Belgium's Novadip Biosciences raises €10.4 million to fund pivotal clinical trial and unlock EIB loan tranche

Novadip Biosciences, a Belgian late-stage clinical BioTech company specialising in regenerative medicine, has closed a €10.4 million (roughly $12 million) convertible financing round.

The round was led by US-based New Science Ventures, with participation from a syndicate of Novadip’s existing backers, including Fund+, Wallonie Entreprendre, VIVES Fund, ORSA Tech, Sambrinvest, Noshaq and Invest.BW. The financing follows the company securing a €9.6 million convertible loan last year, bringing the total to €20 million in convertible financing since June 2025.

“This financing is a strong vote of confidence from our investors, and I’d like to thank them for their ongoing support. 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,” said Dr. Denis Dufrane, founder and CEO of Novadip.

Founded in Belgium in 2013 as a spin-off from Université Catholique de Louvain and St. Luc University Hospital, Novadip grew out of research by its founder, Dr. Dufrane. The company has built a proprietary platform, known as 3M³, that uses adipose-derived stem cells arranged within a three-dimensional extracellular matrix to create tissue capable of healing large bone defects, non-union fractures and spinal fusion cases in a single procedure.

Its test pipeline is built on two candidates: NVDOO3 and NVDX3. The NVD003, which is at the heart of this financing round, is a moldable, autologous graft built from a patient’s own stem cells, designed to be implanted within three months of cell collection. The company says it has already shown durable bone fusion at 24 months and mobility maintained up to four-year follow-up.

The company’s second candidate, NVDX3, an allogenic (donor-derived) bone grafting material, has completed Phase 1b/2a trials in trauma surgery and spinal fusion, and has FDA clearance to begin a Phase 2b/3 trial.

The financing will primarily support the completion of a pivotal Phase 3 trial of NVD003 for congenital pseudarthrosis of the tibia (CPT), a rare and difficult-to-treat pediatric bone condition. The trial is already running in both the United States and the European Union.

The funds will also cover preparation of a Biologics License Application (BLA) to the US Food and Drug Administration, and support the company’s push toward what it calls “value-creating milestones”, including potential strategic partnerships and, if the BLA is approved, a Rare Pediatric Disease Priority Review Voucher from the FDA, which the company values at more than $100 million.

“With a pivotal Phase 3 program underway, regulatory preparation advancing and a significant commercial opportunity, Novadip is entering a critical value-creating period. This financing provides the means to execute on these priorities and prepare the business for its next stage of development,” said Eric Pâques, Chairman of the Board.

Novadip is aiming to obtain market authorisation for NVD003 in congenital pseudarthrosis of the tibia by 2028, followed by approval for adults with critical-size bone defects by 2031.

Novadip says hitting the €10.4 million target opens access to a tranche of an €18 million venture debt agreement Novadip signed in 2023 with the European Investment Bank, backed by the European Union’s InvestEU programme. It now employs 53 people and has raised €137 million in equity and non-dilutive funding since inception.