Company Overview

A biomedical spin-off for regenerative medicine, in full expansion.

Founded in 2013 by Dr. Denis Dufrane and Dr. Jean-François Pollet, Novadip Biosciences is a regenerative medicine spin-off company from the University of Louvain (UCL) and St. Luc University Hospital. The creation of Novadip Biosciences was supported by the Louvain Technology Transfer Office (LTTO), Sopartec and VIVES II.

While Novadip’s first mission was to treat patients with bone defects and bone diseases, its innovative adipose stem cell-based technology offers potential for further applications, including skin regeneration. These therapies solve real problems faced by doctors and patients around the world, and are aimed at more positive clinical outcomes and long-term quality of life.

The product pipeline already includes two regenerative medicine products: NVD-001, a 3D osteogenic structure, and NVD-002, a biological bandage for skin. Both use autologous adipose-derived mesenchymal stem cells (AMSCs), offering a wide range of benefits, including a minimally invasive isolation procedure, a high capacity of differentiation, and reduced risk of recipient immunisation or graft rejection. Read more

 

OUR HISTORY

2007    Reflection begins on the best stem cells for large bone defect reconstruction.

2008    Innovative 3-D osteogenic structure (later “NVD-001”) is developed in the tissue bank at Cliniques universitaires Saint-Luc.

2009    Bone reconstruction is demonstrated in pre-clinical studies.

2010    Patent WO2010/139792 is granted for a “multi-dimensional biomaterial” and its production method. (Inventors: D. Dufrane & C. Delloye).

2010    First clinical application of the biological dressing for skin reconstruction in a chronic wound after radionecrosis (later NVD-002) is demonstrated.

2010    First clinical cases with NVD-001, in the hospital exemption setting, as a salvage therapy for bone tumour and non-union indications, show positive safety and efficacy outcomes.

2011    The selection of the adipose stem cells as the best candidate for bone reconstruction is published in Biomaterials Journal.

2012    New clinical cases with NVD-001 for lumbar spine and degenerative disc disease indications also demonstrate positive safety and efficacy outcomes.

2013    Preclinical results are published in Biomaterials, a leading international journal covering the science and clinical application of biomaterials.

2013    Novadip Biosciences is set-up, with a capital increase of EUR 500.000.

2013    Novadip receives grants of EUR 550.000 in non-dilutive funding from the Walloon Region.

2015    Novadip closes a EUR 28 million Series A financing round with US and Belgian investors.

2015    Novadip is granted additional EUR 4.5 million in non-dilutive funding by the Walloon Region.

2015    The development of the concept of the biological dressing for skin reconstruction with NVD-002 is published in the American Journal of Plastic Surgery.

2015    The clinical results of NVD-002 regarding safety and efficacy, are published in: Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different «Hospital Exemption» Clinical Applications. Vériter S, André W, Aouassar N, Poirel HA, Lafosse A, Docquier PL, Dufrane D. PLoS One. 2015 Oct 20;10(10):e0139566

2016    Novadip develops and publishes a tool to discriminate adipose stem cells to fibroblasts. Lafosse A, Dufrane D. (2016) A simple method to determine the purity human adipose-derived stem cells-based cell therapies. Stem Cell Trans Med. 2016 (in press)

2016    Novadip moves to new facilities in Louvain-La-Neuve, with in-house GMP Class A/B cleanrooms to begin the production of clinical batches.

 

Overview

Critical size bone defects following trauma, infection, congenital deficiency, or carcinologic resection remain a major healthcare issue because of the difficulties in reconstructing large bone segments. Bone regeneration has been contemplated for the past decades. The current gold standard remains bone grafting with autologous bone graft with or without osteoinductive materials, but available current techniques remain burdened by comorbidities and poor clinical outcomes.

Tissue engineering and cell therapy using adipose-tissue derived mesenchymal stem cells (AMSC) recently demonstrated several advantages over existing techniques related to their inherent proliferation and differentiation capacities. However, so far the use of AMSCs alone or in combination with scaffolds remained hampered by poorly controlled osteoinduction and disappointing osteogenic properties of the implanted materials.

The technology platform of Novadip Biosciences solves this issue by combining AMSC with Demineralised Bone Matrix (DBM). It overcomes the lack of osteoinduction and osteogenic properties of other synthetic/human materials and showed great healing potential.

Novadip Biosciences holds the worldwide exclusive licence to this technology platform. Its lead product candidate NVD-001 can be sutured, glued or naturally fixed in small or large bone defects. NVD-001 is a differentiated osteogenic structure fully characterized in view to obtain after implant the same properties as a real bone. It is non-immunogenic, with a desirable handling and mechanical characteristics required for perfect engraftment for bone healing disorders and bone defects.

It is the mission of Novadip Biosciences to develop innovative medicines through masterful use of our proprietary technology.

Our vision is to be recognized as a game-changing innovator of solutions in the field of regenerative medicine for bone healing and repair.

We strive to be a sound, well-respected company that values human life.

Our distinguished team includes renowned translational research experts in the field of stem cell biology, tissue engineering and regenerative medicines, regulatory affairs and good practices in clinical development (GCP) and industrialization/manufacturing activities (GMP), who hold the values of openness, innovation, respect, teamwork and commitment to be crucial to our success.

Novadip Biosciences builds on the many years of expertise of its management team in the field of innovative biopharmaceuticals and regenerative medicines to develop unique core competencies and build a broad intellectual property and technology portfolio designed to improve human health whilst create significant value for our stockholders.

Presentation

Intellectual Property

Creost is a proprietary, innovative cellular therapy with a strong patent portfolio

Novadip Biosciences’ intellectual property* covers the NVD-001 and NVD-002 composition, manufacture and the broad range of expertise and active R&D projects that are in progress at Novadip Biosciences and supported research within the laboratories of our academic collaborators.

Novadip Biosciences is committed to the ongoing expansion, broadening, and development of its intellectual property portfolio.

*Dufrane D, Delloye C. Multi-dimensional biomaterial and method for producing the same. Patent PCT/EP2010/057847; 2010.