“A Decade of Progress, An Exciting Future in Regenerative Medicine”

May 20, 2023 | CEO Letter

In 2013, we established Novadip Biosciences to develop a new class of regenerative tissue products that will accelerate healing in patients with limited or no effective treatment options. Over the ensuing 10 years we worked to raise capital to support efforts to achieve a clinical proof of concept through a series of platforms and products.

Today, our 3M3 tissue regeneration platform has produced three unique development programs. With few companies covering this specific industry, we focused our commitment to changing lives by providing innovative regenerative medicine solutions.

Based on the encouraging results from the early application of our autologous ASC-based program, and dramatic results in generating bone tissue in an osteosarcoma patient who underwent surgical resection, we successfully secured €28 million through a series A funding.  This allowed us to consolidate the platform, design clinical trials, and perform tech transfers into the clinic. Since then, and over the past five years, we performed two clinical trials and proposed a new class of products for achieving accelerated, durable healing in patients with critical size bone defects and fractures.

In 2022, we raised an additional €40 million in a Series B round with international shareholders from the United States, Hong Kong, and Europe.  This funding will help advance our clinical stage development programs.

While we are justifiably proud of what we have achieved over the last decade, it is the near-term opportunity to bring these therapies to patients that really excites us. 

We now have three distinct development programs that each address unmet needs and/or large market opportunities:

  • NVD-003, our autologous call-based therapy to treat patients with congenital pseudarthrosis of the tibia. 

We are currently recruiting patients in our Ph 1/2 clinical study in the US and Europe and are on track to begin registrational trials in 2024 that will deliver data read outs at multiple time points throughout 2024-2025.

NVD-003 has orphan drug designation and, if it is approved by the FDA, Novadip becomes eligible for a priority review voucher – a valuable asset that could potentially bring in up to $100 million in additional non-dilutive funding.

  • NVD-X3, an off-the-shelf allogeneic product designed to achieve accelerated and durable bone formation in patients with non-union and spinal fusion.
    • Following positive results from a trial with our autologous product, we are initiating Ph 1/2 trials in the EU and US to evaluate NVD-X3’s ability to achieve accelerated and durable bone healing in patients undergoing spinal fusion and those suffering from bone non-union.
    • NVD-X3 has the potential to become the new standard of care in bone engraftment, with a total addressable market of $7 billion. 
  • NVD-M2, a preclinical asset that utilizes microRNA and proteins delivered via a matrisome to treat solid tumors and metastatic cancers.
    • Based on very positive feedback from a scientific advisory board held in conjunction with AACR 2023, we are accelerating this program with an eye toward entering the clinic in the first half of 2025.   

None of this would have been possible without the support of our dedicated team members.  I am honored and humbled to work alongside a team who showcases resilience, transparency, integrity, partnership, responsiveness, and who implement a supportive culture each day. I look forward to the next ten – this is just the beginning.

With Gratitude and Great Appreciation,

Denis Dufrane, MD, PhD
Founder and Chief Executive Officer
Novadip Biosciences

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