SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1
Document Type: S-1
Date Filed: 2026-02-12
Accession Number: 0001493152-26-006407
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/forms-1.htm

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of approximately 192,000 identifiable and eligible patients in the U.S. based on our estimations. While our priority is conducting the RELIVE Trial, we intend to support post-market surveillance to maintain our Revivent System CE mark and may build a small European commercial organization if funding from this offering or otherwise becomes available in excess of our trial expenses. In addition, we expect to conduct post-approval studies to support marketing and to satisfy any ongoing regulatory requirements. There is no guarantee that the RELIVE Trial will be sufficient for FDA approval, and in such case, we may be required to conduct additional trials for the Revivent System. See “Risk Factors – If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed.” and “Risk Factors – The FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable.”

In the event we receive FDA
PMA approval for our Revivent System, which we anticipate could be by mid-2028, we intend to expand from the 20 or more cardiac surgery
centers participating in the trial to the top 336 United States cardiac surgery centers which represent 30% of hospitals performing cardiac
surgeries and approximately 51% of cardiac surgery volume (“Inpatient and 90-Day Postdischarge Outcomes in Cardiac Surgery,”
The American Journal of Accountable Care). Ultimately, through the approximately 1,120 U.S. cardiac surgery centers, our goal is to
serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. Approximately
28,000 Revivent System-eligible patients are added each year to U.S. prevalence, respectively, and a similar number are lost each year
to mortality. The Revivent System is classified by the FDA as a Class III medical device, which is subject to the most stringent
regulatory requirements, including the requirement to demonstrate reasonable assurance of safety and effectiveness through well-controlled
clinical investigations. While we currently anticipate submitting a PMA following completion of the RELIVE trial, FDA approval may not
be obtained on this timeline or at all, and the FDA could require additional clinical trials or other data before granting any approval.
See “Risks Related to Regulatory Approval and Other Governmental Regulations.”

Principal
Factors Affecting Our Financial Performance

Our
operating results are primarily affected by the following factors:

●	the
ability to obtain regulatory approval to market our product candidates;

●	the
timing, costs and results of clinical trials and other development activities versus expectations;

●	the
ability to manufacture product candidates successfully;

●	competition
from product candidates sold or being developed by other companies;

●	the
price of, and demand for, our product candidates once approved;

●	the
ability to negotiate favorable licensing or other manufacturing and marketing agreements for our product candidates;

●	patent
reinforcement and prosecution; and

●	changes
in laws or the regulatory environment affecting our company.

Our
Status as an Emerging Growth Company and Smaller
Reporting Company

qualify as an “emerging growth company” under the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions
from certain disclosure requirements. For so long as we are an emerging growth company, we will not be required to:

●	have
an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;

●	comply
with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation
or a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e.,
an auditor discussion and analysis);

●	submit
certain executive compensation matters to shareholder advisory votes, such as “say-on-pay” and “say-on-frequency;”
and

●	disclose
certain executive compensation related items such as the correlation between executive compensation and performance and comparisons
of the chief executive officer’s compensation to median employee compensation.

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 have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable
to those of companies that comply with such new or revised accounting standards.

will remain an emerging growth company for up to five years, or until the earliest of (i) the last day of the first fiscal year in which
our total annual gross revenues exceed $1.235 billion, (ii) the date that we become a “large accelerated filer” as defined
in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock that is held by non-affiliates exceeds
$700 million as of the last business day of our most recently completed second fiscal quarter or (iii) the date on which we have issued
more than $1 billion in non-convertible debt during the preceding three year period.

Additionally,
we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take
advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our ordinary shares
held by non-affiliates is equal to or exceeds $250 million as of the prior June 30, or (2) our annual revenues equaled or exceeded $100
million during such completed fiscal year and the market value of our ordinary shares held by non-affiliates is equal to or exceeds $700
million as of the prior June 30. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison
of our financial statements with other public companies difficult or impossible.

Results
of Operations

Comparison
of Years Ended December 31, 2025, and 2024

The
following table summarizes our results of operations for the years ended December 31, 2025, and 2024:

Year Ended December
31, Variance

2025 2024 Amount %

Gross (loss) profit:

Revenue $	- $	- $	- -	%

Cost of goods sold - - - -	%

Gross profit - - - -	%

Operating expenses:

Research and development 1,173,645 589,951 583,694 99	%

General and administrative expenses 5,096,785 2,972,565 2,124,220 71	%

Total operating expenses 6,270,430 3,562,516 2,707,914 76	%

Operating loss (6,270,430	) (3,562,516	) (2,707,914	) 76	%

Other expense:

Interest 1,391,294 309,971 1,081,323 349	%

Other 5,947 (21,813	) 27,760 (127	)%

Total other expense 1,397,241 288,158 1,109,083 385	%

Net loss before taxes (7,667,671	) (3,850,674	) (3,816,997	) 99	%

Income Tax expense (benefit) - - - -	%

Net loss and comprehensive loss (7,667,671	) (3,850,674	) (3,816,997	) 99	%

Revenues

historically recorded product revenue primarily from the sale of our Revivent TC™ TransCatheter Ventricular Enhancement
System. We sold our product candidates in Europe to hospitals through direct sales representatives, as well as through distributors
in selected international markets. All such sales of product in Europe ceased at the end of 2023 when the decision to cease
operations to preserve capital was made and although we have certain approvals to sell in Europe, such sales have not restarted as of
the date of this prospectus.

Research
and Development Expenses

Research
and development program costs include employee compensation and other direct costs plus an allocation of indirect costs, based on certain
assumptions. Our product candidates are in various stages of development and significant additional expenditures will be required if
we commence further clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies,
expand our operations and/or bring our product candidates to market. The total cost of any particular clinical trial is dependent on
a number of factors such as trial design, length of the trial, number of clinical sites, number of patients and trial sponsorship. The
process of obtaining and maintaining regulatory approvals for new product candidates is lengthy, expensive and uncertain. Because of
the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research
and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements,
and, therefore, when, if ever, material cash inflows are likely to commence.

Research
and development activities are central to our business model. We expect that our research and development expenses will continue to increase
substantially and will comprise a large percentage of our total expenses for the foreseeable future.

Research
and development expenses increased $583,694, or by 99%, to $1,173,645 for the year ended December
31, 2025, compared to $589,951 for the prior year. This increase was primarily due to the ramp up of activity
in that began in the second quarter of 2025 in preparation for the RELIVE trial.

Selling,
General and Administrative Expenses