PFSA US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

Form

10-K

(Mark

One)

☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For

the fiscal year ended December 31, 2025

or

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

From

the transition period from to

Commission

file number: 001-41177

PROFUSA,

INC.

(Exact

name of registrant as specified in its charter)

626 Bancroft Way Suite A Berkeley, CA 94710

(Address of principal executive offices) (Zip Code)

(925)997-6925

(Registrant’s

telephone number, including area code)

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading symbol Name of each exchange on which registered

Common Stock, $0.0001 par value PFSA The Nasdaq Stock Market LLC

Securities

registered pursuant to Section 12(g) of the Act:

None

Indicate

by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐

No ☒

Indicate

by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the Registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405

of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was

required to submit such files). Yes ☒ No ☐

Indicate

by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”

“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☒

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C.7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

☒

The

aggregate market value of voting and non-voting common stock held by non-affiliates of the registrant as of June 30, 2025 (the last business

day of the registrant’s most recently completed second fiscal quarter) was approximately $1.3 million.

As

of April 14, 2026, the number of shares outstanding of the Registrant’s common stock, par value $0.0001 per share, was 4,410,268 shares.

EXPLANATORY

NOTE

On

February 9, 2026, Profusa, Inc. effected a reverse stock split of all shares of its issued and outstanding common stock at a ratio of

one-for-seventy five (1:75). The Company accounted for the reverse stock split on a retrospective basis pursuant to Accounting Standards

Codification (“ASC”) 260, Earnings Per Share. All issued and outstanding shares of common stock and share-based awards’

exercise prices and per share data in this report and the consolidated financial statements have been adjusted, on a retrospective basis,

to reflect the reverse stock split for all periods presented. The number of authorized shares and par value of the common stock were

not adjusted because of the reverse stock split.

PROFUSA,

INC.

Annual

Report on Form 10-K

December

31, 2025

INDEX

Page

PART I

Item 1. Business 1

Item 1A. Risk Factors 29

Item 1B. Unresolved Staff Comments 84

Item 1C. Cybersecurity 84

Item 2. Properties 86

Item 3. Legal Proceedings 86

Item 4. Mine Safety Disclosures 86

PART II

Item 6. [Reserved] 87

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 99

Item 8. Financial Statements and Supplementary Data 99

Item 9A. Controls and Procedures 100

Item 9B. Other Information 100

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 100

PART III

Item 10. Directors, Executive Officers and Corporate Governance 101

Item 11. Executive Compensation 107

Item 14. Principal Accountant Fees and Services 111

PART IV

Item 15. Exhibits and Financial Statement Schedules 112

i

PART

I

ITEM

1. BUSINESS

Overview

We

were originally incorporated under the name “Northview Acquisition Corp.” as a blank check company incorporated as a Delaware

corporation and formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar

business combination with one or more businesses. As discussed in this Annual Report, we completed the Business Combination on July 11,

2025 and changed our name to “Profusa, Inc.”

Profusa

is a digital health technology company based in Berkeley, California, that has invested over the last twelve years more than $100 million

from sophisticated venture investors as well as the most sophisticated research institutions in the U.S. (including approximately $30

million from Defense Advance Research Projects Agency, or DARPA, and the National Institutes of Health, or NIH) to develop a unique biosensor

platform that is easily injected subcutaneously to provide, for the first time, real-time, individual biochemistry, that is cost effective

while functioning for more than six times longer than known best-in-class solutions on the market today. Profusa’s LumeeTM

technology does not consist of a single product, but is rather a platform that can potentially launch products for multiple applications.

Profusa’s

overall strategy has been to robustly invest and therefore develop and protect its technology as a private company, first in Europe where

the barriers to regulatory approval traditionally are not as great as they are in the U.S. Accordingly, Profusa has validated its technology

and gained approval of its first product, Lumee Oxygen, with CE approval in the European Union (“EU”) and is in the process

of migrating to meet new MDR requirements in Europe. In 2026 Profusa plans to launch this product in the U.S., if approved by the U.S.

Food and Drugs Administration (“FDA”), for sophisticated wound care management through a partner with distribution, sales

and in-servicing experience. The accessible markets for Profusa’s technology are not limited to the U.S. and the EU. Sophisticated

investors from Asia, such as 3E Bioventures, Tasly Pharma, and VMS Capital, who already see the far-reaching benefit of Profusa’s

platform, have not only been interested for several years, but have invested in Profusa’s development to date with the continuing

interest of being partners in the near future. To date, these investors from Asia have collectively invested over $50 million in preferred

stock and convertible notes of Profusa. Profusa is in continuing discussions with investors to establish a joint venture to provide Profusa

with access to Asia Pacific markets.

