Clinical Validation

Validation strategy

As any other medical diagnostic device, Rilemo's apparatus must be validated through a sequence of pre-clinical investigations that culminates in a first-in-human clinical study. Rilemo's pre-clinical validation portfolio is built around four complementary strands, each addressing a specific aspect of the device's readiness for the clinical phase.

Test	Year	What it validates
In-silico validation on a 30-head digital twin	Q1 2026	The full imaging pipeline, on the target organ (the head), on the target pathologies (haemorrhagic and ischaemic events)
Anthropometric applicability (separate engineering strand)	Q1 2026	The mechanical fit of the Head Unit across the full target population, validated across 18,431 Monte Carlo simulated heads
Ex-vivo human cadaver imaging	May 2025	The device on real human tissues, in a final clinical environment, with operative-threshold haemorrhagic targets
Quantitative ex-vivo bovine bone imaging with CT ground truth	March 2025	µL-scale fluid detection against CT, statistically significant on a sample large enough for analysis
Ex-vivo bovine bone imaging	October 2024	Fluid detection and quantification on biological samples closely resembling human tissues, against MRI ground truth
In-vitro phantom imaging	May 2024	The feasibility of portable fluid imaging and the usability of the user interface, against X-ray ground truth

On in-vivo animal trials

Studies on live animals are not required for Rilemo's medical CE certification and are not planned. This was verified with four independent CROs and Notified Bodies, and is consistent with the regulatory pathway for the device class. The validation strategy proceeds directly from the strands described above to the first-in-human clinical investigation funded by this Seed round.

In-silico validation on a 30-head digital twin (Q1 2026)

This is the latest validation in Rilemo's portfolio addressing the target organ (the head) and the target pathology (intracranial haemorrhagic events).

Methodology in brief

The device's electromagnetic acquisition chain is simulated end-to-end in software (the "digital twin").
Simulated acquisitions are reconstructed by the same AI pipeline that runs on the production device, producing the three-modality output described in Technology Overview.
The dataset is built from 30 anatomically realistic head models from the IT’IS Foundation Population Head Models (PHM) repository, with tissue dielectric properties from the IT'IS Foundation database, the de facto standard for electromagnetic medical-device simulation.
Haemorrhagic and ischaemic lesion volumes and geometries are derived from published clinical literature so that the simulated cases are coherent with realistic scenarios.

The healthy reference case is presented in the Technology Overview section. This section focuses on diagnostic discrimination between healthy and pathological cases.

Case 1: Central haemorrhagic event

Central haemorrhagic event, three-modality output (Tomography / Radar / Dielectric Permittivity). The haemorrhage is clearly visible across all three modalities

In the Tomography panel, the central haemorrhagic event introduces a localised intensity change in the affected region of the brain parenchyma, distinct from the homogeneous distribution observed in the healthy reference.