Profusa, Inc.
Profusa, Inc. is a U.S.-based medical technology company focused on developing and commercializing implantable biosensor products for continuous biochemical monitoring. Its core platform includes the Lumee Oxygen and Lumee Glucose devices, and it also operates through a Singapore subsidiary created to support development and commercialization in Asia Pacific.
Fiscal year 2025 · change from previous year
Development 2021–2025
Business
Share of revenueCore sensor products designed to measure biochemical signals continuously in the body.
Lumee Glucose products intended for glucose sensing and diabetes-related monitoring.
Lumee Oxygen products intended for oxygen sensing and related clinical monitoring.
Customers
Profusa’s customers are primarily healthcare and life-science users that need continuous physiological monitoring, including clinical, research, and commercialization partners. The company’s products are designed for applications where implantable sensing can provide more persistent data than intermittent testing. Its Asia Pacific structure also suggests future collaboration with regional commercial partners for product development and market access.
Hospitals, clinicians, and care providers that would use continuous monitoring data for patient management.
Organizations collaborating on device validation, product development, and clinical evidence generation.
Third parties that help develop, manufacture, or distribute Lumee products in target markets.
Regional partners involved in the planned APAC joint venture for development and commercialization.
Strategy
Profusa’s strategy centers on advancing Lumee Oxygen and Lumee Glucose through regulatory, manufacturing, and commercialization milestones. The company is also building a regional partnership structure in Asia Pacific to support development and market entry, while preserving flexibility to raise additional capital as needed.
The devices cannot be commercialized at scale without required approvals and validation.
The company needs manufacturing, sales, and marketing infrastructure to convert development assets into revenue.
The Singapore subsidiary and planned joint venture are intended to extend market reach and localize execution.
Geography
Profusa is headquartered in the United States and operates through a U.S. parent structure with a wholly owned Singapore subsidiary for Asia Pacific activities. The Singapore entity was created to support development, manufacturing, and commercialization of Lumee products with a regional partner, indicating an intended footprint beyond the U.S. Geography matters because regulatory approvals, manufacturing coordination, and commercialization partnerships may differ by market.
Risks
Profusa faces the typical risks of a development-stage medical device company: regulatory uncertainty, product development risk, manufacturing scale-up risk, and dependence on external financing. The reports also highlight public-company compliance costs, going-concern sensitivity, and fair-value volatility from convertible instruments and warrants, which can materially affect reported results.
- Financing and going-concern dependenceImpact: CriticalLikelihood: High
The company may need additional equity or debt to fund R&D, manufacturing, and commercialization.
Exposure: Corporate funding and operating runway
- Regulatory approval delaysImpact: HighLikelihood: Low
The Lumee products require approvals before broad commercialization, and delays would push out revenue generation.
Exposure: Lumee Oxygen and Lumee Glucose
- Manufacturing and scale-up executionImpact: High
Medical device commercialization depends on reliable production, quality control, and supply chain readiness.
Exposure: Product ramp-up and partner manufacturing
- Valuation volatility from complex instrumentsImpact: MediumLikelihood: High
Convertible notes, warrant liabilities, and related-party loans are remeasured at fair value.
Exposure: Earnings and balance sheet volatility
Accounting
Judgemental itemsWarrants are recorded as liabilities and remeasured each period, creating earnings volatility unrelated to operations.
Impact: Non-cash gains or losses in other income/expense
The note uses a compound option and present value model with significant judgment and unobservable inputs.
Impact: Fair value changes can materially affect reported results
The loan is classified as a Level 3 instrument and remeasured using scenario-based assumptions.
Impact: Quarterly earnings sensitivity to valuation assumptions
Grant revenue was recognized in 2024 but not in 2025, showing that revenue can be irregular and non-operating in nature.
Impact: Comparability across periods is limited
The merger was accounted for as a reverse capitalization, affecting historical presentation and equity structure.
Impact: Period-to-period comparability and capital structure analysis
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Last updated: 24/09/2026