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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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.

The estimates and projections
we describe in this prospectus and may provide from time to time in the future (including, but not limited to, those relating to addressable
market sizes, target patient populations, procedure costs, insurance reimbursement levels and other financial or operational matters)
reflect numerous assumptions made by management, including assumptions with respect to our specific as well as general business, economic,
market and financial conditions and other matters, all of which are difficult to predict and many of which are beyond our control.  For
our company in particular, since the condition we are targeting with the Revivent System (restoring left ventricular function in heart
failure patients with reduced ejection fraction) is a subset of overall heart failure and heart disease, we are required to extrapolate
different data to reach conclusions regarding certain of our estimates and projections (for example, see the section of this prospectus
captioned Business – Market Opportunity Assumptions).  Accordingly, there is a risk that the assumptions made in preparing
our estimates and projections, or the estimates and projections themselves, will prove inaccurate. There will be differences between
actual and projected results, and actual results may be materially different from those contained in our estimates and projections. The
inclusion of such estimates projections in this prospectus should not be regarded as an indication that we or our management or representatives
considered or consider the projections to be a reliable prediction of future events, and our estimates and projections should not be
relied upon as such.

may be unable to continue to successfully demonstrate to heart failure specialists, 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.

Heart
failure specialists and surgeons play the primary
role in determining the course of treatment and, ultimately, the type of product candidates that will be used to treat our patient
phenotype. As a result, our success depends, in large part, on our ability to effectively market and demonstrate to heart failure
specialists and 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 heart failure specialists and
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 heart failure specialists and surgeons may be reluctant to change their 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 heart failure specialists, 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 heart failure
specialists, 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, heart failure
specialists, surgeons, and hospitals 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.

There
is a risk that we may be unable to address any of these criteria or any additional criteria that might affect the market acceptance of
our product candidates. If our product candidates achieve market acceptance, they may not maintain that market acceptance over time if
competing product candidates or technologies are introduced that are received more favorably or are more cost-effective. Failure to achieve
or maintain market acceptance would limit our ability to generate revenue and would have a material adverse effect on our business, financial
condition, results of operations and prospects.

Our
employees, independent contractors, consultants, commercial partners, distributors, and vendors may engage in misconduct or other improper
activities, including noncompliance with regulatory standards and requirements.