Profusa, Inc 8-K, filed Oct 30, 2025
Profusa, Inc. (PFSA)
About this 8-K
Profusa, Inc filed this 8-K on October 30, 2025.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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Item 7.01 Regulation FD Disclosure
Press Release
On October 30, 2025, Profusa, Inc. (the “Company”) issued a press release outlining its path to revenue generation. A copy of the press release is attached hereto as Exhibit 99.1.
Investor Presentation
On October 30, 2025, the Company published an updated investor presentation to its website (the “Investor Presentation”). The Company may use the Investor Presentation, possibly with modifications, in presentations from time to time thereafter to current and potential investors, analysts, lenders, business partners, customers, employees and others with an interest in the Company and its business.
The Investor Presentation contains forward-looking statements. See page two of the Investor Presentation for a discussion of certain forward-looking statements that are included therein and the risks and uncertainties related thereto.
A copy of the Investor Presentation is attached hereto as Exhibit 99.2.
The information provided in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section. Such information shall not be deemed incorporated by reference into any filing of the Company under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as otherwise expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press Release, dated October 30, 2025 | |
| 99.2 | Investor Presentation, dated October 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: October 30, 2025 | Profusa, Inc. | |
| By: | /s/ Ben Hwang | |
| Name: | Ben Hwang | |
| Title: | Chief Executive Officer | |
2
Exhibit 99.1
Profusa Outlines Potential Path to $250 Million
Revenue by 2030, Driven by
Sequential Lumee™ Oxygen and Glucose
Monitoring Launches
EU commercialization expected in early 2026; U.S. entry and expanded indications to follow as digital-health pioneer advances tissue-integrated biosensor platform
BERKELEY, Calif, October 30, 2025 (GLOBE NEWSWIRE) — Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering a next-generation technology platform enabling the continuous monitoring of an individual’s biochemistry, outlines its path to revenue generation led by Lumee tissue oxygen monitoring, with commercialization in the European Union (EU) expected in the beginning of 2Q 2026.
Following recently-announced manufacturing capabilities, intended distributor partnerships, and commercial and clinical collaboration wins, Profusa estimates it now has approximately 35% of the European population covered through its intended distribution channels. Combined with expanding coverage in Europe and planned geographic reach into the United States markets, as well as potential additional indications on its Lumee technology platform – such as continuous glucose monitoring – Profusa anticipates $200 to $250 million in potential revenue by 2030.
“We believe Profusa is bringing to market a first-of-its-kind, disruptive biochemistry monitoring platform designed for use both in the clinic and at home,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO. “Backed by more than a decade of development and over $100 million in investment, our Lumee™ technology enables continuous, real-time measurement of tissue oxygen directly within the body—offering a less invasive, more convenient experience for patients while reducing costs for healthcare systems and insurers through earlier detection and improved disease management.
“Following years of innovation and clinical validation, we are preparing for the commercial launch of Lumee tissue oxygen monitoring in Europe in 2Q 2026, supported by strong momentum from clinicians, patients, and research institutions eager to harness our technology to address conditions with a significant unmet medical need,” Dr. Hwang continued.
“As we begin our commercial journey, Profusa is targeting $200 to $250 million in revenue by 2030, supported by multiple high-growth indications. In tissue oxygen monitoring alone, we estimate a $10.5 billion global addressable market across peripheral artery disease, chronic wounds, and critical limb ischemia—representing more than 716,000 CLI procedures annually in Europe. In addition, current solutions for continuous glucose monitoring serve roughly 9 million type 1 diabetes patients, whereas Lumee’s glucose platform is designed to reach a much broader population of over 500 million people living with type 1, type 2, or pre-diabetes worldwide,” concluded Dr. Hwang.
Fred Knechtel, Profusa’s CFO, said, “We expect to layer on additional indications on our Lumee platform technology over time. Tissue oxygen monitoring revenue in Europe is expected to commence in the second quarter of 2026. With our current pipeline of commercial and clinical collaborations and intended distribution network, we are projecting potential revenue of $0.5 to $2 million in in 2026.
