Pilot Study Underway

We are conducting a pilot study in Australia for NELL-1 as a bone graft substitute for spine fusion. The study is evaluating the NB1 bone graft device in combination with the NELL-1 protein with demineralized bone matrix with the goal of providing rapid, specific and guided control over bone regeneration. The study design was reviewed by the FDA’s Division of Orthopedic Devices and is intended to support our progression to a pivotal clinical study in the U.S.

Technology Benefits

A major challenge in orthopedic surgery is effective bone regeneration, especially in hard healers. NELL-1 is being developed to address orthobiologics industry challenges by benefitting patients through faster healing and better outcomes, and to benefit the healthcare system through reduced surgical time and lower costs. 

• Preclinical studies have demonstrated successful spine fusion across multiple animal models, including rodents, sheep and non-human primates.  In a pivotal sheep study, NELL-1 demonstrated a 37.5% increased frequency of fusion compared with the control group.
• Safer healing by acting later in the bone formation pathway. NELL-1 minimizes risks such as inflammation and tissue growth in non-bone areas.
• No adverse reactions in two clinically relevant sheep studies in which NELL-1 was shown to promote bone fusion without complications.
• Target bone regeneration with NELL-1addresses the issue of unwanted rapid, uncontrolled bone growth that causes an unsound structure and unwanted bone formation where bone is not intended.
• Comprehensive validation of NELL-1 through advanced imaging and biomechanical testing.
• Supporting validation with NELL-1 viewed positively in more than 45 peer-reviewed publications demonstrating technological viability.

Market Overview

Orthopedic disorders impact millions around the world. The need for improved solutions is driven by:

• An increasing likelihood of systemic medical issues and re injury due to insufficient bone healing.
• An increasing susceptibility to bone injuries among an aging population.

The orthobiologics industry with its technology advancements will benefit patients and health systems through better outcomes, reduced surgical time, faster healing, and reduced costs.