Novadip’s unique technology platform is generating highly innovative allogeneic, “off-the-shelf” product candidates with no viable cells to address prevalent indications in hard and soft tissue reconstruction, including bone grafting procedures such as spinal fusions.

NVD-X3 is in clinical development for common orthopedic conditions, with learnings from Novadip’s earlier autologous clinical programs.

Two parallel phase 1b/2a clinical trials for distal radius fracture following trauma and spinal fusion are underway in the EU.

3MALLO-REG is our allogeneic approach to accelerated, stable bone union in engraftment procedures. Preclinical research has demonstrated superior safety and bioactivity compared to other bone grafting platforms.

3MALLO-ONCO is our allogeneic approach to reduce tumor progression. Ongoing preclinical studies are evaluating the possibilities for our 3MALLO-ONCO applications in oncology, specifically solid tumors.

Spinal fusion is a major surgery procedure used to correct problems with vertebrae. Vertebrae are fused together and heal into a single, solid bone. This is done to eliminate painful motion or to restore stability to the spine.1

Bone non-union (BNU) in trauma is when the bone does not heal properly leaving the limb with pain and instability, following the injury from a traumatic event or in an emergency.

3MALLO: Groundbreaking “off-the-shelf” product for common orthopedic conditions

  • Potential to disrupt the $7 billion bone graft market
  • Validated and de-risked by clinical experience with 3MAUTO program
  • Lead asset NVD-X3 poised to enter clinical development in 2022
  • 3MALLO matrix contains multiple bioactive factors at physiological concentrations to induce tissue healing
  • Superior intraoperative handling characteristics
  • “Off-the-shelf” product can be shipped and stored at room temperature
  • Competitive COGS profile supports broad distribution and expanded patient access

Preclinical studies of NVD-X3 suggest superior safety and efficacy in comparison to an available treatment widely used off-label in bone grafting procedures.

3MALLO: NVD-X3 can benefit more patients requiring bone grafting procedures

1.6Mn Bone Grafting Procedures Annually

    • Intervertebral Lumbar 33% 
    • Cervical Fusion 18%

    51% Spine Fusion

    • Trauma Surgery 29%
    • CMF 8%
    • Extremities 5%
    • Joint Revision 7%

    NVD-X3 addresses 93% of bone grafting procedures

    On Label*: ca. 93% (excludes Joint Revision)

    (*)clinical program requirements to pursue broader product label will be discussed with FDA

    Source: Decision Resources Group (2019 base year).
    Bone graft procedural numbers include autograft.
    CMF = craniomaxillofacial

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