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De Novo Ossification using human engineered cartilage as cell-free biomaterialbroad

DENOVOSS · Horizon Europe grant · 2026-06-01–2029-05-31

EC contribution

€2,497,375

Total cost

€0

Beneficiaries

4
About the data

Source: CORDIS (official EU open data), Horizon Europe. Framework HORIZON · call HORIZON-EIC-2025-TRANSITIONOPEN · scheme HORIZON-EIC · topic HORIZON-EIC-2025-TRANSITIONOPEN. CORDIS record →

Objective

Bone trauma and critical skeletal defects remain a major global health challenge, affecting millions of patients each year and driving multi-billion-euro costs for healthcare systems. Current grafting solutions face persistent limitations in effectiveness and scalability. The unmet need is clear: a potent, safe, consistent, and off-the-shelf product that reliably induces bone formation across clinical contexts.The DENOVOSS consortuim proposes OssiGel, a first-in-class, cell-free regenerative biomaterial derived from engineered human cartilage. OssiGel is produced from a standardized immortalized mesenchymal stem cell line, decellularized to yield a stable extracellular matrix gel that retains structural proteins and over 2,000 bioactive factors. This unique composition triggers endochondral ossification, the natural developmental pathway of bone formation, thereby orchestrating host-mediated recruitment of progenitor cells and vascularization. Unlike current options, OssiGel combines the potency of living grafts with the safety, reproducibility, and scalability of an acellular, shelf-stable product.The project will advance OssiGel from TRL4 to TRL6, finalizing a GMP-compliant formulation, validating efficacy in large-animal mandibular models, completing GLP safety studies, and preparing a clinical trial application for first-in-human testing in alveolar ridge augmentation—an accessible, high-volume entry indication in dental and maxillofacial surgery. In parallel, DENOVOSS will establish market validation, reimbursement mapping, IP consolidation, and investor readiness to ensure a credible commercialization pathway.Ossigel will be addressing urgent patient needs while opening significant commercial opportunities. Capturing a market opportunity estimated at €300–600M annually in safety-priority cohorts with an additional €200–250M in general populations. DENOVOSS will thus deliver a clinically credible, commercially viable, and transformative solution.

Beneficiaries (4)

OrganisationCountryRoleEC contributionSME
LUNDS UNIVERSITET SE coordinator €440,000
UNIVERSITAT BASEL CH participant €1,198,418
Dhalion Biotech AB SE participant €434,338 Yes
NANTES UNIVERSITE FR participant €424,620

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