The Hazitek IDIMO Project develops new advanced medical devices

Here is the professional English translation of the press release detailing the completion and outcomes of the IDIMO consortium project:

IDIMO Consortium Partners

The IDIMO project, led by the Basque cooperative i+Med S. Coop. (i+Med)—a firm specializing in the development of pharmaceutical and biotechnological solutions—has successfully concluded following more than two and a half years of intensive research and collaboration, generating high-value synergies for the Basque biomedical ecosystem.

With a total budget of €4.3 million and a duration of 33 months, IDIMO received support from the Basque Government, which co-funded the project alongside the European Union through the European Regional Development Fund (ERDF) with €1.57 million. This support was granted via the Hazitek 2023 program (file ZE-2023/00035) for business R&D under its strategic projects track. The project, which ended on December 31, addressed key current challenges in the advanced medical device sector with a focus on scientific excellence: improving safety, durability, and personalization.

Adverse immune responses, poor implant integration, and associated infections—which place a heavy clinical and economic burden on European healthcare systems—were tackled through the research and development of immunomodulatory biomaterials, advanced surfaces, and diagnostic and monitoring systems designed to reduce complications and extend implant lifespan.

Cross-Cutting Approach

IDIMO stood out for its cross-cutting and integrative approach, driven by the effective cooperation of a multidisciplinary consortium of leading companies and technology centers from the Basque Country's biomedical sector. This partnership combined expertise in biomaterials, medical device manufacturing, diagnostics, validation, and regulatory compliance. Joining i+Med were:

1. AJL Ophthalmic S.A. (AJL): The only Spanish company dedicated to manufacturing intraocular lenses (IOLs) and ophthalmic medical devices.
2. Asparia Glycomics S.L. (Asparia): A Contract Research Organization (CRO) specialized in custom glycan synthesis and advanced glycobiological analysis services.
3. Createch Medical S.L. (Createch): A dental engineering firm.
4. Innovative Technologies in Biological Systems S.L. (Innoprot): A biotechnology company developing and commercializing innovative solutions (primary cells, immortalized cell lines, and recombinant cell lines) for drug discovery.
5. Certinalia S.L. (Certinalia): A certification entity for industrial and technological products.

Additionally, IDIMO featured broad participation from members of the Basque Network for Science, Technology, and Innovation (RVCTI): GAIKER Foundation, TECNALIA R&I, CIC biomaGUNE, CREATECH INSTITUTE, CIDETEC, and the METABOLOMIPs research group from the University of the Basque Country (UPV/EHU).

Key Project Outcomes

Thanks to this extensive network, the project successfully concluded with positive results, generating new knowledge that establishes a solid foundation for future industrial and clinical transfer. Specifically:

1. i+Med: Developed a new injectable scaffold with controlled anti-inflammatory release for cartilage regeneration in osteoarthritis patients, as well as a new multifunctional coating featuring triple anti-inflammatory, antibiotic, and regenerative action for hip and knee implants.
2. AJL Ophthalmic: Synthesized a highly biocompatible material with excellent optical and mechanical properties to restore vision while maintaining transparency and shape, alongside a hydrophobic acrylic material with immunomodulatory properties. Furthermore, AJL created a clinical data management platform ensuring patient data traceability, integrity, and privacy in compliance with GDPR/MDR regulations, facilitating post-implant monitoring and real-world clinical evidence generation.
3. Asparia Glycomics: Synthesized 8 new standards using an innovative method that includes complex glycans labeled with the commercial reagent Rapifluor™ and 7 tryptic IgG glycopeptides labeled with ¹³C and ¹⁵N. All standards were validated on a new analytical platform, and multiple methods were established for their use as internal standards.
4. Createch Medical: Developed a new miniaturized, functional sensor embedded within a custom product designed to monitor oral health.
5. Innoprot: Created a 3D corneal model combined with immune cells, enabling the study of corneal fibrosis, its treatment, and corneal inflammatory processes.
6. Certinalia: Authored two technical guides to streamline conformity assessment: one for a sensorized dental implant diagnosing in vivo infections, and another for a medical device detecting in vitro inflammatory markers in tear samples. Both guides ensure compliance with applicable European regulations right from the design phase by outlining assessment pathways and required documentation.

Executive Commentary & Next Steps

Dr. Virginia Sáez-Martínez, who led the project from i+Med, expressed great satisfaction with its completion:

"The culmination of IDIMO demonstrates the power of collaboration between companies and tech centers to drive genuine innovation in healthcare. It strengthens a robust, competitive business ecosystem capable of originating proprietary technologies and taking a leading position internationally. Furthermore, these results lay the groundwork for personalized, safe, and effective medical solutions that directly improve patients' quality of life."

Moving forward, each partner will advance their respective roadmaps:

1. i+Med will complete preclinical development, scale-up process optimization, and clinical development for both the injectable scaffold and multifunctional coating to secure regulatory approval and subsequent commercialization.
2. AJL Ophthalmic will execute preclinical and clinical validation, industrial scaling, and technical file submission for regulatory approval, while finalizing the digital integration of its clinical platform for hospital system interoperability.
3. Innoprot will optimize immune cell culture conditions to ensure viability throughout the process and refine cell immortalization to extend the 3D model to other organs.
4. Certinalia will launch a conformity assessment service tailored to medical devices and in vitro diagnostic medical devices.