High value-added solutions for strategic markets
DEVELOPMENT OF BIOCOMPATIBLE ELECTROSPUN BIOMATERIALS AND REGULATORY PREPARATION FOR THEIR CLINICAL VALIDATION AS MEDICAL DEVICES
BIO_CLINIC
Motivation
The project is justified by the need to develop advanced electrospun biomaterials based on chitosan and other polymers, capable of addressing current demands in the healthcare sector for medical and dermato-functional applications. Integrating material optimization, advanced characterization, biocompatibility validation, and early regulatory preparation within a single development process enables the generation of a technologically mature outcome directly aligned with market needs and European regulatory requirements.
This strategy significantly reduces market entry barriers for companies, facilitating the adoption, scaling, or incorporation of these biomaterials into new medical devices or dermo-cosmetic product lines
Objectives
The main objective of the project is to develop electrospun biomaterials targeted at medical and dermato-functional applications, to characterize their performance and biocompatibility, and to prepare the regulatory documentation necessary to enable their future clinical investigation as medical devices.
Expected results
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Obtaining electrospun biomaterials based on chitosan and other polymers with optimized formulations and controlled fiber morphology.
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Comprehensive characterization of these biomaterials in terms of mechanical properties, degradation behavior, and biocompatibility.
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Availability of technical evidence supporting their suitability for specific medical and dermato-functional applications.
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Generation of all the regulatory documentation required to obtain authorization from the competent authorities.
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Development of a document management system associated with regulatory compliance.
Grant number: PENDING
Programme: Plan of non-economic activities 2026
Period of execution: January 2026 – December 2026
Status: In progress
More information: PLAN OF ACTION
Entity: IVACE
Project supported by the Ministry of Innovation, Industry, Commerce and Tourism of the Generalitat Valenciana, through IVACE.
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R&D AREAS
New high-performance functionalised materials
Circular economy and sustainability
Advanced manufacturing, smart textiles and digitalisation
High value-added solutions for strategic markets
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NEWS
AITEX is present at the Babykid FIMI fair at Feria Valencia from January 26 to 28, presenting tests and certifications for children’s products.
AITEX has attended the Cosmetorium fair in Barcelona once again on October to present its new products for the cosmetic sector.
AITEX has hosted the LIFE POLITEX workshop entitled “Closing the textile polyester cycle: challenges and opportunities”, based on promoting sustainable solutions for the management and recycling of textile materials.