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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.

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Topic(s)

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HORIZON-EIC - HORIZON EIC Grants

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Call for proposal

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

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Coordinator

LUNDS UNIVERSITET
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 440 000,00
Address
Paradisgatan 5c
22100 Lund
Sweden

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Region
Södra Sverige Sydsverige Skåne län
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

No data

Participants (3)

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