The Problem
Current periodontal regeneration produces structure without function.
Current Approaches Fail Because:
- ✗Focus on bone/tissue scaffolds alone
- ✗Ignore the neural component entirely
- ✗Produce ankylosis (direct bone-tooth fusion)
- ✗No proprioception, no bite force sensing
Clinical Reality:
- ✗87% of treated sites show incomplete regeneration
- ✗Long junctional epithelium instead of true attachment
- ✗Recurrent disease in 30-50% within 5 years
The Insight
Neural ingrowth precedes and coordinates periodontal regeneration.
🧠
NERVES
First
→
🩸
VESSELS
Second
→
🦷
PDL
Third
This developmental hierarchy is preserved in adult regeneration but ignored by current therapies.
The Solution
4-Signal Minimal Viable Construct delivering the complete regenerative signal.
NGF
Nerve Growth Factor
Neural ingrowth
PDGF-BB
Platelet-Derived GF
Vascular support
BMP-7
Bone Morphogenetic
PDL differentiation
BDNF
Brain-Derived NF
Neural survival
Three-Phase Commercialization
PHASE 1
Cell-Free Construct
Hydrogel + 4 signals only. Lower regulatory burden (510(k)/De Novo). Fastest path to market and revenue.
Timeline: 18-24 months
PHASE 2
Construct + Cells
Add autologous or allogeneic cells. BLA pathway through CBER. Enhanced efficacy for severe cases.
Timeline: 36-48 months
PHASE 3
Vertical Integration
In-house cell sourcing, manufacturing, and distribution. Maximum margins, supply chain control.
Timeline: 48-60 months