Novadip Biosciences
Clinical-stage biotechnology company developing stem-cell derived regenerative tissue products for large bone defects, non-union and spine fusion. The company develops both autologous and allogeneic osteogenic grafts using a three-dimensional stem-cell based tissue engineering approach, advances candidates through preclinical large-animal models and staged clinical trials, and works with regulators toward market authorization.
Industries
Nr. of Employees
small (1-50)
Novadip Biosciences
Patents
Biomaterial comprising adipose-derived stem cells and method for producing the same
US-11602579-B2
View Details
Biomaterial comprising adipose-derived stem cells and method for producing the same
US-11602579-B2
View DetailsProducts
Autologous adipose-derived 3D osteogenic graft
A scaffold-free, three-dimensional osteogenic implant produced from a patient’s own differentiated adipose-derived stem cells combined with mineral particulates, designed for reconstruction of critical-size bone defects and non-union.
Allogeneic lyophilized osteogenic graft material
An off-the-shelf, lyophilized bone graft material derived from osteogenic adipose-derived cells and formulated as a powder/matrix intended for use in trauma repair and spinal fusion procedures.
miRNA / exosome product candidates (preclinical)
Therapeutic candidates based on purified, specific miRNAs/exosomes produced from differentiated stem cells for systemic tissue indications and oncology applications.
3MALLO
An allogeneic, off-the-shelf bone graft product candidate containing multiple bioactive factors at physiological concentrations to address prevalent indications in hard and soft tissue reconstruction, including spinal fusions and trauma fractures.
NVD-X3
An allogeneic, off-the-shelf bone graft product candidate containing multiple bioactive factors at physiological concentrations to address prevalent indications in hard and soft tissue reconstruction, including spinal fusions and trauma fractures.
3MALLO-REG
Allogeneic approach to accelerated, stable bone union in engraftment procedures.
Autologous adipose-derived 3D osteogenic graft
A scaffold-free, three-dimensional osteogenic implant produced from a patient’s own differentiated adipose-derived stem cells combined with mineral particulates, designed for reconstruction of critical-size bone defects and non-union.
Allogeneic lyophilized osteogenic graft material
An off-the-shelf, lyophilized bone graft material derived from osteogenic adipose-derived cells and formulated as a powder/matrix intended for use in trauma repair and spinal fusion procedures.
miRNA / exosome product candidates (preclinical)
Therapeutic candidates based on purified, specific miRNAs/exosomes produced from differentiated stem cells for systemic tissue indications and oncology applications.
3MALLO
An allogeneic, off-the-shelf bone graft product candidate containing multiple bioactive factors at physiological concentrations to address prevalent indications in hard and soft tissue reconstruction, including spinal fusions and trauma fractures.
NVD-X3
An allogeneic, off-the-shelf bone graft product candidate containing multiple bioactive factors at physiological concentrations to address prevalent indications in hard and soft tissue reconstruction, including spinal fusions and trauma fractures.
3MALLO-REG
Allogeneic approach to accelerated, stable bone union in engraftment procedures.
Expertise Areas
- Bone tissue engineering
- Autologous cell therapy development
- Allogeneic graft development
- Clinical trial management for regenerative medicine
Key Technologies
- Adipose-derived mesenchymal stem cells (ASCs)
- 3D tissue engineering of osteogenic grafts
- Hydroxyapatite / beta-tricalcium phosphate biomaterials
- Lyophilization and off-the-shelf graft formulation
News & Updates
First two pediatric patients enrolled were implanted during Feb–Mar 2026; investigational autologous grafts are manufactured in Belgium and shipped to trial centers.
FDA granted Regenerative Medicine Advanced Therapy designation for the company’s autologous adipose-derived tissue regeneration product for congenital pseudarthrosis of the tibia.
No refractures reported during five-year follow-up; high durable union rates reported at 24 months in treated patients.
Four pediatric patients with congenital pseudarthrosis of the tibia treated under compassionate-use programs achieved complete healing with no subsequent refracture after four to seven years of follow-up.
Preclinical ovine PLF model showed early bone formation and functional fusion; early clinical cohorts reported safety and early signs of fusion with no product-related adverse events.
Investigational New Drug authorization was granted to initiate US clinical trials for an autologous regenerative bone product.
First two pediatric patients enrolled were implanted during Feb–Mar 2026; investigational autologous grafts are manufactured in Belgium and shipped to trial centers.
FDA granted Regenerative Medicine Advanced Therapy designation for the company’s autologous adipose-derived tissue regeneration product for congenital pseudarthrosis of the tibia.
No refractures reported during five-year follow-up; high durable union rates reported at 24 months in treated patients.
Four pediatric patients with congenital pseudarthrosis of the tibia treated under compassionate-use programs achieved complete healing with no subsequent refracture after four to seven years of follow-up.
Preclinical ovine PLF model showed early bone formation and functional fusion; early clinical cohorts reported safety and early signs of fusion with no product-related adverse events.
Investigational New Drug authorization was granted to initiate US clinical trials for an autologous regenerative bone product.