“In 2027, we plan to enter the US tissue oxygen monitoring market in the first quarter and add continuous glucose monitoring in the EU in mid-2027. Projected potential revenue in 2027 is $9 to $13 million. In parallel, additional conditions for evaluation – through expected partnerships or licensing agreements – include lactate, carbon dioxide, sodium, and ethanol, which we expect will all contribute to 2030’s projected potential revenue. We look forward to executing on this aggressive and dynamic growth agenda,” Mr. Knechtel concluded.
| ● | 2026 potential revenue is targeted to be $0.5 to $2 million |
| ○ | EU Lumee oxygen revenue commences in 2Q 2026 |
| ○ | Revenue projected to be €600 – €800 per procedure |
| ○ | Equipment revenue projected to be €30-000 – €40,000 per center per year (3-4 kits per center) |
| ○ | EU CE marking GMED certification anticipated late 1Q 2026 |
| ● | 2027 potential revenue is targeted to be $9 to $13 million |
| ○ | US Lumee Oxygen anticipated launch in 1Q 2027 |
| ○ | EU Lumee Glucose anticipated launch in mid-2027 |
| ● | 2030 potential revenue is targeted to be $200 to $250 million |
| ○ | US/EU Lumee Oxygen targeted revenue to be $100 to $120 million |
| ○ | US/EU Lumee additional indications including glucose targeted revenue to be $100 to $130 million |
About Profusa
Based in Berkeley, Calif., Profusa is a commercial stage digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors in the development of a new generation of tissue-integrated sensors to detect and continuously transmit actionable, medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely on.
“LUMEE”, “PROFUSA” and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.
For more information, visit https://profusa.com.
Special Note Regarding Forward-Looking Statements
Certain statements in this press release (this “Press Release”) may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described in the definitive proxy/final prospectus relating to the business combination, which has been filed with the SEC, and in other documents filed by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate.
Contacts
Investor and Media Contacts
email: info@coreir.com
phone: 1 (212) 655-0924
Exhibit 99.2
NASDAQ: PFSA October 2025 INVESTOR PRESENTATION ”Pioneering real time biochemistry that drives AI - led, personalized healthcare technologies”
NASDAQ: PFSA DISCLAIMER AND SAFE HARBOR STATEMENT 2 Disclaimer This presentation (“Presentation”) is being issued by Profusa, Inc. (the “Company” or “Profusa”) for information purposes only. The content of this Presentation has not been approved by any securities regulatory authority. Reliance on this Presentation for the purpose of engaging in any investment activity may expose an individual to a significant risk of losing all of the property or other assets invested. This Presentation is not an admission document, prospectus or an advertisement and is being provided for information purposes only and does not constitute or form part of, and should not be construed as, an offer or invitation to sell or any solicitation of any offer to purchase or subscribe for any securities of the Company in the United States or any other jurisdiction. Neither this Presentation, nor any part of it nor anything contained or referred to in it, nor the fact of its distribution, should form the basis of or be relied on in connection with or act as an inducement in relation to a decision to purchase or subscribe for or enter into any contract or make any other commitment whatsoever in relation to any securities of the Company. No representation or warranty, express or implied, is given by or on behalf of the Company, its directors, officers and advisors or any other person as to the accuracy, sufficiency or completeness of the information or opinions contained in this Presentation and no liability whatsoever is accepted by the Company, its directors, officers or advisors or any other person for any loss howsoever arising, directly or indirectly, from any use of such information or opinions or otherwise arising in connection therewith. Forward - Looking Statements Certain statements contained in this Presentation constitute “forward - looking information” or “forward - looking statements” (collectively, “forward - looking statements”) within the meaning of applicable Canadian and United States securities laws relating to, without limitation, expectations, intentions, plans and beliefs, including information as to the future events, results of operations and the Company’s future performance (both operational and financial) and business prospects. In certain cases, forward - looking statements can be identified by the use of words such as “expects”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes”, “plans”, “seeks”, “projects” or variations of such words and phrases, or state that certain actions, events or results “may” or “will” be taken, occur or be achieved. Such forward - looking statements reflect the Company’s beliefs, estimates and opinions regarding its future growth, results of operations, results of litigation, future performance (both operational