Following

validation of Profusa’s technology and application via Lumee Oxygen in the EU, Profusa’s next step in the development process

is to seek approval of both Lumee Oxygen as well as Lumee Glucose from the U.S. FDA. Profusa believes that the generation of additional

clinical data, which it plans to collect in connection with obtaining regulatory approval, combined with Profusa’s sophisticated

patent protection, will expand partnership interest from prospective medical partners in the U.S. and worldwide. Profusa’s plan

is to gain approval of Lumee Oxygen in the U.S. by early 2026, followed by approval of Lumee Glucose in late 2026 or early 2027. While

Lumee Oxygen is authorized for commercialization in the EU pending migration of CE approval to new MDR regulations, Lumee Glucose is

not yet authorized for commercial sale in any jurisdiction and Profusa does not yet have regulatory approval for the sale of any of its

products in the U.S. Profusa’s plans for commercialization of its products are dependent upon obtaining regulatory approval in

relevant jurisdictions on a timely basis, which cannot be assured. See “- Government Regulation - FDA Premarket Clearance and

Approval Requirements.”

Profusa’s

sensor platform has the potential to generate an individualized real time biochemistry data stream, with a substantially better user-friendly

form factor, accessibility for a broad user base, lower burden of healthcare costs, and significantly increased total addressable user

base compared to current market solutions. Profusa believes that the combination of the potential advantages of this platform will enable

it to generate both short-term revenue in the high-value clinical applications of wound care and diabetes management as noted above,

but to also leverage core technology and develop and add to Profusa’s product portfolio to potentially tackle the management of

other chronic conditions, while in the future creating the foundation for the technology enabled health care where the large volume of

biomarker data is aligned with up-to-the-minute actions and choices of the individual. Therefore, Profusa’s data stream could become

a key enabler for high-growth healthcare sectors such as telemedicine and health and wellness coaching, and sophisticated evaluation

of biomarkers for both molecular diagnostics and potentially therapeutic purposes.

1

Importantly

today, Profusa believes that Lumee’s biosensor and artificial intelligence platform compares very attractively with some of the

largest products in this market sector. Profusa believes its validated core technology can easily bridge the gap that exists in the current

technology landscape for monitoring real time biochemistry. The current approaches either have tailored clinical application at high

costs and burdensome user experiences, such as CGMs today; or broad potential user base in consumer-friendly costs and user experience,

but limited clinical utility, such as health and wellness wearables. Other products are strictly software and analytics-driven solutions

such as telemedicine and coaching apps which have limited clinical utility due to the lack of real time data. Profusa’s technology

today has the potential to provide the solution of bringing sophisticated, real-time to a broad population of needy patients globally

at a more reasonable cost.

Profusa’s

core platform technology is the foundation for its growth strategy, which includes:

2

Profusa’s

Addressable Market

There

have been many attempts to develop technologies that provide real time biochemistry and biomarker data for individuals. The most compelling

use case has been for measurement of glucose in the management of diabetes. The first traditional approach to glucose measurement is

to take measurements at discrete points in time via a self-monitoring of blood glucose (SMBG) method, which requires the collection of

a drop of blood via a lancet and applying that drop of blood in a test strip which is then read by a reader. A second approach is to

have a patient monitor their glucose levels by using a continuous glucose monitoring (CGM) device which provides a continuous stream

or real time glucose measurement. The CGM approach has the benefit of being able to provide a data stream which elucidate not just the

glucose level at any given time, but the trending of the glucose levels throughout the day. This ability to visualize trending of a patient’s

glycemic levels is important to predict significant excursions of an individual’s blood sugar levels and prevent serious adverse

events caused by hypoglycemic or hyperglycemic to the patient and enable the patient to inject insulin or take medication to manage the

disease. The following graphic illustrates the comparative advantage of CGM over SMBC.

Comparison

of finger-pricking self-monitoring of blood glucose (SMBC) and continuous glucose monitoring (CGM).

While

there have been attempts to use energy waves to non-invasively measure glucose in a patient’s body, those efforts have proven to

be unsuccessful due to their lack of ability to deliver accurate and reliable measurements. Other experimental approaches utilize molecular

spectroscopy, but have to date not received U.S. regulatory approval and, despite some attaining European Regulatory Approval, have not

gained significant commercial traction there. Profusa believes this demonstrates that the non-invasive nature of a technology, even in

the unlikely case it was of comparable accuracy to existing devices, has little bearing on marketability if other criteria are not met,

such as competitive pricing, low production costs, user-friendliness and as well as pre-existing relationships with larger CGM players

who can contribute to a plan to bring the product to market, all of which are areas where Profusa believes it has a winning advantage.

There

are also other non-invasive approaches to measure biomarkers and analytes available, such as those measuring steps, blood oxygen levels,

heart rate, and body temperature. These solutions provide some data for general wellness management; however, their clinical utility

has been limited since there is not a large defined set of clinical evaluation that links these parameters to specific clinical diagnosis

or outcomes. Accordingly, Profusa believes that for a technology platform to measure clinically reliable data that can inform high-value

clinical decisions, a sensing element inside the body to take direct measurements of the analyte of interest is of critical importance.

