Hyperfine, Inc.
Hyperfine, Inc. designs and commercializes the Swoop® portable MRI system, a low-field brain imaging platform used in hospitals and other care settings. The company combines hardware, software, and AI/cloud-enabled features to expand access to brain imaging beyond traditional MRI suites and into more decentralized clinical workflows.
Tilikausi 2025 · muutos edellisvuodesta
Kehitys 2020–2025
Liiketoiminta
Osuus liikevaihdostaSales of the Swoop® system and related hardware to healthcare providers.
Support, maintenance, and related services for installed systems.
Tuotteet
Raportoitu · osuus liikevaihdosta- Products84,0 %
- Services16,0 %
Lähde: 10-K FY2025, yhtiön tuotelinjoittain raportoima liikevaihto (SEC XBRL). Osuudet on laskettu näytetyistä riveistä ja ne summautuvat 100 %:iin.
Asiakkaat
Hyperfine sells primarily to hospitals and hospital systems that want brain imaging at the point of care, especially in critical care and emergency settings. It is also expanding into hospital-based neurology clinics and outpatient neurology offices, where portability and lower infrastructure requirements can broaden MRI access. International customers include healthcare providers in Canada, Europe, Australia, and New Zealand as the company expands regulatory approvals and commercialization.
Buy Swoop® systems for inpatient and critical-care brain imaging and to improve access without a traditional MRI suite.
Use the portable system for rapid neuro assessment and triage when speed and bedside access matter.
Buy the system to support routine neurological imaging in a more flexible outpatient-like setting.
Adopt the platform for outside-the-hospital imaging use cases as commercialization broadens.
Purchase the system in markets where regulatory approvals now allow commercialization and MRI penetration is lower.
Strategia
Hyperfine is focused on expanding adoption of the Swoop® system through direct U.S. sales coverage, broader clinical use cases, and international market entry. The company is also investing in AI and cloud capabilities to make the platform more valuable as a brain imaging and clinical decision support tool, which could strengthen differentiation and support future profitability.
Expands the addressable market beyond initial critical-care customers and increases system utilization.
Regulatory approvals in Canada, Europe, Australia, and New Zealand create new growth channels.
Software enhancements can improve product differentiation and support a higher-value clinical workflow offering.
Maantiede
Q1/2026Revenue is generated in the United States and in selected international markets. The company has begun commercialization in Canada, parts of Europe, Australia, and New Zealand, and recent CE/UKCA approvals support broader European expansion. Geography matters because market access depends on local regulatory clearances, and international expansion is tied to regions with unmet MRI demand and lower installed imaging capacity.
Riskit
Hyperfine remains exposed to commercialization risk because adoption depends on convincing hospitals to change imaging workflows and purchase a new category of device. The company also faces financing and listing risk, as it has disclosed Nasdaq bid-price noncompliance and ongoing dependence on capital access to fund development and expansion. As a medical device company, it also faces regulatory, reimbursement, product performance, and international execution risks.
- Nasdaq delisting riskVaikutus: KorkeaTodennäköisyys: Korkea
The company received notice that its Class A common stock fell below the minimum bid price requirement.
Kohdistuu: Could reduce liquidity and impair access to capital or strategic transactions.
- Financing and liquidity riskVaikutus: KorkeaTodennäköisyys: Korkea
The company states that access to capital is not assured and may be needed to fund operations and expansion.
Kohdistuu: Could force delays or reductions in product development and commercialization.
- Commercial adoption riskVaikutus: Korkea
Revenue depends on hospitals and clinics adopting a new portable MRI workflow and sustaining utilization.
Kohdistuu: Slower-than-expected system placements or usage would pressure revenue growth.
- Regulatory and market-access riskVaikutus: KeskitasoTodennäköisyys: Matala
Commercialization in each geography depends on device clearances and local approvals.
Kohdistuu: Delays or restrictions could slow international revenue expansion.
Kirjanpito
Harkinnanvaraiset erätDevice sales and service revenue may be recognized at different times, affecting quarter-to-quarter comparability.
Vaikutus: Can create volatility in reported revenue and gross margin mix.
Management notes dependence on capital access and future sales to fund operations.
Vaikutus: Affects disclosure, investor perception, and financing assumptions.
Recent registered direct offerings included shares and warrants, which can affect dilution and equity classification.
Vaikutus: Impacts share count, capital structure, and potentially fair value measurements.
Management relies on assumptions for expenses, commercialization plans, and future benefits from AI/software investments.
Vaikutus: Can materially affect reported operating results and asset valuations.
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Päivitetty: 24.9.2026