Clinical & Economic unmet need
Neurological emergencies represent one of the most urgent and demanding areas of acute medicine. Stroke alone affects 11.9 million people annually worldwide, with incidence increasing by 70% since 1990 and projected to rise further as populations age. The global economic cost of stroke exceeds $890 billion per year and is expected to nearly double by 2050. [1]
Despite the urgency, access to neuroimaging remains structurally constrained. Brain imaging is the essential prerequisite for clinical decision-making in stroke, head trauma, and intracranial bleeding, yet it remains confined to centralised radiology departments in virtually all healthcare systems. As a result, reperfusion therapy reaches fewer than 10% of stroke patients globally, with delayed or unavailable imaging identified as a primary contributor. [2]
The economic footprint of this bottleneck is measurable and material. The cost of managing a CT-indicated patient rises from around €230 when imaging is available on-site to €908 when an external transfer is required. [3] Inter-hospital transfers of critically ill neurological patients add an estimated $9,600 per ICU admission in additional costs. [4] ICU daily costs in European settings range from €1,225 to €1,911 per patient per day, [5] and delays in imaging-based decision-making directly extend length of stay and worsen clinical outcomes across tens of thousands of acute neurological admissions every year.
Beyond direct transfer costs, the need to reserve imaging capacity for acute neurological emergencies structurally reduces the availability of CT and MRI slots for scheduled use, a well-documented operational constraint that compounds inefficiencies across the broader hospital imaging pathway. [6]
Evidence from analogous technologies suggests that earlier bedside imaging-derived information can generate per-patient savings of several thousand EUR through avoided imaging costs, reduced transfers, and 0.4–1.5 day reductions in ICU and hospital length of stay. These savings materialise when bedside imaging reduces unnecessary transfers, avoids non-contributory CT/MRI scans, and supports faster escalation decisions. [7] [8]
Voice of the market
To validate its clinical and commercial assumptions, Rilemo conducted 317 structured interviews with physicians, radiologists, emergency medicine specialists, and clinical staff across Europe and the United States between 2023 and 2025, using a Customer Scientific Interview methodology designed to minimize interviewer bias. Interviews were conducted at major clinical events, including the European Congress of Radiology (ECR 2024 and ECR 2025) and through direct outreach to hospital departments across multiple geographies.
The results consistently identified point-of-care imaging for acute neurological conditions as the most validated clinical and commercial opportunity across all seven business models tested, by a significant margin.
Three signals emerged with particular clarity from the dataset:
- The absence of viable bedside imaging options is widely recognized as a structural gap. The overwhelming majority of respondents reported problems with current point-of-care diagnostic methods and identified the lack of out-of-hospital neurological assessment as a critical unmet need.
- The demand is active rather than latent. Most respondents are already paying for partial solutions that do not fully satisfy their needs, and are actively seeking alternatives.
- The clinical urgency is real. Respondents consistently highlighted the need to monitor patients between examinations and to identify hemorrhagic events at the bedside in trauma and post-surgical settings.
These findings are reinforced by feedback from Rilemo's clinical advisors.
Dr. Jody Filippo Capitanio, Neurosurgeon at IRCCS San Raffaele Hospital, has highlighted the need for portable imaging in intensive care and ward settings, where repeated patient transport to radiology represents both an operational burden and a patient safety risk.
Dr. Luca Sconfienza, Head of Diagnostic and Interventional Radiology at IRCCS Galeazzi–Sant'Ambrogio and Full Professor at the University of Milan, has noted that current imaging technologies present significant limitations in detecting fluids in small quantities and cannot be deployed in ambulatory or decentralized settings.
Market Sizing - TAM / SAM / SOM
The clinical evidence and direct market feedback presented above confirm a large, structurally underserved opportunity. The following analysis quantifies the scale of this opportunity across Rilemo's target care settings.
Rilemo's addressable market is structured around three care settings where portable neurological imaging creates direct clinical value: hospital departments (emergency, neurology, neurosurgery, and intensive care), ambulances and pre-hospital services, and residential care facilities. These settings align with Rilemo's regulatory pathway and go-to-market strategy, with hospitals representing the primary commercial entry point and the remaining segments addressed progressively over time.
Market sizing has been conducted using a bottom-up approach, estimating the number of installable devices per segment based on explicit operational assumptions and publicly available healthcare infrastructure data. The device density assumptions are consistent with the deployment logic validated through clinical interviews.
Sizing assumptions
- Hospital departments (Emergency, Neurology, Neurosurgery, Intensive Care): 1 device per relevant bed, applied to acute care and critical care bed counts from Eurostat and peer-reviewed literature,
- Ambulances: 1 device per ambulance unit,
- Residential care facilities: 1.5 devices per centre, reflecting multi-ward deployment.
Device pricing: €50k per device in Europe, €100k in the United States, consistent with the conservative base case, explained in the 
Business Model & Pricing section.
TAM - Total Addressable Market (Europe + United States)
Segment | Devices |
Hospitals | ~279,000 |
Ambulances | ~65,500 |
Residential care | ~243,000 |
Total | ~588,000 devices / ~€42B |
The TAM presented here covers Europe and the United States only. Beyond these core geographies, CE marking may facilitate access to additional international markets depending on local regulatory frameworks, while FDA clearance would support further expansion in regions aligned with US regulatory standards. These represent meaningful additional upside not captured in the current estimate.
SAM - Serviceable Addressable Market (Europe)
The SAM reflects the European market addressable under Rilemo's current 
Regulatory Pathway. As the CE marking under MDR Class IIa is expected to cover all three target settings, the SAM includes hospitals, ambulances, and residential care facilities across Europe. Commercial prioritisation across these segments follows a phased approach, the initial go-to-market focuses exclusively on the hospital channel as described in the 
Go-to-Market section.
Segment | Devices |
Hospitals | ~160,000 |
Ambulances | ~37,500 |
Residential care | ~139,000 |
Total | ~337,000 devices / ~€17B |
The TAM and SAM estimates are deliberately conservative and exclude home care, anticipated as a subsequent expansion phase, as well as markets outside Europe and US.
SOM - Serviceable Obtainable Market
The SOM reflects Rilemo's expected near-term market capture and is directly consistent with the company's 
Financial Plan.
Horizon | Devices | HW Revenue |
FY2028 (year 1 post-launch) | ~340 | ~€15.4M |
FY2030 (year 3 post-launch) | ~1,520 | ~€56.7M |
These figures correspond to a penetration of approximately 0.1% and 0.3% of the European SAM respectively. A conservative ramp-up reflecting the realities of hospital procurement cycles and Rilemo's go-to-market approach. Software recurring revenues are not included and represent additional upside as the installed base grows.
Note: TAM and SAM estimates represent the theoretical addressable market based on full device density assumptions. Near-term commercial focus and financial projections are fully reflected in the SOM figures, which are directly aligned with the company's financial plan.
References
- Martet Sizing data sources: EU hospital and acute care beds - Eurostat 2022; EU critical care beds - Rhodes et al., Intensive Care Medicine 2012; US hospitals - AHA 2023; EU/US ambulance fleet - Emergency Ambulance Market Report 2023.
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