Current

CGM sensors typically have a small needle coated with a sensing chemistry which is placed through the skin so the needle can take measurements

in the interstitial space of a patient. These needles, however small, elicits a “foreign body response” within the patient

as the body’s natural defense mechanism against objects that are recognized as foreign. The foreign body response begins to encapsulate

the sensing needle of these CGMs in scar tissue and renders the data from these sensors unreliable within a matter of days. This is the

major reason the longevity of these CGMs is limited to approximately 7-14 days. A longer-term 12-month solution where a sensor is surgically

implanted into a patient’s body is available as well, however the sensor requires a surgical implantation with sutures to close

the surgical wound. This approach has a limitation of a much more invasive deployment procedure and associated higher cost.

3

All

data is from the manufacturer website. The products provided in this chart are:

● Dexcom G6

● Abbott Freestyle Libre 2

● Medtronic Guardian Connect

● Senseonics Eversense E3

Profusa’s

CGM Product (Lumee Glucose) is not approved in the United States. The > 270 days usage time is based on the data acquired through

Profusa’s glucose program clinical study.

Profusa’s

Technology

It

is Profusa’s belief, based on an understanding of the biological response to current available sensors, that a viable solution

that could provide data for clinical utility and wide-scale adoptions, needs to have the following three key characteristics: direct

measurement of the body’s chemistry to enable accuracy, ease of deployment of the platform and long-term functionality to encourage

adoption by a large population, and low cost to breakdown the economic barrier for adoption by those who can benefit from this data stream.

Profusa’s

sensor platform has the potential to deliver on these requirements and are composed of the following components:

● Hydrogel Sensor

Profusa’s

passive sensor is composed of a class of materials called hydrogels, which are similar to the material from which modern contact lenses

are made. The sensor is designed to overcome the effect of the foreign body response and thus has been demonstrated to be able to collect

biochemical data for up to 6-months in the case of Lumee Oxygen, and up to 9-months based on the data acquired through Profusa’s

glucose program clinical study. This hydrogel scaffolding is soft and pliable and serves as the base material on which specific fluorescent

molecules are bound. These fluorescent molecules bind specifically to the analyte of interest and their fluorescent characteristics change

depending on whether the analyte is bound or unbound. The hydrogel sensors are devoid of any electronics or power source, and are simply

composed of the hydrogel scaffolding and the fluorescence sensing chemistry. Depending on the sensor type, Profusa may also imbed a reference

chemistry for reference purposes during data processing. The hydrogel sensor measures approximately 400 microns in diameter by 3 millimeters

in length and is injected subcutaneously via a hypodermic needle injection at a depth of 2 - 6 millimeters from the surface. Upon injection,

the sensor is designed to be integrated as a part of the tissue and is not noticeable. As this sensor is passive in nature, while the

binding and unbinding of the analyte of interest is constantly occurring, data from the sensor is not actively broadcasted outside of

the body until a reader (described below) is placed on the skin over the sensor.

By

“decoupling the sensor and the reading elements,” we believe that our approach has a few major advantages:

2. The act of data acquisition is controlled by the user and action is secure;

4

● Reusable Reader

An

optical reader has been developed to be worn on the skin above the sensor and is designed to interrogate and gather sensor signal for

data processing. This optical reader has a small wearable form factor dimensions of the oxygen reader and is worn on the skin via a double-sided

medical grade adhesive. The readers are rechargeable via conductive charging and currently have a functional lifetime of 24 hours on

a single charge in the case of Lumee Oxygen. When a datapoint is desired, the firmware of the reader instructs the device to pulse a

light source shining an excitation light of a specific wavelength to illuminate the sensor under the skin. The return fluorescent light

from the sensor is then detected by the reader via a series of photo detectors and the data is captured for algorithm processing. By

continuously pulsing the light and capturing the return signal from the hydrogel sensor, the reader is designed to be able to collect

a stream of data allowing for the continuous monitoring of the biochemistry inside the body. This device is also designed to have the

capability to measure multiple wavelengths of light allowing for the capture of changes in tissue optical properties and reference chemistry

signals, providing input to the data algorithm to potentially correct for variability of subject tissue types and individuals change

in tissue properties over time. Additionally, the reader is designed to be able to include thermistors, or temperature-sensitive resistors,

and motion detectors, enabling the collection of additional parameters the algorithm may use to increase the accuracy of the analyte

measurement. The externally worn device is designed to be a durable component of the system and can be reused for multiple sensor injections.

5

● Data Algorithm

Software

algorithms operating in firmware and mobile applications compute clinically relevant values based on optical signals and temperature

measurements provided by the reader hardware. Lumee Oxygen uses an oxygen sensor whose optical intensity, after excitation from an LED,

decreases at a rate that is a function of tissue oxygen. The hardware is designed to provide rapid optical intensity measurements. The

firmware fits the decrease in intensity to a model whose coefficients represent the oxygen intensity. The firmware produces a Lumee Oxygen

Index (LOI) value every few seconds and the tablet application visualizes the data and determines the percent change over time. The glucose

hydrogel is an intensity-based system with two dyes: a reference dye whose intensity is independent of glucose and other chemical properties

of its environment, and a glucose dye whose intensity after excitation changes predictably with glucose concentration. The ratio of the

glucose and reference intensity provides an approximation of the glucose signal. The glucose system is designed to use several wavelengths

of light from defined LED sources and optical detectors. Every measurement sample includes 84 unique optical measurements that form a

data set that is used to determine the glucose dye intensity, tissue optical properties, and position of the sensor. The hardware and

firmware in the glucose system capture and store these raw measurements. The data processing on the glucose system is performed primarily

on a mobile device. The mobile application computes glucose intensity changes and calibrates the values to establish a measurement of

blood glucose.

