What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-02-28 compared with 2024-02-29 · 61 added, 62 removed, 56 unchanged (69% of the section changed)

Management’s Discussion and Analysis of Financial

Condition and Results of Operations

Discussion and Analysis of Financial Condition and Results of Operations

following discussion should be read in conjunction with our consolidated financial statements and the related notes contained elsewhere

30 unchanged sentences

we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA (see the section entitled “Risk

Factors” in our Annual Report on Form 10-K).

Factors” in this Annual Report on Form 10-K).

There are currently no devices approved as surgical or non-surgical replacement venous

2 unchanged sentences

have been commercially successful.

We develop and manufacture our products in a 14,507 sq.

leased manufacturing facility in Irvine,

California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical

We develop and manufacture our products in connection with our clinical trials in a 14,507 sq.

leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing

of tissue based implantable medical devices.

of Operations

of the year ended December 31, 2024 to the year ended December 31, 2023

a late-stage clinical medical device Company, we are not currently generating revenue and our future revenue, if any, is dependent on our ability

to commercialize our product candidates.

We do not expect to begin generating revenue with respect to any of our product candidates in

the near term.

We hope to eventually achieve revenues by commercializing and selling our products or licensing our technologies to companies

that have the resources and infrastructure in place to manufacture, market and sell our products.

The commercialization and/or licensing

of any of our products may take several years, if it is to occur at all, and depends on our ability to obtain regulatory approval.

a late-stage clinical medical device Company, we are not currently generating revenue and our future revenue, if any, is dependent

on our ability to commercialize our product candidates.

We will not begin generating revenue with respect to any of our product

candidates until after we obtain FDA approval, if at all.

We hope to eventually achieve revenues by commercializing and selling our products or licensing

our technologies to companies that have the resources and infrastructure in place to manufacture, market and sell our products.

commercialization and/or licensing of any of our products may take several years, if it is to occur at all, and depends on our

ability to obtain regulatory approval.

reported net losses of $21.8 million and $23.5 million for the years ended December 31, 2024 and 2023, respectively, representing a decrease

in net loss of $1.2 million or 5%, resulting from, as described in further detail below, an increase in operating expenses of $0.3 million,

in net loss of $1.7 million or 7%, resulting from, as described in further detail below, a decrease in operating expenses of $1.5 million,

and an increase in other income of $0.2 million.

General and Administrative Expenses

the year ended December 31, 2023, selling, general and administrative expenses decreased by $3.3 million or 22%, to $11.7 million

from $15.0 million for the year ended December 31, 2022.

This decrease is primarily driven by share-based compensation.

related to grants made in 2021 was $4.2 million lower in 2023 than in 2022.

This decrease was partially offset by the expense from

grants made in 2022, resulting in a net reduction of $3.6 million in share-based compensation from 2022 to 2023.

Selling, general

and administrative expenses also decreased $0.2 million from warrants issued to a vendor in 2022 with no similar warrants issued in 2023, and $0.1 million from lower

insurance cost in 2023.

These decreases were partially offset by $0.6 million of higher cash

compensation related to management bonuses paid during 2023 compared to 2022 when no bonus was paid.

and Development Expenses

the year ended December 31, 2023, research and development expenses increased by $3.7 million or 37%, to $13.6 million from $9.9

the year ended December 31, 2024, research and development expenses decreased by $1.4 million or 10%, to $12.2 million from $13.6

million for the year ended December 31, 2023.

The increase is due to an increase of $2.7 million in costs for the SAVVE trial from $3.5 million in 2022 to $6.2 million in 2023, and $1.1 million in compensation from the increases in staffing

also to support the SAVVE trial, partially offset by a decrease of $0.1 million in other lab costs for development and other preparation for the enVVe

income in 2023 was $1.7 million consisting of $1.2 million in interest income and realized gains, and $0.5 million of unrealized gains,

all related to our investments in US Treasury securities.

Interest income and realized gains were $0.2 million, and unrealized gains

were $0.1 million in 2022.

The decrease is due to a decrease of $2.2 million in costs for the SAVVE trial, and a

$0.3 million decrease in other lab costs, partially offset by an increase of $0.9 million in employee compensation from the

increases in staffing, and an increase of $0.2 million in costs related to the GLP study for the enVVe.

Costs related to SAVVE

decreased in 2024 because, after full enrollment in 2023, activity shifted to ongoing monitoring, data collection, and preparation

and filing of the PMA.

The increase in compensation cost is due to the hiring of additional personnel supporting ongoing VenoValve

testing and trial activity in addition to the preparation for the enVVe GLP study.

