Periodic Reporting for period 3 - SPARTHACUS (Innovative multifunctional and smart coatings to prevent medical device related infections)
Berichtszeitraum: 2024-08-01 bis 2025-07-31
Hospital-acquired infections cause 16M additional hospitalisation days per year and over €7B in healthcare costs. Medical devices are a major source, with 4x higher infection risk. To address this, SPARTHA Medical developed antimicrobial coatings for medical devices, significantly reducing infection risk. Within SPARTHACUS, the goal was to create instruments to apply these coatings in hospitals and production facilities, preparing the technology for clinical trials. Coatings were also enhanced with antifungal, antiviral and antibiofilm properties.
The project’s overarching aim was to advance coatings and devices toward industrialisation and clinical trials. Market analysis, KOL interviews and regulatory assessments were conducted. Devices were tested preclinically and trial preparation initiated. The project also enabled development of multifunctional consumer products (antimicrobial + antiviral, cosmetics, health products).
SPARTHACUS focused on finalising protect|ION: a handheld device applying thin membranes on surgical and chronic wounds to reduce infections and accelerate healing. This system could benefit millions of patients, cut infection rates (currently 10–15%), save hundreds of millions in healthcare costs, and generate €50M+ in annual revenues.
The project’s overarching aim was to advance coatings and devices toward industrialisation and clinical trials. Market analysis, KOL interviews and regulatory assessments were conducted. Devices were tested preclinically and trial preparation initiated. The project also enabled development of multifunctional consumer products (antimicrobial + antiviral, cosmetics, health products).
SPARTHACUS focused on finalising protect|ION: a handheld device applying thin membranes on surgical and chronic wounds to reduce infections and accelerate healing. This system could benefit millions of patients, cut infection rates (currently 10–15%), save hundreds of millions in healthcare costs, and generate €50M+ in annual revenues.
Key achievements include:
• Prototype of an industrial dipping robot, now operational.
• Regulatory classification of protect|ION as a Class IIB medical device (EU MDR 2017/745).
• 1st protect|ION prototype tested with strong antimicrobial activity; full production chain established.
• 2nd, production-friendly version manufactured for clinical trials.
• Preclinical studies confirmed efficacy in multiple scenarios (spraying, wound treatment, contamination control).
• Validated coating in diverse uses: dental, textiles, implants, ophthalmology, cosmetics.
• KOL interviews defined trial criteria; CRO and hospital partners engaged; protocols prepared for colorectal surgery & chronic wounds.
• New multifunctional gel (antimicrobial, antifungal, antiviral) and adapted sprays for cosmetic use.
• QMS aligned with ISO 13485/14971.
• AI in silico models built for anti-inflammatory/antibiofilm properties, identifying novel peptide motifs.
• Hair-specific formulation clinically evaluated; coating efficacy proven against fungi (Aspergillus spp.).
• 2 patents filed, trademark (ION|aspis) submitted.
• 3 high-impact publications and further manuscripts in review.
• 2 preclinical studies with industrial partners; initial regulatory feedback obtained on sexual protection device.
• 510(k) pathway defined for woundcare; AATCC100 testing completed; FDA pre-submission prepared.
• Production QC implemented (FTIR spectroscopy).
• Clinical trial preparations initiated with Strasbourg hospitals (IHU & HUS).
• Project presented at EWMA and global conferences; FDA pre-registration achieved.
• Prototype of an industrial dipping robot, now operational.
• Regulatory classification of protect|ION as a Class IIB medical device (EU MDR 2017/745).
• 1st protect|ION prototype tested with strong antimicrobial activity; full production chain established.
• 2nd, production-friendly version manufactured for clinical trials.
• Preclinical studies confirmed efficacy in multiple scenarios (spraying, wound treatment, contamination control).
• Validated coating in diverse uses: dental, textiles, implants, ophthalmology, cosmetics.
• KOL interviews defined trial criteria; CRO and hospital partners engaged; protocols prepared for colorectal surgery & chronic wounds.
• New multifunctional gel (antimicrobial, antifungal, antiviral) and adapted sprays for cosmetic use.