The

glucose algorithm in the mobile application is designed to perform a series of corrections to account for changes in the optical signals

that do not originate in the glucose dye. These include correcting for variability in the LED brightness at different temperatures; correcting

for changes in the reader’s position relative to the sensor, by triangulating the position of the sensor using 4 opposing LEDs

that excite the reference dye; and correcting for changes in the tissue’s light absorption using 72 source-detector pairs. The

reader position and tissue absorptions are computed by fitting the measurements to a principle-based optical model. Finally, the glucose

signal intensity is corrected for temperature changes to account for the glucose dye’s sensitivity to temperature. The corrected

optical glucose signal is calibrated into a measurement of blood glucose. Profusa’s calibration model includes support for different

user calibration schemes. Profusa has also developed a collection of machine-learning models which use these same optical signals as

inputs to improve corrections. These machine learning models include using the tissue optical property measurements as inputs to generate

background fluorescence, a deep learning model which uses all the optical signals to generate a blood glucose estimate, and machine learning

models to detect signal errors. Additionally, in conjunction of work with DARPA, Profusa developed machine learning models that operate

over time-series data to detect specific events.

Both

the glucose and oxygen systems have firmware and Bluetooth low energy (BLE) hardware designed to communicate between the reader and the

mobile device. The mobile device is initially paired with the reader using a passkey and later utilizes 128-bit encryption for data transmission.

The reader identifies if the connection between the reader and the mobile device is disconnected. It retains the data and transmits the

data once the connection is re-established. The mobile device also notifies the user if a disconnection occurs.

● App and Data Visualization

Lumee

Oxygen includes a tablet device that is designed to provide real-time traces of tissue oxygen levels from multiple readers simultaneously,

and allow the operator to annotate events and normalize values at a point in time to identify the relative improvement of a patient’s

tissue oxygen. The system also supports PDF and CSV data export. Profusa has also developed Lumee O2 Go, currently for research use only,

that operates on a mobile phone and uploads data to the cloud. This mobile application is being developed to provide real-time visualization

of changes in oxygen, data annotation, and incorporation of third party data via Apple’s HealthKit.

6

The

initial glucose professional product, once approved, is intended to allow physicians and care providers to visualize a patient’s

glucose over a series of days. This first product mobile interface is designed to encourage compliance, log activities, and facilitate

correct operation without providing the patients access to the system’s measured blood glucose values. The second real time use

product, once approved, is planned to allow for users to have real time access to the system’s measured blood glucose values to

enable care decisions. An essential feature of the glucose system is a visualization that allows the patient to correctly locate the

reader over the sensor. This mobile user interface will show a real-time depiction of the reader as it is moved over the sensor in the

body to maximize signal quality and optimal position.

Profusa

uses Amazon Web Services (AWS) infrastructure to host and secure data. For authentication and authorization, Profusa’s web application

utilizes Amazon Cognito. To provide network security, data is transmitted over the public network using TLS. All data communication from

Profusa’s application is transmitted through Amazon’s Application Load Balancer which provides both data encryption and allows

Profusa’s system to reside entirely on a private network. Amazon’s systems provide the capabilities to ensure that data is

encrypted during transmission and at rest. Profusa’s mobile applications upload data regularly but do not rely on a network connection

to operate. Nonetheless, to deliver a robust service, Profusa’s cloud infrastructure is hosted on redundant, fault-tolerant application

servers, to improve availability.

The

core technology platform described above is the foundation for Profusa’s future products for the measurement of real time biochemistry,

including Lumee Oxygen and Lumee Glucose. By tailoring the fluorescence chemistry with the optical properties of the multi-channel reader,

Profusa believes that its ability to develop products to measure other analytes and expand our product portfolio is enhanced while maintaining

the key value propositions of the platform. It is conceivable in the future that Profusa may be able to develop a sensor and reader pair

to measure multiple analytes within one product, creating streams of data for a biochemical panel for broader applications.