and financial), and business prospects and opportunities at the time such statements are made, and the Company undertakes no obligation to update forward - looking statements if these beliefs, estimates and opinions or circumstances should change. Forward - looking statements are necessarily based upon a number of estimates and assumptions made by the Company that are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Forward - looking statements are not guarantees of future performance. In particular, this Presentation contains forward - looking statements pertaining, but not limited, to: total addressable market for the Company’s products; future sales; timelines for clinical development, manufacturing and supply; market opportunities; expectations respecting future competitive conditions; and the Company’s objectives, strategies and competitive strengths. By their nature, forward - looking statements involve numerous current assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from those anticipated by the Company and described in the forward - looking statements. Factors, risks and uncertainties that could cause results to differ materially from those anticipated and described herein are more fully described in the Registration Statement on Form S - 4 (File No. 333 - 269417) and the Company’s other filings with the SEC. You should not place undue reliance on these forward - looking statements, which are made only as of the date hereof or as of the dates indicated in the forward - looking statements. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in its forward - looking statements there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that forward - looking statements will materialize or prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The forward - looking statements contained in this Presentation are expressly qualified by this cautionary statement. Except as may be required by law, the Company expressly disclaims any intention or obligation to revise or update any forward - looking statements or information whether as a result of new information, future events or otherwise. Trademarks This presentation includes trademarks of Profusa, which are protected under applicable intellectual property laws and are the property of Profusa or its subsidiaries. This presentation also includes other trademarks, trade names and service marks that are the property of their respective owners. Solely for convenience, in some cases, the trademarks, trade names and service marks referred to in this proxy statement/prospectus are listed without the applicable ®, м and SM symbols, but they will assert, to the fullest extent under applicable law, their rights to these trademarks, trade names and service marks.
3 KEY INVESTMENT HIGHLIGHTS • Platform technology yields multiple commercial revenue opportunities in the US and Europe • >$10.5B+ global TAM in tissue and pulse oximetry oxygen monitoring by 2030 (1) • 500M+ people globally with diabetes in 2024, growing 45% by 2050 (2) • Commercial stage Oxygen Platform with large addressable markets • Projected revenue $0.5 - 2 million in 2026, growing to $200 – 250M by 2030 • Lumee tissue oxygen monitoring product launch: expected 1Q2026E (Europe) and 1H2027E (US) • Sales from research only use: expected 1Q2026 • Pipeline opportunities • Lumee continuous glucose monitoring (CGM) clinical data • Robust data discovery platform • Capital Investment - $150M+ • $22M PIPE - $12M drawn • $100M Equity Line of Credit - $5M drawn • Bitcoin treasury strategy • Strong Family Office and Venture Capital support • National Institutes of Health (NIH). Defense Advanced Research Projects Agency (DARPA) • 67 global patents issued and 18 pending (1) https:// www.grandviewresearch.com/industry - analyis/pulse - oximeter - market; https://growthmarketreports.com/report/wearable - tissue - oxygenation - sensors - market; https:// www.reanin.com/reports/global - medical - oxygen - sensors - market NASDAQ: PF S A ( 2 ) https://diabetesatlas.org/resources/idf - diabetes - atlas - 2025/
NASDAQ: PFSA PROFUSA PLATFORM TECHNOLOGY 4 Profusa Cloud Low maintenance, cost effective, AI adaptive personal health management platform Low - cost novel subcontainous biologically compatible hydrogel micro - sensor 9+ months functionality INJECTABLE HYDROGEL MICRO - SENSOR REUSABLE OPTICAL READER AND DATA MANAGEMENT Continuous monitoring and data management of body chemistry PERSONALIZED CLINICAL INSIGHTS Low - cost optoelectronic reader, reusable consuming only an on - body adhesive AI and Machine Learning enables personalized clinical insights
NASDAQ: PFSA 5 ARTIFICAL INTELLIGENCE (AI) DRIVEN DIGITAL HEALTHCARE LUMEE PRODUCT PORTFOLIO • Machine learning to create algorithms for enhanced monitoring • Accounting for variations of the tissue composition for continuous accuracy while still using the single injectable sensor • Multiple calculations around other physical variables and fluctuations with regard to creating accurate oxygen and glucose measurements • Providing real - time comparison across data sets DATA DISCOVERY PLATFORM • Building using best - in - class Nvidia technology backbone • Potential of large volume of real - time data for clinical insight • Profusa’s critical body of data enable future AI - driven healthcare • Planned physician portal to link real - time biochemistry with EMR and published clinical literature • Machine discernment between privacy - protected data and useable data across any given network
