What changed in this filing

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Item 1. Business

2026-04-15 compared with 2025-03-31 · 1297 added, 820 removed, 0 unchanged (100% of the section changed)

We are a blank check company

formed under the laws of the State of Delaware April 19, 2021.

We were formed for the purpose of effecting a merger, share exchange, asset

acquisition, share purchase, reorganization or similar business combination with one or more businesses, which we refer to throughout

this prospectus as our initial business combination.

Although there is no restriction or limitation on what industry our target operates

in, it is our intention to pursue prospective targets that are focused on healthcare innovation.

We anticipate targeting what are traditionally

known as small cap companies domiciled in North America, Europe and/or the APAC regions that are developing assets in the biopharmaceutical,

medical technology/medical device and diagnostics space which aligns with our management team’s experience in operating health care

companies and in drug and device technology development as well as diagnostic and other services.

Recent Developments

Proposed Business Combination

On November 7, 2022, NorthView

entered into a Merger Agreement and Plan of Reorganization (the “Merger Agreement”), by and among NorthView, NV Profusa Merger

Sub Inc., a Delaware corporation and a direct, wholly-owned subsidiary of NorthView (“Merger Sub”), and Profusa, Inc., a California

corporation (“Profusa”).

The Merger Agreement provides

that, among other things, at the closing (the “Closing”) of the transactions contemplated by the Merger Agreement, Merger

Sub will merge with and into Profusa (the “Merger”), with Profusa surviving as a wholly-owned subsidiary of NorthView.

connection with the Merger, NorthView will change its name to “Profusa, Inc.” The Merger and the other transactions contemplated

by the Merger Agreement are hereinafter referred to as the “Business Combination.”

The Business Combination is

subject to customary closing conditions, including the satisfaction of the minimum available cash condition, the receipt of certain governmental

approvals and the required approval by the stockholders of NorthView and Profusa.

There is no assurance that the Business Combination

will be completed.

The aggregate consideration

to be received by the Profusa stockholders is based on a pre-transaction equity value of $155,000,000.

The exchange ratio will be equal

to (a) $155,000,000, divided by an assumed value of NorthView Common Stock of $10.00 per share.

Subject to certain future

revenue and stock-price based milestones, Profusa stockholders will have the right to receive an aggregate of up to an additional 3,875,000

shares of NorthView common stock (the “Earnout Shares”).

One-quarter of the Earnout Shares will be issued if, between the

18-month anniversary and the two year anniversary of the Closing, the combined company’s common stock achieves a daily volume weighted

average market price of at least $12.50 per share for any 20 trading days within a 30 consecutive trading day period (“Milestone

One-quarter of the Earnout Shares will be issued if, between the first and second anniversary of the Closing, the combined

company’s common stock achieves a daily volume weighted average market price of at least $14.50 per share for a similar number of

days (“Milestone Event II”).

One-quarter of the Earnout Shares will be issued upon the consummation of the Tasly JV (as defined

in the amended Merger Agreement) during fiscal year 2024, and one-quarter of the Earnout Shares will be issued if the combined company

achieves at least $99,702,000 in revenue in fiscal year 2025 (or up to one-half of the Earnout Shares if both revenue milestones are achieved).

Additionally, if Milestone

Event I or Milestone Event II are achieved by the second anniversary of the Closing, NorthView’s sponsor, NorthView Sponsor I, LLC

and Profusa stockholders, will be issued additional shares up to the amount of any shares forgone as an inducement to obtaining Additional

Financings (as defined in the Merger Agreement).

September 12, 2023, the parties to the Merger Agreement entered into Amendment No.

1 to the Merger Agreement (the “Amendment”)

pursuant to which the parties agreed to revise the revenue earnout milestones to reflect updated projections provided by Profusa.

Specifically,

Amendment No.

1 revised the definition of “Milestone Event III” and “Milestone Event IV” such that one-quarter

of the Earnout Shares would be issued to Profusa stockholders if the combined company achieves Earnout Revenue of $11,864,000 for the

fiscal year ended December 31, 2024, and one-quarter of the Earnout Shares would be issued to Profusa stockholders if the combined company

achieves Earnout Revenue of $99,702,000 for the fiscal year ended December 31, 2025.

Amendment No.

1 also clarified the exercise price

of certain of the Company’s Warrants.

On January 12, 2024, the

parties to the Merger Agreement entered into Amendment No.

2 to the Merger Agreement (the “Amendment”) pursuant to which

the parties agreed to revise the definition of “Milestone Event III” and such that the Earnout Revenue milestone of $11,864,000

for the fiscal year ended December 31, 2024, was replaced with a milestone requiring consummation of the Tasly JV (a joint venture contemplated

among Profusa and Tasly (International) Healthcare Capital Company Limited, as described in the Amendment) and receipt of the related

funding during the fiscal year ended December 31, 2024.

Amendment No.

2 also extended the Outside Date (the date by which the Business

Combination must be consummated, otherwise the Merger Agreement becomes terminable by Profusa or the Company) from September 21, 2023,

to June 22, 2024.

On March 4, 2024, the parties to the Merger

Agreement entered into an Amendment No.

3 to the Merger Agreement (“Amendment No.

3 to the Merger Agreement”) pursuant

to which the parties agreed to revise the Company Reference Value to adjust for financing proceeds and debt conversions that could be

received by Profusa prior to the Business Combination.

On March 14, 2024, NorthView filed a Current Report on Form 8-K regarding

Amendment No.

3 to the Merger Agreement with the SEC.

On February 11, 2025, the

parties to the Merger Agreement entered into an Amendment No.

4 to the Merger Agreement (“Amendment No.

4 to the Merger Agreement”)

pursuant to which the parties agreed to revise the Company Reference Value to adjust for financing proceeds that could be received by

Profusa prior to the Business Combination, along with debt conversions and incentive shares being issued that.

On February 19, 2025, NorthView

filed a Current Report on Form 8-K regarding Amendment No.

4 to the Merger Agreement with the SEC.

Extension Meeting

The Company initially had

15 months from the closing of its initial public offering to complete a Business Combination.

On March 10, 2023, the Company held a vote

to amend its amended and restated certificate of incorporation to extend the date by which the Company must consummate a Business Combination

from March 22, 2023 to December 22, 2023 (the “First Extension Meeting”).

On December 21, 2023, the Company held a vote to

amend its amended and restated certificate of incorporation to extend the date by which the Company must consummate a Business Combination

from December 22, 2023 to March 22, 2024 (the “Second Extension Meeting”).

On March 21, 2024, the Company held a vote

to amend its amended and restated certificate of incorporation to extend the date by which the Company must consummate a Business Combination

from March 22, 2023 to September 22, 2024 (the “Third Extension Meeting”).

On September 19, 2024, the Company held a

vote to amend its amended and restated certificate of incorporation to extend the date by which the Company must consummate a Business

Combination from September 22, 2024 to March 22, 2025 (the “Fourth Extension Meeting”).

On March 21, 2025, the Company had

the Special Meeting.

At the Special Meeting, shareholders approved an extension for the Company to consummate an initial business combination

from March 22, 2025 to June 22, 2025 (the “Fifth Extension Meeting”).

If the Company is unable to complete a Business Combination

within the Combination Period, the Company will (i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably

possible but not more than ten business days thereafter, redeem the Public Shares, at a per-share price, payable in cash, equal to the

aggregate amount then on deposit in the Trust Account including interest earned on the funds held in the Trust Account and not previously

released to the Company to pay taxes, divided by the number of then outstanding Public Shares, which redemption will completely extinguish

public stockholders’ rights as stockholders (including the right to receive further liquidating distributions, if any), subject

to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject to the approval of the Company’s

remaining stockholders and the Company’s board of directors, dissolve and liquidate, subject in each case to the Company’s

obligations under Delaware law to provide for claims of creditors and the requirements of other applicable law.

Nasdaq Delisting

On December 20, 2024, NorthView

received a delisting determination letter from Nasdaq as the 36-month anniversary from its IPO has passed on December 27, 2024, and NorthView’s

securities were suspended from trading and delisted from Nasdaq.

As of the same date, NorthView’s securities started being quoted

Our Sponsors and Competitive Advantages

We believe that the combination

of a high-quality management team with extensive operational, financial, merger and acquisition, and public company experience, combined

with the resources of a high quality investment bank focused on evaluating and assisting quality private companies to access the public

markets, is an attractive format.

It is particularly important that our management team and our sponsor have successfully worked together

It is also important that our sponsor, management team and directors have deep experience, contacts and relationships in

the healthcare sector.

Opportunity & Acquisition Target Criteria

We will seek to acquire small

cap businesses in the biopharmaceutical, medical technology/device industries or diagnostic and other services sector.

We believe these

industries are attractive for a number of reasons, including:

they represent attractive markets, which are characterized by a high level

of innovation and they include a large number of emerging high growth companies that have the right size as potential targets.

We believe our structure will

make us an attractive business combination partner to target businesses.

As an existing public company, we offer a target business an

alternative to the traditional initial public offering through a merger or other business combination.

In this situation, the owners of

the target business would exchange their shares of stock in the target business for shares of our stock or for a combination of shares

of our stock and cash, allowing us to tailor the consideration to the specific needs of the sellers.

We believe target businesses might

find this method a more certain and cost-effective method to becoming a public company than the typical initial public offering.

once the business combination is consummated, the target business will have effectively become public, whereas an initial public offering

is always subject to the underwriters’ ability to complete the offering, as well as general market conditions that could prevent

the offering from occurring.

Once public, we believe the target business should then have greater access to capital and an additional

means of providing management incentives consistent with stockholders’ interests than it would have as a privately held company.

It can offer further benefits by augmenting a company’s profile among potential new customers and vendors and aid in attracting

talented employees.

While we believe that our

status as a public company will make us an attractive business partner, some potential target businesses may view the inherent limitations

in our status as a blank check company as a deterrent and may prefer to affect a business combination with a more established entity or

with a private company.

These inherent limitations include limitations on our available financial resources, which may be inferior to

those of other entities pursuing the acquisition of similar target businesses;

the requirement that we seek stockholder approval of a

business combination or conduct a tender offer in relation thereto, which may delay the consummation of a transaction;

and the existence

of our outstanding rights and warrants, which may represent a source of future dilution.

Our Acquisition Process

In evaluating a prospective

target business, we expect to conduct a thorough due diligence review that will encompass, among other things, meetings with incumbent

management and employees, document reviews, inspection of facilities, as well as a review of financial and other information that will

be made available to us.

In conducting our due diligence review, we intend to leverage the experience of members of our management team,

directors, sponsors and advisors on an efficient and cost-effective basis as we deploy them to review matters related to their specific

areas of functional expertise.

