. To conduct the clinical assessment of the antibacterial wound dressing.
OBJECTIVE 3. To establish the quality management system (QMS) at Nanordica Medical.
OBJECTIVE 4. To ensure the execution of the project and training of the participants.
Objective 1 – achieved.
We defined the business model, analyzed the key markets, shaped financial projections, performed competitor analyses, defined our unique selling points, reviewed target indications and connected to the key stakeholders. We shortlisted 3 countries (Estonia (test market), Spain and Germany) and connected to the main stakeholders in these countries, including key opinion leaders, medical device companies and health agencies. We established strong connections, prepared joint clinical trial protocols, established indications for our wound dressing during the NEXTNANO and continue to work with these stakeholders also after NEXTNANO.
Objective 2 – achieved
We worked on positioning of our wound dressing in the treatments scheme together with medical doctors and compiled comprehensive documentation to receive permission for clinical cases and conduct them. The clinical case studies revealed the significant effectiveness of the Nanordica Medical wound dressing in promoting wound healing. Particularly during the early stages of application, the dressing showed a robust capacity for reducing wound size, which is a critical factor in effective wound management
Objective 3 – achieved
Nanordica Medical has established and implemented QMS according to ISO 13485. We have conducted an internal audit and waiting for Notified Body (NB), British Standards Institution (BSI) to carry out a conformity assessment of QMS. We have hired a quality manager whose primary task is to support and keep Nanordica’s QMS constantly in compliance with ISO 13485.
Objective 4 – achieved
We improved the pitch, business plan and communication, so we were able to close the first investment round and received many startup awards: we won sTARTUp Day 2022 and were in TOP3 in Arctic15 pitch competition.
More specifically, we defined and articulated our unique value proposition, performed competitor analysis, included preclinical and clinical information and positioning of our solution against competitors into the business plan and pitch deck and built a CRM database of investors, distributors and key opinion leaders on PipeDrive platform.
OBJECTIVE 1. To upgrade the commercialization strategy of Nanordica Medical.
OBJECTIVE 2. To conduct the clinical assessment of the antibacterial wound dressing.
OBJECTIVE 3. To establish the quality management system (QMS) at Nanordica Medical.
OBJECTIVE 4. To ensure the execution of the project and training of the participants.
Objective 1 – achieved.
We defined the business model, analyzed the key markets, shaped financial projections, performed competitor analyses, defined our unique selling points, reviewed target indications and connected to the key stakeholders. We shortlisted 3 countries (Estonia (test market), Spain and Germany) and connected to the main stakeholders in these countries, including key opinion leaders, medical device companies and health agencies. We established strong connections, prepared joint clinical trial protocols, established indications for our wound dressing during the NEXTNANO and continue to work with these stakeholders also after NEXTNANO.
Objective 2 – achieved
We worked on positioning of our wound dressing in the treatments scheme together with medical doctors and compiled comprehensive documentation to receive permission for clinical cases and conduct them. The clinical case studies revealed the significant effectiveness of the Nanordica Medical wound dressing in promoting wound healing. Particularly during the early stages of application, the dressing showed a robust capacity for reducing wound size, which is a critical factor in effective wound management
Objective 3 – achieved
Nanordica Medical has established and implemented QMS according to ISO 13485. We have conducted an internal audit and waiting for Notified Body (NB), British Standards Institution (BSI) to carry out a conformity assessment of QMS. We have hired a quality manager whose primary task is to support and keep Nanordica’s QMS constantly in compliance with ISO 13485.
Objective 4 – achieved
We improved the pitch, business plan and communication, so we were able to close the first investment round and received many startup awards: we won sTARTUp Day 2022 and were in TOP3 in Arctic15 pitch competition.
More specifically, we defined and articulated our unique value proposition, performed competitor analysis, included preclinical and clinical information and positioning of our solution against competitors into the business plan and pitch deck and built a CRM database of investors, distributors and key opinion leaders on PipeDrive platform.
The project revealed the mechanisms of synergy of antibacterial nanoparticles, which were described in a peer-reviewed publication (https://doi.org/10.1038/s41598-023-36460-2).
The project developed a new medical device, an antibacterial wound dressing, which will be described in a peer-reviewed publication.
The project generated initial proof-of-concept for the new device, demonstrating its safety in vitro and in vivo.
The project developed a new medical device, an antibacterial wound dressing, which will be described in a peer-reviewed publication.
The project generated initial proof-of-concept for the new device, demonstrating its safety in vitro and in vivo.