BioCore™

Adaptive Structural Implant Platform 

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The next-generation adaptive structural implant platform designed to replace rigid, pre-manufactured orthopedic implants with minimally invasive, in-situ formed biological structures.

 

Instead of forcing anatomy to conform to hardware, BioCore enables implants to conform to the patient, formed inside the body using a sealed, anatomically shaped membrane that is filled and cured after placement.

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A fundamental shift in reconstructive and orthopedic surgery

From Machined Parts → To In-Body Manufacturing.

 

Core Innovation

At the heart of BioCore is a biocompatible containment membrane pre-shaped to match the target anatomy (e.g., finger phalanx, facial bone, cranial segment). The membrane is:

• Inserted through a small incision

• Positioned precisely under intact skin

• Filled in situ with a structural bio-composite

• Allowed to cure and integrate with surrounding bone

 

The result is a patient-specific implant, formed inside the body with minimal tissue disruption.

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Surgical Workflow (Minimally Invasive)

1. Pre-operative imaging
   CT/MRI used to select appropriate BioCore membrane geometry

2. Small incision & access
   Single entry point for delivery tube (no large exposure)

3. Membrane placement
   Flexible, sealed implant positioned under skin and soft tissue

4. In-situ filling
   Injectable composite delivered via thin tube
   Implant may be partially filled (e.g., 50%) or fully filled depending on indication

5. Controlled curing
   Time-controlled or chemistry-controlled solidification

6. Closure
   Tube withdrawn, incision closed
   Skin remains intact over the final structure

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Initial Clinical Targets (High Probability)

Tier 1 – Near-Term

Low mechanical risk, fast regulatory path:

• Facial reconstruction

  • Orbital floor

  • Maxillofacial trauma

• Cranial defects

  • Post-trauma

  • Post-tumor resection

• Fingers and toes

  • Phalangeal reconstruction

  • Non-joint structural restoration

• Bone void filling

  • Non-load-critical regions

 

These applications benefit immediately from BioCore’s conformal geometry, reduced incision size, and lower revision risk.

 

Expansion to Load-Bearing & Joints

BioCore is designed as a platform, not a single implant class.

 

Joint Strategy (Hip, Knee, Shoulder)

Rather than a monolithic metal implant, BioCore uses a multi-material hybrid architecture:

1. Structural Core
   Injectable ceramic-polymer composite
   Tunable stiffness to match bone modulus

2. Reinforcement Scaffold
   Fiber or lattice structure embedded during fill
   Oriented along primary load paths

3. Interface Zone
   Gradient stiffness region to reduce stress shielding

4. Articulation Surface (optional)
   Separate wear surface (polymer or ceramic)
   Replaceable without removing the structural core

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This architecture directly addresses the leading causes of implant failure:

• Stress shielding

• Fatigue mismatch

• Poor anatomical fit

• Revision surgery complexity

 

Manufacturing Paradigm Shift

Traditional Orthopedics / BioCore

CNC-machined implants vs. In-body formation

Large SKU inventories vs. Small standardized kits

Rigid geometry vs. Patient-conformal

Large incisions vs. Minimally invasive

High logistics cost vs. Distributed deployment

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BioCore moves manufacturing into the operating room.

 

Regulatory Pathway (Indication-Based)

• Cranial / Facial / Digits
  Likely 510(k) or De Novo
  Timeline: ~2–3 years

• Small load-bearing structures
  Extended mechanical validation
  Timeline: ~3–4 years

• Major joints
  PMA-level data
  Long-term fatigue and wear studies
  Timeline: ~5–7 years

 

Key advantage: BioCore can be approved incrementally, not all at once.

 

Development Cost (Platform Level)

• Tier 1 indications: $20–30M

• Tier 2 expansion: $15–25M

• Joint systems: $40–70M

Total full-platform development:
≈ $75–120M
(significantly lower than pharma or robotics platforms)

 

Market Opportunity & ROI

Global Orthopedic Market

• Joint replacements: ~$130–145B annually

• Growing faster than GDP due to aging populations

Conservative BioCore Penetration

• 0.25% market share → ~$300M+/year

• 0.5% market share → ~$600M+/year

• 1.0% market share → ~$1.3B+/year

 

Platform margins: 40–55%
(driven by lower COGS and premium outcomes)

 

Strategic Positioning

BioCore is not a single product.
 

It is a foundational platform that:

• Reduces inventory complexity

• Improves patient outcomes

• Lowers revision rates

• Enables future AI-guided surgical integration

 

BioCore™

Is to Implants what Additive Manufacturing was to Aerospace

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