Periodic Reporting for period 2 - SPARTHACUS (Innovative multifunctional and smart coatings to prevent medical device related infections)
Berichtszeitraum: 2023-08-01 bis 2024-07-31
Hospital acquired infections are a common cause of additional hospitalisation (16 Million additional days per year) and significant healthcare costs (more than 7 billion Euros per year). One of the most frequent causes of such infections are medical devices (4 times more chance of infections). To resolve this problem SPARTHA Medical has developed coatings that can be applied to medical devices that will render them antimicrobial and significantly diminish the risk of infection. During SPARTHACUS project the aim is to develop the necessary instrumentation to use these coatings in hospitals and also in medical device production facilities. We aim to improve the coatings by incorporating additional features (such as antifungal, antiviral and antibiofilm properties).
The overarching goal of the project is to bring these coatings and application devices for industrialisation on one hand and for clinical trials on the other. For this aim, in-depth market analysis of different use cases, key opinion leader interviews and regulatory status analysis are carried out. The newly developed devices are tested in pre-clinical settings and its technical folder for the clinical trials is in preparation. The project also enabled the development of new products that can be used in consumer markets with multifunctionality (simultaneous antimicrobial and antiviral activity).
SPARTHACUS project aims to bring a high impact product (protect|ION); a handheld device that can be used to apply thin membranes on open wounds after surgeries and during chronic wound treatment which decreases the possibility of infection and hence increase the healing of such wounds. Such a system can aid millions of patients suffering from chronic wounds and decrease post-surgical infection rates significantly (currently at 10-15%), thus saving hundreds of millions of healthcare costs while having a potential of more than 50 Million euros annual revenues.
The overarching goal of the project is to bring these coatings and application devices for industrialisation on one hand and for clinical trials on the other. For this aim, in-depth market analysis of different use cases, key opinion leader interviews and regulatory status analysis are carried out. The newly developed devices are tested in pre-clinical settings and its technical folder for the clinical trials is in preparation. The project also enabled the development of new products that can be used in consumer markets with multifunctionality (simultaneous antimicrobial and antiviral activity).
SPARTHACUS project aims to bring a high impact product (protect|ION); a handheld device that can be used to apply thin membranes on open wounds after surgeries and during chronic wound treatment which decreases the possibility of infection and hence increase the healing of such wounds. Such a system can aid millions of patients suffering from chronic wounds and decrease post-surgical infection rates significantly (currently at 10-15%), thus saving hundreds of millions of healthcare costs while having a potential of more than 50 Million euros annual revenues.
Within the first 24 months since the start of the project in August 2022, we have performed the following activities:
- A prototype of the industrial dipping robot was developed, implemented in our facilities, tested and validated.
- The regulatory status of our clinical product (protect|ION) has been analysed and classification of the product has been finalised (Class IIB).
- The first prototype of the protect|ION Class IIB Medical device has been designed, developed and tested and its activity against bacteria in pre-clinical settings has been validated.
- The production chain of the product has been established.
- The production-friendly second version of the product has been designed, prototyped and is being produced for clinical trials.
- Pre-clinical validation of the coatings has been done, the necessary certified tests have been qualified and the necessary steps are taken for carrying them out.
- The design of the pre-clinical in vivo tests has been finalised, preliminary tests have been carried out. Multiple final use scenarios (Contamination and Spraying, spraying to prevent contamination and spraying already infected wounds) have been successfully tested.
- The application of the coatings under different conditions and different microenvironments (such as root canal therapy, medical textiles, multiple implants, hair, cosmetic products) has been implemented.
- Interviews with several Key Opinion Leaders (Surgeons, clinicians, infirmaries) have been carried out and the design and the use case of the protect|ION has been validated. The premise and the patient inclusion/exclusion criteria of the clinical trial have been set.
- A hospital and a CRO have been engaged, the clinical trial premise (Colorectal surgery) and the clinical investigation design has been done.
- New features implementation into the coatings have been carried out: a new antimicrobial, antifungal and antiviral gel has been developed. The handheld applicator designs were modified for cosmetic applications.
- Quality Management System implementation has been carried out.
- A machine learning based in silico model of polymer anti-inflammatory property prediction has been developed and implemented, a similar model of antibiofilm activity has been also finished with the discovery of potential new, potent motifs and sequences.
- A specific formulation for hair applications has been developed, and considered to be tested in clinical settings by one of our cosmetic partners.
- Coating efficacy against persistent fungi (Aspergillus species) has been demonstrated in the context of opthalmologic applications.
- 2 patent applications were done, a new trademark for the aforementioned consumer product technologies has been submitted (ION|aspis).
- 3 high impact scientific publications were done.
- 2 pre-clinical studies with the coatings on other products are ongoing
- An initial regulatory response on the sexual protection product has been obtained from the French Authorities.
- Potential route for 510K application for the coated advanced woundcare products has been established with the clients and the necessary tests (AATCC100) has been carried out.
