Rilemo has crossed the line that historically separates a laboratory project from a manufacturable medical device. The hardware architecture is frozen and industrialised, the manufacturing partner is engaged, the pre-clinical validation portfolio spans in-vitro phantoms, ex-vivo bovine bone, ex-vivo human cadaver, and in-silico digital-twin simulations on human heads, and the regulatory documentation set required to enter the certification pathway has been delivered.
The Seed round funds the company through the three remaining gates that separate Rilemo from market entry: the first-in-human clinical investigation, CE marking under MDR Class IIa, and the first commercial deployments to research and clinical accounts.
The last twelve months were the most operationally intense in the company’s history. Engineering risk, traditionally the dominant uncertainty for a hardware medical device at this stage, has been substantially closed. The most material achievements, several of which were not yet planned at the time of the SAFE round, are summarised below.
Industrialised hardware architecture frozen. The full Head Unit, Bedside Unit, and Calibration Phantom have been redesigned for manufacturability, with per-PCB specifications, BOM, and supplier audit completed.
CDMO partnership with Creanova initiated, which lead to the creation of a complete documentation package including User Needs, System Requirements, GSPR, Hazard Traceability Matrix, Usability and Mechanical Requirements, Software Architecture Review (IEC 62304 Class B), Design Records Review (ISO 13485), Hardware Architecture Review (IEC 60601-1), Preliminary Test Strategy, and Information Checklists.
First peer-reviewed validation against clinical CT ground truth completed in 2025 in collaboration with IRCCS Sant’Ambrogio Galeazzi Hospital (Milan), demonstrating µL-scale fluid detection in biological tissue with statistically significant correlation against directly measured volumes (Pearson r = 0.78, p = 0.037). The paper, co-authored with Prof. Luca Maria Sconfienza (Head of Diagnostic and Interventional Radiology at IRCCS Galeazzi-Sant’Ambrogio), is currently awaiting publication.
Anthropometric fit validated across 18,431 Monte Carlo head simulations spanning 5th to 95th percentile populations and four cephalic-index categories, confirming that the Head Unit accommodates the full target patient population without compromising contact quality or signal integrity.
In-silico validation on a 30-head digital-twin dataset completed. The campaign uses anatomically realistic head models from the IT’IS Foundation Population Head Models (PHM) repository, dielectric tissue properties drawn from the IT’IS Foundation database with literature-guided variability, and haemorrhagic and ischaemic lesion geometries derived from published clinical literature.
Ex-vivo human cadaver imaging campaign at the Trecchi Human Lab (Cremona, Italy, May 2025) completed with positive results across all samples, validating the device on real human tissues in a final clinical environment, with direct involvement of neurosurgeons and clinical staff.
300+ structured clinician interviews completed across Europe and the United States between 2023 and 2025, identifying point-of-care imaging for acute neurological conditions as the most validated commercial opportunity by a significant margin (see Market Overview).
The calendar below is aligned to the Go-to-Market and Financial Plan . Dates are stated explicitly with the assumptions they depend on, so that each milestone can be stress-tested independently.
Q2 2026 - Design freeze and engineering build at Creanova. The industrialised architecture moves from documentation to first physical articles built under the CDMO’s quality system. Pre-compliance bench testing begins in parallel.
Q2-Q3 2026 - Expanded ex-vivo human cadaver campaign. A second cadaver campaign extends the May 2025 dataset, increases the number of imaged samples, and produces the structured pre-clinical data package that supports the clinical investigation submission. This work also reduces the patient count required for the clinical investigation, compressing the overall certification calendar (see Clinical Validation).
Q3 2026 - Compliance test campaigns begin. EMC pre-scans and electrical safety pre-tests under IEC 60601-1 and IEC 60601-1-2 are run first because they are the highest-risk failure modes in the compliance pathway. Biocompatibility testing on patient-contacting materials runs in parallel.
Q4 2026 - First research-device deliveries to selected universities, IRCCS institutions, and independent research centres, in line with the Financial Plan.