Novadip Biosciences SA

At six months post-grafting surgery with NVDX3, x-rays demonstrate that 90% of patients have reached, or are steadily progressing towards, complete bone healing Derived from Novadip’s 3M 3 stem cell platform, NVDX3, a unique ‘off-the-shelf allogeneic matrix product to cure common but challenging orthopedic conditions, has potential to replace existing allogeneic bone substitutes to heal fractures MONT SAINT-GUIBERT, Belgium I October 17, 2024 I Novadip Biosciences, a clinical stage biotechnology company specializing in regenerative medicine, today announces positive interim results from its first-in-human clinical trial, NVDX3-CLN01, assessing the safety and efficacy of NVDX3 to heal distal radius fractures in adults. Originating from Novadip’s 3M 3 platform, NVDX3 is an allogeneic bone grafting material created from human osteogenic adipose tissue-derived mesenchymal stem cells (ASCs). It is formulated as a lyophilized powder intended to be used as an ‘off-the-shelf’ implant to induce bone formation between two bone segments in both orthotopic and heterotopic environments. NVDX3 is a new class of regenerative tissue products that accelerates bone healing in a single treatment for patients at high risk of nonunion due to co-morbidities (ageing, diabetes, obesity, smoking and other conditions) and medication use. NVDX3-CLN01 (NCT05987033) is a single-arm, open-label clinical trial designed to assess the safety and preliminary efficacy of NVDX3 in adults with distal radius fractures, involving the wrist joint with multiple bone fragments. Ten participants, aged 28 to 84 years old, were treated. Radiologically, 90% of patients have achieved, or are on-track to achieve, complete bone healing. All but one are progressing as expected clinically. There is no apparent impact of age or sex on the efficacy of NVDX3, despite the complexity of fractures treated. There have also been no safety concerns arising from this study. “The interim results of this first clinical trial mirror the safety and efficacy of NVDX3 demonstrated in our nonclinical program. NVDX3 is the first and only bone graft product following a Biologics License Application (BLA) pathway.Based on these preliminary data, NVDX3 has the potential to address the high unmet needs of patients with bone defects who, due to co-morbidity factors, experience delayed bone formation or nonunion,” said Denis Dufrane, MD, PhD, CEO of Novadip Biosciences. “We will share the results of this trauma study with the US FDA as part of our IND submission to support the further clinical development of NVDX3 as we explore its potential for the treatment of complex cervical spine fusion.” “We need more options to improve outcomes in bone healing, particularly for patients with co-morbidities like advanced age, diabetes and smoking,” said Philipp Leucht, MD, PhD, Vice Chair of Research, Department of Orthopedic Surgery at NYU Grossman School of Medicine. “These interim results suggest that NVDX3 may have the potential to address this unmet need.” The 12-month results of NVDX3-CLN01 are expected at the end of 2024. In parallel to NVDX3-CLN01, Novadip is investigating the safety and preliminary efficacy of NVDX3 as a bone graft to achieve spine fusion in the lumbar spine in trial NVDX3-CL02 (NCT05961956). One-year results from this trial are expected in March 2025. In addition to its allogeneic program with NVDX3, the clinical development of the company’s lead autologous program, NVD003, will soon be entering phase 3 for the treatment of congenital pseudarthrosis of the tibia, a rare pediatric disease that often leads to amputation. Planning for a pivotal phase 3 trial and BLA submission is underway. About Novadip’s 3M 3 platform The 3M 3 platform drives multiple classes of product candidates, with an initial focus on autologous cell therapies for critical size tissue reconstruction and allogeneic therapeutics in development for prevalent bone grafting procedures and solid tumors. The platform consists of a 3-dimensional, scaffold-free, extracellular matrix (ECM) utilizing differentiated adipose-derived stem cells (ASCs), to generate highly specific growth factors and miRNAs to restore the physiology of natural healing. The components of the 3M 3 include a matrix with ASCs to deliver growth factors/miRNA, the mature implant mimicking the physiology of natural healing. About Novadip Biosciences Novadip is a Belgium-based clinical stage biotech company aiming at advancing the standard of care in bone and tissue regenerative medicine. Based on the scientific discoveries of founder Prof. Dr. Denis Dufrane, MD, PhD, the company is developing its unique 3M³ tissue regeneration technology platform, which has the potential to generate an array of candidates that utilize 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. Novadip is a spin-off company from the Université Catholique de Louvain (UCLouvain) and St. Luc University Hospital. www.novadip.com SOURCE: Novadip Biosciences

