Revolutionary, ready-to-use and biological
An innovative family of cell-based regeneration therapies.
Novadip Biosciences pioneers the growth of 3-dimensional biologics based on adipose-derived stem cells (ASC), to regenerate hard and soft tissues. ASCs offer sizable advantages in regeneration medicine. The fatty tissue has demonstrated a much higher proportion of stem cells compared to the bone marrow, which is another reservoir of stem cells. The ASC can be isolated from a fatty tissue sample collected via a minimally invasive subcutaneous procedure, right in the doctors’ office. ASCs can also be prepared to deliver therapeutic benefit more easily, enabling the development of a family of products for more diverse indications. At Novadip, the ASCs are primed to restore functional tissue structure under proprietary quality controls.
Furthermore, by using the patient’s own stem cells, Novadip develops therapies that are not causing auto-immunization or graft rejection, for better clinical outcomes. That is the philosophy behind “Your cells, your treatment”.
With this technology, Novadip Biosciences is already developing two products:
NVD-001 is a patented cellular therapy to treat bone healing disorders. It is a differentiated osteogenic structure, fully characterised to obtain the same properties as real bone upon implant, while offering the desirable handling and mechanical characteristics required for perfect engraftment. This autologous 3D osteogenic structure allows reconstructing without the use of any scaffold. The “putty”-like material is easily and directly implantable by the surgeon on the bone defect; the 3D implant can be sutured, glued or naturally fixed in small or large bone defects. It can also be used with minimally invasive approaches, such as injection.
NVD-002 is Novadip Bioscience’s therapy for dermal reconstruction. It is designed to avoid formation of painful hypertrophic and unsightly scars following skin transplant that are caused by the limited supply of blood from the underlying wound bed to the transplant. The ASC-derived therapy promotes neovascularisation in the oxygen-depleted environment in severe dermal wounds after burn, diseases, infections or traumas. The cells are cultured at Novadip’s laboratories using proprietary techniques and incorporated into a carrier to form a biological bandage, which is placed directly onto the wound to restore the blood supply prior to performing the skin transplant.
Novadip’s adipose stem cell technology originates from research lead by Dr. Denis Dufrane (MD, PhD) (CSO and co-founder) and colleagues at the Cell and Tissue Therapy Centre of St Luc University Hospital and Université catholique de Louvain.
Why Autologous AMSCs ?
Novadip’s adipose stem cell technology originates from research lead by Dr. Denis Dufrane (MD, PhD) (CSO and co-founder) and colleagues at the Cell and Tissue Therapy Centre of St Luc University Hospital and Université catholique de Louvain. The advantages of autologous ASCs include:
- Obtained after a minimally invasive subcutaneous procedure.
- Tissue procurement can be achieved in a doctor’s office.
- High concentration of stem cells in adipose tissue (~500 x higher than bone marrow)
- Superior capacity of expansion and differentiation.
- No risk of recipient immunisation and graft rejection.
- Economically sustainable manufacturing process, ready for upscale and automatization with a lean manufacturing approach.
- Manufacturing process that matches clinical timelines.
- Prolonged shelf life for lean distribution.
- Cell survival in hypoxic host tissue.
- Intrinsic angiogenic properties (VEGF secretion).
Since 2013, Novadip Biosciences has been developing breakthrough innovations in cell-based therapies for hard and soft tissue. While our first mission was to treat patients with bone defects and bone diseases, our adipose stem cell-based technology now offers potential for further applications, including skin regeneration.
Pre-clinical and clinical data
Two proof of concept studies for NVD-001 on relevant animal models (pigs) and clinical data from 10 patients requiring orthopaedic surgery treated with first generation NVD-001 with authorization of the Ethical Committee of the participating hospital (Medical Faculty of Catholic University of Louvain, Brussels, Belgium) are available to support development. Similarly, for NVD-002, 7 patients with non-healing wounds have already been treated.
Novadip runs state-of-the-art grade A/B cleanrooms for GMP production of clinical batches to support upcoming clinical developments.
The GMP manufacturing process for the product pipelines is simple, robust, fully controlled and scalable.
Demonstration Of Clinical Safety & Efficacy
Outcomes of clinical cases performed in the academic setting showed promising clinical efficacy without significant side effect, even in salvage cases.