Novadip Biosciences secures US$12M to advance regenerative therapy
Novadip will use the proceeds to advance NVD003, its lead autologous cell-based therapy, through late-stage clinical development and regulatory preparation.
BELGIUM — Novadip Biosciences, a biotechnology company developing regenerative medicine therapies, has raised €10.4 million (US$11.98 million) through a convertible financing round led by US-based New Science Ventures.
The financing also received support from the company’s existing investors, including Fund+, Wallonie Entreprendre, VIVES Fund, ORSA Tech, Sambrinvest, Noshaq and Invest.BW.
Combined with a €9.6 million (US$11.07 million) convertible loan secured in 2025, the latest financing brings Novadip’s total convertible funding to €20 million (US$23.05 million).
Funding to support NVD003 development
Novadip will use the proceeds to advance NVD003, its lead autologous cell-based therapy, through late-stage clinical development and regulatory preparation.
The company is conducting a pivotal Phase 3 trial of NVD003 in the US and Europe for congenital pseudarthrosis of the tibia (CPT), a rare condition in children in which a fractured tibia fails to heal properly.
The funding will support completion of the trial and preparation of a US Biologics License Application (BLA).
Novadip is targeting market authorization for NVD003 in CPT by 2028.
It also plans to develop the therapy for adults with critical-sized bone defects, with a target authorization date of 2031.
The company said the program could also qualify for a Rare Pediatric Disease Priority Review Voucher from the US Food and Drug Administration following BLA approval.
Venture debt facility unlocked
The financing also allows Novadip to access the final tranche of an €18 million (US$20.71 million) venture debt facility agreed with the European Investment Bank in 2023, supported by the European Union’s InvestEU initiative.
Denis Dufrane, MD, PhD, CEO and founder of Novadip, said the financing would provide resources to advance NVD003 through key clinical and regulatory milestones.
“This financing is a strong vote of confidence from our investors,” Dufrane said.
“It provides the resources to advance NVD003 through several major clinical and regulatory milestones, including completion of our pivotal Phase 3 program in congenital pseudarthrosis of the tibia and preparation for regulatory submission in the United States.”
Eric Pâques, Chairman of the Board, said the company was entering an important stage as it progressed its lead program toward commercialization.
Other clinical programs
Alongside NVD003, Novadip is preparing a Phase 3 clinical trial of the therapy in adults with critical size bone defects.
The company has also completed Phase 1b/2a trials of NVDX3, an allogeneic bone grafting material, in trauma surgery and lumbar intervertebral spine fusion.
The FDA has approved Novadip’s request to begin a Phase 2b/3 trial under an Investigational New Drug application.
Novadip said its current focus is advancing its clinical programs, regulatory preparations, and development activities toward potential commercialization.
Be the first to leave a comment