NASDAQ: PFSA OPERATIONAL FOCUS TO DRIVE REVENUE 6 Q2 ‘26 Revenue; Projected $200 - 250 million by 2030 Manufacture/ Operations Regulatory/ Clinical Finance/ Resources Revenue/ Commercial AI and Data Science • In - house Sensor manufacturing clean room certified • Excess manufacturing footprint to meet demand • EU clinical studies for application expansion • US regulatory studies underway • Q1 ‘26 expected EU MDR certification • $22M PIPE • $100M ELOC facility • Bitcoin treasury management strategy • Access to additional public equity • 3 collaborations with high volume centers in key EU markets with additions planned • Distribution network covering ~35% of EU market • NVIDIA Collaboration for AI backbone • AI - driven decision and insight portal • AI - driven data algorithm 85 global patents granted or pending Addressing large unmet global clinical needs Advanced proprietary technology More than $100 million invested, $30 million from DARPA
NASDAQ: PFSA REVENUE PLATFORM BY CLINICAL INDICATION OXYGEN PLATFORM: GLUCOSE PLATFORM: DATA DISCOVERY: • Potential true enablement of AI - driven health care • Enables remote monitoring • Mass - adoption potential due to cost advantage • Wide - ranging applications • Potential of simultaneous sensing of multiple analytes • Planned AI Integration for physician portal and coaching 7 • Planned 1 Q 2026 E Critical Limb Ischemia (CLI) EU product launch • Planned 1 Q 2027 E CLI US product launch • Wound care applications • Home remote monitoring potential • Other potential applications : cell hydration, physical performance, infection surveillance • Large, high - growth global market potential • Clinical need for continuous glucose monitoring >270 days • Applications beyond Type I diabetes • Low - cost position provides accessibility for global users Platform Opportunity Users in Glucose, Oxygen (US/EU) Other opportunities: Lactate, CO 2 , Sodium, Ethanol Clinical - Grade Real - Time Data; Long - Term Usability; Simple Deployment; Cost Advantage; Substantial Support from DARPA and NIH
NASDAQ: PFSA MISSION DRIVEN EXECUTIVE MANAGEMENT 8 Ben Hwang Ph.D., Chairman, CEO From his early exposure as an undergraduate research fellow at the lab of Leroy Hood at Caltech, where the automated DNA sequencer was developed, to bringing cutting edge life sciences tools to the market at Life Technologies Corp. (acquired by Thermo Fisher Scientific, Inc.), Ben has seen first - hand the transformative impact that science and technology have to change our world. Bill McMillan Co - founder, CSO & Head of Research Bill was the initial driving force behind Profusa, he built the company road map, enlisted top talent & secured seed funding. A co - inventor of Profusa’s biologically integrated sensor & optical reader, Bill is a biotech pioneer whose career has spanned more than three decades in the development of next - generation diagnostic, medical device technologies and products, the last 20 years as an entrepreneur. Fred Knechtel Chief Financial Officer Fred led finance and operations activities from start - ups to multi - billion dollar publicly traded companies. As CFO, he guided organizations operating in the life sciences, automotive, consumer products and aerospace industries through profitable growth, capital restructure, mergers/acquisitions/sales and IPOs. Companies include Northrop Grumman, Stanley Black and Decker, DuPont, Remy International, Sims Metal Management and GENEWIZ (Azenta) Sean Givens Head of Government Business Sean comes to Profusa with 20 years of experience in government accounting and contracting, as well as extensive operations experience in consumer electronics, medical devices and drug development. Most recently Sean was a co - founder and COO of MIODx, a company focused on immune repertoire, Kerstin Rebrin, M.D., Ph.D., VP of Medical Affairs & Clinical Development Kerstin is responsible for developing & executing Profusa’s Medical & Clinical strategies. Dr. Rebrin is a seasoned physician - scientist with clinical & research experience in the field of diabetes & other metabolic diseases. She is known for her pioneering artificial pancreas research with introducing continuous glucose sensing & therapy algorithms based on glucose monitoring for various routes of insulin delivery. Aide Sordet GM OF EUROPE Aude brings extensive international experience in commercial strategy, marketing, and business leadership across Europe and Asia in senior roles at Bayer, M8 Pharmaceuticals and GC Aesthetics. Aude has successfully led cross - functional teams, driven market growth, and forged strategic partnerships to expand regional presence. Aude combines medical insight with strategic vision to advance innovative healthcare solutions and strengthen Profusa’s European operations.