We are not prohibited from

pursuing an initial business combination with a company that is affiliated with our advisors or our sponsor, officers or directors.

the event we seek to complete our initial business combination with a company that is affiliated with our officers or directors, we, or

a committee of independent directors, will obtain an opinion from an independent investment banking firm which is a member of the Financial

Industry Regulatory Authority, or FINRA, or an independent accounting firm that our initial business combination is fair to our company

from a financial point of view.

Members of our management

team and our independent directors directly or indirectly own founder shares and/or private placement warrants following our initial public

offering and, accordingly, may have a conflict of interest in determining whether a particular target business is an appropriate business

with which to effectuate our initial business combination.

Further, each of our officers and directors may have a conflict of interest

with respect to evaluating a particular business combination target if the retention or resignation of any such officers and directors

was included by a target business as a condition to any agreement with respect to our initial business combination.

Initial Business Combination

So long as we maintain a listing

for our securities on Nasdaq, our initial business combination must be with one or more target businesses that together have an aggregate

fair market value equal to at least 80% of the value of the assets held in the trust account (excluding taxes payable on the interest

earned on the trust account) at the time of our signing a definitive agreement in connection with our initial business combination.

our board is not able to independently determine the fair market value of the target business or businesses, we will obtain an opinion

from an independent investment banking firm that is a member of FINRA or an independent accounting firm with respect to the satisfaction

of such criteria.

Additionally, pursuant to Nasdaq rules, any initial business combination must be approved by a majority of our independent

We anticipate structuring

our initial business combination so that the post-transaction company in which our public stockholders own shares will own or acquire

100% of the equity interests or assets of the target business or businesses.

We may, however, structure our initial business combination

such that the post-transaction company owns or acquires less than 100% of such interests or assets of the target business in order to

meet certain objectives of the target management team or stockholders or for other reasons.

However, we will only complete such business

combination if the post-transaction company owns or acquires 50% or more of the outstanding voting securities of the target or otherwise

acquires a controlling interest in the target sufficient for it not to be required to register as an investment company under the Investment

Company Act of 1940, as amended, or the Investment Company Act.

Even if the post-transaction company owns or acquires 50% or more of the

voting securities of the target, our stockholders prior to the business combination may collectively own a minority interest in the post-transaction

company, depending on valuations ascribed to the target and us in the business combination transaction.

For example, we could pursue a

transaction in which we issue a substantial number of new shares in exchange for all of the outstanding capital stock of a target.

this case, we would acquire a 100% controlling interest in the target.

However, as a result of the issuance of a substantial number of

new shares, our stockholders immediately prior to our initial business combination could own less than a majority of our outstanding shares

subsequent to our initial business combination.

If less than 100% of the equity interests or assets of a target business or businesses

are owned or acquired by the post-transaction company, the portion of such business or businesses that is owned or acquired is what will

be valued for purposes of the 80% of net assets test.

If the business combination involves more than one target business, the 80% of net

assets test will be based on the aggregate value of all of the target businesses and we will treat the target businesses together as the

initial business combination for purposes of a tender offer or for seeking stockholder approval, as applicable.

Financial Position

We had funds available in

the Trust Account for a business combination of approximately $8.3 million, as of December 31, 2024.

On March 21, 2025, the Company’s

stockholders elected to redeem 532,958 public shares of Common Stock in connection with the extension of our business combination

period for up to three months, from March 22, 2025, ultimately until as late as June 22, 2025.

In connection with this

extension, the Company is required to make a one-time contribution of $30,000 to the Trust Account for the entire extension period, which

occurred on March 21, 2025.

Following the extension, we have available funds in the Trust Account of approximately $1.9 million as of

March 21, 2025.

This amount includes $2.0 million of the business combination marketing fee payable to I-Bankers and Dawson James, payable

in cash upon the Closing of our business combination with Profusa.

As the business combination marketing fee exceeds the funds available

in the Trust Account, the Company is expected to use proceeds from a private financing to pay a portion of the business combination marketing

fee at the closing of the business combination.

Lack of Business Diversification

For an indefinite period of

time after the completion of our initial business combination, the prospects for our success may depend entirely on the future performance

of a single business.

Unlike other entities that

have the resources to complete business combinations with multiple entities in one or several industries, it is probable that we will

not have the resources to diversify our operations and mitigate the risks of being in a single line of business.

By completing our initial

business combination with only a single entity, our lack of diversification may:

us to negative economic, competitive and regulatory developments, any or all of which may have a substantial adverse impact on the particular

industry in which we operate after our initial business combination, and

us to depend on the marketing and sale of a single product or limited number of products or services.

Limited ability to evaluate the target’s

management team

Although we intend to closely

scrutinize the management of a prospective target business when evaluating the desirability of effecting our business combination with

that business, our assessment of the target business’ management may not prove to be correct.

In addition, the future management

may not have the necessary skills, qualifications or abilities to manage a public company.

Furthermore, the future role of members of

our management team, if any, in the target business cannot presently be stated with any certainty.

While it is possible that one or more

of our directors will remain associated in some capacity with us following our business combination, it is unlikely that any of them will

devote their full efforts to our affairs subsequent to our business combination.

Moreover, we cannot assure you that members of our management

team will have significant experience or knowledge relating to the operations of the particular target business.

We cannot assure you that

any of our key personnel will remain in senior management or advisory positions with the combined company.

The determination as to whether

any of our key personnel will remain with the combined company will be made at the time of our initial business combination.

Following a business combination,

we may seek to recruit additional managers to supplement the incumbent management of the target business.

We cannot assure you that we

will have the ability to recruit additional managers, or that additional managers will have the requisite skills, knowledge or experience

necessary to enhance the incumbent management.

Stockholders may not have the ability to approve

our initial business combination

We may conduct redemptions

without a stockholder vote pursuant to the tender offer rules of the SEC.

However, we will seek stockholder approval if it is required

by law or applicable stock exchange rule, or we may decide to seek stockholder approval for business or other legal reasons.

in the table below is a graphic explanation of the types of initial business combinations we may consider and whether stockholder approval

is currently required under Delaware law for each such transaction.

Type of Transaction

Whether Stockholder

Approval is Required

Purchase of assets

Purchase of stock of target not involving a merger with the company

Merger of target into a subsidiary of the company

Merger of the company with a target

Under Nasdaq’s listing

rules, stockholder approval would be required for our initial business combination if, for example:

issue shares of common stock that will be equal to or in excess of 20% of the number of shares of our common stock then outstanding (other

than in a public offering);

of our directors, officers or substantial stockholders (as defined by Nasdaq rules) has a 5% or greater interest (or such persons collectively

have a 10% or greater interest), directly or indirectly, in the target business or assets to be acquired or otherwise and the present

or potential issuance of common stock could result in an increase in outstanding common shares or voting power of 5% or more;

issuance or potential issuance of common stock will result in our undergoing a change of control.

Permitted purchases of our securities

In the event we seek stockholder

approval of our business combination and we do not conduct redemptions in connection with our business combination pursuant to the tender

offer rules, our initial stockholders, directors, officers, advisors or their affiliates may purchase shares in privately negotiated transactions

or in the open market either prior to or following the completion of our initial business combination.

However, they have no current commitments,

plans or intentions to engage in such transactions and have not formulated any terms or conditions for any such transactions.

the funds in the trust account will be used to purchase shares in such transactions.

They will not make any such purchases when they are

in possession of any material non-public information not disclosed to the seller or if such purchases are prohibited by Regulation M under

the Exchange Act.

Such a purchase may include a contractual acknowledgement that such stockholder, although still the record holder of

our shares is no longer the beneficial owner thereof and therefore agrees not to exercise its redemption rights.

We have an insider trading

policy that requires insiders to:

(i) refrain from purchasing shares during certain blackout periods and when they are in possession of

any material non-public information and (ii) to clear all trades with our legal counsel prior to execution.

We cannot currently determine

whether our insiders will make such purchases pursuant to a Rule 10b5-1 plan, as it will be dependent upon several factors, including

but not limited to, the timing and size of such purchases.

Depending on such circumstances, our insiders may either make such purchases

pursuant to a Rule 10b5-1 plan or determine that such a plan is not necessary.

In the event that our initial

stockholders, directors, officers, advisors or their affiliates purchase shares in privately negotiated transactions from public stockholders

who have already elected to exercise their redemption rights, such selling stockholders would be required to revoke their prior elections

to redeem their shares.

We do not currently anticipate that such purchases, if any, would constitute a tender offer subject to the tender

offer rules under the Exchange Act or a going-private transaction subject to the going-private rules under the Exchange Act;

if the purchasers determine at the time of any such purchases that the purchases are subject to such rules, the purchasers will comply

with such rules.

The purpose of such purchases

would be to (i) vote such shares in favor of the business combination and thereby increase the likelihood of obtaining stockholder approval

of the business combination or (ii) to satisfy a closing condition in an agreement with a target that requires us to have a minimum net

worth or a certain amount of cash at the closing of our business combination, where it appears that such requirement would otherwise not

This may result in the completion of our business combination that may not otherwise have been possible.

In addition, if such purchases

are made, the public “float” of our common stock may be reduced and the number of beneficial holders of our securities may

be reduced, which may make it difficult to maintain or obtain the quotation, listing or trading of our securities on a national securities

Our initial stockholders,

officers, directors and/or their affiliates anticipate that they may identify the stockholders with whom our initial stockholders, officers,

directors or their affiliates may pursue privately negotiated purchases by either the stockholders contacting us directly or by our receipt

of redemption requests submitted by stockholders following our mailing of proxy materials in connection with our initial business combination.

To the extent that our initial stockholders, officers, directors, advisors or their affiliates enter into a private purchase, they would

identify and contact only potential selling stockholders who have expressed their election to redeem their shares for a pro rata share

of the trust account or vote against the business combination.

Our initial stockholders, officers, directors, advisors or their affiliates

will only purchase shares if such purchases comply with Regulation M under the Exchange Act and the other federal securities laws.

Any purchases by our initial

stockholders, officers, directors and/or their affiliates who are affiliated purchasers under Rule 10b-18 under the Exchange Act will

only be made to the extent such purchases are able to be made in compliance with Rule 10b-18, which is a safe harbor from liability for

manipulation under Section 9(a)(2) and Rule 10b-5 of the Exchange Act.

Rule 10b-18 has certain technical requirements that must be complied

with in order for the safe harbor to be available to the purchaser.

Our initial stockholders, officers, directors and/or their affiliates

will not make purchases of common stock if the purchases would violate Section 9(a)(2) or Rule 10b-5 of the Exchange Act.

Redemption Rights for Public Stockholders Upon

Completion of Our Initial Business Combination

In connection with a special meeting of NorthView stockholders, held

on March 10, 2023, the NorthView stockholders elected to redeem 18,000,868 public shares of NorthView Common Stock and to extend NorthView’s

business combination period monthly, for up to nine months, from March 22, 2023, ultimately until as late as December 22, 2023.

on December 21, 2023, the NorthView stockholders elected to redeem 140,663 public shares of NorthView Common Stock in connection with

a shareholder meeting, related to the extension of NorthView’s business combination period monthly, for up to three months, from

December 22, 2023, ultimately until as late as March 22, 2024.

