Novadip Biosciences announced 12-month results of its first-in-human proof-of-concept study of NVDX3 in distal radius fractures in adults, following the interim results unveiled in October 2024.
The single-arm, open-label clinical trial evaluated safety and preliminary efficacy of NVDX3, an allogeneic bone grafting material created from human osteogenic adipose tissue-derived mesenchymal stem cells (ASCs). This trial focused on adults with distal radius fractures involving the wrist joint with multiple bone fragments.
The participants, aged 28-84 years old, were treated with NVDX3 with follow-ups conducted at 3, 6 and 12 months. At the 12-month follow-up visit, 100% of patients had bone union of their fractures, regardless of age and complexity of fractures treated, with the majority of patients achieving this by the six-month visit. No adverse events were deemed by the investigator to be related to NVDX3.
“I’m very excited by these results, as they strongly indicate that NVDX3 has the potential to address the high unmet needs of patients with bone defects who, due to comorbidity factors (e.g., smoking, age), experience delayed bone formation, or nonunion. Currently, no on-label osteobiologic can prevent or cure bone nonunion (up to 30%). With NVDX3, we are addressing a potential market of up to $12B,” said Denis Dufrane, MD, PhD, CEO of Novadip Biosciences.
In parallel to the trauma study, Novadip is investigating the safety and preliminary efficacy of NVDX3 as a bone graft to achieve spine fusion in the lumbar spine. One-year results are expected in March 2025.
Novadip Biosciences announced 12-month results of its first-in-human proof-of-concept study of NVDX3 in distal radius fractures in adults, following the interim results unveiled in October 2024.
The single-arm, open-label clinical trial evaluated safety and preliminary efficacy of NVDX3, an allogeneic bone grafting material created from...
Novadip Biosciences announced 12-month results of its first-in-human proof-of-concept study of NVDX3 in distal radius fractures in adults, following the interim results unveiled in October 2024.
The single-arm, open-label clinical trial evaluated safety and preliminary efficacy of NVDX3, an allogeneic bone grafting material created from human osteogenic adipose tissue-derived mesenchymal stem cells (ASCs). This trial focused on adults with distal radius fractures involving the wrist joint with multiple bone fragments.
The participants, aged 28-84 years old, were treated with NVDX3 with follow-ups conducted at 3, 6 and 12 months. At the 12-month follow-up visit, 100% of patients had bone union of their fractures, regardless of age and complexity of fractures treated, with the majority of patients achieving this by the six-month visit. No adverse events were deemed by the investigator to be related to NVDX3.
“I’m very excited by these results, as they strongly indicate that NVDX3 has the potential to address the high unmet needs of patients with bone defects who, due to comorbidity factors (e.g., smoking, age), experience delayed bone formation, or nonunion. Currently, no on-label osteobiologic can prevent or cure bone nonunion (up to 30%). With NVDX3, we are addressing a potential market of up to $12B,” said Denis Dufrane, MD, PhD, CEO of Novadip Biosciences.
In parallel to the trauma study, Novadip is investigating the safety and preliminary efficacy of NVDX3 as a bone graft to achieve spine fusion in the lumbar spine. One-year results are expected in March 2025.
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