NOVADIP Biosciences S.A.

13 years after reconstruct a patient following an osteosarcoma’s resection with our first autologous Tissue engineered product, Hara (VP R&D) presented the potential of our platform to cure the bone tumors. Very proud

News release // New milestone for Novadip Biosciences We are thrilled to announce that Novadip’s NVDX3 has reached key milestones leading to IND approval from FDA to start phase 2b/3 study in cervical spine fusion 📅Key trial details: • Phase 2b/3 study expected to begin enrollment in H2 2025 across 10 sites in the US. • The FDA-approved IND study will assess the efficacy of NVDX3 compared to standard-of-care treatments in level two cervical spine fusion 📣 Denis Dufrane, MD, PhD, CEO of Novadip, explains: “The trial will accelerate our capability to bring NVDX3 to patients with complex needs, providing them with a better chance of healing compared to standard-of-care treatments. These strategic steps enable us to take NVDX3 to the next level.” Built upon robust preclinical and clinical data, NVDX3 is poised to disrupt current treatment options by offering a single treatment solution for patients at high risk of nonunion due to complex comorbidities such as aging, diabetes, obesity, and smoking. 👉 Stay tuned for more clinical updates #RegenerativeMedicine #SpinalFusion #BoneHealing #ClinicalTrials #CervicalSpineFusion

📣 Online event // Our CEO Denis Dufrane will be participating in the European Commission online event on the “Implementation of the Hospital Exemption in the EU and its role in boosting innovation and patient access to innovative therapies” this Thursday, Nov 21, at 3:40pm. This event will bring together a wide range of experts and representatives from academia, the biotech industry, professional organizations and national authorities to explore the impact of the Hospital Exemption pathway on patient access to #ATMP. 🔬Novadip is a pioneer in the implementation of the Hospital Exemption rule in Belgium, which allowed us to develop our innovative therapy NVD003 to avoid amputation in children with congenital tibial pseudarthrosis. Join us this Thursday to follow Denis’ session “Supporting academic developers of ATMPs and competitiveness of the EU biotech sector” 👉 https://lnkd.in/dgK2jnia   #biotech #innovation #regenerativemedicine

🗞️ Our CEO Denis Dufrane spoke with Orthopedics This Week about the excellent results from our first-in-human proof-of-concept Trauma Study into the safety and efficacy of NVDX3, a unique “Off the Shelf” allogeneic matrix product to cure common but challenging orthopedic conditions. Read the full interview with Denis👇 https://lnkd.in/gg3bpyfz #biotech #clinicaltrial #orthopedics #regenerativemedicine #stemcells #celltherapy

📣 Last month at DKOU_Berlin 2024, the German Congress of Orthopaedics and Traumatology, Prof. Gerich Torsten, Chief of Trauma Service at the Centre Hospitalier de Luxembourg, presented the promising results of our clinical trial with NVD003 in Bone Nonunion (BNU).  👉Prof Gerich, the trial’s lead investigator, reported that 8 of 9 patients who were treated with NVD003, an autologous tissue engineered product generated from the patients’ own adipose stem cells, achieved complete consolidation with a mean time to clinical healing of 6 months. At 24 months, continued bone union was confirmed on Xray. No adverse events were judged to be related to NVD003.    📝To learn more about the results and read the abstract : https://lnkd.in/d69bzUig About NVD003: https://lnkd.in/eWXTmSuD Denis Dufrane #biotech #clinicaltrial #regenerativemedicine #stemcells #celltherapy

We are looking for a controller to join our dynamic team 🚀 If you're looking for a new challenge or know someone who might be a great fit, we’d love to hear from you!

📣 Novadip dans L'Echo : « Résultats prometteurs chez Novadip, qui prépare une nouvelle levée de fonds »   Un bel article qui revient sur les résultats de NVDX3, notre produit biologique unique dérivé de cellules allogéniques destiné à soigner des pathologies orthopédiques courantes mais difficiles à prendre en charge, et nos prochaines étapes de développement.    Olivier Gosset Denis Dufrane  #biotech #innovation  ------- 📣 Novadip is in the leading Belgian publication L'Echo 📰   L’Echo reports on our promising interim results from our first-in-human proof-of-concept trial with NVDX3, a stem-cell derived bone graft alternative to cure common but challenging orthopedic conditions. It has the potential to replace existing allogeneic bone substitutes to heal fractures.    👉To read our full news release: https://lnkd.in/dSa7GkXE https://lnkd.in/e-KpBVaJ

📢 We are pleased to announce the promising interim results from our first-in-human proof-of-concept trial with NVDX3 This is a game changer for regenerative medicine in bone healing as x-rays show that 90% of adult patients with distal radius fractures reaching or steadily progressing towards complete bone health at six months post-grafting surgery with NVDX3💪 Derived from our 3M3 stem cell platform, NVDX3, a unique “Off the Shelf” allogeneic matrix product to cure common but challenging orthopedic conditions, has the potential to replace existing allogeneic bone substitutes to heal fractures. "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. Philipp Leucht #biotech #bone #clinicaltrial #regenerativemedicine #stemcells #celltherapy #fractures

🪧 🗣️ Yesterday our VP R&D Hara Episkopou attended the Advanced Therapies in Belgium event in Namur. Hara delivered a pitch on our unique exosome and matrisome based products derived from the 3M³ Onco platform. The program has the potential to address a variety of cancers with solid tumors, such as osteosarcoma, melanoma, and glioblastoma. 💪 The event was a great opportunity to present Novadip to potential partners and experts giving us the chance to boost our visibility and open the doors for growth and collaboration. Many thanks to the organizers BioWin and MEDVIA #ATMPs #exosome #oncology #wallonia #flanders #innovation #celltherapy

🤝 Our CEO, Denis Dufrane, Chief Medical Officer Judy Ashworth, MD, Head of Regulatory Affairs Lola Tome, Director QC Carmen Brenner and Neil Johnson had the pleasure of meeting with the FDA yesterday to align on our clinical strategy for our Phase 3 trial for NVD003 for the treatment of congenital pseudoarthrosis of the tibia (CPT), a rare pediatric bone condition. 🔬 NVD003 is our lead autologous therapy derived from adipose stem cells as a potential single treatment to save limbs and restore mobility to patients with CPT and other rare pediatric bone disorders. To learn more, visit our website 👇 https://lnkd.in/eWXTmSuD #biotech #bone #clinicaltrial #pediatrics #orphandrug #regenerativemedicine