For children with congenital pseudarthrosis of the tibia, repairing a broken bone can become years of repeat surgery rather than a single recovery. The rare disorder causes the tibia to fracture and fail to unite, leaving some patients with impaired mobility and, in severe cases, the prospect of amputation. Novadip Biosciences is trying to change that trajectory with a graft built from the patient’s own cells.
The Belgian biotech has raised €10.4 million in convertible financing, led by New Science Ventures with participation from Fund+, Wallonie Entreprendre, VIVES Fund, ORSA Tech, Sambrinvest, Noshaq and Invest.BW. Combined with a €9.6 million convertible loan secured previously, Novadip has now raised €20 million in convertible financing since June 2025.
But the round does more than extend the company’s runway. Reaching the €10.4 million financing target also gives Novadip access to the final tranche of an €18 million venture-debt agreement with the European Investment Bank, signed in 2023 under InvestEU. The amount of that remaining tranche has not been disclosed.
The capital is centered on NVD003, Novadip’s autologous regenerative therapy. The product begins with adipose-derived stem cells collected from the patient and differentiated within a three-dimensional, scaffold-free extracellular matrix. Novadip says this matrix delivers growth factors and microRNAs intended to recreate elements of the body’s natural bone-healing environment. The resulting moldable graft is implanted directly into the bone defect during reconstructive surgery.
That approach emerged from research led by founder and CEO Denis Dufrane at UCLouvain and St. Luc University Hospital. Novadip was spun out in 2013 and has since built its broader 3M³ platform around both patient-derived and donor-derived regenerative products.
NVD003 is now being tested in a randomized pivotal Phase 3 study against iliac crest bone grafting in pediatric CPT patients, with recruitment underway across the US and Europe. Novadip previously said the study would enroll 12 children across eight sites.
The program has already accumulated early clinical evidence, although it remains investigational. When Novadip announced FDA Regenerative Medicine Advanced Therapy designation in 2025, it reported that seven of eight children across an earlier Phase 1b/2a study and compassionate-use programs achieved fracture healing. Separately, four compassionate-use patients were reported to have complete healing without recurrent fractures after four to seven years of follow-up. Those results come from small, early cohorts and do not substitute for the ongoing controlled Phase 3 trial.
NVD003 has also received Orphan Drug, Rare Pediatric Disease, Fast Track and RMAT designations from the FDA. RMAT status is intended for qualifying regenerative therapies addressing serious conditions with preliminary clinical evidence suggesting potential to meet an unmet medical need; it can provide more intensive interaction with the agency during development.
The new funding will support completion of the pivotal study and preparation of a Biologics License Application in the US. Novadip is targeting market authorization in CPT by 2028, although that timing remains dependent on trial results and regulatory review. If NVD003 ultimately receives the required FDA approval, the company also expects the program to be eligible for a Rare Pediatric Disease Priority Review Voucher.
Denis Dufrane framed the financing around that clinical objective: “Most importantly, it allows us to remain fully focused on our mission of bringing transformative regenerative therapies to patients with limited treatment options, with the aim of becoming a leader in limb sparing treatment.”
Novadip is not relying on NVD003 alone. Its second clinical-stage program, NVDX3, takes a different approach: an allogeneic, donor-derived “off-the-shelf” bone-grafting material aimed at more common orthopedic procedures. Phase 1b/2a studies in trauma and lumbar spinal fusion have been completed, and the company says the FDA has cleared it to proceed into a Phase 2b/3 IND study.
The immediate test, however, is much narrower and more consequential. The €10.4 million financing gets Novadip closer to the point where NVD003 must demonstrate in a controlled pivotal trial that the encouraging results from small early cohorts can translate into a reproducible treatment for children facing one of orthopedic medicine’s most difficult bone-healing problems.