Additionally, the NorthView stockholders elected to redeem 95,394 public

shares of NorthView Common Stock in connection with a shareholder meeting on March 21, 2024, related to the extension of NorthView’s

business combination period monthly, for up to six months, from March 22, 2024, ultimately until as late as September 22,

On September 19, 2024, the NorthView stockholders elected to redeem 50,556 public shares of NorthView Common Stock in

connection with the extension of NorthView’s business combination period monthly, for up to six months, from September 22,

2024, ultimately until as late as March 22, 2025.

The aggregate of 18,287,481 public shares redeemed in connection with the Extension

represented approximately 75.7% of the total NorthView shares of common stock outstanding following NorthView’s IPO and approximately

96.4% of the public shares previously outstanding.

As of December 31, 2024, NorthView had 687,519 public shares of NorthView Common Stock

outstanding, and held approximately $8.3 million in the Trust Account.

In connection with this Extension, each monthly extension shall

require NorthView or its designee to contribute $0.05, per public share outstanding, to the Trust account.

We will provide our public

stockholders with the opportunity to redeem all or a portion of their shares of common stock upon the completion of our initial business

combination at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account as of two business

days prior to the consummation of the initial business combination, including interest (which interest shall be net of taxes payable)

divided by the number of then outstanding public shares, subject to the limitations described herein.

The amount in the trust account

was initially approximately $10.10 per public share.

This amount has increased as a result of contributions to the trust account in connection

with the Extension, as well as interest earned on the amounts held in the trust account.

The per share amount we will distribute to stockholders

who properly exercise their redemption rights will not be reduced by the fee payable to I-Bankers and Dawson James pursuant to the business

combination marketing agreement.

Our sponsor, officers and directors have entered into a letter agreement with us, pursuant to which they

have agreed to waive their redemption rights with respect to their founder shares and any public shares they may hold in connection with

the completion of our business combination, although they will be entitled to liquidating distributions from the trust account with respect

to any public shares they hold if we fail to complete our initial business combination within the prescribed time frame.

Ability to Extend Time to Complete Business

We will have until the end

of the combination period to consummate our initial business combination.

However, if we anticipate that we may not be able to consummate

our initial business combination within 15 months from our initial public offering, we may, by resolution of our board if requested by

our sponsor, extend the period of time to consummate a business combination up to two times, each by an additional three months (for a

total of up to 21 months to complete a business combination), subject to the sponsor depositing additional funds into the trust account

as set out below.

In connection with a special meeting of NorthView stockholders, held on March 10, 2023, the NorthView stockholders elected

to redeem 18,000,868 public shares of NorthView Common Stock and to extend NorthView’s business combination period monthly, for

up to nine months, from March 22, 2023, ultimately until as late as December 22, 2023.

Separately, on December 21, 2023, the NorthView

stockholders elected to redeem 140,663 public shares of NorthView Common Stock in connection with a shareholder meeting, related to the

extension of NorthView’s business combination period monthly, for up to three months, from December 22, 2023, ultimately until as

late as March 22, 2024.

Additionally, the NorthView stockholders elected to redeem 95,394 public shares of NorthView Common Stock in connection

with a shareholder meeting on March 21, 2024, related to the extension of NorthView’s business combination period monthly,

for up to six months, from March 22, 2024, ultimately until as late as September 22, 2024.

On September 19, 2024,

the NorthView stockholders elected to redeem 50,556 public shares of NorthView Common Stock in connection with the extension of NorthView’s

business combination period monthly, for up to six months, from September 22, 2024, ultimately until as late as March 22,

On March 21, 2025, the NorthView stockholders elected to redeem 532,958 public shares of NorthView Common Stock in connection with

the extension of NorthView’s business combination period from March 22, 2025, until as late as June 22, 2025.

At the time of the

stockholder vote on March 21, 2025, NorthView’s stockholders redeemed 9.1% of the total outstanding shares.

The aggregate of 18,820,439

public shares redeemed in connection with the Extension represented approximately 77.9% of the total NorthView shares of common stock

outstanding following NorthView’s IPO and approximately 99.2% of the public shares previously outstanding.

In connection with this

extensions, NorthView or its designee to contributed funds to the Trust Account.

Any such payments have been and will be made in the form

Any such loans will be non-interest bearing and payable upon the consummation of our initial business combination.

If we complete

our initial business combination, we would repay such loaned amounts out of the proceeds of the Trust Account released to us.

not complete a business combination, we will not repay such loans.

Furthermore, the letter agreement with our initial stockholders contains

a provision pursuant to which our sponsor has agreed to waive its right to be repaid for such loans out of the funds held in the Trust

Account in the event that we do not complete a business combination.

In the event that we receive notice from our sponsor five days prior

to the applicable deadline of its wish for us to effect an extension, we intend to issue a press release announcing such intention at

least three days prior to the applicable deadline.

In addition, we intend to issue a press release the day after the applicable deadline

announcing whether or not the funds had been timely deposited.

Our sponsor and its affiliates or designees are not obligated to fund the

Trust Account to extend the time for us to complete our initial business combination.

If we choose to extend the period of time to consummate

a business combination as set forth herein, you will not have the ability to vote or redeem your shares of common stock in connection

with either of the three-month extensions.

However, if we seek to complete a business combination during an extension period, investors

will still be able to vote and redeem their shares of common stock in connection with that business combination.

See “Recent Developments

- Extension Meeting” above for information about our extension of the combination period from our shareholders.

Manner of Conducting Redemptions

We will provide our public

stockholders with the opportunity to redeem all or a portion of their shares of common stock upon the completion of our initial business

combination either (i) in connection with a stockholder meeting called to approve the business combination or (ii) by means of a tender

The decision as to whether we will seek stockholder approval of a proposed business combination or conduct a tender offer will

be made by us, solely in our discretion, and will be based on a variety of factors such as the timing of the transaction and whether the

terms of the transaction would require us to seek stockholder approval under the law or stock exchange listing requirement.

rules, asset acquisitions and stock purchases would not typically require stockholder approval while direct mergers with our company where

we do not survive and any transactions where we issue more than 20% of our outstanding common stock or seek to amend our amended and restated

certificate of incorporation would require stockholder approval.

We may conduct redemptions without a stockholder vote pursuant to the

tender offer rules of the SEC unless stockholder approval is required by law or stock exchange listing requirement or we choose to seek

stockholder approval for business or other legal reasons.

So long as we obtain and maintain a listing for our securities on Nasdaq, we

would be required to comply with such rules.

If a stockholder vote is not

required and we do not decide to hold a stockholder vote for business or other legal reasons, we will, pursuant to our amended and restated

certificate of incorporation:

the redemptions pursuant to Rule 13e-4 and Regulation 14E of the Exchange Act, which regulate issuer tender offers, and

tender offer documents with the SEC prior to completing our initial business combination which contain substantially the same financial

and other information about the initial business combination and the redemption rights as is required under Regulation 14A of the Exchange

Act, which regulates the solicitation of proxies.

Upon the public announcement

of our initial business combination, we or our initial stockholders will terminate any plan established in accordance with Rule 10b5-1

to purchase shares of our common stock in the open market if we elect to redeem our public shares through a tender offer, to comply with

Rule 14e-5 under the Exchange Act.

In the event we conduct redemptions

pursuant to the tender offer rules, our offer to redeem will remain open for at least 20 business days, in accordance with Rule 14e-1(a)

under the Exchange Act, and we will not be permitted to complete our initial business combination until the expiration of the tender

offer period.

In addition, the tender offer will be conditioned on public stockholders not tendering more than a specified number of

public shares which are not purchased by our initial stockholders.

If public stockholders tender more shares than we have offered to

purchase, we will withdraw the tender offer and not complete the initial business combination.

If, however, stockholder approval

of the transaction is required by law or stock exchange listing requirement, or we decide to obtain stockholder approval for business

or other legal reasons, we will, pursuant to our amended and restated certificate of incorporation:

the redemptions in conjunction with a proxy solicitation pursuant to Regulation 14A of the Exchange Act, which regulates the solicitation

of proxies, and not pursuant to the tender offer rules, and

proxy materials with the SEC.

In the event that we seek

stockholder approval of our initial business combination, we will distribute proxy materials and, in connection therewith, provide our

public stockholders with the redemption rights described above upon completion of the initial business combination.

If we seek stockholder approval,

we will complete our initial business combination only if a majority of the outstanding shares of common stock voted are voted in favor

of the business combination.

A quorum for such meeting will consist of the holders present in person or by proxy of shares of outstanding

capital stock of the company representing a majority of the voting power of all outstanding shares of capital stock of the company entitled

to vote at such meeting.

Our sponsor, executive officers and directors will count toward this quorum and have agreed to vote their founder

shares and any public shares purchased during or after our initial public offering in favor of our initial business combination.

quorum and voting thresholds, and the voting agreements of our sponsor, executive officers and directors may make it more likely that

we will consummate our initial business combination.

Each public stockholder may elect to redeem its public shares irrespective of whether

they vote for or against the proposed transaction.

In addition, our sponsor, officers and directors have entered into a letter agreement

with us, pursuant to which they have agreed to waive their redemption rights with respect to their founder shares and public shares in

connection with the completion of a business combination.

Redemptions of our public

shares may also be subject to a net tangible asset test or cash requirement pursuant to an agreement relating to our initial business

For example, the proposed business combination may require:

(i) cash consideration to be paid to the target or its owners,

(ii) cash to be transferred to the target for working capital or other general corporate purposes or (iii) the retention of cash to satisfy

other conditions in accordance with the terms of the proposed business combination.

In the event the aggregate cash consideration we

would be required to pay for all shares of common stock that are validly submitted for redemption plus any amount required to satisfy

cash conditions pursuant to the terms of the proposed business combination exceed the aggregate amount of cash available to us, we will

not complete the business combination or redeem any shares, and all shares of common stock submitted for redemption will be returned

to the holders thereof.

Limitation on redemption upon completion of

our initial business combination if we seek stockholder approval

Notwithstanding the foregoing,

if we seek stockholder approval of our initial business combination and we do not conduct redemptions in connection with our business

combination pursuant to the tender offer rules, our amended and restated certificate of incorporation provides that a public stockholder,

together with any affiliate of such stockholder or any other person with whom such stockholder is acting in concert or as a “group”

(as defined under Section 13 of the Exchange Act), will be restricted from seeking redemption rights with respect to Excess Shares.

believe this restriction will discourage stockholders from accumulating large blocks of shares, and subsequent attempts by such holders

to use their ability to exercise their redemption rights against a proposed business combination as a means to force us, our initial stockholders

or our management to purchase their shares at a significant premium to the then-current market price or on other undesirable terms.

this provision, a public stockholder holding an aggregate of 15% or more of the shares sold in our initial public offering could threaten

to exercise its redemption rights if such holder’s shares are not purchased by us, our initial stockholders or our management at

a premium to the then-current market price or on other undesirable terms.

