Novadip Biosciences develops a 3M³ adipose-derived stem cell tissue regeneration platform intended to deliver one-time or off-the-shelf therapies for large bone defects and related orthopedic indications. Its lead allogeneic product, NVD-X3, is designed as an off-the-shelf matrix to accelerate durable bone union in spinal fusion and non-healing fractures and can be stored at room temperature for easy distribution. Its autologous program, NVD-003, targets critical-size bone defects such as congenital pseudarthrosis of the tibia (CPT) and is supported by Phase 1b/2a and compassionate-use data from more than 50 adult and pediatric patients with up to five years of follow-up. Novadip plans to initiate a Phase 1/2 trial for NVD-X3 in Europe and Phase 1b/2a CPT trials in the US and EU by end of 2022. NVD-003 has received orphan drug and rare pediatric disease designations from the FDA; if approved, the company could be eligible for a priority review voucher worth more than $100 million. The company estimates a $7 billion addressable market for its 3MALLO program and a $2.2 billion peak sales opportunity for NVD-X3; Novadip is headquartered in Mont Saint-Guibert, Belgium and was co-founded in 2013. Novadip Biosciences is a clinical-stage company leveraging its proprietary 3M³ 3D extracellular-matrix platform, which uses adipose-derived stem cells to deliver growth factors and miRNAs for tissue reconstruction. Its lead autologous product, NVD-003, has positive interim Phase I/IIa adult data and an FDA IND allowing a US pilot study in pediatric congenital pseudarthrosis of the tibia (ages 2–8). The company is also developing an allogeneic off-the-shelf product, NVD-X3, with a first clinical trial expected in 2022, and is exploring exosomal miRNA applications for solid tumors with trials planned in the US and Europe. Novadip was spun off from the University of Louvain (UCL) and Saint-Luc University Hospital and is advancing both autologous and allogeneic programs to address critical-size bone reconstruction and broader indications. The financing announced strengthens the balance sheet to support continued clinical development, platform innovation and potential future clinical paths in China. The company is based in Mont Saint-Guibert, Belgium. Novadip Biosciences is a biopharmaceutical spin‑off of Université catholique de Louvain advancing Creost, a ready‑to‑use natural three‑dimensional tissue that can be modelled to fill large and small bone defects. Creost will initially be investigated for complex lumbar spine fusion, an unmet medical need affecting more than 100,000 patients per year worldwide. The company plans to use the proceeds from its recent financing for clinical development and process industrialization of its lead compound. Leadership includes CEO and co‑founder Jean‑François Pollet and CSO and co‑founder Denis Dufrane. The technology originates from research led by Prof Denis Dufrane at the Cell and Tissue Therapy Centre of St Luc University Hospital and Université catholique de Louvain. Novadip closed a €28M Series A to fund these next development steps.

Total raised

$93M

Funding rounds

4

Latest round

Series B

Latest activity

Nov 2022