Short-Term

Opportunity with Lumee Oxygen and Lumee Glucose

Realtime

monitoring of validated and clinically relevant data from individuals have profound upside. By monitoring real-time metabolic parameters

such as tissue oxygen and glucose, Profusa’s technology, if approved, could benefit chronic conditions affecting more than 500

million people across the world. Over the past two decades, the health care community has begun the trend of developing technology solutions

to create infrastructure and real time data in an effort to bring the potential of clinical decisions away from the costly hospital and

clinics to the individuals in the comfort of their homes and daily lives. From chronic conditions that can benefit from real time monitoring,

such as diabetes management, dialysis treatment, infection monitoring, surgical recovery, to the infrastructure of telemedicine and remote

access to healthcare professional for diagnosis and health data interpretation, the technology enabled future of health care has gained

greater footing to becoming more mainstream. The total market size of telemedicine platforms have doubled from $41 billion to over $80

billion from 2019 to 2021, and the market for remote coaching platforms has also grown from hundreds of millions to just under $14 billion

over the past decade. Additionally, CMS has implemented reimbursement codes for remote patient monitoring (RPM) for chronic conditions

and data interpretation. This can lead to reimbursement of more than $200 monthly per patient as of 2022. Furthermore, these codes can

be used in addition to existing Chronic Care Management (CCM) codes. These trends provide significant momentum for Profusa’s technology

platform to potentially be the indispensable data stream to support this vision of the technology-enabled health care future, potentially

replicating the impact that technology platforms such as Google have had in advertising to the high-value arena of healthcare. With respect

to oxygen and glucose monitoring specifically, the size of the continuous glucose monitoring market is estimated to be approximately

$2.8 billion in the U.S. and over $800 million in Europe by the end of 2024. The global oxygen monitoring market is estimated to be over

$3.1 billion and $3.4 billion in 2025 and 2026, respectively.

Profusa’s

plan to capture this opportunity is anchored by its product launch plan, beginning with the near-term launch of Lumee Oxygen, once approved,

as it serves the critical limb ischemia wound care population. Creating a solution that aligns to a critical clinical need and demonstrating

the benefit of a real time biochemical data stream from operating room to the home in ambulatory care would create credibility and capability

build for Profusa on this journey. The second phase would be to launch Profusa’s glucose product, once approved, for the well-defined

diabetes market and leveraging its value proposition to expand the number of patients who can benefit from CGM to beyond the current

type 1 diabetes population. Profusa believes that its solution could benefit those in the type 2 and pre-diabetes populations to both

potentially broaden the product reach beyond the currently available solutions, but also generate a broad set of clinical data across

a large heterogeneous population to inform the clinical science behind diabetes care throughout the disease spectrum. Lastly, by adding

additional analytes and partnering with the telemedicine and health and wellness coaching sectors, Profusa hopes to truly bring the power

of the broad real time biochemistry data stream and create enduring value.

7

Lumee

Oxygen for Critical Limb Ischemia management and management of peripheral arterial disease (PAD)

Peripheral

arterial disease (PAD) is a vascular condition caused by the blockage of arteries below the knee of a patient. These blockages decrease

the blood supply to the extremities, in this case the foot, and is characterized by pain in walking, neuropathy, resting pain, and ultimately

tissue death requiring amputation. The progression of PAD is described clinically by the Rutherford Scale, a medical classification describing

seven categories of peripheral artery disease, including both the patient’s clinical symptoms as well as objective findings, with

class 1 being the mildest form of the disease characterized by the patient experience foot pain from walking, to the most severe of class

6 characterized by major tissue death/loss in the foot. The classes of patients with Rutherford classes 4-6 are described as having Critical

Limb Ischemia (CLI). According to articles in Endovascular Today and various market research firms, the number of cases across the United

States and European Union of CLI has grown from approximately two to six million over the past 10 years and is growing at a compound

annual growth rate (CAGR) of 8.3% from 2022 to 2027 due to increased diagnosis rates. This patient population usually present with multiple

comorbidities, including diabetes in approximately 45% of cases CLI costs healthcare systems more than $200 billion in the United States

alone annually.

The

current therapeutic regimen for treating CLI is to debride the usually heavily infected wounds of the foot, to remove dead tissue to

prevent further infections, and to perform vascular therapy surgically or endovascularly through ballooning and stenting the blockages

of the arteries to restore blood flow to the foot. While surgical or endovascular procedures in restoring blood flow to the extremities

are usually achieved in the operating room, the causality of technical success in the OR leading to healing of the wounds caused by the

tissue loss of the disease is less certain. In approximately 50% of endovascularly treated cases, the wounds of these patients are not

healed within six months post-surgery. This is caused by the fact that the surgical procedure performed on the large arteries in the

leg does not necessarily restore oxygenation to the tissues to the wound. The need for healthy microvasculature that enables oxygen exchange

between blood and tissue are compromised in this patient population. Lumee Oxygen is designed to provide the physician the data to understand

whether their surgical procedure not only could restore blood flow to the lower extremities, but more importantly, whether the tissue

in the effective area is receiving sufficient oxygen as a result.

Lumee

Glucose for Diabetes Management

Diabetes

is a chronic metabolic disorder suffered by more than 400 million individuals globally, according to the World Health Organization, and

approximately 1 billion individuals when including pre-diabetic patients. The cause of this condition is due to the patient’s inability

to product or use insulin, which cause the body to ineffectively manage the level of blood glucose. The resulting inability to maintain

adequate control of blood glucose level cause a variety of serious downstream health conditions and complications including vascular

disorders, chronic wounds and tissue loss, amputations, heart disease, kidney malfunction, blindness, coma, and even death. Unfortunately,

diabetes is a condition that continues to see global rise in patient populations due to lifestyle choices, improvements in global living

standards which lead to dietary changes, and the increase in the aging population.

