Bone Biologics

NELL-1 Product Pipeline

While Bone Biologics has chosen to focus its initial product development efforts in spinal fusion, we believe that this regenerative medicine technology has potential in the broader fields of bone regeneration and repair including osteoporosis and trauma applications.

Product Development & Manufacturing
Nell-1 Product pipeline Table Graph
Nell-1 Product pipeline Table Graph Mobile

Platform Technology

Spine

Spine

Spine fusion is a surgical procedure to join or fuse two or more vertebrae in the back to relieve nerve pain.

The global spine market is $10 billion and growing in low single digits.

Approximately 30% of the U.S. population reports back pain, of which 2% receive a diagnosis, and 65% get treatment.

Trauma

Trauma

The global trauma market is approximately $7 billion.

Increase in trauma cases owing to urbanization, higher frequency road accidents, sports-related injuries and increase in geriatric population.

Orthobiologics are typically used for the treatment of nonunions, delayed unions or bone defects in orthopedic trauma.

Osteoporosis

Osteoporosis

Osteoporosis occurs when the creation of new bone does not keep up with the loss of old bone.

50% of women and 25% of men age 50 and older will break a bone due to osteoporosis.

Osteoporosis drugs fall into two classes – anti-resorptive drugs, which slow down bone loss, and anabolic drugs, which improve bone formation, combined they account for $11 billion market.

Addressable Market

* $3 Billion Global
Orthobiologics Market

We estimate about 13% market share for BBC of the total $3B market – 5 years after commercialization.

Market Graph 1

Addressable Market

* $3 Billion Global
Orthobiologics Market

We estimate about 13% market share for BBC of the total $3B market – 5 years after commercialization.

Market BG Mobile

Pilot Animal Studies

First ever clinically relevant sheep study shows that rhNELL-1 increases the interbody fusion rate and significantly increases quantity of bone.

Results Fusion Rate
(uCT)
New Bone Vol
(uCT)
New Bone Area
(Histo Morph)
Bone Strength
(Biomech)
rhNELL-1 Better than Control (sDBX) Blue Check Blue Check Blue Check Blue Check
Results rhNELL-1 Better than Control (sDBX)
Fusion Rate
(uCT)
Blue Check
New Bone Vol
(uCT)
Blue Check
New Bone Area
(Histo Morph)
Blue Check
Bone Strength
(Biomech)
Blue Check

Fusion Rates and Bone Volume (uCT)

rhNELL-1 increases the fusion rate 37.5 points

Fusion Rate and Bone Volume (uCT)

Histomorphometry - Bone Area At 16 Weeks

rhNELL-1 significantly increases bone quantity at 16 weeks

* P=0.03
Y axis: Bone Area of 1 is entire area

>30% increase in bone area

Histomorphometry - Bone Area At 16 Weeks

Biomechanics At 16 Weeks

Less bending means more rigid. Flexion and flexion-extension reduced with rhNELL-1 + sDBX

Biomechanics
Biomechanics Graph

* P<0.05
Statistically significant

>30% decrease in lateral bending