Pre-Clinical Evidence

Pre-Clinical Evidence: Engineered to Reduce Subsidence

Our optimization technology has been tested through pre-clinical studies: computational modelling, biomechanical testing, and peer-review. Pre-clinical data demonstrates consistent subsidence risk reduction*,***.

Off-the-shelf OptimalPSI

Peer-Reviewed Scientific Validation

OptimalPSI's approach to subsidence reduction has been tested through pre-clinical peer-reviewed research published in leading biomechanical engineering journals. Two studies, one based on computational modeling and the other on physical biomechanical testing, provided converging evidence of substantial performance improvements over existing solutions.

Module 1 · Computational Modeling Study

Computational Modeling Study

In-silico medical device testing of anatomically and mechanically conforming patient-specific spinal fusion cages designed by full-scale topology optimization

Smit, T., Aage, N., Haschtmann, D., Ferguson, S. J., and Helgason, B. (2024). Frontiers in Bioengineering and Biotechnology, 12, 1347961.

Study design: In-silico finite element analysis on patient cohort with varying bone quality levels
Key findings
89% median subsidence risk reduction with titanium implants vs. off-the-shelf implants
75% reduction vs. anatomy-only patient-specific solutions

What it shows: Computational validation demonstrates that optimization addresses the fundamental mechanical problem causing subsidence, not just improving anatomical fit. Authors include OptimalPSI employees and compensated advisors. See publication for full conflict-of-interest disclosures.

Overloaded bony structures comparison across implant types

Overloaded bony structures are highlighted in green for PEEK and red for Titanium. A Off-the-shelf implant. B Anatomy-only patient-specific implant. C Patient-specific optimized implant (OptimalPSI)

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Module 2 · Biomechanical Testing Study

Biomechanical Testing Study

Ex-vivo mechanical evaluation of anatomically and mechanically conforming patient-specific spinal fusion cages designed by full-scale topology optimization

Du, X., Smit, T., Rubin, W., Cheruparambil, C., Shah, R., Haschtmann, D., Helgason, B., Ferguson, S. J.

Study design: Ex-vivo mechanical testing using human cadaveric specimens
Key findings
~2x higher resistance to subsidence vs. off-the-shelf implants
Statistically significant performance (p = 0.03)

What it shows: Experimental testing confirms that computational predictions translate to physical mechanical performance. Authors include OptimalPSI employees and compensated advisors. See publication for full conflict-of-interest disclosures.

Failure force comparison: off-the-shelf vs OptimalPSI

Mechanical testing results summarized. Failure (subsidence force) vs. implant type, off-the-shelf and OptimalPSI.

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Subsidence Reduction Across Wide Range of Bone Quality Levels

Off-the-shelf implants show significantly worse outcomes subsidence1,2. OptimalPSI's optimization aims to deliver meaningful subsidence reduction across the entire patient spectrum.

Subsidence risk reduction vs. off-the-shelf implants in pre-clinical computational modelling*,**
89%
median reduction — overall patient cohort for titanium implant
Why this matters

High subsidence rates with off-the-shelf implants? OptimalPSI's aims to offer consistent performance, as demonstrated in pre-clinical testing.

On our way to FDA clearance

OptimalPSI follows established medical device validation protocols, progressing systematically from computational analysis through physical testing.

Completed 2024
Phase 1: In-Silico Computational Modeling

Computational modeling optimizes implant design for patient-specific fit and mechanics.

Completed 2025
Phase 2: Human Cadaveric Testing

Physical testing validates computational predictions and informs final design specifications.

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OptimalPSI research team in the lab
Founder credibility

Scientific Foundation: ETH Zürich Research Collaboration

OptimalPSI's optimization approach emerged from doctoral research at ETH Zürich's Laboratory for Orthopaedic Technology under Prof. Stephen Ferguson, conducted in collaboration with spine surgeon PD Dr. med. Daniel Haschtmann at Schulthess Klinik. This academic foundation ensures that our technology is grounded in rigorous biomechanical principles and validated through established research methodologies.

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Why This Evidence Matters: Aiming for Real Clinical Impact

Subsidence isn't just a radiographic finding, it causes persistent pain, reduces fusion success, and in worst cases, can lead to revision surgery. With off-the-shelf cages affecting a substantial number of patients1, preventing subsidence addresses the primary driver of poor outcomes and patient dissatisfaction.

OptimalPSI's patient-specific TLIF implant aims to transform outcomes for your patients, especially those who face the highest failure rates with standard implants.

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