Diabetes

can be characterized into three populations: type 1 diabetes, type 2 diabetes, and pre-diabetes. Type 1 diabetes is a genetic disorder

that typically develops while the patient is in childhood and is primarily caused by the patient’s inability to produce insulin,

or inability to respond to the presence of insulin (insulin resistance). Patients suffering from type 1 diabetes must maintain their

glucose level in healthy range through the frequent and dose-specific administration of insulin. Type 1 diabetes is a genetic disorder

that is characterized by the patient’s inability to either produce the hormone insulin, or becomes resistant to the effect of insulin

in the management of their blood glucose levels. Individuals suffering from type 2 diabetes similarly have impairments that lead to the

body’s inability to manage glucose well. This is primarily caused by either the body’s insufficient production of insulin,

or cells’ poor response to insulin. Type 2 diabetes is primarily a chronic condition that is lifestyle driven, and usually present

symptoms later in a patient’s life. Those who suffer from type 2 diabetes usually require the management of their disease through

careful monitoring of their diet and nutritional intake, level of exercise, and maintaining a regimen of oral medications or the injection

of insulin to regulate their blood glucose levels within the healthy range. Pre-diabetes refers to those individuals whose blood glucose

levels are higher than normal, but not high enough yet to trigger the clinical definition of type 2 diabetes. Those identified as having

pre-diabetes have a much higher likelihood of developing type 2 diabetes without intervention. For individuals who have been diagnosed

as pre-diabetic, the management of their condition is typically through nutritional counseling, management of their dietary habits, and

exercise in an attempt to slow down the progression of their diabetes to the clinical threshold.

8

As

the monitoring of the blood glucose level in a patient is a critical component to effectively manage the disease or progress of the disease,

many individuals with diabetes utilize technologies to actively measure their blood glucose levels throughout the day. One traditional

method of monitoring blood glucose levels is through self-monitoring of blood glucose (SMBG). SMBG technology approach requires the collection

of a small drop of blood through lancing the fingertips and applying that drop of blood sample to a test strip which is read by a glucose

meter. This traditional approach, more commonly referred to as “fingersticks”, are usually done multiple times throughout

the day and night and generate a point-in-time measurement of the blood glucose level of the patient. This method is painful, at times

difficult to self-administer to get an accurate reading and does not provide the important information of blood glucose trends that is

important for effective disease management. Alternatively, continuous glucose monitoring (CGM) technologies are generally less painful

to deploy, create a stream of continuous glucose level data to the patient and care providers throughout the day and night, and have

the ability to present blood glucose trending data that is important to disease management. Current CGM solutions available to patients

are often inconvenient and require frequent changes. Deployment of the technology in certain cases requires surgical implantation that

is often a barrier to adoption from the points of view of both the user and physicians. Additionally, the cost of the current CGM solutions

are typically at a level where insurance reimbursement will only be available to the most brittle of type 1 and 2 patients (the latter

of which, to be covered by insurance, often require daily insulin intake). The high costs and cumbersome usability exclude the adoption

of such solutions to the larger type-2 population, particularly those not regularly using insulin, and pre-diabetes patients who can

benefit clinically from the real time glucose data.

Profusa’s

Product Path and Clinical Programs

Lumee

Oxygen

Lumee

Oxygen is designed to be an adjunct instrument intended for continuous and long-term monitoring of the oxygen in the subcutaneous tissue

in the upper extremity, shoulder, or lower extremity. In jurisdictions where it has received regulatory approval, the Platform is indicated

for use in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring. Its use in those

jurisdictions in conjunction with the physician’s diagnosis and judgement has the potential to create a potential new paradigm

for wound care.

Lumee

Oxygen is designed, developed and manufactured by Profusa. The first generation Lumee Oxygen Platform received its CE Mark on September

27, 2016. The device had undergone significant design updates since to include wireless components. This updated platform is referred

to as the Wireless Lumee Oxygen Platform to reflect this change. The Wireless Lumee Oxygen Platform received CE Mark on January 14, 2020.

Profusa’s commercialization efforts of this product were critically hampered by the closure of hospitals and operating suites to

non-essential personnel due to the COVID pandemic. Profusa plans to take advantage of the relaxation of COVID protocols to execute on

its commercial plans in Europe beginning in early 2026.

There

have been ongoing communications with FDA along the device development path in consideration of submission for FDA marketing authorization.

Early during the development in 2014, it had been established with FDA that the Profusa Oxygen sensing device would be a good candidate

for an Investigational Device Exemptions (IDE) application with “significant risk designation” acknowledging permanent injection

of the hydrogel sensor in subcutaneous tissue. Frequent FDA communication followed during the time period 2015 - 2017 which resulted

in approval of an IDE application for performing studies in the U.S. as described below. Communications with FDA in 2019 did focus on

design questions for a pivotal study with the Wireless Lumee Oxygen Platform which would serve the needs of a subsequent De Novo submission.