General and Administrative Expenses

For the year ended December 31, 2024, selling, general and administrative

expenses decreased by $0.1 million or 1%, to $11.6 million from $11.7 million for the year ended December 31, 2023.

This decrease is primarily

driven by share-based compensation which decreased $1.1 million from 2023 to 2024.

Selling, general and administrative expenses also decreased

$0.1 million from lower travel cost, and $0.1 million from lower insurance cost in 2024.

These decreases were partially offset by a $0.7 million increase in legal costs and a $0.5 million increase in

costs related to conferences, and market research as the Company started increasing its market visibility in anticipation of commercialization activity if FDA approval

of the VenoValve PMA is received.

For the year ended December 31, 2024, other income increased $0.3 million

to $2.0 million from $1.7 million for the year ended September 30, 2023.

Other income in both periods reflects realized gains, interest,

and unrealized gains from our program to invest excess cash in U.S.

Treasury securities.

and Capital Resources

the year ended December 31, 2024, the Company incurred losses from operations of $23.8 million and used $16.8 million cash in operating

The net cash used in operating activities during 2023 increased by $3.3 million from $15.6 million for the year ended December

31, 2022, primarily due to the increase in research and development expenses from 2022 to 2023.

Our cash balance as of December 31, 2023, is $3.6 million.

In addition, we have $42.8 million in investments, for

total cash and investments of $46.4 million.

The net cash used in operating activities during 2024 decreased by $2.1 million from $18.9 million for the year ended December

31, 2023, primarily due to the decrease in research and development expenses from 2023 to 2024.

Our cash balance as of December 31, 2024,

is $1.8 million.

In addition, we have $41.4 million in investments, for total cash and investments of $43.2 million.

operating losses and the uses of cash are primarily due to the Company’s product research and development and administrative activities.

2 unchanged sentences

Research and development activities are for continued product development and clinical trials for

the VenoValve and for the enVVe.

The Company will continue to incur these costs to complete its clinical trials, enhance products, develop

new products, and operate as a public company for the foreseeable future as we seek to obtain regulatory approval for our studies and product candidates.

We are not currently generating revenue.

VenoValve and for enVVe.

The Company will continue to incur these costs to complete its clinical trials, enhance products, develop new

products, and operate as a public company for the foreseeable future as we seek to obtain regulatory approval for our studies and product

are not currently generating revenue.

However, with the filing of our final PMA module completed in December 2024, we hope to

receive FDA approval during 2026, and we have commenced limited activity toward commercial launch in anticipation of that approval.

To-date, this activity is primarily market research and attendance at conferences.

If and when we receive FDA approval of our PMA,

we expect to significantly increase costs related to commercial launch and to direct spending toward establishing our market presence and

generating revenue.

do not currently have material commitments for capital expenditures or other expenditures with the exception of our facility lease commitment

of $0.3 million per year.

We expect a modest increase in purchases of property and equipment as we continue SAVVE, commence TAVVE, and plan for

commercialization of the VenoValve.

We expect a modest increase in purchases of property and equipment and in facility lease costs as we continue

SAVVE, commence TAVVE, and plan for commercialization of the VenoValve.

future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials

and related product development costs and our ability to successfully bring products to market.

We anticipate that our cash burn

rate will increase from current levels of approximately $4 million to $5 million per quarter to $5 million to $6 million per quarter in 2025.

Even after considering this increase, we should have sufficient cash to

fund operations through late 2025.

have historically funded our operations through financing activities such as the capital raise completed in 2023 and will need to raise additional capital in the future.

Any inability to

raise additional financing would have a material adverse effect on us.

We anticipate that our cash burn rate

will increase from current levels of approximately $4 million to $5 million per quarter to $5 million to $6 million per quarter in 2025.

Even after considering this increase, we should have sufficient cash to fund operations through mid-2026.

have historically funded our operations through financing activities such as the capital raises completed in 2024 and 2023.

to raise additional capital in the future.

Any inability to raise additional financing would have a material adverse effect on us.

upon our cash and working capital as of December 31, 2024, we have sufficient capital resources to meet our obligations as they become

due within at least one year after the date of this Annual Report and sustain operations.

Sheet Arrangements

a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide the information requested

by paragraph (a)(5) of this Item.

Quantitative and Qualitative Disclosure About Market

a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required

by this Item.

Financial Statements

and Supplementary Data

see the financial statements beginning on page F-1 following the signature pages in this Annual Report on Form 10-K and incorporated

herein by reference.

Changes in and Disagreements with Accountants on

Accounting and Financial Disclosure

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 7. Management’s Discussion and Analysis