Novadip Secures €10.4M for Pivotal Phase 3 Bone Repair Cell Therapy Trial
The ongoing US and EU study is testing NVD003, an autologous cell-based therapy, in patients with a rare, difficult-to-treat pediatric bone condition.
Key Points
- Novadip completed €10.4 million ($11.98 million) in convertible financing, bringing its total convertible financing since June 2025 to €20 million ($23.3 million).
- The funding will support completion of the pivotal Phase 3 trial of NVD003 in congenital pseudarthrosis of the tibia and preparation of a US regulatory submission.
- Reaching the financing target allows Novadip to access the final tranche of an €18 million European Investment Bank venture debt agreement.
Novadip Biosciences completed a €10.4 million ($11.98 million) convertible financing round led by New Science Ventures.
Combined with a previous €9.6 million convertible loan, the transaction brings Novadip’s total convertible financing since June 2025 to €20 million ($23.3 million).
Funding Supports NVD003 Phase 3 Program
Novadip will use the funding to advance NVD003, an autologous (sourced from the patient) cell-based therapy, through the final stage of clinical development and prepare for regulatory submission. The funding will support:
- Completion of the pivotal Phase 3 trial in congenital pseudarthrosis of the tibia (CPT), which is underway in the US and EU.
- Preparation of a US Biologics License Application (BLA).
- Clinical, regulatory and strategic activities related to the NVD003 program.
- Potential receipt of a Rare Pediatric Disease Priority Review Voucher from the FDA following BLA approval.
Novadip’s goal is to obtain market authorization for NVD003 in CPT by 2028 and in adults with critical size bone defects by 2031. The company is targeting multi-billion-dollar peak sales worldwide.
Meeting the €10.4 million financing target also allows Novadip to access the final tranche of its €18 million venture debt financing agreement signed with the European Investment Bank in 2023. The agreement is supported by the European Union’s InvestEU initiative.
“This financing is a strong vote of confidence from our investors, and I’d like to thank them for their ongoing support,” said Denis Dufrane, MD, PhD, CEO and founder of Novadip. “This is an important step forward for Novadip. It provides the resources to advance NVD003 through several major clinical and regulatory milestones, including the completion of our pivotal Phase 3 program in congenital pseudarthrosis of the tibia and the preparation for regulatory submission in the United States. Most importantly, it allows us to remain fully focused on our mission of bringing transformative regenerativetherapies to patients with limited treatment options, with the aim of becoming a leader in limb sparing treatment”.
“With a pivotal Phase 3 program underway, regulatory preparation advancing and a significant commercial opportunity, Novadip is entering a critical value-creating period,” said Eric Pâques, Chairman of the Board. “This financing provides the means to execute on these priorities and prepare the business for its next stage of development.”
Clinical Pipeline
NVD003 is in a Phase 3 trial in the US and EU for CPT, a rare pediatric bone condition that is difficult to treat. Study start-up activities are also underway for a Phase 3 trial in adults with critical size bone defects.
Novadip is also developing NVDX3, an allogeneic (donor derived) bone grafting material. Phase 1b/2a trials have been completed in trauma surgery and lumbar intervertebral spine fusion. The FDA has authorized the company to begin a Phase 2b/3 Investigational New Drug (IND) trial.
Company Background
Novadip was founded in Belgium in 2013 based on scientific discoveries by Denis Dufrane, MD, PhD, and research from UCLouvain and St. Luc University Hospital. Its 3M³ tissue regeneration technology platform is designed to develop regenerative tissue products for large bone defects, bone nonunion and spine fusion.
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