SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: S-1/A
Date Filed: 2026-05-15
Accession Number: 0001493152-26-023752
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226023752/forms-1a.htm

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net losses and negative cash flows from operations for the foreseeable future. Our future capital requirements will depend on many factors, including: ● the cost, timing and results of our clinical trials and regulatory reviews; ● the cost and timing of establishing sales, marketing and distribution capabilities; ● the terms and timing of any other collaborative, licensing and other arrangements that we may establish; ● the timing, receipt and amount of sales from our current and potential product candidates; ● the degree of success we experience in commercializing our product candidates; ● the emergence of competing or complementary technologies; ● the cost of preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights; and ● the extent to which we acquire or invest in businesses, product candidates or technologies, although we currently have no commitments or agreements relating to any of these types of transactions.

will require additional financing to fund working capital and pay our obligations. We may seek to raise any necessary additional capital
through a combination of public or private equity offerings and/or debt financings. There can be no assurance that we will be successful
in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us. If adequate funds are not available
on acceptable terms when needed, we may be required to significantly reduce operating expenses, which may have a material adverse effect
on our business and/or results of operations and financial condition. If we do raise additional capital through public or private equity
or convertible debt offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities
may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through
debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional
debt, making capital expenditures or declaring dividends. If we raise additional funds through strategic collaborations or marketing,
distribution, licensing and royalty arrangements with third parties, we may have to relinquish valuable rights to our intellectual property
or technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable
to us or issue equity or convertible debt securities, which may result in dilution to our stockholders. Additional capital may not be
available on reasonable terms, or at all.

we are unable to establish an effective network for commercialization, including effective distribution channels and sales and marketing
functions, it may adversely affect our business, financial condition, results of operations, and prospects.

Our
limited commercialization experience and lack of approved or cleared product candidates in the United States make it difficult to evaluate
our current business and assess our prospects. We also currently have limited sales and marketing experience. If we are unable to establish
effective sales and marketing capabilities or if we are unable to commercialize any of our product candidates, we may not be able to
effectively generate product revenue, sustain revenue growth and compete effectively. In order to generate future growth, we plan to
continue to expand and leverage our sales and marketing infrastructure to increase our customer base and grow our business. Identifying
and recruiting qualified sales and marketing personnel and training them on our product candidates, applicable federal and state laws
and regulations, and on our internal policies and procedures requires significant time, expense and attention. It often takes several
months or more before a sales representative is fully trained and productive. Our business may be harmed if our efforts to expand and
train our sales force do not generate a corresponding increase in revenue, and our higher fixed costs may slow our ability to reduce
costs in the face of a sudden decline in demand for our product candidates. Any failure to hire, develop and retain talented sales and
marketing personnel, to achieve desired productivity levels in a reasonable timeframe or timely leverage our fixed costs could have a
material adverse effect on our business, financial condition and results of operations. Moreover, the members of our direct sales force
will likely be at-will employees. The loss of these personnel to competitors or otherwise could materially harm our business. If we are
unable to retain our direct sales force personnel or replace them with individuals of equivalent technical expertise and qualifications,
or if we are unable to successfully instill technical expertise in replacement personnel, our revenue and results of operations could
be materially harmed.

Our
ability to increase our customer base and achieve market acceptance of our product candidates will also depend to a significant extent
on our ability to develop and expand our marketing efforts as we plan to dedicate significant resources to our marketing programs. Our
business may be harmed if our marketing efforts and expenditures do not generate a corresponding increase in revenue. In addition, we
believe that developing and maintaining broad awareness of our brand in a cost-effective manner is critical to achieving broad acceptance
of our product candidates and penetrating new customer accounts. Brand promotion activities may not generate patient or physician awareness
or increased revenue, and even if they do, any increase in revenue may not offset the costs and expenses we incur in building our brand.
If we fail to successfully promote, maintain and protect our brand, or if we incur substantial expenses in an unsuccessful attempt to
promote and maintain our brand, we may fail to attract or retain the physician acceptance necessary to realize a sufficient return on
our brand building efforts, or to achieve the level of brand awareness that is critical for broad adoption of our product candidates,
which would have an adverse effect on our business, financial condition and results of operations.

These
factors also make it difficult for us to forecast our financial performance and growth, and such forecasts are subject to a number of
uncertainties, including our ability to successfully develop additional product candidates that add functionality, reduce the cost of
product candidates sold, broaden our commercial portfolio offerings and obtain FDA 510(k) clearance or premarket approval (“PMA”)
for, and successfully commercialize, market and sell, our planned or future product candidates in the United States or in international
markets. See “Risks Related to Regulatory Approval and Other Governmental Regulations — The FDA regulatory approval, clearance
and license process is complex, time-consuming and unpredictable.” If our assumptions regarding the risks and uncertainties
we face, which we use to plan our business, are incorrect or change due to circumstances in our business or our markets, or if we do
not address these risks successfully, our operating and financial results could differ materially from our expectations and our business
could suffer.

have limited experience marketing and selling our product candidate.

Our
limited commercialization experience and limited number of approved or cleared product candidates make it difficult to evaluate our current
business and predict our future prospects. These factors also make it difficult for us to forecast our future financial performance and
growth, and such forecasts are subject to a number of uncertainties, including our ability to successfully complete clinical trials and
obtain pre-market approval or 510(k) clearance by the FDA for our current investigational and future planned product candidates in the
United States or in key international markets. Our commercialization efforts will depend on the efforts of our management and sales team,
our third-party suppliers, physicians and hospitals, and general economic conditions, among other factors, including the following:

●	the
effectiveness of our marketing and sales efforts in the United States and internationally;

●	our
success in educating physicians and patients about the benefits, administration and use of the Revivent System, if approved;

●	the
acceptance by physicians, patients and payors of the safety and effectiveness of the Revivent System, including the long-term data;

●	our
third-party suppliers’ ability to supply the components utilized in the Revivent System in a timely manner, in accordance with
our specifications and in compliance with applicable regulatory requirements, and to remain in good standing with regulatory agencies;

●	the
availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing therapies;

●	our
ability to obtain, maintain and enforce our intellectual property rights in and to the Revivent System;

●	the
emergence of competing technologies and other adverse market developments, and our need to enhance the Revivent System or develop
new product candidates to maintain market share in response to such competing technologies or market developments;

●	our
ability to raise additional capital on acceptable terms, or at all, if needed to support the commercialization of the Revivent System;
and

●	our
ability to achieve and maintain compliance with all regulatory requirements applicable to the Revivent System.