An IDE application was approved in April 2019 and a supplement to accommodate Covid pandemic conditions was subsequently approved. Nevertheless,

the practical execution of the study had been significantly and negatively impacted by the pandemic due to the lack of access of non-essential

personnel in health care settings. Today the pilot phase of the study has been completed confirming the pivotal study phase design, and

the study will continue into the pivotal phase.

9

Lumee

Oxygen Clinical Study Overview

The

Profusa Wireless Lumee Oxygen Platform and its predecessor, the Lumee Oxygen Platform, are designed to measure changes of oxygen level

in the tissue, continuously and long-term. It is designed to report oxygen levels intra-operatively during an operation at a medical

facility, and/or used as a monitoring method pre- or post-operatively at a clinic. Up to four anatomical sites can be measured and reported

concurrently. It is intended for use in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit

from monitoring.

The

features of both the Profusa Wireless Lumee Oxygen Platform and the Lumee Oxygen Platform are expected to provide added value to clinicians

when compared with current alternative technologies. Both Lumee systems provide a new method for measuring tissue oxygen concentration

in the interstitial fluid without perturbing the tissue after the initial injection. In addition, the Wireless Lumee Platform uses a

small portable reader and tablet to display tissue oxygen. This increased usability lends itself to use within many settings, such as

ambulatory care settings.

The

Lumee Oxygen Platform and the Wireless Lumee Oxygen Platform do not estimate oxygen saturation in the vasculature, nor is it an averaged

measurement across a large volume of tissue, rather it provides a direct measure of oxygen availability in the interstitial fluid (referred

to as tissue oxygen concentration). The Lumee Oxygen sensor can be placed at a target depth of 3-6mm beneath the skin, enabling clinicians

to monitor tissues of interest, and it is not limited to measurement of superficial tissue layers. Furthermore, it can provide insight

into the changes occurring in tissue oxygen levels in both acute and chronic use cases. The Lumee Oxygen system has been tested in measuring

changes in oxygen in specific tissues due to systemic oxygen challenges (hypoxia model), peripheral flow disturbances (occlusion/reperfusion

protocols and monitoring of vascular interventions), and wound healing state (ulcerated feet in peripheral artery disease). Because of

its small footprint and a portable design, the Wireless Lumee Oxygen Platform especially provides a method for continuous and long-term

monitoring of tissue oxygen levels.

Lumee

Oxygen Clinical Study History

The

Wireless Lumee Oxygen Platform had been registered in various European countries upon CE Mark following a determination that it was equivalent

to its predecessor platform, Lumee Oxygen Platform. The sensors involved are the same. The following is a description of Profusa’s

clinical study history for this product from proof-of-concept through approval in Europe. To date, these clinical studies have involved

328 sensor insertions, in 45 of subjects, with no device related serious adverse events (SAE). Study results served investigational device

development purposes in support of the CE approval of the first generation device in 2016.

10

Device

Safety

As

of April 14, 2026, the company is not aware of any serious adverse events (SAEs) that occurred related to Lumee Oxygen.

Continuous

Glucose Monitoring product

Lumee

Glucose is an investigative product development system as Profusa has yet to receive the regulatory approval necessary for commercialization

in any jurisdiction. It is under development to monitor optical signals that represent glucose levels in the interstitial fluid of subcutaneous

tissue continuously and long-term. This glucose sensing system is composed of 1) a Glucose Sensing Hydrogel, 2) a Hydrogel delivery/injection

pen, and 3) a Hydrogel Reader and software. The software is designed to be used with a User Interface on a Tablet or Smartphone.

Lumee

Glucose is designed and developed by Profusa. The Profusa Glucose First-In-Human (FIH) Platform had been approved for investigational

use by the Competent Authority in Germany (BfArM) on May 4, 2018. Follow-up development studies with significantly improved Glucose Platform

components, including the sensing hydrogel and reader, received approval for investigational use in several jurisdictions: by the Competent

Authority in Austria (AGES) on May 8, 2020 and January 11, 2021; by the Competent Authority in Germany (BfArM) on November 26, 2020;

by the Competent Authority in Vietnam (Ministry of Health) on September 10, 2020. Study conduct took place in all jurisdictions with

a total enrollment of 54 subjects. The active glucose monitoring phase for up to 12 months had been completed by the end of 2021. The

European studies are still open for extended safety monitoring per protocol for up to 3 years observation. The study in Vietnam does

allow amendments for additional device iterations, which will be implemented as soon as practical for the next phase of Profusa’s

clinical study program.

Profusa

continues to have ongoing communication with the Competent Authorities in Europe for the current studies periodically reporting on extended

safety observations for long-term sensor placement. Submission of new study protocols is expected in 2026, employing the first commercial

generation platform demonstrating safety and effectiveness (accuracy and intended use performance) aiming at regulatory clearance purposes,

i.e. CE Mark.

