Novadip Raises €10.4 Million ($11.98 Million) To Complete NVD003 Phase 3 Trial

Novadip Biosciences has raised €10.4 million ($11.98 million) in convertible financing to advance its lead regenerative medicine program NVD003 through pivotal Phase 3 development and prepare for a U.S. regulatory submission. The financing was led by U.S.-based New Science Ventures, with participation from existing investors Fund+, Wallonie Entreprendre, VIVES Fund, ORSA Tech, Sambrinvest, Noshaq and Invest.BW.

Combined with a €9.6 million convertible loan secured in 2025, the latest financing brings Novadip’s total convertible funding since June 2025 to €20 million ($23.3 million).

Novadip plans to use the funding to complete the ongoing Phase 3 trial of NVD003 in congenital pseudarthrosis of the tibia, or CPT, in the U.S. and European Union.

The company will also use the proceeds to prepare a U.S. Biologics License Application.

NVD003 is an autologous cell-based therapy being developed for bone regeneration in patients with limited treatment alternatives.

Novadip is targeting market authorization for NVD003 in CPT by 2028 and for adults with critical-size bone defects by 2031.

The company believes the indications could ultimately support multi-billion-dollar peak worldwide sales.

Completing the €10.4 million financing also allows Novadip to access the final tranche of an €18 million venture debt agreement it signed with the European Investment Bank in 2023 with support from the European Union’s InvestEU program.

Novadip is additionally preparing a Phase 3 study of NVD003 in adults with critical-size bone defects.

Its second lead product, NVDX3, is an allogeneic bone grafting material. Phase 1b/2a trials have been completed in trauma surgery and lumbar intervertebral spine fusion, and the FDA has authorized the company to begin a Phase 2b/3 IND trial.

Novadip was founded in Belgium in 2013 and employs 53 people. Since inception, the company has raised €137 million through equity and non-dilutive financing.

KEY QUOTES:

“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. 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.”

Denis Dufrane, M.D., Ph.D., CEO and Founder of Novadip

“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.”

Eric Pâques, Chairman of the Board of Novadip