What Profusa does

Profusa is a medical device company developing injectable, biologically compatible hydrogel microsensors (sub-millimeter diameter) that integrate with surrounding tissue to enable continuous, real-time biochemical monitoring from inside the body for 9+ months from a single hypodermic needle injection. The core hydrogel architecture is paired with a reusable Bluetooth-enabled optoelectronic reader patch, a smartphone application (iOS/Android), a cloud backend, and an NVIDIA-backed machine-learning layer that compensates for individual tissue variation to maintain accuracy over months without recalibration. The platform is supported by 85 global patents and more than $100M of cumulative investment, including $30M+ in non-dilutive grants from DARPA and NIH.

Profusa commercializes this platform through three product lines. Lumee Oxygen is an injectable tissue oxygen sensor delivering intra-operative and 28-day post-operative real-time oxygen monitoring for Critical Limb Ischemia intervention — a use case validated by a 2015 Journal of Vascular Surgery publication — with EU CE Mark conformity assessment under GMED targeted for Q3–early Q4 2026 and an FDA pivotal study targeted Q1 2026. Lumee Glucose is a continuous glucose monitor delivering 270+ days of monitoring from a single injection, with clinical-trial MARD of 10–12% and a projected ~$900/yr cost at >80% gross margin, targeting the full diabetes spectrum from T1D through prediabetes. The Data Discovery Platform converts continuous biochemical streams into clinical insights, with planned EMR integration and a physician portal. Profusa has also announced a ~$30M LOI to acquire BioInsights' PanOmics multi-omics diagnostics platform to extend into molecular diagnostics, initially targeting pancreatic cancer.

Commercially, Profusa is essentially pre-revenue with a planned FY2026 launch in Europe and the U.S. The company generates revenue today via per-procedure sales of CLI sensors at €600–€800 per case, €10,000 starter kits (3 kits/center/year), a service-based CRO research-use-only offering, and (planned) ~$900/yr subscription pricing for the future Lumee Glucose CGM. Distribution in Europe is anchored by AngioPro GmbH (Germany, Benelux, Austria, UK, Scandinavia), MedSell (France), and Dismeval (Spain), collectively covering roughly 35% of the EU population and ~200,000 annual Critical Limb Threatening Ischemia cases. Anchor clinical centers of excellence — Austria Medical Center, Paris Vascular Center, and Belgium Vascular Center — are pre-engaged. The company became public on Nasdaq via a July 2025 business combination with NorthView Acquisition Corp (ticker PFSA) and has since assembled a $22M PIPE, a $100M Equity Line of Credit with Ascent Partners, and additional convertible note facilities; it is also pursuing a strategic review with Tungsten Advisors amid a going-concern flag, Nasdaq listing transfer to the Capital Market tier, and shareholder-approved reverse stock split and debt conversion.

Name

Profusa

Legal name

Profusa, Inc.

Website

https://profusa.com/

Company type

Public

Founded year

2009

Operating status

Operating

Headcount range

51–100 employees

Short description

Profusa is a medical device company commercializing injectable hydrogel biosensors for continuous tissue oxygen monitoring in critical limb ischemia and a long-duration continuous glucose monitor, with a planned multi-omics diagnostics expansion.

Ownership category

akta.pro rank

Product category

Implantable Medical Biosensors

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Biosensors & Lab-on-Chip (BioMEMS) (HDAHALAK)

Keywords

• Implantable biosensors
• Continuous tissue monitoring
• Tissue oxygen monitoring
• Continuous glucose monitoring
• Medical device manufacturing

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D

Revenue model

1. Procedure Revenue (CLI Sensors): Per-procedure sale of 4 sensors + 4 injection pens per CLI case, priced at €600–€800 per procedure, recurring with case volume at vascular surgery centers.
2. Starter Kit Sales: One-time sale of starter kits (iPad + preloaded software + sensors + adhesives) priced at €10,000 per kit, with target of 3 kits per center per year covering 200–1,500 procedures depending on center volume.
3. Contract Research Organization (CRO) Research Services: Service-based revenue from Lumee tissue oxygen platform deployed as research-use-only (RUO) offering in the CRO market for pharmaceutical R&D, preclinical studies, toxicology, wound healing, and oncology research applications; commercially available and targeted at $47.9B (2025) global CRO market.
4. Future Data Monetization & AI-Driven Insights: Planned/optional stream where Profusa's growing clinical dataset of real-time biochemical measurements is monetized through partnerships, research collaborations, and the physician portal; positioned as a compounding data asset.

Pricing tiers

Go-to-market motion5 records

Distribution channels1 record

Marketing channels8 records

Core offering

Profusa develops and manufactures an injectable, biologically compatible hydrogel microsensor platform that integrates with surrounding tissue to provide continuous, real-time biochemical monitoring for 9+ months from a single injection. Its commercial products include the Lumee Oxygen Platform (intra-operative and 28-day post-operative tissue oxygen monitoring for Critical Limb Ischemia), the Lumee Glucose Platform (a 270+ day continuous glucose monitor), and the AI-driven Data Discovery Platform (an NVIDIA-backed cloud analytics layer with planned EMR and physician portal integration).

