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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third-party suppliers’ ability to supply the components utilized in the Revivent System in a timely manner, in accordance with our specifications and in compliance with applicable regulatory requirements, and to remain in good standing with regulatory agencies; ● the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing therapies; ● our ability to obtain, maintain and enforce our intellectual property rights in and to the Revivent System; ● the emergence of competing technologies and other adverse market developments, and our need to enhance the Revivent System or develop new product candidates to maintain market share in response to such competing technologies or market developments; ● our ability to raise additional capital on acceptable terms, or at all, if needed to support the commercialization of the Revivent System; and ● our ability to achieve and maintain compliance with all regulatory requirements applicable to the Revivent System.

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, it will negatively affect our business, financial condition
and results of operations.

will initially depend on revenue generated from a single product and in the foreseeable future will be significantly dependent on a limited
number of product candidates.

the event we are able to successfully develop, gain regulatory approval for and commercialize our Revivent technology in the United
States (of which no assurances can be given as to any of these matters), we will initially depend on revenue generated from our
Revivent product for the foreseeable future and will be significantly dependent on a single or limited number of product candidates.
Given that, for the foreseeable future, our business will depend on a single or limited number of product candidates, to the extent that
a particular product is not well-received by the market, our sales volume, prospects, business, results of operations and financial condition
could be materially and adversely affected.

may expend our limited resources to pursue a particular product or indication and fail to capitalize on product candidates or indications
that may be more profitable or for which there is a greater likelihood of success.

Because
we have limited financial and managerial resources, we focus on specific product candidates, indications and discovery programs. As a
result, we may forgo or delay pursuit of other opportunities with others that could have had greater commercial potential. Our resource
allocation decisions may cause us to fail to capitalize on viable commercial product candidates or profitable market opportunities. Our
spending on current and future research and development programs for specific indications may not yield any commercially viable product
candidates. If we do not accurately evaluate the commercial potential or target market for a particular potential product, we may relinquish
valuable rights to that potential product through future collaborations, licenses and other similar arrangements in cases in which it
would have been more advantageous for us to retain sole development and commercialization rights to such potential product.

The
commercial success of our product candidates will depend upon attaining significant market acceptance of these product candidates among
physicians, healthcare payors and the medical community.

Our
success will depend, in part, on the acceptance of our product candidates as safe, effective and, with respect to providers and third
party payors, cost effective. We cannot predict how quickly, if at all, physicians will accept our product candidates or, if accepted,
how frequently they will be used. Our product candidates and planned or future product candidates we may develop or market may never
gain broad market acceptance among physicians, the medical community or third party payors for some or all of our targeted indications.
Healthcare providers must believe that our product candidates offer benefits over alternative treatment methods. The degree of market
acceptance of any of our product candidates will depend on a number of factors, including:

●	whether
physicians and others in the medical community consider our product candidates to be safe and cost effective treatment methods;

●	the
potential and perceived advantages of our product candidates over alternative treatment methods;

●	the
prevalence and severity of any side effects associated with using our product candidates;

●	product
labeling, product insert or marketing and advertising requirements by the FDA or other regulatory authorities;

●	limitations
or warnings contained in the labeling cleared or approved by the FDA or other authorities;

●	the
cost of treatment in relation to alternative treatments methods;

●	the
convenience and ease of use of our product candidates relative to alternative treatment methods;

●	the
availability of coverage and adequate reimbursement for procedures using our product candidates from third-party payors, including
government authorities;

●	the
willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors, including
government authorities;

●	the
size of the market for such product, based on the size of the patient subsets that we are targeting, in the territories for which
we gain regulatory approval;

●	our
ability to provide incremental clinical and economic data that show the safety, clinical efficacy and cost effectiveness of, and
patient benefits from, our product candidates; and

●	the
effectiveness of our sales and marketing efforts for our product candidates.

Additionally,
even if our product candidates achieve market acceptance, they may not maintain that market acceptance over time if competing product
candidates or technologies, which are more cost effective or received more favorably, are introduced. Failure to achieve or maintain
market acceptance and/or market share would limit our ability to generate revenue and would have a material adverse effect on our business,
financial condition and results of operations.

manufacture and sell product candidates that are used in a limited number of procedures and there is a limited total addressable market
for our product candidates. The sizes of the markets for our current product candidates have not been established with precision, and
may be smaller than we estimate.

The
Revivent System, in the event it achieves FDA approval or clearance, intends to target an identifiable U.S. patient population of approximately
192,000 monitored individuals suffering from STEMI induced heart failure, with an additional 28,000 patients added and 28,000 patients
lost each year. With approximately 192,000 monitored individuals, the potentially addressable U.S. patient population for the
Revivent System remains substantial. We believe that we are well-positioned to serve a substantial, underserved global addressable market
of $16 billion in eligible and appropriate patients (prevalence) and once served, $2.4 billion of annually recurring patients (incidence);
the U.S. could potentially represent a $10 billion addressable market. However, the total addressable market for our product candidates
is subject to change from year to year and geography, and may be further limited by FDA restrictions, limitations on use or more narrowly
defined indications, any of which could have a material adverse effect on our business, financial condition and results of operations.

Our
estimates of the annual total addressable markets for our current product candidates are based on a number of internal and third-party
estimates, including, without limitation, the number of individuals suffering from STEMI-induced heart failure treatable by our product
candidates and the assumed prices at which we can sell our product candidates in markets that have not yet been fully established. While
we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and
the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying
factors. As a result, our estimates of the annual total addressable market for our current or future product candidates may prove to
be incorrect. If the actual number of patients who would benefit from our solution, the price at which we can sell our product candidates,
or the annual total addressable market for our product candidates is smaller than we have estimated, it may impair our sales growth and
negatively affect our business, financial condition and results of operations.

The estimates
and projections that we may make from time to time are subject to inherent risks and may prove incorrect in the future.