By limiting our stockholders’ ability to redeem to less

than 15% of the shares sold in our initial public offering, we believe we will limit the ability of a small group of stockholders to unreasonably

attempt to block our ability to complete our business combination, particularly in connection with a business combination with a target

that requires as a closing condition that we have a minimum net worth or a certain amount of cash.

However, we would not be restricting

our stockholders’ ability to vote all of their shares (including Excess Shares) for or against our business combination.

Tendering stock certificates in connection

with a tender offer or redemption rights

We may require our public

stockholders seeking to exercise their redemption rights, whether they are record holders or hold their shares in “street name,”

to either tender their certificates to our transfer agent prior to the date set forth in the tender offer documents mailed to such holders,

or up to two business days prior to the vote on the proposal to approve the business combination in the event we distribute proxy materials,

or to deliver their shares to the transfer agent electronically using Depository Trust Company’s DWAC (Deposit/Withdrawal At Custodian)

System, at the holder’s option.

The tender offer or proxy materials, as applicable, that we will furnish to holders of our public

shares in connection with our initial business combination will indicate whether we are requiring public stockholders to satisfy such

delivery requirements.

Accordingly, a public stockholder would have from the time we send out our tender offer materials until the close

of the tender offer period, or up to two business days prior to the vote on the business combination if we distribute proxy materials,

as applicable, to tender its shares if it wishes to seek to exercise its redemption rights.

Given the relatively short exercise period,

it is advisable for stockholders to use electronic delivery of their public shares.

There is a nominal cost associated

with the above-referenced tendering process and the act of certificating the shares or delivering them through the DWAC System.

agent will typically charge the tendering broker and it would be up to the broker whether or not to pass the cost on to the redeeming

However, the fee would be incurred regardless of whether or not we require holders seeking to exercise redemption rights to tender

their shares.

The need to deliver shares is a requirement of exercising redemption rights regardless of the timing of when such delivery

must be effectuated.

The foregoing is different

from the procedures used by some blank check companies.

In order to perfect redemption rights in connection with their business combinations,

many blank check companies would distribute proxy materials for the stockholders’ vote on an initial business combination, and a

holder could simply vote against a proposed business combination and check a box on the proxy card indicating such holder was seeking

to exercise his or her redemption rights.

After the business combination was approved, the company would contact such stockholder to arrange

for him or her to deliver his or her certificate to verify ownership.

As a result, the stockholder then had an “option window”

after the completion of the business combination during which he or she could monitor the price of the company’s stock in the market.

If the price rose above the redemption price, he or she could sell his or her shares in the open market before actually delivering his

or her shares to the company for cancellation.

As a result, the redemption rights, to which stockholders were aware they needed to commit

before the stockholder meeting, would become “option” rights surviving past the completion of the business combination until

the redeeming holder delivered its certificate.

The requirement for physical or electronic delivery prior to the meeting ensures that

a redeeming holder’s election to redeem is irrevocable once the business combination is approved.

Any request to redeem such

shares, once made, may be withdrawn at any time up to the date set forth in the tender offer materials or the date of the stockholder

meeting set forth in our proxy materials, as applicable.

Furthermore, if a holder of a public share delivered its certificate in connection

with an election of redemption rights and subsequently decides prior to the applicable date not to elect to exercise such rights, such

holder may simply request that the transfer agent return the certificate (physically or electronically).

It is anticipated that the funds

to be distributed to holders of our public shares electing to redeem their shares will be distributed promptly after the completion of

our initial business combination.

If our initial business combination

is not approved or completed for any reason, then our public stockholders who elected to exercise their redemption rights would not be

entitled to redeem their shares for the applicable pro rata share of the trust account.

In such case, we will promptly return any certificates

delivered by public holders who elected to redeem their shares.

If our initial business combination

is not completed, we may continue to try to complete a business combination with a different target until the end of the combination period.

Redemption of public shares and liquidation

if no initial business combination

We will have only until the

end of the combination period to complete our initial business combination.

If we are unable to complete our initial business combination

within the combination period, we will:

(i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably

possible but not more than ten business days thereafter, redeem the public shares, at a per-share price, payable in cash, equal to the

aggregate amount then on deposit in the trust account, including interest (less up to $100,000 of interest to pay dissolution expenses,

which interest shall be net of taxes payable) divided by the number of then outstanding public shares, which redemption will completely

extinguish public stockholders’ rights as stockholders (including the right to receive further liquidation distributions, if any),

subject to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject to the approval of our remaining

stockholders and our board of directors, dissolve and liquidate, subject in each case to our obligations under Delaware law to provide

for claims of creditors and the requirements of other applicable law.

There will be no redemption rights or liquidating distributions

with respect to our rights and warrants, which will expire worthless if we fail to complete our initial business combination within the

combination period.

Our initial stockholders have

agreed to waive their rights to liquidating distributions from the trust account with respect to their founder shares if we fail to complete

our initial business combination within the combination period.

However, if our initial stockholders acquire public shares in or after

our initial public offering, they will be entitled to liquidating distributions from the trust account with respect to such public shares

if we fail to complete our initial business combination within the allotted combination period.

Our sponsor, officers and

directors have agreed, pursuant to a written letter agreement with us, that they will not propose any amendment to our amended and restated

certificate of incorporation that would affect (i) the substance or timing of our obligation to redeem 100% of our public shares if we

do not complete our initial business combination within the combination period or (ii) with respect to any other provision relating to

stockholders’ rights or pre-business combination activity, unless we provide our public stockholders with the opportunity to redeem

their shares of common stock upon approval of any such amendment at a per-share price, payable in cash, equal to the aggregate amount

then on deposit in the trust account, including interest (which interest shall be net of taxes payable) divided by the number of then

outstanding public shares.

We expect that all costs and

expenses associated with implementing our plan of dissolution, as well as payments to any creditors, will be funded from amounts remaining

out of the proceeds held outside the trust account, although we cannot assure you that there will be sufficient funds for such purpose.

However, if those funds are not sufficient to cover the costs and expenses associated with implementing our plan of dissolution, to the

extent that there is any interest accrued in the trust account not required to pay taxes, we may request the trustee to release to us

an additional amount of up to $100,000 of such accrued interest to pay those costs and expenses.

If we were to expend all of

the net proceeds of our initial public offering and the private placement, other than the proceeds deposited in the trust account, and

without taking into account interest, if any, earned on the trust account, the per-share redemption amount received by stockholders upon

our dissolution would be approximately $10.10.

The proceeds deposited in the trust account could, however, become subject to the claims

of our creditors which would have higher priority than the claims of our public stockholders.

We cannot assure you that the actual per-share

redemption amount received by stockholders will not be substantially less than $10.10.

Under Section 281(b) of the DGCL, our plan of dissolution

must provide for all claims against us to be paid in full or make provision for payments to be made in full, as applicable, if there are

sufficient assets.

These claims must be paid or provided for before we make any distribution of our remaining assets to our stockholders.

While we intend to pay such amounts, if any, we cannot assure you that we will have funds sufficient to pay or provide for all creditors’

Although we will seek to

have all vendors, service providers, prospective target businesses or other entities with which we do business execute agreements with

us waiving any right, title, interest or claim of any kind in or to any monies held in the trust account for the benefit of our public

stockholders, there is no guarantee that they will execute such agreements or even if they execute such agreements that they would be

prevented from bringing claims against the trust account including but not limited to fraudulent inducement, breach of fiduciary responsibility

or other similar claims, as well as claims challenging the enforceability of the waiver, in each case in order to gain an advantage with

respect to a claim against our assets, including the funds held in the trust account.

If any third party refuses to execute an agreement

waiving such claims to the monies held in the trust account, our management will perform an analysis of the alternatives available to

it and will only enter into an agreement with a third party that has not executed a waiver if management believes that such third party’s

engagement would be significantly more beneficial to us than any alternative.

Examples of possible instances where we may engage a third

party that refuses to execute a waiver include the engagement of a third party consultant whose particular expertise or skills are believed

by management to be significantly superior to those of other consultants that would agree to execute a waiver or in cases where management

is unable to find a service provider willing to execute a waiver.

In addition, there is no guarantee that such entities will agree to

waive any claims they may have in the future as a result of, or arising out of, any negotiations, contracts or agreements with us and

will not seek recourse against the trust account for any reason.

In order to protect the amounts held in the trust account, our sponsor

has agreed that it will be liable to us if and to the extent any claims by a vendor for services rendered or products sold to us, or

a prospective target business with which we have discussed entering into a transaction agreement, reduce the amount of funds in the trust

account to below (i) $10.10 per public share or (ii) such lesser amount per public share held in the trust account as of the date of

the liquidation of the trust account, due to reductions in value of the trust assets, in each case net of the amount of interest which

may be withdrawn to pay taxes, except as to any claims by a third party who executed a waiver of any and all rights to seek access to

the trust account and except as to any claims under our indemnity of the underwriters of our initial public offering against certain

liabilities, including liabilities under the Securities Act.

In the event that an executed waiver is deemed to be unenforceable against

a third party, then our sponsor will not be responsible to the extent of any liability for such third-party claims.

We have not asked

our sponsor to reserve for such indemnification obligations, and our sponsor’s only assets are securities of our company.

we cannot assure you that our sponsor would be able to satisfy those obligations.

We believe the likelihood of our sponsor having to

indemnify the trust account is limited because we will endeavor to have all vendors and prospective target businesses as well as other

entities execute agreements with us waiving any right, title, interest or claim of any kind in or to monies held in the trust account.

In the event that the proceeds

in the trust account are reduced below (i) $10.10 per public share or (ii) such lesser amount per public share held in the trust account

as of the date of the liquidation of the trust account, due to reductions in value of the trust assets, in each case net of the amount

of interest which may be withdrawn to pay taxes, and our sponsor asserts that it is unable to satisfy its indemnification obligations

or that it has no indemnification obligations related to a particular claim, our independent directors would determine whether to take

legal action against our sponsor to enforce its indemnification obligations.

While we currently expect that our independent directors

would take legal action on our behalf against our sponsor to enforce its indemnification obligations to us, it is possible that our independent

directors in exercising their business judgment may choose not to do so in any particular instance.

Accordingly, we cannot assure you

that due to claims of creditors the actual value of the per-share redemption price will not be substantially less than $10.10 per share.

We will seek to reduce the

possibility that our sponsor will have to indemnify the trust account due to claims of creditors by endeavoring to have all vendors, service

providers, prospective target businesses or other entities with which we do business execute agreements with us waiving any right, title,

interest or claim of any kind in or to monies held in the trust account.

Our sponsor will also not be liable as to any claims under our

indemnity of the underwriters of our initial public offering against certain liabilities, including liabilities under the Securities Act.

