Rethinking Subsidence Reduction for High-Risk Patients

We're developing patient-specific, optimized TLIF implants engineered aiming to reduce subsidence risk in high-risk patients, an underserved population with limited options.

Off-the-shelf OptimalPSI

Minimal Workflow Disruption

Standard TLIF procedure with 5-minute pre-op planning, no new equipment, minimal training required.

1
CT Imaging & Surgical Input
Add the CT scan and input surgical plan via platform
2
AI Automated Design Workflow
Automation of the patient-specific design workflow by AI and generation of treatment plan
3
Treatment Plan Approval
Review and approve treatment plan by surgeon
4
Optimization
Patient-specific computational optimization
5
Manufacturing
Medical-grade titanium 3D printing
6
Surgery
Standard TLIF procedure with implant specific instruments
Timeline: Lead time fits standard hospital planning windows
Integration: No workflow changes, compatible with robotic-assisted surgery

Many Spinal Fusion Patients Experience Subsidence

Published studies report radiographic subsidence rates of 51%1 in using standard implants, with 6.1% of patients requiring revision surgery2. The problem is significantly worse in compromised bone quality patients, where weak bone cannot withstand concentrated loading from standard cage designs.

The dilemma

Do you proceed with spinal fusion surgery knowing standard cages have high failure rates, or do you turn away patients who could benefit from this procedure?

Simulated load distribution — anatomy-only patient-specific implant vs. the OptimalPSI implant

Why Anatomy-Only Solutions Are Not Enough

Patient-specific implants that only match anatomy can still lead to subsidence. Fitting the bone shape doesn't address load distribution through strong bone, away from weak bone.

The OptimalPSI Difference: Our optimization algorithm optimizes for bone quality, not just anatomy, creating variable internal implant architecture that directs load to strong bone and away from vulnerable areas.

The Result: 75% subsidence reduction vs. anatomy-only patient-specific solutions, 90% vs. standard cages in pre-clinical testing*,**.

Learn About Our Evidence →

Potential Benefits for Your Practice

More Reimbursement Potential

Patient-specific orthopedic devices may qualify for enhanced DRG reimbursement pathways~, supporting the business case for adoption.

Reduce Complications

Designed to meaningfully reduce subsidence risk vs. currently available off-the-shelf cages and anatomy-only solutions. As a TLIF solution, OptimalPSI also offers single-position surgical access across all lumbar segments.

Improve Predictability and Efficiency

5-minute Pre-OP planning will provide upfront information on each patient, aiming to replace guesswork with data-driven confidence.

Expand Your Patient Population

Confidently offer fusion to patients you might otherwise turn away.

Partner With Us as an Early Adopter

OptimalPSI is advancing through final pre-clinical validation toward FDA submission. Surgeons in our early adopter network receive:

Priority updates on validation milestones and regulatory progress
Opportunities to provide clinical input on product development
First access to limited market release following FDA clearance