- A new quality control system has been implemented based on handheld FTIR measurements.
- The project has been highlighted in Global Conferences and Fairs.
- A prototype of the industrial dipping robot was developed, implemented in our facilities, tested and validated.
- The regulatory status of our clinical product (protect|ION) has been analysed and classification of the product has been finalised (Class IIB).
- The first prototype of the protect|ION Class IIB Medical device has been designed, developed and tested and its activity against bacteria in pre-clinical settings has been validated.
- The production chain of the product has been established.
- The production-friendly second version of the product has been designed, prototyped and is being produced for clinical trials.
- Pre-clinical validation of the coatings has been done, the necessary certified tests have been qualified and the necessary steps are taken for carrying them out.
- The design of the pre-clinical in vivo tests has been finalised, preliminary tests have been carried out. Multiple final use scenarios (Contamination and Spraying, spraying to prevent contamination and spraying already infected wounds) have been successfully tested.
- The application of the coatings under different conditions and different microenvironments (such as root canal therapy, medical textiles, multiple implants, hair, cosmetic products) has been implemented.
- Interviews with several Key Opinion Leaders (Surgeons, clinicians, infirmaries) have been carried out and the design and the use case of the protect|ION has been validated. The premise and the patient inclusion/exclusion criteria of the clinical trial have been set.
- A hospital and a CRO have been engaged, the clinical trial premise (Colorectal surgery) and the clinical investigation design has been done.
- New features implementation into the coatings have been carried out: a new antimicrobial, antifungal and antiviral gel has been developed. The handheld applicator designs were modified for cosmetic applications.
- Quality Management System implementation has been carried out.
- A machine learning based in silico model of polymer anti-inflammatory property prediction has been developed and implemented, a similar model of antibiofilm activity has been also finished with the discovery of potential new, potent motifs and sequences.
- A specific formulation for hair applications has been developed, and considered to be tested in clinical settings by one of our cosmetic partners.
- Coating efficacy against persistent fungi (Aspergillus species) has been demonstrated in the context of opthalmologic applications.
- 2 patent applications were done, a new trademark for the aforementioned consumer product technologies has been submitted (ION|aspis).
- 3 high impact scientific publications were done.
- 2 pre-clinical studies with the coatings on other products are ongoing
- An initial regulatory response on the sexual protection product has been obtained from the French Authorities.
- Potential route for 510K application for the coated advanced woundcare products has been established with the clients and the necessary tests (AATCC100) has been carried out.
- A new quality control system has been implemented based on handheld FTIR measurements.
- The project has been highlighted in Global Conferences and Fairs.
We have developed a handheld system that can coat living tissues without any cytotoxic effectively. The system can be molded using 2 molds and the spraying effect is obtained by the modification of individual pressure-based spray systems. As a result of the system, we can apply a complex coating with ease. To our best knowledge there is no equivalent system in the market. This system has been submitted as a patent application and a second version for the cosmetic applications has been developed and currently obtaining the necessary authorisations to be tested with the end users. The device has been validated in 4 separated the pre-clinical configurations and has demonstrated unexpected positive impact on mechanical pressure, heat sensitivity on the wound by animals and with improved mobility by the animals in a paw incision model. The next step is the clinical trials clinical trials. The potential of such a system is several hundreds of thousands of units per year only in Europe as potentially it can be used for all at risk surgeries and post-surgery care with a potential turnover in the range of 30 -60 M€ alone.
We have developed a functional prototype for the industrial application of our coatings, which was appreciated by our industrial clients for the potential inclusion of our technology in their products.
We have developed a new antimicrobial, antiviral and antifungal hydrogel which is only based on biopolymers; given the contradictory needs of such products (effectively killing pathogens while being environment and health friendly) without resorting to disinfectants having such a system which is also biocompatible can open a new generation of disinfectant products which are better for human health and environment. A patent application has been submitted and a market analysis has already been carried out with sexual protection against multiple pathogens in the form of a gel being the first target (coating of contact lenses is second).
We have developed in silico models for the prediction of the properties of the final coatings, one on the immunomodulatory aspects for medical devices and another on the antibiofilm capacities for more general applications.
We have developed a functional prototype for the industrial application of our coatings, which was appreciated by our industrial clients for the potential inclusion of our technology in their products.
We have developed a new antimicrobial, antiviral and antifungal hydrogel which is only based on biopolymers; given the contradictory needs of such products (effectively killing pathogens while being environment and health friendly) without resorting to disinfectants having such a system which is also biocompatible can open a new generation of disinfectant products which are better for human health and environment. A patent application has been submitted and a market analysis has already been carried out with sexual protection against multiple pathogens in the form of a gel being the first target (coating of contact lenses is second).
We have developed in silico models for the prediction of the properties of the final coatings, one on the immunomodulatory aspects for medical devices and another on the antibiofilm capacities for more general applications.