We will not have significant funds remaining from the proceeds of our initial public offering with which to pay any such potential claims

(including costs and expenses incurred in connection with our liquidation, currently estimated to be no more than approximately $100,000).

In the event that we liquidate and it is subsequently determined that the reserve for claims and liabilities is insufficient, stockholders

who received funds from our trust account could be liable for claims made by creditors.

Under the DGCL, stockholders

may be held liable for claims by third parties against a corporation to the extent of distributions received by them in a dissolution.

The pro rata portion of our trust account distributed to our public stockholders upon the redemption of our public shares in the event

we do not complete our initial business combination within the combination period may be considered a liquidation distribution under Delaware

If the corporation complies with certain procedures set forth in Section 280 of the DGCL intended to ensure that it makes reasonable

provision for all claims against it, including a 60-day notice period during which any third-party claims can be brought against the corporation,

a 90-day period during which the corporation may reject any claims brought, and an additional 150-day waiting period before any liquidating

distributions are made to stockholders, any liability of stockholders with respect to a liquidating distribution is limited to the lesser

of such stockholder’s pro rata share of the claim or the amount distributed to the stockholder, and any liability of the stockholder

would be barred after the third anniversary of the dissolution.

Furthermore, if the pro rata

portion of our trust account distributed to our public stockholders upon the redemption of our public shares in the event we do not complete

our initial business combination within the combination period, is not considered a liquidation distribution under Delaware law and such

redemption distribution is deemed to be unlawful (potentially due to the imposition of legal proceedings that a party may bring or due

to other circumstances that are currently unknown), then pursuant to Section 174 of the DGCL, the statute of limitations for claims of

creditors could then be six years after the unlawful redemption distribution, instead of three years, as in the case of a liquidation

distribution.

If we are unable to complete our initial business combination within the combination period, we will:

(i) cease all operations

except for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the

public shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account, including interest

(net of the amount of interest which may be withdrawn to pay taxes, and less up to $100,000 of interest to pay dissolution expenses),

divided by the number of then outstanding public shares, which redemption will completely extinguish public stockholders’ rights

as stockholders (including the right to receive further liquidation distributions, if any), subject to applicable law, and (iii) as promptly

as reasonably possible following such redemption, subject to the approval of our remaining stockholders and our board of directors, dissolve

and liquidate, subject in each case to our obligations under Delaware law to provide for claims of creditors and the requirements of other

applicable law.

Accordingly, it is our intention to redeem our public shares as soon as reasonably possible following the combination

period and, therefore, we do not intend to comply with those procedures.

As such, our stockholders could potentially be liable for any

claims to the extent of distributions received by them (but no more) and any liability of our stockholders may extend well beyond the

third anniversary of such date.

Because we will not be complying

with Section 280, Section 281(b) of the DGCL requires us to adopt a plan, based on facts known to us at such time that will provide for

our payment of all existing and pending claims or claims that may be potentially brought against us within the subsequent 10 years.

because we are a blank check company, rather than an operating company, and our operations will be limited to searching for prospective

target businesses to acquire, the only likely claims to arise would be from our vendors (such as lawyers, investment bankers, etc.) or

prospective target businesses.

As described above, pursuant to the obligation contained in our underwriting agreement, we will seek to

have all vendors, service providers, prospective target businesses or other entities with which we do business execute agreements with

us waiving any right, title, interest or claim of any kind in or to any monies held in the trust account.

As a result of this obligation,

the claims that could be made against us are significantly limited and the likelihood that any claim that would result in any liability

extending to the trust account is remote.

Further, our sponsor may be liable only to the extent necessary to ensure that the amounts in

the trust account are not reduced below (i) $10.10 per public share or (ii) such lesser amount per public share held in the trust account

as of the date of the liquidation of the trust account, due to reductions in value of the trust assets, in each case net of the amount

of interest withdrawn to pay taxes, and will not be liable as to any claims under our indemnity of the underwriters of our initial public

offering against certain liabilities, including liabilities under the Securities Act.

In the event that an executed waiver is deemed to

be unenforceable against a third party, our sponsor will not be responsible to the extent of any liability for such third-party claims.

If we file a bankruptcy petition

or an involuntary bankruptcy petition is filed against us that is not dismissed, the proceeds held in the trust account could be subject

to applicable bankruptcy law, and may be included in our bankruptcy estate and subject to the claims of third parties with priority over

the claims of our stockholders.

To the extent any bankruptcy claims deplete the trust account, we cannot assure you we will be able to

return $10.10 per share to our public stockholders.

Additionally, if we file a bankruptcy petition or an involuntary bankruptcy petition

is filed against us that is not dismissed, any distributions received by stockholders could be viewed under applicable debtor/creditor

and/or bankruptcy laws as either a “preferential transfer” or a “fraudulent conveyance.” As a result, a bankruptcy

court could seek to recover some or all amounts received by our stockholders.

Furthermore, our board may be viewed as having breached

its fiduciary duty to our creditors and/or may have acted in bad faith, and thereby exposing itself and our company to claims of punitive

damages, by paying public stockholders from the trust account prior to addressing the claims of creditors.

We cannot assure you that claims

will not be brought against us for these reasons.

Our public stockholders will

be entitled to receive funds from the trust account only upon the earliest to occur of:

(i) the completion of our initial business combination,

(ii) the redemption of any public shares properly tendered in connection with a stockholder vote to amend our amended and restated certificate

of incorporation (A) to modify the substance or timing of our obligation to redeem 100% of our public shares if we do not complete our

initial business combination within the combination period or (B) with respect to any other provision relating to stockholders’

rights or pre-business combination activity, and (iii) the redemption of all of our public shares if we are unable to complete our initial

business combination within the combination period, subject to applicable law.

In no other circumstances will a stockholder have any right

or interest of any kind to or in the trust account.

In the event we seek stockholder approval in connection with our initial business

combination, a stockholder’s voting in connection with the business combination alone will not result in a stockholder’s redeeming

its shares to us for an applicable pro rata share of the trust account.

Such stockholder must have also exercised its redemption rights

described above.

We currently have two executive

Members of our management team are not obligated to devote any specific number of hours to our matters but they intend to devote

as much of their time as they deem necessary to our affairs until we have completed our initial business combination.

The amount of time

that any member of our management team will devote in any time period will vary based on whether a target business has been selected for

our initial business combination and the current stage of the business combination process.

Periodic Reporting and Financial Information

We have registered our common

stock, rights, and warrants under the Exchange Act and have reporting obligations, including the requirement that we file annual, quarterly

and current reports with the SEC.

In accordance with the requirements of the Exchange Act, our annual reports will contain consolidated

financial statements audited and reported on by our independent registered public auditors.

We will provide stockholders

with audited consolidated financial statements of the prospective target business as part of the tender offer materials or proxy solicitation

materials sent to stockholders to assist them in assessing the target business.

In all likelihood, these consolidated financial statements

will need to be prepared in accordance with GAAP.

We cannot assure you that any particular target business identified by us as a potential

acquisition candidate will have consolidated financial statements prepared in accordance with GAAP or that the potential target business

will be able to prepare its consolidated financial statements in accordance with GAAP.

To the extent that this requirement cannot be met,

we may not be able to acquire the proposed target business.

While this may limit the pool of potential acquisition candidates, we do not

believe that this limitation will be material.

We are now required to evaluate

our internal control procedures each fiscal year , which began with the fiscal year ending December 31, 2022 as required by the Sarbanes-Oxley

Only in the event we are deemed to be a large accelerated filer or an accelerated filer will we be required to have our internal

control procedures audited.

A target company may not be in compliance with the provisions of the Sarbanes-Oxley Act regarding adequacy

of their internal controls.

The development of the internal controls of any such entity to achieve compliance with the Sarbanes-Oxley

Act may increase the time and costs necessary to complete any such acquisition.

We are an “emerging

growth company,” as defined in Section 2(a) of the Securities Act, as modified by the JOBS Act.

As such, we are eligible to take

advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging

growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section

404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements,

and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any

golden parachute payments not previously approved.

If some investors find our securities less attractive as a result, there may be a less

active trading market for our securities and the prices of our securities may be more volatile.

In addition, Section 107 of

the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided

in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.

In other words, an “emerging

growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We intend to take advantage of the benefits of this extended transition period.

We will remain an emerging

growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial

public offering, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large

accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior

June 30 th , and (2) the date on which we have issued more than $1.00 billion in non-convertible debt securities during the prior

three-year period.

References herein to “emerging growth company” shall have the meaning associated with it in the JOBS Act.

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.”

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 Lumee™

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

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.

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.

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.

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.

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 .”

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.

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.

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

term product revenue in Europe from the CE approved Lumee Oxygen which measures dissolved

tissue oxygen for up to six months following sensor injection.

Initial product uses include

application for the management of wound care for critical limb ischemia patients in surgical

settings, followed by use in ambulatory settings, subject to future regulatory approval.

Profusa estimates that the current total addressable market size for critical limb ischemia

across the United States and European Union is approximately five million patients.

anticipates beginning commercialization of Lumee Oxygen in Europe in early 2026 and continuing

study for submission for U.S.

FDA marketing authorization late 2026.

may not be commercialized in the U.S.

until FDA marketing authorization has been obtained.

product revenues from Profusa’s second product, Lumee Glucose, a continuous glucose

monitoring platform, that will provide real time glucose levels for patients suffering from

diabetes, subject to regulatory approval.

Profusa has generated proof-of-concept clinical

data from 54 diabetes subjects over four clinical sites (two in Europe and two in Asia) in

human trials during the time period 2019 -2022.

Using Profusa’s current data analytics

algorithm, the glucose platform has demonstrated potential for mean absolute relative difference

(MARD) of approximately 11% with up to nine months of functionality post injection.

there have been zero incidences of device-related severe adverse events (SAE).

Profusa anticipates

the start of its next validation study in the first half of 2026 and regulatory submission

in early 2026.

Profusa believes that its technological approach may create advantages to

current glucose monitoring solutions on the market to substantially increase the number of

users who can benefit from this data stream from the current type 1 diabetes population to

the much larger type 2 and pre-diabetes populations, as well as any individuals outside of

these aforementioned populations interested in having access to long-lasting continuous glucose

future product revenues from other analytes such as lactate, CO2, ethanol, pH and other important

metrics in the management of other chronic conditions, which may be targeted by Profusa’s

research and development.

future revenues from the data streams of the above applications, which could become a key

enabler to achieve the technology-enabled future for healthcare being brought to bear by

nascent healthcare growth sectors such as telemedicine and health and wellness coaching platforms.

The total value of this space is expected to reach almost $400 billion by end of 2028.

these platforms are beginning to gain users and engagement demonstrating some degree of clinical

utility, Profusa believes that the growth of these platforms suffer from the lack of real

time clinical data.

