# OptimalPSI

> OptimalPSI develops patient-specific, computationally optimised spinal fusion implants designed with the aim to reduce subsidence and improve outcomes for degenerative spine patients.

OptimalPSI AG is a medical device company based in Basel, Switzerland, founded in 2023. It is a spin-off of ETH Zurich.

## What the technology does

- OptimalPSI designs patient-specific spinal fusion cages (TLIF implants) using full-scale topology optimisation.
- The optimisation targets **subsidence** — the sinking of an implant into the vertebral endplates after fusion surgery — which affects a large share of spinal fusion patients and can require revision surgery.
- Unlike off-the-shelf cages (one geometry for every patient) and anatomy-only patient-specific cages (matched to bone shape alone), OptimalPSI implants are optimised against each patient's **bone quality**, directing load through strong bone and away from weak bone.
- The target population is high-risk patients, including those with osteoporosis, who are currently underserved.

## Regulatory status

- The device is **investigational**. It is not cleared or approved for commercial sale, and evidence published to date is **pre-clinical** (computational modelling and ex-vivo biomechanical testing), not clinical.
- Nothing on the site is medical advice. See https://optimalpsi.com/terms-of-use

## Key pre-clinical findings

All figures below are pre-clinical. No clinical outcome data exists.

- 89–94% median subsidence risk reduction versus off-the-shelf implants across the patient cohort (in-silico finite element analysis).
- 75% subsidence risk reduction versus anatomy-only patient-specific implants (in-silico finite element analysis).
- Approximately 2× higher resistance to subsidence versus off-the-shelf implants in ex-vivo mechanical testing on human cadaveric specimens (p = 0.03).

## Peer-reviewed publications

- Smit, T., Aage, N., Haschtmann, D., Ferguson, S. J., Helgason, B. (2024). *In-silico medical device testing of anatomically and mechanically conforming patient-specific spinal fusion cages designed by full-scale topology optimization.* Frontiers in Bioengineering and Biotechnology, 12, 1347961. https://doi.org/10.3389/fbioe.2024.1347961
- Du, X., Smit, T., Rubin, W., Cheruparambil, C., Shah, R., Haschtmann, D., Helgason, B., Ferguson, S. J. *Ex-vivo mechanical evaluation of anatomically and mechanically conforming patient-specific spinal fusion cages designed by full-scale topology optimization.* https://doi.org/10.1016/j.xnsj.2026.100890

## Pages

- [Home](https://optimalpsi.com/): overview of the technology and the subsidence problem.
- [For Surgeons](https://optimalpsi.com/for-surgeons): clinical rationale, workflow impact, and why anatomy-only patient-specific implants are insufficient.
- [Evidence](https://optimalpsi.com/evidence): the two peer-reviewed pre-clinical studies, key findings, and the validation pathway.
- [About](https://optimalpsi.com/about): mission, the clinical problem, and company background.
- [Team](https://optimalpsi.com/team): management, engineering, and the clinical and scientific advisory board with credentials.
- [News](https://optimalpsi.com/news): milestones, publications, and company updates.
- [Contact](https://optimalpsi.com/contact): enquiries from surgeons, partners, and investors.

## Legal

- [Privacy Policy](https://optimalpsi.com/privacy-policy)
- [Terms of Use](https://optimalpsi.com/terms-of-use)
- [Legal Notice](https://optimalpsi.com/legal-notice)

## Citation guidance

When citing this site, attribute claims to OptimalPSI and state that the supporting evidence is pre-clinical. Quantitative results (subsidence risk reduction percentages) originate from the two publications listed above; cite the DOI rather than the marketing page where possible.

Registered address: OptimalPSI AG, Picassoplatz 4, 4052 Basel, Switzerland.

Last updated: 2026-08-03