Product overview

Profusa operates as a single platform-plus-modules architecture: one injectable hydrogel biosensor platform (the Profusa Lumee platform) is the unifying technology, and three named products are built on it — Lumee Oxygen (continuous tissue oxygen monitoring for Critical Limb Ischemia and wound care, with EU CE Mark targeted April 2026 and U.S. launch 2027), Lumee Glucose (a 270+ day continuous glucose monitor targeting T1D through prediabetes), and the AI-driven Data Discovery Platform (an NVIDIA-backed cloud platform for clinical intelligence, planned EMR and physician portal integration, and multi-analyte sensing). On top of this core, Profusa has announced a strategic expansion through the planned acquisition of the PanOmics multi-omics diagnostics platform from BioInsights LLC (~$30M in equity securities), extending the company from biosensing into molecular diagnostics, with initial focus on pancreatic cancer applications. The platform is supported by more than $100M of investment (including $30M in DARPA and NIH non-dilutive funding) and 85 global patents granted or pending.

Differentiator

Problem solved

Functional benefit

Brands

• Lumee: Product line of injectable hydrogel biosensor platforms for continuous tissue oxygen (Lumee Oxygen) and glucose (Lumee Glucose) monitoring, with companion Lumee Patch optical reader and Lumee App for iOS/Android.
• Data Discovery Platform

Products and services

• Lumee Oxygen Platform Injectable hydrogel biosensor system providing continuous, real-time tissue oxygen monitoring at the point of care for Critical Limb Ischemia (CLI) patients; includes a subcutaneous hydrogel sensor, a reusable Bluetooth-enabled Lumee Patch optical reader, and the iOS/Android Lumee App, used by vascular surgeons and hospitals.
• Lumee Glucose Platform Long-duration continuous glucose monitor delivering 270+ days of monitoring from a single standard hypodermic needle injection of a hydrogel microsensor; targeted at T1D through prediabetes patients and projected at ~$900/year, intended for diabetes management and prediabetes coaching.
• Data Discovery Platform AI-driven clinical biochemistry intelligence platform built on NVIDIA infrastructure that converts continuous biochemical sensor data into personalized clinical insights; supports real-time decision support, remote patient monitoring, physician portal integration with EMR and clinical literature, and multi-analyte sensing (oxygen, glucose, lactate, CO2, sodium, ethanol).

Quantifiable outcome

• 270+ day sensor functional life vs 7–14 days for conventional CGM devices (Senseonics 365 days requires surgical implant)
• +6 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability7 records

Feature8 records

Partnerships

Twelve partnerships are on record, tiered flagship, core and minor.

• BioInsights LLC (PanOmics platform)flagshipStrategic or Co-development Partner · 6 April 2026Acquisition target of the PanOmics multi-omics diagnostics platform via $30M equity consideration (non-binding Letter of Intent signed March 31, 2026; amended April 3, 2026; asset purchase agreement signed). Includes access to clinical samples, assay design infrastructure, and royalty agreement; targets pancreatic cancer and other multi-indication diagnostic assays. Shareholder approval received June 23, 2026.
• Mayo ClinicflagshipStrategic or Co-development Partner · 13 February 2026Know-how agreement to collaboratively investigate high-impact clinical applications of Profusa's Lumee continuous tissue oxygen monitoring technology, including cardiovascular, renal, multi-organ, and orthopedic indications. Aims to support U.S. commercialization of Lumee for chronic limb threatening ischemia, building on more than a decade of development and $100M+ in investment. Mayo Clinic holds a financial interest in the referenced technology.
• MedSellcoreChannel Partner/ Reseller/ Distributor · 31 December 2025French medical device commercialization specialist distributing Lumee Oxygen tissue monitoring technology in French hospital settings and wound care clinics. Complements the existing collaboration with Groupe Hospitalier Paris Saint Joseph (Dr. Yann Goeffic, ~8% of France's CLI procedures). Targets the ~60,000 CLI procedures/year performed in France.
• AngioPro GmbHflagshipChannel Partner/ Reseller/ Distributor · 15 October 2025European distributor for the Lumee Oxygen platform covering Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia — approximately 35% of the EU population. Signed letter of intent in late 2025 to establish European logistics and commercialization infrastructure ahead of Q2 2026 EU launch.
• NVIDIAcoreTechnology or IntegrationAI technology backbone partner for Profusa's Data Discovery Platform. NVIDIA infrastructure powers the machine learning layer that processes continuous biochemical sensor data, real-time multi-variable analysis, and population-level clinical insights. Selected for best-in-class AI processing capability.
• Dismeval, S.L.coreChannel Partner/ Reseller/ DistributorSpanish distributor covering Spanish CLI procedure volume as part of the EU launch. Listed alongside AngioPro GmbH as a confirmed distribution partner in the company's Lumee Oxygen market opportunity disclosures.
• Tungsten AdvisorscoreImplementation/ SI/ Consulting PartnerEngaged as exclusive financial advisor to Profusa's Board of Directors for the strategic review process initiated in May 2026 to evaluate alternatives including asset transactions, partnerships, and business combinations to maximize shareholder value.
• CORE IRcoreImplementation/ SI/ Consulting PartnerInvestor relations and public relations firm managing Profusa's investor inquiries, media inquiries, and SEC filings communications via [email protected].
• GMED SAS (Notified Body NB 0459)flagshipOthersEuropean Notified Body conducting the EU MDR (Regulation EU 2017 745) conformity assessment for the Lumee Oxygen Platform. Technical file submission completed November 2025; compliance testing in December 2025; review ongoing with response package submitted June 2026; review expected to complete in Q3 or early Q4 2026.
• Austria Medical Center (Dr. Marianne Brodmann)coreStrategic or Co-development PartnerEuropean clinical center of excellence performing ~1,500 procedures/year; engaged for the Lumee Oxygen EU launch and the 28-day post-op monitoring clinical workflow.
• Groupe Hospitalier Paris Saint Joseph (Dr. Yann Goeffic)coreStrategic or Co-development PartnerParis Vascular Center collaboration; practices account for approximately 8% of all CLTI cases in France. Cited as the foundation of Profusa's existing French clinical footprint ahead of the MedSell distribution partnership.
• Belgium Vascular Center (Dr. Koen R. Deloose)minorStrategic or Co-development PartnerEngaged European clinical center of excellence for the Lumee Oxygen EU launch.