• QMS aligned with ISO 13485/14971.
• AI in silico models built for anti-inflammatory/antibiofilm properties, identifying novel peptide motifs.
• Hair-specific formulation clinically evaluated; coating efficacy proven against fungi (Aspergillus spp.).
• 2 patents filed, trademark (ION|aspis) submitted.
• 3 high-impact publications and further manuscripts in review.
• 2 preclinical studies with industrial partners; initial regulatory feedback obtained on sexual protection device.
• 510(k) pathway defined for woundcare; AATCC100 testing completed; FDA pre-submission prepared.
• Production QC implemented (FTIR spectroscopy).
• Clinical trial preparations initiated with Strasbourg hospitals (IHU & HUS).
• Project presented at EWMA and global conferences; FDA pre-registration achieved.
Over the full course of SPARTHACUS, SPARTHA Medical delivered major innovations advancing antimicrobial technologies, device coatings, and clinical systems.
The main breakthrough was a handheld dual-component spray device applying supramolecular antimicrobial membranes directly on living tissues. Validated in four preclinical models, it showed infection prevention plus added benefits in wound healing, pain reduction, and mobility recovery. A patent was filed, and a cosmetic version tested safely in humans.
In parallel, a functional industrial prototype was developed for large-scale coating, enabling integration into partners’ manufacturing lines and attracting multinational interest.
SPARTHA also created a biopolymer-based hydrogel with antimicrobial, antiviral, and antifungal activity, providing a safe, eco-friendly alternative to conventional disinfectants. A patent was filed, with initial applications in sexual protection and contact lens coatings.
To accelerate R&D, SPARTHA built AI-driven in silico models predicting immunomodulatory and antibiofilm properties. These generated synthetic peptides (Pep7, Pep9, Pep11) validated with strong efficacy and low cytotoxicity; a patent is in preparation.
The spray device design evolved with clinician and engineer input, improving ergonomics, lowering contamination risk, and enabling mass production. A key connector innovation ensured fine mist and consistent coating.
Beyond medical use, a cosmetic proof-of-concept showed polymer sprays improved hydration, shine, and frizz control on hair without adverse effects, supporting future consumer health applications.
SPARTHA’s IP strategy secured 7 patent filings and 3 pending applications, covering compositions, devices, AI peptides, and product-specific claims, ensuring freedom to operate and supporting commercialization.
Together, these achievements position SPARTHA as a pioneer in smart antimicrobial technologies, with innovations ready for clinical trials, industrial deployment, and market entry.
The main breakthrough was a handheld dual-component spray device applying supramolecular antimicrobial membranes directly on living tissues. Validated in four preclinical models, it showed infection prevention plus added benefits in wound healing, pain reduction, and mobility recovery. A patent was filed, and a cosmetic version tested safely in humans.
In parallel, a functional industrial prototype was developed for large-scale coating, enabling integration into partners’ manufacturing lines and attracting multinational interest.
SPARTHA also created a biopolymer-based hydrogel with antimicrobial, antiviral, and antifungal activity, providing a safe, eco-friendly alternative to conventional disinfectants. A patent was filed, with initial applications in sexual protection and contact lens coatings.
To accelerate R&D, SPARTHA built AI-driven in silico models predicting immunomodulatory and antibiofilm properties. These generated synthetic peptides (Pep7, Pep9, Pep11) validated with strong efficacy and low cytotoxicity; a patent is in preparation.
The spray device design evolved with clinician and engineer input, improving ergonomics, lowering contamination risk, and enabling mass production. A key connector innovation ensured fine mist and consistent coating.
Beyond medical use, a cosmetic proof-of-concept showed polymer sprays improved hydration, shine, and frizz control on hair without adverse effects, supporting future consumer health applications.
SPARTHA’s IP strategy secured 7 patent filings and 3 pending applications, covering compositions, devices, AI peptides, and product-specific claims, ensuring freedom to operate and supporting commercialization.
Together, these achievements position SPARTHA as a pioneer in smart antimicrobial technologies, with innovations ready for clinical trials, industrial deployment, and market entry.