In the field of telemedicine, physician and patient interactions still

require visits to labs for blood test to inform physician diagnosis and feedback.

case of coaching platforms, the lack of inexpensive real time data relegates the business

model to rely on expensive technologies and nurses/coaches to provide the clinical feedback

Profusa believes that, at scale, the data Profusa’s platform generates from

its initial products will be a key enabler for the productivity and business models for both

of these sectors to expand and reach more of their full potential.

Profusa’s plan is

to partner and provide such data streams as a further growth driver for Profusa.

Addressable Market

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

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

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

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.

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

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.

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.

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.

data is from the manufacturer website.

The products provided in this chart are:

Freestyle Libre 2

Guardian Connect

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.

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:

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.

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

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

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.

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

cost of the system is quite low as the sensors are low cost to manufacture and the more expensive

reader component can be reused through multiple sensor injections;

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

sensor deployment is a common hypodermic needle procedure that can be performed by healthcare

professionals across a variety of common settings;

sensor functionality lifetime is limited by the stability of the fluorescence molecule and

not by the foreign body response, which translates into months of functionality.

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.

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

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

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.

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.

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.

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;

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.

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.

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.

and Data Visualization

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.

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.

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

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

servers, to improve availability.

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.

Opportunity with Lumee Oxygen and Lumee Glucose

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.

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.

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.

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

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.

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.

Glucose for Diabetes Management

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.

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.

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

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.

Product Path and Clinical Programs

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.

Oxygen is designed, developed and manufactured by Profusa.

The first generation Lumee Oxygen Platform received its CE Mark on September

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.

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.

Oxygen Clinical Study Overview

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.

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.

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).

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.

Oxygen Clinical Study History

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.

● Proof-of-Concept

study - A Feasibility Study to Characterize the Performance of the PROFUSA Oxygen Sensor

The first-in-human “Si Se Puede” Study used micro-oxygen sensors

that were injected into the feet of patients with limb-threatening ischemia to measure oxygen

changes during endovascular therapy.

A total of 48 sensors were studied in 10 CLI patients

and 4 healthy volunteers.

The injected sensors could be readily located during measurement

There were no adverse events of safety concern related to the investigational product.

● Feasibility

of Continuous Tissue Oxygen Monitoring in Healthy Adults.

This study was an interventional

feasibility study that was designed to characterize the performance of the Lumee Oxygen Platform

in healthy adult volunteers.

The analysis summarized here includes data on multiple study

end points, including usability, safety, and effectiveness.

Tissue oxygen levels were measured

in 7 subjects (total of 14 sensors) during provocation tests that were used to induce changes

in peripheral tissue oxygen.

During provocations, local tissue oxygen was measured continuously

using both Lumee Oxygen sensors and a commercially available transcutaneous oximetry (non-invasive

measuring of oxygen levels through the skin) device.

Results showed that Lumee Oxygen measurements

were reliably obtained and provided signals sufficiently above a signal to noise threshold.

There were no adverse events of safety concern related to the investigational product.

(Oxygen Monitoring Near Ischemic Areas) European Registry Study .

This study was a Post-Market

Follow-up study which explored use cases and characterizing the diagnostic value of the Lumee

Oxygen Platform in Critical Limb Ischemia patients.

As a registry, the study intended to

provide real-world experience and to prepare implementation of the Lumee Oxygen Platform

in the European market.

Enrollment of the study has concluded with a total of 35 subjects.

There was no indication of adverse reactions specific to the hydrogels.

Data analysis confirmed

Lumee Oxygen is responsive to interventions during revascularization therapies.

Baseline Data of Tissue Oxygen Levels in Healthy Volunteers.

This study was a development

study was conducted in the U.S.

toward the development of a next generation device and was

aimed at collecting physiological integration and baseline data of tissue oxygen levels in

various anatomical locations and usability data in healthy adult volunteers in daily life

using a prototype version of Profusa’s Wireless Lumee Oxygen Platform.

The study has

been completed, it generated observations to inform wireless technology development, attachment

and formfactor design, as well as software considerations for a next generation device.

design changes to Lumee Oxygen will occur prior to regulatory approval of the current existing

Once FDA marketing authorization has been obtained, any design changes for a next

generation of Lumee Oxygen will be planned, implemented, and verified and additional performance

data or proof of equivalency will be submitted to FDA in an amendment to the original submission.

Pivotal Study in the U.S.

for submission purposes to FDA - Effectiveness of Measuring

Local Tissue Oxygen in Response to Induced Hemodynamic Changes with The Profusa Wireless

Lumee Oxygen Platform in Patients with PAD.

This is an ongoing IDE study in the United

States with the objective to assess the effectiveness of monitoring changes in local tissue

oxygen with Profusa’s Wireless Lumee Oxygen Platform in comparison to transcutaneous

oxygen measurements in patients with peripheral artery disease (PAD).

This study characterizes

the response to hemodynamic changes, or changes in cardiovascular function such as arterial

pressure or cardiac output, induced by vascular occlusion tests and positional maneuvers.

The study has been approved for conduct at four study sites with enrollment of up to 65 subjects.

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

Glucose Monitoring product

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.

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.

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.

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,

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

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.

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.

Glucose Clinical Study History

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

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

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.

of Concept Feasibility Assessment:

The study was conducted in Germany in 2018/19.

objective of the study was to evaluate the Lumee Glucose FIH Platform in human subjects,

establishing long-term Lumee Glucose measurements in the subcutaneous interstitial space

as representation of glycemia.

The Lumee hydrogel signal was to be compared to established

glucose reference measurements of capillary blood under controlled conditions for potential

signal artefacts like movement, temperature, and ambient light.

Initial signal processing

algorithms would be established including retrospective accuracy evaluation considering a

defined relationship between the Lumee signal and blood glucose reference measurements.

subjects had been enrolled with insulin-dependent diabetes, male and female, of 18 years

The study served as Proof-of Concept for the technology and for safe use in human.

Both the hydrogel sensor and the reader design have been significantly modified since in

order to improve sensing sensitivity/responsiveness of the system for the subsequent study.

Integration and Monitoring with the Lumee Glucose Hydrogel in the Subcutaneous Interstitium:

The study was conducted in Austria in 2020/21 employing two versions of the reader system

and an upgraded sensor version.

Twelve subjects with insulin-dependent diabetes, 18 years

and older have been enrolled.

The objective of the study was to evaluate tissue integration,

location reliability and glucose response characteristics over a period of three and six

months after sensor placement.

Correlation of Lumee signals with IV sampled blood reference

values was to be established during glucose excursions at meals at repeated in clinic visits.

Reader localization effectiveness was checked additionally by using an infrared sensitive

camera and by high frequency ultrasound.

The active monitoring phase has been completed.

Long-term safety observations are ongoing.

Monitoring with the Lumee Glucose Hydrogel in the Subcutaneous Tissue:

The multi-site

study was initiated in Austria, Germany, and Vietnam in August/October 2021.

subjects across all sites with insulin-dependent diabetes, 18 years and older have been enrolled.

The objective of the study was to evaluate glucose response characteristic of the Lumee Glucose

hydrogel in tissue over a period >3 months with active monitoring sessions and 3 years

of placement safety observations.

Analysis endpoints did include:

Correlation of Lumee signals

with IV sampled blood reference values, Signal processing/algorithm effectiveness, correction

approaches for motion, temperature, ambient light, signal stability over time.

Selected in-clinic

24-hour monitoring sessions were performed.

For Lumee Glucose Studies

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.

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

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.

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;

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

and zone E represents altered clinical action - could have

dangerous consequences.

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.

predictions modeled from held-out clinical sessions

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

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.

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

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

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

management, but certain service providers of Profusa have served as co-authors for some of these publications.

Additionally, Profusa’s

goal is to build upon our distribution strategy to create a network of commercial partners covering key geographic regions, while building

focused technical sales leadership team to manage key local relationships and maintain performance excellence of its local distribution

Lastly, Profusa plans to strategically engage in commercial B2B relationships to capture a portion of the large coaching, telemedicine,

and health and wellness segments.

received CE approval for Lumee Oxygen on January 28, 2020.

Due to pandemic-related restrictions at hospitals and clinics for non-essential

personnel visits, Profusa was unable to carry out its commercialization plans in Europe.

Profusa anticipates initiating its commercialization

effort beginning in early 2026.

By taking advantage of the identified distributor partners in key countries in Europe, Profusa’s

marketing infrastructure and collateral, the KOL network and associated publications and conference presentations, Profusa expects to

be able to accelerate its product launch in Europe.

Profusa is also in the midst of its clinical program for U.S.

Profusa anticipates

being able to launch Lumee Oxygen in the U.S.

late 2026, subject to regulatory approval.

strategy to commercialize its glucose CGM product will mirror that of Lumee Oxygen.

While there are a few large companies with significant

CGM offering, the large patient population and the high cost to health care system have attracted many other attempts to provide alternative

solutions by other potential healthcare companies.

Unfortunately, those attempts have historically been unsuccessful technically, and

unproductively economically for these companies.

Profusa believes that upon achieving the clinical and regulatory milestones over the

next 18 months, it could become an attractive candidate to partner with one of these large players and leverage their commercial footprint

to enter this patient population.

believes that the data stream its platform can generate could become a critical component of solutions being offered today in sectors

such as telemedicine, pre-diabetes management, lifestyle coaching platforms/apps, and health and wellness apps.

Profusa bases this hypothesis

on the belief that clinically relevant data, in real time, is central to these AI-driven platforms’ ability to deliver automated

meaningful insights to the users.

In telemedicine, a physician/patient interaction would be more efficient if real time biochemistry

parameters are available during the tech-enabled visit.

As these platforms and apps are also much more consumer-oriented, the user-experience

and cost of the real-time sensor technology need to be aligned to the user expectation and consumer cost levels.

Profusa believes its

technology could ultimately be that enabling data stream to these other high-growth healthcare sectors.

strategy to enter and create value in these more consumer sectors centers around a B2B approach.

The relationships and expertise of reaching

a large scale consumer-based population belong with the telemedicine and apps providers.

Additionally, the cost of customer acquisition

and marketing infrastructure to acquire users are high and complex.

Profusa’s aim is to partner with these providers on a B2B level,

and make available our technology and data stream to enable our partner’s success.

This approach would align the core competencies

of the respective organizations, while creating value for both partners.

The partner would have a data stream that drives their adoption

and business model, while Profusa would benefit from accessing a large user population without the associated marketing and user acquisition

Opinion Leaders (KOLs)

has worked with a small number of key opinion leaders (KOLs) in both oxygen and glucose applications, receiving their advice and expertise

on product development, physician use cases, clinical needs, and clinical study support.

In certain instances, KOLs are the principal

investigators in Profusa’s clinical studies and have summarized its product and clinical data in podium talks at major conferences

and through publications.

