What's New

3MALLO: NVD-X3

3MALLO: NVD-X3

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.

References:
1. https://orthoinfo.aaos.org/en/treatment/spinal-fusion/

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

    Our Science

    Novadip is developing a new class of regenerative tissue products that accelerate healing in a single treatment.

    Read More

    Patients

    Learn how we are transforming the lives of patients.

    Read More

    What’s New

    Stay updated on the latest news from Novadip, including corporate and clinical announcements.

    Learn More