---
title: Pre-Clinical Evidence | OptimalPSI
description: Pre-clinical peer-reviewed and biomechanical evidence showing OptimalPSI's optimized implants reduce subsidence risk by up to 89% versus off-the-shelf spinal cages.
image: https://optimalpsi.com/hubfs/raw_assets/public/optimalpsi-theme/images/optimalpsi-social.jpg
---
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2. OptimalPSI | 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 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)
[Access Publication →](https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2024.1347961/full)
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.
Mechanical testing results summarized. Failure (subsidence force) vs. implant type, off-the-shelf and OptimalPSI.
[Access Publication →](https://doi.org/10.1016/j.xnsj.2026.100890)
## 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.
Want to discuss how this validation approach applies to your clinical practice or investment thesis?
[Get in touch](https://optimalpsi.com/contact?hsLang=en)
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.
[Learn About Our Team →](https://optimalpsi.com/team?hsLang=en)
## 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.
### Schedule a Meeting
Discuss how OptimalPSI's technology works.
[Schedule Meeting →](https://optimalpsi.com/contact?hsLang=en)
### Schedule an Investor Meeting
Review our regulatory pathway, technology, and market opportunity in detail.
[Schedule Investor Meeting →](https://optimalpsi.com/contact?hsLang=en)
Patient-specific, optimized spinal fusion implants. An official ETH Zürich spin-off.
Quick links
[Home](https://optimalpsi.com/?hsLang=en) [About](https://optimalpsi.com/about?hsLang=en) [Evidence](https://optimalpsi.com/evidence?hsLang=en)
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[Team](https://optimalpsi.com/team?hsLang=en) [Contact](https://optimalpsi.com/contact?hsLang=en) [News](https://optimalpsi.com/news?hsLang=en)
Legal
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\* In-Silico medical device testing: Smit et al. (2024). Frontiers in Bioengineering and Biotechnology, 12, 1347961.
\*\* Pre-clinical computational modeling: Smit et al. (2024). Journal of Mechanical Behavior of Biomedical Materials, 159, 106695.
\*\*\* Ex-vivo biomechanical testing: Du et al. (2026). NASSJ, 26, 100890.
¹ Parisien et al. (2022). Subsidence of Spinal Fusion Cages: A Systematic Review. Table 6. Occurrence of subsidence per TLIF method considering >2 mm migration of the cage in the endplate.
² Carlson et al. (2020). Prevalence of osteoporosis and osteopenia diagnosed using quantitative CT in 296 consecutive lumbar fusion patients.
³ Godolias et al. (2023). Cage subsidence — A multifactorial matter!
Published clinical literature references available upon request.
OptimalPSI's patient-specific optimized TLIF implants are investigational. They have not been cleared or approved by the U.S. Food and Drug Administration (FDA) and do not hold CE marking. They are not available for sale in any market. Statements regarding performance are based on pre-clinical data; clinical performance has not been established.
© 2026 OptimalPSI AG. All rights reserved. Website version 2026.01.
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