With the exception of two KOLs who provided services to Profusa and received stock options for 10,000 shares

and 30,000 shares, respectively, of Profusa’s Common Stock, KOLs are not compensated or provided equity awards;

however, KOLs do

receive customary expense reimbursement.

protects its intellectual property through patents, trade secrets, and copyright/trademarks.

Additionally, Profusa requires all officers,

employees, and third parties to enter into standard agreements containing provisions requiring confidentiality of proprietary information

and assignment to Profusa of all inventions made during the course of their employment or consulting relationship.

Profusa also enter

into nondisclosure agreements with its commercial counterparties and limits access to, and distribution of, its proprietary information.

Except in the case of certain software, Profusa currently require no third party licenses.

and applications cover several different technology classes, including in vivo sensors, sensor signaling chemistry compositions and scaffolding

compositions, methods of and apparatus for sensor interrogation by fluorescent readers, data reduction algorithms for signal processing,

and combined biochemical data and sensor data methods.

As of April 14, 2026, Profusa owns 25 issued U.S.

patents and 32 rest-of-world

patents, including patents in Australia, Canada, China, Europe, Hong Kong, India, Japan, South Korea, and Israel.

Profusa’s issued

patents expire between March 2030 and January 2040.

table below summarizes Profusa’s portfolio of issued patents, all of which are utility patents and all of which are owned by Profusa:

AND SYSTEM FOR DIRECTING A

TISSUE-INTEGRATING

AND METHODS FOR DETECTING

AND DEVICE FOR CORRECTING

TRANSCUTANEOUS

READER FOR USE WITH

TRANSCUTANEOUS

READER FOR USE WITH

TRANSCUTANEOUS

READER FOR USE WITH

POLYMERIZABLE

AND SINGLE-CHANNEL BIOSENSOR

GLUCOSE SENSORS

SENSING TISSUE-

MULTI-ANALYTE

SENSING TISSUE-

OXIDASE-BASED

SENSORS AND METHOD

GLUCOSE SENSORS

FILTER DEVICE, SYSTEM, AND

and Chemistry

United States of America

and Chemistry

table below summarizes Profusa’s portfolio of pending patents, all of which are utility patents and all of which are owned by Profusa:

Patent Office

European Patent Office

Patent Office

United States of America

States of America

and Chemistry

Patent Office

and Chemistry

Patent Office

and Chemistry

Patent Office

and Chemistry

Patent Office

and Chemistry

Cooperation Treaty

Manufacturing

and Quality Systems

manufactures class III medical device implantable sensors within an ISO compliant manufacturing facility and quality system.

manufacturing activities are conducted and managed per current Good Manufacturing Practices (cGMP), which are the recognized standards

for the FDA and other global regulatory agencies.

Profusa manufacturing processes comply with all aspects of cGMP and has procedures

in place for the following activities:

Supplier selection, evaluation and monitoring, Incoming receiving inspection requirements, Documented

manufacturing procedures and work instructions, Operator training program, and compliant manufacturing spaces including a certified,

class 7, controlled environment room (CER).

Over 90% of the implantable sensor manufacturing process, including production, cleaning,

sizing, testing and packaging is conducted within a clean room, which is inspected and certified on a quarterly basis.

Additionally,

all devices are produced utilizing a validated production process with multiple inspection and testing points to ensure quality throughout

The overall process, including embedded test methods, is re-validated as necessary to ensure continued compliance with cGMP

All manufacturing steps, materials, equipment, personnel and tools utilized in the production process are documented in highly

detailed Device History Records (DHR) to provide a written production history.

The DHR also documents demonstrated compliance to Manufacturing

Process Instructions (MPI) used and followed throughout the process.

Profusa only selects, utilizes, and monitors qualified vendors for services or products related to manufacturing processes, which include

Contract Manufacturers, and Testing and Sterilization services.

Prior to selection, Profusa Quality Assurance conducts on-site Quality

System audits to ensure they are compliant with cGMP requirements and any other required regulatory requirements.

Additionally, all external

produced products or services conducted for Profusa manufactured products undergo testing at nationally accredited and certified testing

facilities and must meet Incoming Inspection criteria which Profusa had previously established prior to acceptance and utilization.

competitive landscape regarding both the Lumee Oxygen and Lumee Glucose sensing systems, if approved, is multi-faceted, with many companies

with device offerings that provide biochemical data in real time, as further described below.

Oxygen is designed to be used complementarily with angiographic (radiographic visualization of blood vessels after injection of a radiopaque

substance) and computer tomographic (imaging of parts of the body with any kind of penetrating waves) technologies, or alone.

We anticipate

the creation of a guidance algorithm to be used by a physician or other vascular specialist to incorporate both Lumee Oxygen values and

angiographic or computer tomographic readings.

of such technologies include digital subtraction angiography devices developed by Philips or Computed Tomography (CT) for peripheral

use developed by Siemens Healthineers.

Oxygen will also compete with devices that use transcutaneous oximetry (TCPO2) to measure peripheral perfusion, such as those developed

by Perimed AB, Radiometer Medical or SenTec AG, to name examples.

doppler or cuff devices measuring Ankle-Brachial Index (ABI), Toe-Brachial Index (TBI) or Segmental Pressure Values (SPP), as well as

those enabling Pulse Volume Recording (PVR) are anticipated to be competitive with Lumee Oxygen.

Other experimental approaches include

Near-Infrared Spectroscopy (NIRS) for peripheral purposes.

the personal use case, Lumee Glucose will compete with existing Continuous Glucose Monitoring technologies, including those manufactured

by Dexcom, Abbott, Medtronic, Senseonics, Diamontech, Movano and Nemaura Medical.

Each of these companies currently market Continuous

Glucose Monitoring products that target both Type 1 and Type 2 diabetes patients, as well as pre-diabetics.

the professional use case Lumee Glucose will compete with Dexcom, Abbott and Medtronic technologies.

Profusa anticipates the launch of

multiple noninvasive technologies in the next years which may affect the competitive landscape, which may take the form of wristbands

or smartwatches.

States Food and Drug Administration

the United States, our products are subject to regulation by the FDA as medical devices pursuant to the Federal Food Drug and Cosmetic

The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling,

packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion,

marketing and distribution, and import and export of medical devices to ensure that medical devices distributed domestically are safe

and effective for their intended uses and otherwise meet the requirements of the FDCA.

Premarket Clearance and Approval Requirements

an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket

notification, approval of a De Novo application, or approval of a premarket approval (PMA).

Under the FDCA, medical devices are classified

into one of three classes - Class I, Class II or Class III - depending on the degree of risk associated with each medical device and

the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness.

Class I includes devices with the lowest

risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls

for medical devices, which include compliance with the applicable portions of the Quality System Regulation (QSR) facility registration

and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.

Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety

and effectiveness of the device.

These special controls can include performance standards, post-market surveillance, patient registries

and FDA guidance documents.

most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required

to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.

The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k)

Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices,

or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed

device, are placed in Class III, requiring approval of a PMA.

Some pre-amendment devices are unclassified, but are subject to FDA’s

premarket notification and clearance process in order to be commercially distributed.

Based on discussion with FDA to date, we believe

that Lumee Oxygen is a Class III device and that Lumee Glucose is a Class III device.

Clearance Marketing Pathway

obtain 510(k) clearance, we must submit to the FDA a premarket notification submission demonstrating that the proposed device is “substantially

equivalent” to a predicate device already on the market.

A predicate device is a legally marketed device that is not subject to

PMA, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device

that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process.

The FDA’s 510(k) clearance process usually takes from three to twelve months, but often takes longer.

The FDA may require additional

information, including clinical data, to make a determination regarding substantial equivalence.

In addition, the FDA collects user fees

for certain medical device submissions and annual fees for medical device establishments.

the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance

to commercially market the device.

If the FDA determines that the device is “not substantially equivalent” to a previously

cleared device, the device is automatically designated as a Class III device.

The device sponsor must then fulfill more rigorous PMA

requirements, or can request a risk-based classification determination for the device in accordance with the “De Novo” process,

which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate

If a De Novo request is granted, the device may be legally marketed and a new classification is established.

If the device is

classified as Class II, the device may serve as a predicate for future 510(k) submissions.

If the device is not approved through De Novo

review, then it must go through the standard PMA process for Class III devices.

a device receives 510(k) marketing clearance, any modification that could significantly affect its safety or effectiveness, or that would

constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification,

PMA approval.

The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k) or a PMA in

the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination.

If the FDA disagrees

with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified

device until 510(k) marketing clearance or PMA approval is obtained.

Also, in these circumstances, the manufacturer may be subject to

significant regulatory fines or penalties.

Approval Pathway

III devices require approval of a PMA before they can be marketed, although some pre-amendment Class III devices for which the FDA has

not yet required a PMA are cleared through the 510(k) process.

The PMA process is more demanding than the 510(k) premarket notification

In a PMA application, the manufacturer must demonstrate that the device is safe and effective, and the PMA application must

be supported by extensive data, including data from preclinical studies and human clinical trials.

The PMA application must also contain

a full description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing,

and proposed labeling.

Following receipt of a PMA application, the FDA determines whether the application is sufficiently complete to

permit a substantive review.

If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of

a PMA application, although in practice, the FDA’s review often takes significantly longer, and can take up to several years.

advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to

the FDA as to the approvability of the device.

The FDA may or may not accept the panel’s recommendation.

In addition, the FDA will

generally conduct a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing

facility or facilities to ensure compliance with the QSR.

PMA devices are also subject to the payment of user fees.

FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA application constitute

valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s).

may include post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions

on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported

the PMA or requirements to conduct additional clinical studies post-approval.

The FDA may condition PMA approval on some form of post-market

surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a

larger population or for a longer period of use.

In such cases, the manufacturer might be required to follow certain patient groups for

a number of years and to make periodic reports to the FDA on the clinical status of those patients.

Failure to comply with the conditions

of approval can result in material adverse enforcement action, including withdrawal of the approval.

changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the

design performance specifications, which affect the safety or effectiveness of the device, require submission of a PMA supplement.

supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed

to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of

an advisory panel.

Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes

a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new

generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change

in demonstrating a reasonable assurance of safety and effectiveness.

None of our products are currently marketed pursuant to a PMA.

Novo Classification

device types that the FDA has not previously classified as Class I, II or III are automatically classified into Class III regardless

of the level of risk they pose.

To market low to moderate risk medical devices that are automatically placed into Class III due to the

absence of a predicate device, a manufacturer may request a De Novo down-classification.

This procedure allows a manufacturer whose novel

device is automatically classified into Class III to request classification of its medical device into Class I or Class II on the basis

that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application.

A medical device

may be eligible for De Novo classification if the manufacturer first submitted a 510(k) premarket notification and received a determination

from the FDA that the device was not substantially equivalent or a manufacturer may request De Novo classification directly without first

submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination.