11

In

parallel, the technology is going be presented to FDA to obtain Investigational Device Exemptions for study conduct in the U.S. Potential

clinical study sites have been targeted and respective IDE submission documentation is in preparation. A PMA (Pre-Market Approval) pathway

is expected for marketing authorization in the U.S. It will likely require a pivotal study performed in the United States with an estimated

enrollment of 120 - 160 subjects and an active glucose measurement period of at least 3 months.

The

first commercial implementation of Lumee Glucose will be, subject to regulatory approval, a professional-use device for retrospective

data download and data evaluation by health care professionals. This approach is typical in the CGM market and will be a controlled and

limited use case in preparation for the release of a fully featured real-time use CGM device generation in the near future, subject to

obtaining required regulatory approval.

Lumee

Glucose Clinical Study History

Lumee

Glucose is a CGM product candidate that was first entered into clinical study through our first-in-human (FIH) study in 2018. To date,

we have tested 108 sensors in 54 subjects in our clinical program for the glucose product, and tested 20 sensors in our FIH study in

10 subjects. These studies have been conducted in global sites in Germany, Austria, and Vietnam. No serious adverse events related to

the device have been reported with safety data neither during the active 12 months post injection period nor during extended observation

up to three years per protocol.

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Demographics

For Lumee Glucose Studies

A

total of 54 subjects have been enrolled with 108 Lumee Glucose sensors injected and 398 study visits completed. These visits have yielded

745 glucose traces and more than 18,000 paired reference points.

Location Germany Austria Vietnam Vietnam

Results

The

feasibility study at the four clinical sites provided data on sensor locatability, system performance (the ability to accurately estimate

glucose), in addition to monitoring for adverse events. All the sensors were locatable. The feasibility study was not designed and powered

to provide a robust estimate of the commercial performance of the system, however, data collected in the study enabled the refinement

of the algorithm. Using the data, Profusa was able to show evidence of the system’s ability to track glucose. Data indicate that

the sensors were responsive to glucose during the study period and provided a significant body of data for algorithm development and

evaluation. Performance analysis of the data yielded an aggregate mean absolute relative difference (MARD) of 11.7% for sessions from

7 - 90 days post-injection. The consensus error grid and cumulative MARD distribution are presented below, representing 163 sessions

from 37 patients that passed the data quality filters, resulting in 2406 paired blood glucose reference points. Data quality filters

that were developed and automated during the algorithm development exclude problematic traces including poorly placed readers over the

sensor, unexpected fluorescence contamination of the skin surface over the sensor, and poor adhesion of the reader over the sensor yielding

low signal to noise.

13

The

figure above shows a standard Consensus Error grid, which is a tool used to evaluate the accuracy of blood glucose meters. It visualizes

the paired data points that passed the quality filters. This includes 163 sessions of data collection approximately 6 hours in duration

from 37 patients over the course of 90-days. Measured signals are calibrated using 3-point blood glucose calibration in each session.

Each dot on the figure shows the relationship between the Profusa reported blood glucose value (Y-axis) compared with the corresponding

reference measured blood glucose value (X-axis). The colors of the dots distinguish patients. The grid is divided into zones signifying

the degree of risk posed by the incorrect measurement: zone A represents no effect on clinical action; zone B represents altered clinical

action - little or no effect on clinical outcome; zone C represents altered clinical action - likely to affect clinical outcome; zone

D represents altered clinical action - could have significant medical risk; and zone E represents altered clinical action - could have

dangerous consequences.

The

pair of figures above shows an alternative visualization of the data presented above. For each data collection session, the system accuracy

(MARD) is computed. The per-session MARD distribution shows performance across the 163 sessions. “Held-out test set” refers

to the machine learning technique. Following the FDA’s recommendations for utilizing machine learning, the algorithm used to process

the data was not used in its training.

14

Glucose

predictions modeled from held-out clinical sessions

Performance

beyond 90 days was also evaluated in two separate groups - days 91 - 150 and days 151 - 275.

The

figures above were processed using the same filters and methods as in prior figures. Subjects had the opportunity to stay in the study

after 90 days from the initial injection. The population of 13 subjects in the 91 - 150 days period and 8 subjects in the 151 - 275 day

period is a subset of those in the initial 90 - day data.

Device

Safety

As

of April 14, 2026, the company is not aware of any serious adverse events (SAEs) that occurred related to Lumee Glucose. As of the study

closure at the end of 2023 and related study report, seven adverse events (AEs) related and four AEs possibly related to Lumee Glucose

were reported. All of the related and possibly related AEs were mild, such as slight pain or small induration, or thickening and hardening

of the skin. All but one of the AEs resolved within three days, and the last AE resolved within 12 days.

Commercial

Strategy

Profusa’s

commercial strategy centers around leveraging its core expertise in product development and scientific excellence, while augmenting its

capabilities through local partnerships in commercial execution. For Lumee Oxygen and Lumee Glucose, Profusa aims to continue investing

in its key opinion leader relationships and create clinical relevancy through building upon its current body of publications and conference

presentations. To date, Profusa has been featured in more than 25 publications in peer-reviewed journals and public presentations of

its science and product applications. None of these publications were commissioned by Profusa or written at the direction of Profusa’s