1st US patient treated with an autologous cell-based product (NVD-003) in a rare pediatric disease Full enrollment of patients on track for year-end completion in allogeneic cell-derived product (NVD-X3) trial in patients with a distal radius fracture following trauma MONT SAINT-GUIBERT, Belgium, Dec. 5, 2023 /PRNewswire/ -- Novadip Biosciences SA ("Novadip" or "the Company"), a clinical-stage biopharmaceutical company developing a new class of regenerative tissue products to accelerate healing of large bone defects and injuries in a single treatment, today announced that the first US patient has been implanted with its investigational tissue regeneration product, NVD-003, in its Phase 1b/2a clinical trial in Congenital Pseudarthrosis of Tibia (CPT), a rare pediatric bone condition. An autologous therapy derived from a patient's own adipose stem cells (ASC), NVD-003 has the potential to accelerate healthy bone formation, restore mobility and avoid the need for amputation in children with CPT. "This is an exciting moment to be able to treat one of our patients with NVD-003," said Philip K. McClure, MD, FAAOS, Director of the International Center for Limb Lengthening, Baltimore, Maryland and the principal investigator in the US on this trial. "Three months after we collected the patient's adipose tissue in here in Baltimore, the NVD-003 graft, which was then manufactured in Belgium, was sent to us for implantation. With NVD-003, there's hope that the standard use of invasive iliac crest bone grafting, which can be very painful and lead to complications such as infection, bleeding and large scar formation, can be avoided. This is particularly important for patients who have had previous surgeries on the pelvis, making graft harvest of higher risk." According to Novadip, this Phase 1b/2a trial has now reached full enrolment; 3 patients have been enrolled in Belgium, of whom 2 have already been grafted with NVD-003 by Professor Pierre-Louis Docquier, MD, PhD, a specialist in pediatric surgery at the University Hospital Saint-Luc in Brussels. The company is actively planning the pivotal trial to support NVD-003's approval by the US Food and Drug Administration (FDA). Novadip also provided an update on NVD-X3, their allogeneic off the shelf matrix product, which entered clinical development this past summer with two parallel Phase 1b/2a EU clinical trials. Enrolment in the first trial, for the treatment of a distal radius fracture following trauma, is near completion with 9 of 10 patients already treated. In addition, the first patient has been treated in the second trial investigating NVD-X3 in spine fusion. "We are very pleased with the speed of recruitment in our first clinical trial with NVD-X3," said Judy Ashworth, MD, Novadip's CMO. "As we now begin to prepare our Investigational New Drug Application to submit to the FDA, we're anxious to advance NVD-X3 into an aggressive phase 2 program in the US with trials beginning in early 2025." "We are excited by the progress of both of our programs in Europe and in US," said Denis Dufrane, MD, PhD, CEO, and founder of Novadip Biosciences. "We have demonstrated our capacity to manage multiple clinical trials in parallel as well as the robustness of our manufacturing platform for two different classes of cell-based and cell-derived products with the aim to deliver the best therapeutic agents to the patients. Novadip is now a clinical advanced company." About NVD-003 and CPT Congenital pseudarthrosis of the tibia, or CPT, is a devastating diagnosis. Impacting patients in just .5-3.5 in 150,000[1][2][3] live births, the condition is very rare and debilitating. Treatment of CPT is difficult and once a fracture occurs, subsequent fractures are likely. Children with CPT can face impaired mobility, years of corrective surgeries to try to repair and stabilize the bone, it is not uncommon for patients to ultimately undergo amputation of the limb. Novadip is developing NVD-003, an autologous therapy derived from adipose stem cells as a potential single treatment to save limbs and restore mobility in patients with congenital pseudoarthrosis of the tibia (CPT) and other rare pediatric bone disorders. About NVD-X3 for Spinal Fusion and Bone Non-Union Applications The risk of bone non-union following fracture is greater than 50% across all bones due to fracture severity, co-morbidities (diabetes, obesity, smoking and other conditions) and medication use[1]. Additionally, more than 600,000 spine fusion procedures are performed annually. Together, these indications represent a peak sales opportunity for Novadip of $2.2 billion. Novadip's lead allogeneic product, NVD-X3, employs a matrix containing multiple bioactive factors that induce accelerated tissue healing. Designed as an "off-the-shelf" product, NVD-X3 can be shipped and stored at room temperature and offers superior intraoperative handling characteristics. A favorable COGS profile supports broad distribution and expanded patient access. Preclinical studies demonstrate that NVD-X3 offers superior bioactivity without the undesirable bone formation/resorption and inflammation observed with currently marketed bone engraftment products. About Novadip Biosciences Novadip Biosciences is a clinical stage biopharmaceutical company leveraging its proprietary tissue regeneration technology platform 3M³ to generate multiple product candidates to address tissue reconstruction for patients who have limited or no treatment options. The 3M3 platform involves use of 3-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. Visit for more information. 1. Khan T, Bone Joint J. 2013, PMID: 23908415 2. Heikkinen ES, Acta Orthop Scand. 1999, PMID: 10429605 3. Hefti F, J Pediatr Orthop B. 2000, PMID: 10647103 Logo: Media & Investors Inquiries Denis Dufrane Direct: +32 10 77 92 20 Mobile: +32 477 42 00 34 [email protected] SOURCE Novadip