9 Tissue Oxygen Monitoring NASDAQ: PFSA Computer generated Lumee App image
NASDAQ: PFSA TISSUE OXYGEN MARKET OPPORTUNITY 10 LARGE UNMET NEED • ~6.5 million patients with Critical Limb Ischemia (CLI) in US, Europe, and Japan (1) • ~$4.9 billion market in 2022 growing at 8% CAGR (3) • ~1.1 million CLI procedures in US and EU in 2025 (1)(2)(3) • Lack of decision support: – Decisions largely based on clinical experience – Clinicians need a tool to provide objective information about tissue perfusion EUROPEAN MARKET OVERVIEW AND COMMERCIALIZATION PRIORITIES 2025 Estimated EU ~716,000 CLI procedures/year (2)(3) Top 3 markets in size • Germany ~110 k/ y • France ~60k/ y • Italy ~50k/ y Important markets in size and / or KOL presence • Austria • Benelux • Switzerland • Greece Tier I countries Tier II countries Tier 1 Tier 2 LARGE AND DYNAMIC EUROPEAN ENDOVASCULAR MARKET: ~716,000 annual CLI procedures (~8% CAGR in the 5 next years) (1) https:// www.grandviewresearch.com/industry - analysis/critical - limb - ischemia - treatment - market - report (2) https://pmc.ncbi.nlm.nih.gov/articles/PMC6617560/ (3) https://journals.sagepub.com/doi/10.1177/1358863X19878271?url_ver=Z39.882003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%20 0pu bmed
NASDAQ: PFSA LUMEE OXYGEN IN ACTION WITH CLI PATIENT FIRST OXYGEN APPLICATION REVENUE EXPECTED 2Q2026 in EU 11 Therapeutic Remove Sheath Interventions Lumee Oxygen Index [ - ] Baseline Note (1) J. Vasc. Surg., June 2015, Volume 61:6, 1501 - 10 Lumee Oxygen Platform reports local tissue oxygen levels during PAD/CLI surgical intervention as well as post - operatively for 28 days , and posed a low risk to patients during the study (1) • Actual case data • Intra - operative GPS • Data for real - time decisions • Enables in - home monitoring Lumee TM OXYGEN PROVIDES REAL - TIME INSIGHTS DURING SURGERY VALIDATES PROFUSA TECHNOLOGY PLATFORM
12 Continuous Glucose Monitoring NASDAQ: PFSA Computer generated Lumee App image
>590M DIABETES PATIENTS GLOBALLY – CGM OPPORTUNITY 13 Current CGM TAM FROM “CAN YOU AFFORD IT” TO “DO YOU NEED IT?” Profusa TAM • Established benefit of CGM across diabetes spectrum • Woefully under - penetrated opportunity >2M CGM users ~300M Diagnosed ~30M Diagnosed (US/EU) prediabetes patients (4) Population >500M At - risk Prediabetes Population (3) T1D (1) >9M T2D (1) >500M Up to $7,000/year for CGM (2) >$600 (2) Glucometer/test strips per year ~$500 (5) Coaching Program/Year (1) https://diabetesatlas.org/resources/idf - diabetes - atlas - 2025/ (2) https:// www.goodrx.com/classes/medical - supplies - and - devices/should - you - be - subscribing - to - have - your - test - strips - delivered (3) https:// www.thelancet.com/journals/landia/article/PIIS2213 - 8587(25)00034 - 8/fulltext NASDAQ: P F ( 4 ) S A h tt ps : //p m c . n cb i . n l m . n i h . g o v / a rt i c l es/P M C6507173 / (5) https://nationaldppcsc.cdc.gov/s/article/FAQ - Cost - of - the - Program - 1526419435855#:~:text=On%20average%2C%20the%20cost%20per,who%20are%20uninsured%20or%20underinsured.
