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.

This article was first published on 14 December by the European Investment Bank.