Pre-Clinical Evidence: Engineered to Reduce Subsidence
Our optimization technology has been rigorously validated through computational modeling, biomechanical testing, and peer-review. Pre-clinical data demonstrates consistent subsidence risk reduction across a wide range of bone quality*,***.
Peer-Reviewed Scientific Validation
OptimalPSI's approach to subsidence reduction has been validated through peer-reviewed research published in leading biomechanical engineering journals. Two independent studies, one based on computational modeling and the other on physical biomechanical testing, provided converging evidence of substantial performance improvements over existing solutions.
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.
Clinical significance: Computational validation demonstrates that optimization addresses the fundamental mechanical problem causing subsidence, not just improving anatomical fit.
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 →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.
Clinical significance: Independent validation confirms that computational predictions translate to physical mechanical performance.
Mechanical testing results summarized. Failure (subsidence force) vs. implant type, off-the-shelf and OptimalPSI.
Access Publication →Subsidence Reduction Across Wide Range of Bone Quality Levels
Off-the-shelf implants show significantly worse outcomes in osteoporotic patients1,2. OptimalPSI's optimization aims to deliver meaningful subsidence reduction across the entire patient spectrum, with particularly strong performance in the high-risk population that needs it most.
The range reflects OptimalPSI's adaptive optimization, the algorithm adjusts implant design based on each patient's bone structure, maintaining substantial subsidence reduction.
Many surgeons hesitate to perform TLIF procedures on high-risk patients due to high subsidence rates with off-the-shelf implants. OptimalPSI's consistent performance, as demonstrated in pre-clinical testing, may expand treatment options for an underserved patient population with limited alternatives.
FDA-Recognized Validation Pathway
OptimalPSI follows established medical device validation protocols, progressing systematically from computational analysis through physical testing to ensure our technology delivers on its clinical promise.
Computational modeling optimizes implant design for patient-specific fit and mechanics.
Physical testing validates computational predictions and informs final design specifications.
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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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