SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS
Document Type: DRS
Date Filed: 2025-08-05
Accession Number: 0001641172-25-022123
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000164117225022123/filename1.htm

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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 ST Elevated Myocardial Infarction (“STEMI”) induced
heart failure, with an additional 28,000 patients added and 28,000 patients lost each year. With approximately 140,000 monitored individuals,
the potentially addressable U.S. patient population for the Revivent System remains substantial. Each year, new cases contribute to the
population at a rate comparable to attrition, maintaining a consistent level of prevalence. 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.

may be unable to continue to successfully demonstrate to surgeons or key opinion leaders the merits of our product candidates and technologies
compared to those of our competitors, which may make it difficult to establish our product candidates and technologies as a standard
of care and achieve market acceptance.

Surgeons
play the primary role in determining the course of treatment and, ultimately, the type of product candidates that will be used to treat
a patient. As a result, our success depends, in large part, on our ability to effectively market and demonstrate to cardiovascular surgeons
the merits of our product candidates and methodologies compared to those of our competitors. Acceptance of our product candidates and
methodologies depends on educating surgeons as to the distinctive characteristics, clinical benefits, safety and cost-effectiveness of
the Revivent System and our other product candidates and technologies as compared to those of our competitors, and on training surgeons
in the proper use of our product candidates. If we are not successful in convincing surgeons of the merits of our product candidates
and methodologies or educating them on the use of our product candidates, they may not use our product candidates or may not use them
effectively and we may be unable to increase our sales, sustain our growth or achieve and sustain profitability.

Additionally,
since the Revivent procedure is a new procedure, some surgeons may be reluctant to change their surgical treatment practices for the
following reasons, among others:

●	lack
of experience with our product candidates and procedures;

●	existing
relationships with competitors and distributors that sell competitive product candidates;

●	lack
or perceived lack of evidence supporting additional patient benefits;

●	perceived
liability risks generally associated with the use of new product candidates and procedures;

●	less
attractive availability of coverage and reimbursement by third-party payors compared to procedures using competitive product candidates
and other techniques;

●	costs
associated with the purchase of new product candidates and equipment; and

●	the
time commitment that may be required for training.

These
reasons may affect the pace of adoption of the Revivent System and future product candidates and techniques that we may offer.

addition, third party payors, including private and government healthcare programs, would need to understand the costs and benefits of
our product candidates compared to existing standards of care, if they are to provide reimbursement for the cost of our product candidates
and the procedures to implant our product candidates. We believe recommendations and support of our product candidates and technologies
by influential surgeons and key opinion leaders in our industry are essential for market acceptance and establishment of our product
candidates and procedures as a standard of care. If we do not receive support from such surgeons and key opinion leaders, if long-term
data does not show the benefits of using our product candidates and procedures or if the benefits offered by our product candidates and
procedures are not sufficient to justify their cost, surgeons, hospitals and other health care facilities may not use our product candidates
and we might be unable to establish our product candidates and procedures as a standard of care and continue to achieve market acceptance.

The
training required for clinicians to use our product candidates could reduce the market acceptance of our product candidates and reduce
our revenue.

Clinicians
must be trained to use our product candidates proficiently. It is critical to the success of our business that we ensure that there are
a sufficient number of clinicians familiar with, trained on and proficient in the use of our product candidates. Convincing clinicians
to dedicate the time and energy necessary to obtain adequate training in the use of our product candidates is challenging and we may
not be successful in these efforts. If clinicians are not properly trained, they may misuse or ineffectively use our product candidates.
Any improper use of our product candidates may result in unsatisfactory patient outcomes, patient injury, negative publicity or lawsuits
against us, any of which could harm our reputation and affect future product sales. Furthermore, our inability to educate and train clinicians
to use our product candidates may lead to lower demand for our product candidates.

Even
if we are able to launch our pipeline portfolio successfully, we may experience material delays in our commercialization program relative
to our current expectations.

Even
if we are able to complete development of our pipeline portfolio and obtain regulatory clearance or approval, commercial market acceptance
of our product candidates in the healthcare community, including among physicians, patients and third-party payors, will depend on many
factors, including:

●	our
ability to provide incremental clinical and economic data demonstrating the safety, clinical effectiveness and cost-effectiveness
of, and patient benefit from, our product candidates, and any perceived inadequacy of evidence supporting clinical benefits or cost-effectiveness
over existing alternatives;

●	the
availability of alternative treatments;

●	whether
our product candidates are included on third party payor coverage plans;

●	the
willingness and ability of patients and the healthcare community to adopt new technologies;

●	customer
demand;

●	liability
risks generally associated with the use of new product candidates;

●	the
training required to use a new product;

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

●	the
pricing and reimbursement of our product candidates relative to other treatment methods; and

●	the
marketing and distribution support for our product candidates.