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

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.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-EIC - HORIZON EIC Grants

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Call for proposal

(opens in new window) HORIZON-EIC-2025-TRANSITIONOPEN

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Coordinator

LUNDS UNIVERSITET
Net EU contribution
€ 440 000,00
Address
Paradisgatan 5c
22100 Lund
Sweden
Region
Södra Sverige Sydsverige Skåne län
Activity type
Higher or Secondary Education Establishments
Links
Total cost
No data

Participants (3)