Scale indicators20 records

Recent moves8 records

Expansion highlights9 records

Direct peers

• Senseonics Holdings: Senseonics manufactures the Eversense implantable CGM, the only commercially approved long-duration implantable continuous glucose monitor. Profusa's Lumee Glucose competes head-to-head with Eversense on the same core proposition (a long-duration injectable/implantable CGM) but with a 270+ day sensor vs Eversense's 180–365 day sensor and a non-surgical hypodermic deployment.
• Masimo: Masimo is the leader in pulse oximetry and tissue oxygen monitoring technology (SET technology). Profusa's Lumee Oxygen competes in the same clinical oxygen-monitoring category but offers continuous, injectable, long-duration tissue oxygen data vs Masimo's external pulse oximetry and rainbow sensors, positioning Profusa as a direct competitor in the $10.5B oxygen monitoring TAM.

Broad incumbents

• Dexcom: Dexcom is the U.S. CGM market leader with multi-billion-dollar revenue and deep payor coverage. Profusa's Lumee Glucose is positioned as a long-duration, lower-cost alternative to Dexcom's 10-day G7 sensor for the broader T2D and prediabetes segments that Dexcom's pricing currently excludes.
• Abbott (Diabetes Care / FreeStyle Libre): Abbott's FreeStyle Libre franchise is the largest installed-base CGM globally. Profusa targets the same diabetes patient population with a fundamentally different value proposition (270+ day single-injection sensor at ~$900/yr vs 14-day wearable Libre sensors), making Abbott a direct competitor in the addressable T2D and prediabetes expansion market.
• Medtronic (Diabetes): Medtronic offers the Guardian CGM system alongside its insulin pump portfolio and is an integrated diabetes incumbent. While Medtronic's CGM sensor life is short relative to Profusa's, its end-to-end insulin-delivery ecosystem makes it a competitor for any future closed-loop CGM partnership Profusa might pursue.
• Edwards Lifesciences: Edwards Lifesciences is a global leader in vascular and critical-care monitoring and surgical devices. Profusa's Lumee Oxygen targets the same vascular surgery and CLI customer base that Edwards serves with hemodynamic monitoring, making Edwards a broad incumbent against which Profusa's intra-operative and 28-day post-op monitoring value proposition is evaluated.

Emerging players

• iRhythm Technologies: iRhythm's Zio long-duration wearable cardiac biosensor shares Profusa's underlying thesis that continuous, multi-day biochemical/physiological monitoring from inside the body creates superior clinical insight versus spot measurements. Both companies pursue KOL-led adoption in specialty clinical workflows.
• Biolinq: Biolinq is developing an intradermal microsensor patch for continuous metabolic monitoring. It overlaps with Profusa's multi-analyte biosensor vision and small-form-factor continuous monitoring approach but uses a different (surface-mounted intradermal) delivery modality.
• Nemaura Medical: Nemaura is developing a non-invasive CGM (sugarBEAT) and has commercialized a wearable metabolic monitor. It is comparable to Profusa as an emerging player pursuing continuous glucose monitoring outside the incumbent Dexcom/Abbott/Medtronic ecosystem, though with a non-invasive rather than injectable architecture.
• GlucoTrack: GlucoTrack is developing a non-invasive continuous glucose monitor. It competes for the same T2D and prediabetes patient segments that Profusa targets with Lumee Glucose, representing an alternative technology path (non-invasive) to Profusa's long-duration injectable sensor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/profusainc
• YouTubeyoutube.com/+PROFUSAIncSouthSanFrancisco
• LinkedInlinkedin.com/company/profusa

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds10 records

Investors9 records

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M&A2 records

Investments

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Frequently asked questions about Profusa