SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-10-06
Accession Number: 0001493152-25-016953
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225016953/filename1.htm

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operations. received our European CE mark, indicating that we affirm our product’s conformity with European health, safety and environmental protection standards. We will also need to obtain regulatory approval in other foreign jurisdictions in which we plan to market and sell our products. The time required to obtain registrations or approvals, if required by other countries, may be longer than that required for FDA clearance, and requirements for such registrations, clearances, or approvals may significantly differ from FDA requirements. If we modify our products, we may need to apply for additional regulatory approvals before we are permitted to sell the modified product. In addition, we may not continue to meet the quality and safety standards required to maintain the authorizations that we have received. If we are unable to maintain our authorizations in a particular country, we will no longer be able to sell the applicable product in that country.

addition, there can be no guarantee that we will receive approval to sell our product candidates in any market we target, including the
United States, nor can there be any guarantee that any sales would result even if such approval is received. Even if the FDA grants marketing
approval for a product, comparable regulatory authorities of foreign countries must also approve the manufacturing or marketing of the
product in those countries. Approval in the United States, or in any other jurisdiction, does not ensure approval in other jurisdictions.
Obtaining regulatory approvals could result in significant delays, difficulties and costs for us and require additional trials and additional
expenses. Regulatory requirements can vary widely from country to country and could delay the introduction of our product candidates
in those countries. Clinical trials conducted in one country may not be accepted by other countries, and regulatory approval in one country
does not mean that regulatory approval will be obtained in any other country. If we fail to comply with these regulatory requirements
or to obtain and maintain required approvals, our target market will be reduced and our ability to generate revenue will be diminished.
Our inability to successfully enter all our desired international markets and manage business on a global scale could negatively affect
our business, financial results and results of operations.

Our
future growth may depend, in part, on our ability to continue to operate or expand in foreign markets, where we would be subject to additional
regulatory burdens and other risks and uncertainties.

Our
future growth may depend, in part, on our ability to continue to develop and commercialize our planned and future products in
current and additional foreign markets. We are not permitted to market or promote any of our planned or future products before we receive
regulatory approval from applicable regulatory authorities in foreign markets, and we may never receive such regulatory approvals for
any of our planned or future products. To obtain separate regulatory approval in many other countries we must comply with numerous and
varying regulatory requirements regarding safety and efficacy and governing, among other things, clinical trials, commercial sales, pricing
and distribution of our planned or future products. If we obtain regulatory approval of our products and ultimately commercialize our
planned or future products in foreign markets, we would be subject to additional risks and uncertainties, including:

●	different
regulatory requirements for approval of medical devices in foreign countries;

●	reduced
protection for intellectual property rights;

●	the
existence of additional third-party patent rights of potential relevance to our business;

●	unexpected
changes in tariffs, trade barriers and regulatory requirements;

●	economic
weakness, including inflation or political instability in particular foreign economies and markets;

●	compliance
with tax, employment, immigration and labor laws for employees living or traveling abroad;

●	foreign
currency fluctuations, which could result in increased operating expenses, reduced revenue and other obligations incident to doing
business in another country;

●	foreign
reimbursement, pricing and insurance regimes;

●	workforce
uncertainty in countries where labor unrest is common;

●	production
shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

●	business
interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, typhoons,
floods and fires.

the extent we enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations
and alliances.

The
rapid pace of technological development in the medical technology industry and the specialized expertise required in different areas
of medicine make it difficult for one company alone to develop a broad portfolio of technological solutions. In addition to internally
generated growth through our research and development efforts, we expect to make future investments where we believe that we can stimulate
the development or acquisition of new technologies and product candidates to further our strategic objectives and strengthen our existing
businesses. Collaborative arrangements and strategic alliances in and with medical technology companies are inherently risky, and we
cannot guarantee that any of our previous or future investments or investment collaborations will be successful or will not materially
adversely affect our business, results of operations, financial condition and cash flows.

Any
collaboration arrangement or alliance we have or may have in the future could be terminated for reasons beyond our control or we may
not be able to negotiate future alliances on acceptable terms, if at all. These arrangements and alliances could result in us receiving
less revenue than if we sold our product candidates directly, place the development, sales and marketing of our product candidates outside
of our control, require us to relinquish important rights or otherwise be on unfavorable terms.

Collaborative
arrangements or strategic alliances will also subject us to a number of risks, including the risk that:

may not be able to control the amount and timing of resources that our strategic partners/collaborators may devote
to the product candidates;

●	strategic
partners/collaborators may experience financial difficulties;

●	the
failure to successfully collaborate with third parties may delay, prevent or otherwise impair the development or commercialization
of our product candidates or revenue expectations;

●	business
combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness
or ability to complete their obligations under any arrangement;

collaborator could independently move forward with a competing product developed either independently or in collaboration with others,
including our competitors; and

●	collaborative
arrangements are often terminated or allowed to expire, which would delay the development of, and may increase the cost of developing,
product candidates.

we fail to obtain and maintain necessary governmental approvals for our product candidates and indications, we may be unable to market
and sell our product candidates in certain jurisdictions.

Medical
devices such as ours are extensively regulated by the FDA in the U.S. and by other federal, state, local and foreign authorities. Governmental
regulations relate to the testing, development, manufacturing, labeling, design, sale, promotion, distribution, importing, exporting
and shipping of our product candidates. In the U.S., before we can market a new medical device, or a new use of, or claim for, or significant
modification to, an existing product, we must generally first receive PMA from the FDA. This process can be expensive and lengthy, and
can entail significant expenses, primarily related to clinical trials. It generally takes between one to three years to receive approval,
or even longer, from the time the PMA application is submitted to the FDA. Regulatory clearances or approvals, either foreign or domestic,
may not be granted on a timely basis, if at all. If we are unable to obtain regulatory approvals or clearances for use of our product
candidates under development, or if the patient populations for which they are approved are not sufficiently broad, the commercial success
of these product candidates could be limited. The FDA may also limit the claims that we can make about our product candidates. Any significant
modifications to the design, materials, or intended use of those devices require FDA approval through PMA or humanitarian device extension
(“HDE”) supplemental applications.

we do not receive FDA approval for one or more of our product candidates, we will be unable to market and sell those product candidates
in the U.S., which would have a material adverse effect on our operations and prospects.

also market or are beginning to market our product candidates in international markets, including the European Union. Regulatory approval
processes differ among those jurisdictions and approval in the U.S. or any other single jurisdiction does not guarantee approval in any
other jurisdiction. Obtaining foreign approvals could involve significant delays, difficulties and costs for us and could require additional
clinical trials.

Our
product candidates are subject to extensive regulatory requirements, including continuing regulatory review, which could affect the manufacturing
and marketing of our product candidates.