The FDA is required

to classify the device within 120 calendar days following receipt of the De Novo application, although in practice, the FDA’s review

may take significantly longer.

During the pendency of the FDA’s review, the FDA may issue an additional information letter, which

places the De Novo request on hold and stops the review clock pending receipt of the additional information requested.

In the event the

De Novo requestor does not provide the requested information within 180 calendar days, the FDA will consider the De Novo request to be

If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal for special controls

that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device.

In addition, the FDA may

reject the De Novo request for classification if it identifies a legally marketed predicate device that would be appropriate for a 510(k)

or determines that the device is not low to moderate risk or that general controls would be inadequate to control the risks and special

controls cannot be developed.

In the event the FDA determines the data and information submitted demonstrate that general controls or

general and special controls are adequate to provide reasonable assurance of safety and effectiveness, the FDA will grant the De Novo

request for classification.

When the FDA grants a De Novo request for classification, the device is granted marketing authorization and

further can serve as a predicate for future devices of that type, through a 510(k) premarket notification.

trials are almost always required to support a PMA and are sometimes required to support a 510(k) submission.

All clinical investigations

of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s IDE regulations which govern investigational

device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities

of study sponsors and study investigators.

If the device presents a “significant risk,” to human health, as defined by the

FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human

clinical trials.

A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient

and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating

disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject.

An IDE application

must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the device in humans

and that the testing protocol is scientifically sound.

The IDE will automatically become effective 30 days after receipt by the FDA unless

the FDA notifies the company that the investigation may not begin.

If the FDA determines that there are deficiencies or other concerns

with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval.

addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board (IRB) for each clinical

The IRB is responsible for the initial and continuing review of the IDE study, and may pose additional requirements for the conduct

of the study.

If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific number

of investigational sites with a specific number of patients, as approved by the FDA.

If the device presents a non-significant risk to

the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval

from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators

obtain informed consent, and labeling and record-keeping requirements.

Acceptance of an IDE application for review does not guarantee

that the FDA will allow the IDE to become effective and, if it does become effective, the FDA may or may not determine that the data

derived from the trials support the safety and effectiveness of the device or warrant the continuation of clinical trials.

An IDE supplement

must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the investigational plan that may

affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.

a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting

clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping

and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them.

The clinical investigators

in the clinical study are also subject to FDA regulations and must obtain patient informed consent, rigorously follow the investigational

plan and study protocol, control the disposition of the investigational device, and comply with all reporting and recordkeeping requirements.

Additionally, after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial at any time for various reasons,

including a belief that the risks to study subjects outweigh the anticipated benefits.

a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply.

These include:

● establishment

registration and device listing with the FDA;

requirements, which require manufacturers, including third-party manufacturers, to follow

stringent design, testing, control, documentation and other quality assurance procedures

during all aspects of the design and manufacturing process;

regulations and FDA prohibitions against the promotion of investigational products, or the

promotion of “off-label” uses of cleared or approved products;

● requirements

related to promotional activities;

or approval of product modifications to 510(k)-cleared devices that could significantly affect

safety or effectiveness or that would constitute a major change in intended use of one of

our cleared devices, or approval of certain modifications to PMA-approved devices;

device reporting regulations, which require that a manufacturer report to the FDA if a device

it markets may have caused or contributed to a death or serious injury, or has malfunctioned

and the device or a similar device that it markets would be likely to cause or contribute

to a death or serious injury, if the malfunction were to recur;

● correction,

removal and recall reporting regulations, which require that manufacturers report to the

FDA field corrections and product recalls or removals if undertaken to reduce a risk to health

posed by the device or to remedy a violation of the FDCA that may present a risk to health;

FDA’s recall authority, whereby the agency can order device manufacturers to recall

from the market a product that is in violation of governing laws and regulations;

● post-market

surveillance activities and regulations, which apply when deemed by the FDA to be necessary

to protect the public health or to provide additional safety and effectiveness data for the

Systems Regulation Requirements

manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and

controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution,

installation and servicing of finished devices intended for human use.

The QSR requires that each manufacturer establish a quality systems

program by which the manufacturer monitors the manufacturing process and maintains records that show compliance with FDA regulations

and the manufacturer’s written specifications and procedures relating to the devices.

The QSR also requires, among other things,

maintenance of records and certain documentation, a device master file, device history file, and complaint files.

QSR compliance is necessary

to receive and maintain FDA clearance or approval to market new and existing products.

As a manufacturer, we are subject to periodic

scheduled or unscheduled audits or inspections by the FDA.

Our failure to maintain compliance with the QSR requirements could result

in the shut-down of, or restrictions on, our manufacturing operations and the recall or seizure of our products, which would have a material

adverse effect on our business.

The discovery of previously unknown problems with any of our products, including unanticipated adverse

events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance

or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product

from the market or voluntary or mandatory device recalls.

FDA has broad regulatory compliance and enforcement powers.

If the FDA determines that we failed to comply with applicable regulatory

requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

untitled letters, FDA Form 483s, FDA warning letters, it has come to our attention letters,

fines, injunctions, consent decrees and civil penalties;

● unanticipated

expenditures to address or defend such actions;

notifications or repair, replacement, refunds, recall, detention or seizure of our products;

detention or seizure of our products;

restrictions, partial suspension or total shutdown of production;

or delaying our requests for regulatory approvals or clearances of new products or modified

● withdrawing

of 510(k) clearances or PMA approvals that have already been granted;

to grant export approval for our products;

FDA can also publish Safety Communications or Letters to Health Care Providers when the agency becomes aware of new issues involving

a specific product, or more broadly, a product family.

These communications are posted on the FDA’s website and describe the FDA’s

analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management.

and Reimbursement

ability to commercialize any products successfully will depend in part on the extent to which coverage and adequate reimbursement for

our product candidates, either directly or through procedures utilizing our products performed by health care providers, once approved,

will be available from government health administration authorities, private health insurers and other organizations.

Government authorities

and third-party payors, such as private health insurers and health maintenance organizations, determine which items and services they

will cover and establish reimbursement levels.

Assuming coverage is obtained for the relevant items and/or services covering a given

product by a third-party payor, the resulting reimbursement payment rates may not be adequate to cover our costs or may require co-payments

that patients find unacceptably high.

Patients and their providers generally rely on third-party payors to reimburse all or part of the

costs associated with our products.

Physicians are unlikely to order, and patients are unlikely to use, our products unless coverage

is provided and the reimbursement is adequate to cover all or a significant portion of the direct or indirect cost of our products.

coverage and adequate reimbursement for new products is critical to the acceptance of such new products.

Coverage decisions may depend

upon clinical and economic standards that disfavor new products when more established or lower cost alternatives are already available

or subsequently become available.

authorities and third-party payors are developing increasingly sophisticated methods of cost containment, such as including price controls,

restrictions on coverage and reimbursement, and requirements for substitution of less expensive products and procedures.

Government and

other third-party payors are increasingly challenging the prices charged for health care items and procedures, examining the cost effectiveness

of products, in addition to their safety and efficacy, and limiting or attempting to limit both coverage and the level of reimbursement.

Further, no uniform policy requirement for coverage and reimbursement exists among third-party payors in the United States, which causes

significant uncertainty related to the insurance coverage and reimbursement of newly approved products.

Therefore, coverage and reimbursement

can differ significantly from payor to payor and health care provider to health care provider.

As a result, the coverage determination

process is often a time-consuming and costly process that requires the provision of scientific and clinical support for the use of new

products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained

in the first instance.

may also be significant delays in obtaining coverage and reimbursement for newly approved products, and coverage may be more limited

than the purposes for which the product is approved or cleared by the FDA.

Moreover, eligibility for coverage and reimbursement does

not imply that a product will be paid for, directly or indirectly, in all cases or at a rate which the health care providers who purchase

those products will find cost effective.

Additionally, we expect pricing pressures in connection with the sale of any of our product

candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative

cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available,

what the level of reimbursement will be.

Coverage and reimbursement may impact the demand for, or the price of, any product candidate

for which we obtain marketing approval or clearance.

If coverage and reimbursement are not available or reimbursement is available only

to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing approval or clearance.

United States and some foreign jurisdictions are considering, or have enacted, a number of legislative and regulatory proposals to change

the healthcare system in ways that could affect our ability to sell our products profitably.

Among policy makers and payors in the United

States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare

costs, improving quality or expanding access.

the United States there have been, and continue to be, proposals by the federal government, state governments, regulators and third-party

payors to control or manage the costs of health care and, more generally, to reform the U.S.

healthcare system.

For example, in March

2010, the ACA was enacted, which included changes to the coverage and payment for products under government health care programs.

law was designed to expand access to health insurance coverage for uninsured and underinsured individuals while containing overall healthcare

The ACA and certain of its provisions have been subject to judicial challenges as well as legislative and regulatory efforts to

repeal or replace them or to alter their interpretation or implementation.

For example, on June 17, 2021, the U.S.

Supreme Court dismissed

a lawsuit challenging the constitutionality of certain aspects of the ACA without ruling on the merits of the constitutionality arguments.

The American Rescue Plan Act also temporarily increased premium tax credit assistance for individuals eligible for subsidies under the

ACA for 2021 and 2022 and removed the 400% federal poverty level limit that otherwise applies for purposes of eligibility to receive

premium tax credits.

recently, the Inflation Reduction Act of 2022 (IRA) extended this increased tax credit assistance and removal of the 400% federal poverty

limit through 2025.

In the future, there may be additional challenges and/or amendments to the ACA.

It remains to be seen precisely what

any new legislation will provide, when or if it will be enacted, and what impact it will have on the availability and cost of healthcare

items and services, including medical devices.

legislative changes designed to reduce healthcare expenditures have been proposed and adopted in the United States since the ACA was

For example, through the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments

to providers up to 2% per fiscal year, which went into effect in April 2013 and, following passage of the BBA and the Infrastructure

Investment and Jobs Act, will remain in effect until 2031 unless additional Congressional action is taken (with the exception of a temporary

suspension from May 1, 2020 through March 31, 2022, and a subsequent reduction to 1% from April 1, 2022 until June 30, 2022).

the temporary suspension during the COVID-19 pandemic, in 2030, the sequestration will be 2.25% for the first half of the year, and 3%

in the second half of the year.

In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things,

further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and

increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

expect that these initiatives, as well as other healthcare reform measures that may be adopted in the future, as well as the trend toward

managed healthcare and increasing influence of managed care organizations, may result in more rigorous coverage criteria and lower reimbursement,

and in additional downward pressure on the price that we receive for any approved product.

Any reduction in reimbursement from Medicare

or other government-funded programs may result in a similar reduction in payments from private payors.

The implementation of current

and future cost containment measures or other healthcare reforms may adversely affect our operations and prevent us from being able to

generate revenue, attain profitability or commercialize our product candidates.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business