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CORDIS

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

Obiettivo

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.

Campo scientifico (EuroSciVoc)

Parole chiave

Programma(i)

Argomento(i)

Meccanismo di finanziamento

HORIZON-EIC - HORIZON EIC Grants

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(si apre in una nuova finestra) HORIZON-EIC-2025-TRANSITIONOPEN

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Coordinatore

LUNDS UNIVERSITET
Contributo netto dell'UE
€ 440 000,00
Indirizzo
Paradisgatan 5c
22100 Lund
Svezia
Regione
Södra Sverige Sydsverige Skåne län
Tipo di attività
Higher or Secondary Education Establishments
Collegamenti
Costo totale
Nessun dato

Partecipanti (3)