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
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 a €9.6 million convertible loan the company secured last year, bringing its total convertible financing to €20 million since June 2025.
Dr. Denis Dufrane, founder and CEO of Novadip, said: “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.”
Eric Pâques, Chairman of the Board, added: “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.”
The Technology
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 pipeline is built on two candidates: NVD003 and NVDX3. NVD003, 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, with mobility maintained up to four-year follow-up.
The 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.
What the Funding Supports
The financing will primarily support 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.
Regulatory Roadmap
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.
Unlocking EIB Financing
Novadip says hitting the €10.4 million target opens access to a tranche of an €18 million venture debt agreement the company signed in 2023 with the European Investment Bank, backed by the European Union’s InvestEU programme.
The company now employs 53 people and has raised €137 million in equity and non-dilutive funding since inception.
