SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-12-12
Accession Number: 0001493152-25-027406
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225027406/filename1.htm

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be required to suspend or discontinue clinical trials due to side effects or other safety risks that could preclude approval of our product candidates. Our clinical trials may be suspended at any time for a number of reasons. We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants. In addition, regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to participants. Interim, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From
time to time, we may publicly disclose preliminary or top-line data from our preclinical studies and clinical trials, which is based
on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following
a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations
and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate
all data. As a result, the top-line or preliminary results that we report may differ from future results of the same studies, or different
conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Top-line data also
remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary
data we previously published. As a result, top-line data should be viewed with caution until the final data are available.

From
time to time, we may also disclose interim data from our preclinical studies and clinical trials. Interim data from clinical trials that
we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues
and more patient data become available or as patients from our clinical trials continue other treatments for their disease. As a result,
interim analyses should be viewed with caution until the final data are available. In addition, the data received from an interim analysis
could prompt us to alter the trial design, or even to halt the clinical trial altogether. Finally, we may report interim, top-line or
preliminary data of only certain endpoints rather than all endpoints. Adverse differences between preliminary or interim data and final
data, or between the initially planned trial design and any subsequently altered elements of the trial design due to our analysis of
interim, top-line or preliminary data, could significantly harm our business prospects.

Others,
including regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may
interpret or weigh the importance of data differently, which could impact the value of the particular program, the ability to initiate
further clinical studies, the approvability or commercialization of the particular product candidate or product and our company in general.
In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically
a significant volume of data and other information, and you or others may not agree with what we determine is material or otherwise appropriate
information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with
respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or our business. If
the interim, top-line, or preliminary data that we report differ from final results, or if others, including regulatory authorities,
disagree with the conclusions reached, our ability to obtain clearance or approval for, and commercialize, our product candidates may
be harmed, which could harm our business, operating results, prospects or financial condition.

Even
after receiving regulatory clearance or approval, our product candidates may be subject to product recalls, which could harm our reputation
and divert our managerial and financial resources.

The
FDA and similar governmental authorities in other countries have the authority to order mandatory recall of our product candidates or
order their removal from the market if the government finds that our product candidates might cause adverse health consequences or death.
A government-mandated or voluntary recall by us could occur as a result of component failures, manufacturing errors by us or our suppliers
or design defects, including labeling defects, or unanticipated safety problems. Any recall of our product candidates may harm our reputation
with customers and divert managerial and financial resources.

depend on a limited number of manufacturers and suppliers in connection with the manufacture of the Revivent System, which makes us vulnerable
to supply shortages and price fluctuations that could have a material adverse effect on our business, financial condition, results of
operations, and prospects.

source and rely upon components and sub-assemblies of the Revivent System, as well as manufacturing services from approved manufacturers
and suppliers, some of which are single-source suppliers.

These
components, sub-assemblies and services are critical to us, and there are relatively few alternative sources of supply. Our suppliers
generally are not under long-term contracts with us, and may experience delays or issues, stop producing our components or sub-assemblies,
increase the prices they charge us, or elect to terminate their relationships with us. In any of these cases, we could face a delay of
several months to identify, perform appropriate testing and qualify alternative manufacturers and suppliers with regulatory authorities,
as we currently have transition plans for some but not all of our manufacturers and suppliers. In addition, the failure of our third-party
manufacturers and suppliers to maintain acceptable quality requirements could result in quality issues, including recalls of our product
candidates. If one of our manufacturers or suppliers fails to maintain acceptable quality requirements, we may have to identify and qualify
a new manufacturer or supplier. Although we require our third-party manufacturers and suppliers to supply us with materials, components,
and services that meet our specifications and comply with applicable provisions of the Quality System Regulation (“QSR”)
and other applicable legal and regulatory requirements in our agreements and contracts, and we perform incoming inspection, testing,
or other acceptance activities to ensure the materials and components meet our requirements, there is a risk that they may not supply
components that meet our requirements or supply components in a timely manner.

The
number of third-party manufacturers and suppliers with the necessary manufacturing and regulatory expertise and facilities to produce
our device components is limited and the certification of a new manufacturer or supplier may be complex and time consuming. Any
delay or interruption would likely lead to a delay or interruption in our manufacturing operations. The inclusion of substitute components
must meet our product specifications and could require us to qualify the new manufacturer or supplier with the appropriate regulatory
authorities, including the FDA. The added time and cost to arrange for alternative manufacturers or suppliers could harm our business.
New manufacturers of any planned product would be required to qualify under applicable regulatory requirements and would need to have
sufficient rights under applicable intellectual property laws to the method of manufacturing the planned product. Obtaining the necessary
FDA or international approvals or other qualifications under applicable regulatory requirements and ensuring non-infringement of third-party
intellectual property or other proprietary rights could result in a significant interruption of supply and could require the new manufacturer
to bear significant additional costs that may be passed on to us.

The
report of our independent registered public accounting firm for the year ended December 31, 2024 includes a “going concern”
explanatory paragraph.

The
report of our independent registered public accounting firm on our consolidated financial statements as of and for the year ended December
31, 2024 includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern.
If we are unable to raise sufficient capital when needed, our business, financial condition and results of operations will be materially
and adversely affected, and we will need to significantly modify our operational plans to continue as a going concern. If we are unable
to continue as a going concern, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution
could be significantly lower than the values reflected in our financial statements. The inclusion of a going concern explanatory paragraph
by our auditors, our lack of cash resources and our potential inability to continue as a going concern may materially adversely affect
our share price and our ability to raise new capital or to enter into critical contractual relations with third parties.