Second patient scheduled for implantation with NVD-003 in June 2023 Pivotal trial is expected to begin in the second half of 2024* MONT SAINT-GUIBERT, Belgium--(BUSINESS WIRE)-- Novadip Biosciences SA (“Novadip” or “the Company”), a clinical-stage biopharmaceutical company developing a new class of regenerative tissue products to accelerate healing of large bone defects and injuries in a single treatment, today announced that the first patient has been implanted with its investigational tissue regeneration product, NVD-003, in its Phase 1b/2a clinical trial treating four patients with Congenital Pseudarthrosis of Tibia (CPT). Novadip is developing NVD-003, an autologous therapy derived from adipose stem cells (ASC), as a potential single treatment to save limbs and restore mobility​ in patients with CPT, a rare pediatric bone condition. The patient was treated at the Saint-Luc University Hospital in Brussels by Dr. Pierre-Louis Docquier, EU principal investigator for this study. Dr. Docquier has considerable clinical experience using ASC-based therapies generated from Novadip’s 3M3 tissue regeneration platform in clinical and compassionate use settings. "The potential for this approach to accelerate healthy bone formation, restore mobility and avoid the need for amputation in patients with CPT is tremendous,” said Professor Pierre-Louis Docquier, MD, PhD, a specialist in pediatric surgery at the University Hospital Saint-Luc in Brussels. “I think patients will benefit from this therapy as it does not require invasive iliac crest bone grafting which not only can be very painful for patients but is also associated with co-morbidities such as infection, bleeding and large scar formation.” And as already observed in previous compassionate uses in 4 children. The Phase 1b/2a trial will enroll four CPT patients between two and eight years of age in the US and EU. The primary endpoint of the study is short-term safety of NVD-003 up to 12 months following grafting surgery (GS). Secondary endpoints include evaluation of long-term safety, tibial length, bone formation, bone remodeling and bone union at 3-, 6-, 12- and 24-month time intervals following GS. “We are excited by the progress in patient recruitment and treatment to date and look forward to assessing clinical and patient outcomes at near- and longer-time intervals post implantation,” said Denis Dufrane, MD, PhD, CEO, and founder of Novadip Biosciences. “With our growing research partnerships with the clinical investigators and their peer network in the EU and US, we are confident that we will be able to identify and enroll the CPT patients we will need for our planned pivotal trial, which we expect will begin in 2024,” added Judy Ashworth, MD, Novadip Biosciences’ Chief Medical Officer. NVD-003 Provides Clinical Proof of Concept for Future Development Programs The company previously announced positive data from a Phase 1/2 clinical trial evaluating the safety and clinical activity of NVD-003 in patients with severe bone non-union (BNU) of the lower limb following trauma. The results demonstrate NVD-003’s ability to reverse severe bone deterioration and to achieve accelerated ossification, and derisk the development of the Company’s allogeneic “off-the-shelf” therapeutic, NVD-X3, to provide accelerated, durable bone union in common orthopedic conditions such as spinal fusion and non-healing fractures. Both investigational products are derived from Novadip’s 3M³ platform, a 3-dimensional, extracellular matrix that utilizes adipose-derived stem cells to deliver highly specific growth factors and miRNAs to mimic the physiology of natural tissue healing. About CPT Congenital pseudarthrosis of the tibia, or CPT, is a devastating diagnosis. Impacting patients in just .5-3.5 in 150,0001,2,3 live births, the condition is very rare and debilitating. Treatment of CPT is difficult and once a fracture occurs, subsequent fractures are likely. Children with CPT can face impaired mobility, years of corrective surgeries to try to repair and stabilize the bone, it is not uncommon for patients to ultimately undergo amputation of the limb. About Novadip Biosciences Novadip Biosciences is a clinical stage biopharmaceutical company leveraging its proprietary tissue regeneration technology platform 3M³ to generate multiple product candidates to address tissue reconstruction for patients who have limited or no treatment options. The 3M3 platform involves use of 3-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. Visit for more information. *A pivitol trial is typically a Phase 3 study which presents the data that the FDA uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. 1 Khan T, Bone Joint J. 2013, PMID: 23908415 2 Heikkinen ES, Acta Orthop Scand. 1999, PMID: 10429605 3 Hefti F, J Pediatr Orthop B. 2000, PMID: 10647103