Belgium’s Novadip Biosciences Raises €10.4 Million to Fund Pivotal Phase 3 Trial

Belgian regenerative medicine company Novadip Biosciences has raised €10.4 million in a convertible financing round to advance its lead therapy through a pivotal Phase 3 clinical programme and prepare for regulatory submission in the United States. The round was led by New Science Ventures, with existing investors Fund+, Wallonie Entreprendre, VIVES Fund, ORSA Tech, Sambrinvest, Noshaq and Invest.BW also participating.

Founded in 2013 as a spinout of Université Catholique de Louvain and Saint-Luc University Hospital, Novadip develops regenerative medicine therapies designed to repair large bone defects and difficult-to-heal fractures. The company was co-founded by Dr. Denis Dufrane, who serves as CEO. Novadip's proprietary 3M³ platform uses adipose-derived stem cells within a three-dimensional extracellular matrix to support tissue regeneration and bone healing.

The financing will primarily support NVD003, Novadip's autologous cell-based bone graft. The therapy is being evaluated in a pivotal Phase 3 trial for congenital pseudarthrosis of the tibia (CPT), a rare and serious condition in which the tibia fails to heal properly after a fracture. The trial is already underway in both the United States and Europe.

NVD003 is produced using a patient's own adipose-derived stem cells and is designed as a single-treatment approach for major bone defects. Novadip says earlier clinical data demonstrated durable bone fusion at 24 months, with mobility maintained through four years of follow-up.

Alongside NVD003, Novadip is developing NVDX3, an allogeneic, donor-derived bone graft. The programme has completed Phase 1b/2a trials in trauma surgery and spinal fusion, while the U.S. Food and Drug Administration has cleared the company to begin a Phase 2b/3 study.

The latest financing will also help Novadip prepare a Biologics License Application for the U.S. FDA. The company is targeting potential market authorisation for NVD003 in CPT by 2028, followed by development for adults with critical-size bone defects, with a potential approval target of 2031.

Reaching the €10.4 million financing target also unlocks access to another tranche of an €18 million venture debt facility agreed with the European Investment Bank in 2023 under the EU-backed InvestEU programme. Since its founding, Novadip says it has raised €137 million in equity and non-dilutive funding and now employs 53 people.