Round Overview

Rilemo is raising a €3M seed round structured as a priced equity round, designed to take the company from clinical validation to CE marking and initial market entry in Europe.

The round is currently open. Several business angels from Rilemo's existing investor base have expressed commitment to participate, alongside new investors who have engaged following the company's recent progress.

The technological risk is already substantially mitigated. Rilemo has completed pre-clinical validation on human cadavers at the Trecchi Lab Institute, industrialised its functional components in collaboration with CDMO partner Creanova, and published initial results. The regulatory and clinical pathway is fully defined, with advisors of both areas already engaged. What remains is the regulatory and commercial execution. That is precisely what this round is designed to finance.

1. Clinical Study: initiation of clinical activities in autumn 2026, generating the clinical evidence required to support CE marking submission. Full details are provided in the

Regulatory Pathway and

Clinical Validation sections.

2. CE Marking: submission to the Notified Body and achievement of CE marking under MDR Class IIa, expected in H2 2027, enabling commercialisation across the European Economic Area.

3. Market Entry: commercial launch in H2 2027, targeting private hospital centres across core European markets, as detailed in the

Go-to-Market section.

4. First Commercial Metrics: by the end of the round horizon, Rilemo expects to have generated its first documented commercial traction, including initial device installations, first recurring software contracts, and an active commercial pipeline. These metrics are designed to support the company's next fundraising round from a position of validated market adoption, as detailed in the

Financial Plan and

Go-to-Market sections.

Approximately 75% of the round is allocated directly to the three milestones that unlock market entry: product completion, clinical validation, and CE marking. The remaining 25% supports the commercial and operational infrastructure required to execute.

While the precise allocation may evolve as the roadmap advances, the €3M seed round is expected to be deployed across six areas:

The previous round funded the prototype development and initial industrialization. This allocation completes the transition to a certifiable product configuration, including regulatory-grade engineering, product-level verification and validation activities, and manufacturing readiness documentation required for CE marking.

Execution of Rilemo's clinical validation programme, initiating in autumn 2026. This covers study execution, CRO-supported activities, clinical units, data infrastructure, and the medical-scientific work required to generate the evidence needed for CE marking submission and future commercial credibility. Further details are provided in the

Clinical Validation and

Regulatory Pathway sections.

Regulatory submission verification, validation, and documentation activities required to obtain CE marking under MDR Class IIa, including external testing, technical documentation, quality management system maintenance, and Notified Body submission costs.

Building the commercial foundation ahead of market entry in H2 2027: hiring the first sales representative in Q4 2026, qualifying target reference accounts across core European markets, and establishing the distributor relationships that will support broader reach from FY2028. Further details are provided in the

Go-to-Market section.

Core management, finance, legal, administrative support, insurance, and facilities required to sustain operations during an intensive phase of development.

Maintenance and strengthening of Rilemo's IP position, including existing patent rights, new filings where relevant, and trademark protection.