DIFFERENTIATED, ADVANCED CGM SOLUTION 14 Insertion apparatus Insertion apparatus Surgical insertion and removal Simple injection – hypodermic needle Sensor Functional Lifetime (days) Deployment Method Dexcom Medtronic Abbott Senseonics Source: https:// www.dexcom.com/en - us/faqs/can - i - restart - dexcom - g6 - sensor - after - 10 - days; https:// www.medtronic.com/ca - en/diabetes/home/support/product - support/cgm - sensors.html NASDAQ: P F F r S e e A S t y l e Libre 14 day System | CGM Diabetes Monitor; Senseonics Announces FDA Approval of the Eversense® E3 Continuous Glucose Monitoring System for Use for Up to 6 months; Provides 2022 Business Outlook – Senseonics 270 365 14 10 7 Insertion apparatus Current CGM market in intensively managed type 1 and 2 patients: TAM expansion opportunity with at risk chronic patients VS.
NASDAQ: PFSA DATA RICH, ACCESSIBLE, LOW - COST CGM FOR ALL 15 Profusa Cloud Reader Profusa’s CGM Solution Current CGM Pain Points x Overcomes foreign body response: > 270 days functionality New sensor required every 10 – 14 days x Simple hypodermic needle injection of sensor 180 - day solution requires surgical implant x High margin, low cost : ($900/year at >80% GM potential) (2) Up to $6,000 annual cost (1) x T1D through Health and Wellness patients >500 million TAM Cost effective for intensively managed patients only According to Strategic Market Research, the CGM market is expected to grow from $6B to $16B by 2030 LUMEE Glucose (1) https:// www.healthline.com/health/diabetes/when - you - cant - afford - a - cgm#tips - and - tricks (2) Profusa internal modeling
NASDAQ: PFSA 16 LUMEE GLUCOSE CLINICAL TRIAL Demonstrated Safety and Functionality • Clinical trial evaluated the safety and functionality of the glucose platform, sensor, reader and AI platform – 4 Clinical sites – Two European clinical sites – Two Asian clinical sites • 54 Subjects enrolled • 108 Sensors injected; 398 study visits completed • 745 Glucose traces collected; >18,000 paired reference points • Top line results: MARD (1) 10 - 12%; functionality >270 days: safety profile met (1) Current development data processing and algorithm
NASDAQ: PFSA COMMERCIALIZATION ROADMAP 2027E 2026E 2025E Q4 Q3 Q2 Q1 Q4 Q3 Q2 Q1 Q4 Q3 Program Research Use Only and Government Contract Revenues Research & Government Lumee TM Oxygen Lumee TM Glucose EU Commercialization and Revenues US Oxygen Revenues FDA Submission Process US Pivotal Study Human Validation Data Published Human Pivotal Study Planning US/EU/Asia CE/FDA Submission Process Glucose Commercialization & Revenues 17
NASDAQ: PFSA EU OXYGEN ROADMAP TO REVENUE Manufacturing and Supply Chain 2025 Aug Sep Oct Nov Dec Jan Feb Mar 18 Update EU CE Mark (MDR) Milestones • Technical file submission – Nov 2025 • Commence compliance testing – Dec 2025 • Approval – Apr 2026 Sensor & Pen Production Production Milestones • Sensor production lab – Certified and online • First sensor production lot for GMED approval – Completed • Pen production lot for GMED validation – Dec 2025 Patch/Reader In - house Manufacturing Manufacturing Milestones • Reader production lot for GMED – Nov 2025 2026 Apr May Jun Jul Aug Sep GMED Approval for use in EU – Apr 2026 Revenue (Apr 2026) Reader Outsourced Manufacturing Outsourced Manufacturing Milestones • Vendor contract manufacturing confirmed • Initial commercial production lot – Dec 2025 Supply Chain Development Supply Chain Milestones • Germany: Distributor – AngioPro confirmed. Access to key European countries • Spain: Distributor Dismeval, S.L. confirmed • Inventory build and shipping to distributors – Jan 2026 – Apr 2026
NASDAQ: PFSA OXYGEN PLATFORM REVENUE OPERATING MODEL 19 Distribution partners and Profusa commercial team will market directly to Centers • High Volume Hospital Centers: perform 1,000 to1,500 procedures/year • Ambulatory Centers & Doctors’ Offices: perform 200 – 1,000 procedures/year Equipment required for center to perform procedure • Each center will require 3 kits to perform the annual procedures • Each kit contains (1) tablet (iPad) with software preloaded, (4) patches/sensors and a small supply of adhesives • Each procedure will require (4) sensors and (4) pens Revenue (1) • Projected to be €600 – €800 per procedure • Startup kits projected to be €10,000 per kit (3 - 4 kits per center) (1) Based on Internal projections
