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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may be diminished, or the patient may suffer critical injury. We may also be subject to claims that are caused by the activities of our suppliers, such as those who provide us with components and sub-assemblies. we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or halt commercialization of our product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in: ● decreased demand for our product candidates; ● injury to our reputation; ● initiation of investigations by regulators; ● costs to defend the related litigation; diversion of management’s time and our resources; ● substantial monetary awards to trial participants or patients; ● product recalls, withdrawals or labeling, marketing or promotional restrictions; ● loss of revenue; ● exhaustion of any available insurance and our capital resources; and

●	the
inability to market and sell our product candidates. We believe we have adequate product liability insurance, but it may not prove
to be adequate to cover all liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be able to maintain
or obtain insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Our insurance policy contains
various exclusions, and we may be subject to a product liability claim for which we have no coverage. The potential inability to
obtain sufficient product liability insurance at an acceptable cost to protect against product liability claims could prevent or
inhibit the marketing and sale of product candidates we develop. Assuming we obtain clinical trial insurance for our clinical trials,
we may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are
not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts, which would have
a material adverse effect on our business, financial condition and results of operations. In addition, any product liability claims
brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing
coverage, harm our reputation in the industry, significantly increase our expenses and reduce product sales.

carry product liability insurance for our clinical trials covering $10 million, subject to certain deductibles and exclusions. Although
we believe the amount of our insurance coverage is typical for companies similar to us in our industry, we may not have adequate insurance
coverage or be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to
liability. If and when we obtain marketing approval for product candidates, we intend to expand our insurance coverage to include the
sale of commercial product candidates; however, we may be unable to obtain product liability insurance on commercially reasonable terms
or in adequate amounts. On occasion, large judgments have been awarded in class action lawsuits based on drugs or medical treatments
that had unanticipated adverse effects. A successful product liability claim or series of claims brought against us could cause our stock
price to decline and adversely affect our reputation and, if judgments exceed our insurance coverage, could adversely affect our results
of operations and business.

Some
of our customers and prospective customers may also have difficulty in procuring or maintaining liability insurance to cover their operations
and use of our product candidates. Medical malpractice carriers are withdrawing coverage in certain states or substantially increasing
premiums. If this trend continues or worsens, our customers may discontinue using our product candidates and potential customers may
opt against purchasing our product candidates due to the cost or inability to procure insurance coverage.

Product
liability claims could damage our reputation and adversely affect our financial results.

The
clinical use of medical product candidates, even after regulatory approval, poses an inherent risk of product liability claims. We maintain
limited product liability insurance coverage, subject to certain deductibles and exclusions. We cannot be sure that product liability
insurance will be available in the future or will be available on acceptable terms or at reasonable costs, or that such insurance will
provide us with adequate coverage against potential liabilities. We may be subject to product liability claims alleging defects in the
design, manufacture or labeling of our product candidates. Claims against us, regardless of their merit or potential outcome, may also
hurt our ability to obtain physician endorsement of our product candidates or expand our business. As we continue to expand use or our
existing product candidates and introduce more product candidates, we face an increased risk that a material product liability claim
will be brought against us.

Some
of our product candidates are designed for patients who suffer from late-stage or end-stage heart failure, and many of these patients
do not survive, even when supported by our product candidates. There are many factors beyond our control that could result in patient
death, including the condition of the patient prior to use of the product, the skill and reliability of physicians and hospital personnel
using and monitoring the product and product maintenance by customers. However, the failure of our product candidates used for clinical
testing or sale could give rise to product liability claims and negative publicity.

The
risk of product liability claims is heightened when we sell product candidates that are intended to support a patient until the end of
life. The finite life of our product candidates, as well as complications associated with their use, could give rise to product liability
claims whether or not the product candidates have extended or improved the quality of a patient’s life. If we are forced to pay
product liability claims in excess of our insurance coverage, our financial condition will be adversely affected.

Our
insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.

do not carry insurance for all categories of risk that our business may encounter. Although we carry product liability insurance in the
United States, we can give no assurance that such coverage will be available or adequate to satisfy any claims. Product liability insurance
is expensive, subject to significant deductibles and exclusions, and may not be available on acceptable terms, if at all. If we are unable
to obtain or maintain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against potential
product liability claims, we could be exposed to significant liabilities. A product liability claim, recall or other claim with respect
to uninsured liabilities or for amounts in excess of insured liabilities could have a material adverse effect on our business, financial
condition and results of operations. Defending a suit, regardless of its merit or eventual outcome, could be costly, could divert management’s
attention from our business and might result in adverse publicity, which could result in reduced acceptance of our product candidates
in the market, product recalls or market withdrawals.

do not carry specific hazardous waste insurance coverage, and our insurance policies generally exclude coverage for damages and fines
arising from hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable
for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals 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.