Belgium: InvestEU - EIB venture debt for bone therapy innovator Novadip

• The EIB has signed an €18 million venture debt deal with Belgian biotech company Novadip funding innovation on its therapies for rare bone-related genetic diseases.
• Novadip will further develop its unique bone tissue regeneration platform to create new solutions for patients with limited or no effective treatment options.
• The agreements were made possible with the support of the InvestEU Programme, which aims to trigger more than €372 billion in additional investment between 2021 and 2027.

The European Investment Bank (EIB) and Novadip have signed a €18 million venture debt financing agreement supported by the European Union’s InvestEU initiative. The Belgian biotech company will use the funds to support clinical trials of NVD-003, an autologous bone product that provides one-time curative treatment to achieve long-term union and stability of critical size bone defects. This technology aims to heal damaged tissues by restoring their natural physiology; it brings together over 15 years of academic research with practical surgery experience and proof of principle clinical data.

The favourable safety profile and potential clinical utility of NVD-003 in promoting healthy and durable bone formation is supported by clinical data from more than 50 adults with critical size bone defects and paediatric patients with congenital pseudoarthrosis of the tibia, a rare paediatric bone condition that results in non-healing fractures of the lower limbs. The active cells in NVD-003 helped achieve durable union in critical size bone fractures by avoiding amputation and allowing children to enjoy a normal life, as demonstrated by up to five years of follow-up data.

EIB Vice-President Kris Peeters said: “Research and development in bone tissue engineering plays a crucial role in achieving better results and enhancing bone regeneration, especially for patients with limited or no effective treatment options. We believe that the research and clinical trials that are being conducted and further planned by Novadip’s team will very soon greatly improve existing treatments, leading to much better outcomes for patients. The EIB has built up quite the track record in financing innovative bio and med-tech companies in Belgium in recent years. And we are grateful for the InvestEU support for this type of venture debt transaction, as it allows us to help homegrown technology companies to stay in Europe, enabling them to grow, scale-up and fully develop their potential.”

“We are excited to have the capacity to improve the development of the NVD-003 product with the support of the EIB,” said CEO and founder of Novadip Biosciences Denis Dufrane, MD, PhD. “Indeed, the €18 million venture debt deal will significantly accelerate the manufacturing and the clinical development of NVD-003 that is needed to obtain marketing authorisation and to provide a new therapy to patients without curative alternatives who are at risk of limb amputation.”

On a technical level, the 3M³ platform involves the use of a three-dimensional extracellular matrix and adipose-derived stem cells to deliver highly specific growth factors and miRNAs to mimic the physiology of natural healing to create a range of products that address specific challenges in tissue regeneration. Novadip’s initial focus is on reconstruction of critical size bone defects. The company is also applying its 3M³ platform to develop truly novel off-the-shelf/allogeneic therapies addressing more prevalent tissue defects and miRNA/exosome products for broader indications.

Background information

The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals (amounting to €2.3 billion for projects in Belgium in 2022). The EIB is very active in the life sciences sector, supporting the biotech ecosystem in Belgium (to which it has provided €200 million in venture debt financing over the last five years). More information on www.eib.org and its dedicated venture debt page.

The InvestEU programme provides the European Union with crucial long-term funding by leveraging substantial private and public funds in support of a sustainable recovery. It also helps mobilise private investments for the European Union’s policy priorities, such as the European Green Deal and the digital transition. The InvestEU programme brings together under one roof the multitude of EU financial instruments currently available to support investment in the European Union, making funding for investment projects in Europe simpler, more efficient and more flexible. The programme has three components: the InvestEU Fund, the InvestEU Advisory Hub and the InvestEU Portal. The InvestEU Fund is implemented through financial partners that will invest in projects using the EU budget guarantee of €26.2 billion. The entire budget guarantee will back the investment projects of the implementing partners, increase their risk-bearing capacity and thus mobilise at least €372 billion in additional investment. More information on InvestEU is available here.

Novadip is a Belgium-based clinical stage biopharmaceutical biotech company. Based on the scientific discoveries of Prof Dr Denis Dufrane (MD,PhD), Novadip is a spin-off company from Université Catholique de Louvain (UCLouvain) and St. Luc University Hospital. Novadip Biosciences is developing its unique 3M³ tissue regeneration technology platform, which has the potential to generate an array of product candidates that utilise adipose-derived stem cells to mimic the physiology of natural tissue healing, and hard and soft tissue reconstruction for patients with limited or no treatment options. More information on www.novadip.com