OXYGEN COMMERCIALIZATION PAVES WAY FOR GLUCOSE 20 202 6 202 7 EU O2 203 0 202 8 202 9 US 02 Glucose Projected Revenue ($millions) Assumptions Critical Limb Ischemia (CLI) est. 2025 Market: ~1.1 million procedures in the US and EU, growing at 8% CAGR (1)(2)(3) • 2025 est. procedures in EU: ~716,000 (2)(3) • 2025 est. procedures in US: ~425,000 (2)(3) Estimated Average center performs 400 - 500 procedures per year (4) Expect 20% of center’s procedures to utilize Lumee Oxygen monitoring Revenue sources • Equipment starter kit (3 - 4 kits per center) - €10,000 per kit • €600 - €800 ($700 – $900) revenue per procedure plus ancillary supplies Milestones (Green highlighted complete) AI development – Adoption of NVIDIA technology backbone Update EU Oxygen CE Mark/MDR – Targeting product shipment by 4/26 US FDA – Targeting study commencement in ‘26 approval early ‘27 Engage 10 - 15 Treatment Centers with leading CLI surgeons in ‘26 • Austria Medical Center; Dr. Marianne Brodmann; ~1,500 procedures annually • Paris vascular center; Dr. Yann Goeffic; performs ~8% of France’s CLI procedures • Belgium vascular center; Dr. Koen R Deloose Current Distribution Partnerships covers ~35% of European procedures • AngioPro partnership; territory covers ~30% of EU population • Dismeval, S.L. partnership; covers procedures in Spain Manufacturing and supply chain • Build manufacturing capabilities: Sensor manufacturing lab – Certified • Pen and patch/sensor outsource manufacturing – Targeting Dec 2025 • I nventory build and shipping to distributors – Targeting Feb 2026 $4.0M $10.0M • Cash and cash equivalents • Undrawn cash portion of $22M PIPE $14.0M • Total Cash Availability $95M • Availability under the ELOC $0.8M $0.3M Use of Funds • Monthly Operational burn rate o Salary & benefits $0.2M $0.3M o Operational initiatives o Professional services (IR, Audit, Legal) Sources and Uses of Funds (16 month runway) Liquidity Oxygen $100 - $120M $0.5 - $2M Total Oxygen & Glucose Oxygen $9 - $13M Total Oxygen & Glucose $200 - $250M (1) https:// www.grandviewresearch.com/industry - analysis/critical - limb - ischemia - treatment - market - report (2) https://pmc.ncbi.nlm.nih.gov/articles/PMC6617560/ NASDAQ: PF S ( A 3 ) https://journals.sagepub.com/doi/10.1177/1358863X19878271?url_ver=Z39.88 - 2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed (4) Customer interviews and internal analysis
NASDAQ: PFSA PLATFORM VALUE PROPOSITION 21 DIFFERENTIATED TECHNOLOGY • Potential to change industry standard functionality from 14 to 90 days for initial product and eventually >270 days • ~10 years and ~$100M invested in developing technology. More than 85 global patents issued and pending • Clinical and third - party validation (~$30M DARPA and NIH non - dilutive grants) CLINICAL & REGULATORY MILESTONES • Lumee TM Oxygen MDR qualification: 1Q2026E European product launch • Human safety and performance data for CGM • Defined regulatory pathways for FDA approval LARGE ADRESSABLE MARKET • ~$10.5B+ TAM in oxygen • ~500M+ T1, T2 & at - risk chronic patients in CGM • Other opportunities: lactate, CO 2 , sodium, ethanol, AI - led data discovery platform • Low - cost solution: addresses medical challenge of foreign object rejection and enhances potential for Global markets FINANCIALS • ~1.1 million procedures EU/US market potential growing at 8% GAGR for oxygen platform • Oxygen 2026 revenue expected to be $0.5 - $2.0M and projected to be over $100 million in 2030 • Glucose revenue projected to start in 2027 - over 500M US/EU user market potential • $22M PIPE and $100M Equity Line of Credit
22 Investor & Media Relations: CORE IR email: info@coreir.com phone: 1 (212) 655 - 0924 NASDAQ: PFSA