SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS
Document Type: DRS
Date Filed: 2025-08-05
Accession Number: 0001641172-25-022123
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000164117225022123/filename1.htm

Chunk 6 of 82
Word Count: 1484
Character Count: 9824

Document Content:

features to our existing product candidates. In addition, we expect our general and administrative expenses to increase following this offering due to the additional costs associated with being a public company. The net losses that we incur may fluctuate significantly from period to period. We will need to generate significant revenue in order to achieve and sustain profitability. Even if we ever generate revenue or achieve profitability (of which no assurances can be given), we cannot be sure that such revenues will continue or that we will remain profitable for any substantial period of time. will require substantial additional capital to finance our planned operations, which may not be available to us on acceptable terms or at all. Our failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit, reduce or eliminate our product development programs, commercialization efforts or other operations.

Since
inception, we have incurred significant net losses and expect to continue to incur net losses for the foreseeable future. Since our inception,
our operations have been financed primarily by net proceeds from the sale of our equity and debt securities. We have ongoing clinical
trials, and expect to continue to make substantial investments in these trials and in additional clinical trials that are designed to
provide clinical evidence of the safety and efficacy of our product candidates. We intend to continue to make significant investments
in our sales and marketing organization by increasing the number of U.S. sales representatives and expanding our international marketing
programs to help facilitate further adoption among existing hospital accounts as well as broaden awareness of our product candidates
to new hospitals. We also expect to continue to make investments in research and development, regulatory affairs and clinical studies
to develop future generations of our product candidates, support regulatory submissions and demonstrate the clinical efficacy of our
product candidates. Moreover, we expect to incur additional expenses associated with operating as a public company, including legal,
accounting, insurance, exchange listing and SEC compliance, investor relations and other expenses. Because of these and other factors,
we expect to continue to incur substantial 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.