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

Chunk 19 of 94
Word Count: 1403
Character Count: 9396

Document Content:

could be suspended. also expect that operating as a public company will make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified people to serve on our board of directors, our board committees or as executive officers. We do not know, however, if we will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsured liability may require us to pay substantial amounts, which would negatively affect our business, financial condition and results of operations. Our long-term growth depends on our ability to enhance our product candidates, expand our indications and develop and commercialize additional product candidates in a timely manner.

The
market for our product candidates is highly competitive, dynamic, and marked by rapid and substantial technological development and product
innovation. New entrants or existing competitors could attempt to develop product candidates that compete directly with ours. Demand
for our product candidates and future related product candidates could be diminished by equivalent or superior product candidates and
technologies offered by competitors. If we are unable to innovate successfully, our existing product candidates could become obsolete
and our revenue would decline as our customers purchase our competitors’ product candidates. Developing our current and new product
candidates is expensive and time-consuming and could divert management’s attention away from our core business. The success of
any new product offering or product enhancements to our solution will depend on several factors, including our ability to:

●	assemble
sufficient resources to acquire or discover additional product candidates;

●	properly
identify and anticipate physician and patient needs;

●	develop
and introduce new product candidates and product enhancements in a timely manner;

●	avoid
infringing upon the intellectual property rights of third-parties;

●	demonstrate,
if required, the safety and efficacy of new product candidates with data from preclinical studies and clinical trials;

●	obtain
the necessary regulatory clearances or approvals for expanded indications, new product candidates or product modifications;

fully FDA-compliant with marketing of new devices or modified product candidates;

●	produce
new product candidates in commercial quantities at an acceptable cost;

●	provide
adequate training to potential users of our product candidates;

●	receive
adequate coverage and reimbursement for procedures performed with our product candidates; and

●	develop
an effective and dedicated sales and marketing team.

we are unable to develop or improve product candidates, applications or features due to constraints, such as insufficient cash resources,
high employee turnover, inability to hire personnel with sufficient technical skills or a lack of other research and development resources,
we may not be able to maintain our competitive position compared to other companies. Furthermore, many of our competitors devote a considerably
greater amount of funds to their research and development programs than we do, and those that do not may be acquired by larger companies
that would allocate greater resources to research and development programs. Our failure or inability to devote adequate research and
development resources or compete effectively with the research and development programs of our competitors could harm our business.

addition, we may choose to focus our efforts and resources on potential product candidates or indications that ultimately prove to be
unsuccessful, or to license or purchase a marketed product that does not meet our financial expectations. As a result, we may fail to
capitalize on viable commercial product candidates or profitable market opportunities, be required to forego or delay pursuit of opportunities
with other potential product candidates or other diseases that may later prove to have greater commercial potential, or relinquish valuable
rights to such potential product candidates through collaboration, licensing or other royalty arrangements in cases in which it would
have been advantageous for us to retain sole development and commercialization rights, which could adversely impact our business, financial
condition and results of operations.

Our
operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating
results to fall below expectations or any guidance we may provide.

Our
quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our future operating results.
These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to:

●	the
level of demand for our product candidates and any approved product candidates, which may vary significantly;

●	expenditures
that we may incur to acquire, develop or commercialize additional product candidates and technologies;

●	the
timing and cost of obtaining regulatory approvals or clearances for planned or future product candidates or indications;

●	the
rate at which we grow our sales force and the speed at which newly hired salespeople become effective, and the cost and level of
investment therein;

●	the
degree of competition in our industry and any change in the competitive landscape of our industry, including consolidation among
our competitors or future partners;

●	coverage
and reimbursement policies with respect to our product candidates, if approved, and potential future product candidates that compete
with our product candidates;

●	the
timing and success or failure of preclinical studies or clinical trials for our product candidates or any future product candidates
we develop or competing product candidates;

●	the
timing of customer orders or medical procedures using our product candidates and the number of available selling days in any quarterly
period, which can be impacted by holidays, the mix of product candidates sold and the geographic mix of where product candidates
are sold;

●	seasonality,
including the seasonal slowing of demand for our product candidates we have experienced in the fourth quarter and summer months based
on the elective nature of procedures performed using our product candidates, and which we expect to become more pronounced in the
future as our business grows;

●	the
timing and cost of, and level of investment in, research, development, regulatory approval and commercialization activities relating
to our product candidates, which may change from time to time;

●	the
cost of manufacturing our product candidates, which may vary depending on the quantity of production and the terms of our agreements
with third-party suppliers and manufacturers; and

●	future
accounting pronouncements or changes in our accounting policies.

The
cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.
As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past
results as an indication of our future performance.

This
variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors
for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may
provide to the market, it could have a material adverse effect on our business, financial condition and results or operations.

Litigation
and other legal proceedings may adversely affect our business.

From
time to time we may become involved in legal proceedings relating to patent and other intellectual property matters, product liability
claims, employee claims, tort or contract claims, federal regulatory investigations, securities class action and other legal proceedings
or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of
our management from the operation of our business. Litigation is inherently unpredictable and can result in excessive or unanticipated
verdicts and/or injunctive relief that affect how we operate our business. We could incur judgments or enter into settlements of claims
for monetary damages or for agreements to change the way we operate our business, or both. There may be an increase in the scope of these
matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could have a material adverse
effect on our business, financial condition and results of operations. Adverse publicity about regulatory or legal action against us
could damage our reputation and brand image, undermine our customers’ confidence and reduce long-term demand for our product candidates,
even if the regulatory or legal action is unfounded or not material to our operations.

we experience significant disruptions in our information technology systems, our business may be adversely affected.