SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: S-1/A
Date Filed: 2026-03-18
Accession Number: 0001493152-26-010642
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226010642/forms-1a.htm

Chunk 11 of 85
Word Count: 1493
Character Count: 9960

Document Content:

and other therapies could be developed that replace or reduce the importance of our product candidates. Our product candidates could be rendered obsolete because of future innovations by our competitors or others in the treatment of cardiovascular diseases, which would have a material adverse effect on our business, financial condition and results of operations. Accordingly, our success will depend in part on our ability to respond quickly to medical and other changes through the development and introduction of new product candidates. Product development involves a high degree of risk, and there can be no assurance that our new product development efforts will result in any commercially successful product candidates. hospitals, clinicians and other healthcare providers are unable to obtain coverage and reimbursement from third-party payors for procedures performed using our product candidates, adoption of our product candidates may be delayed, and it is unlikely that they will gain further acceptance.

Growing
sales of our product depends on the availability of adequate coverage and reimbursement from third-party payors, including government
programs such as Medicare and Medicaid, private insurance plans, and managed care programs. Hospitals, clinicians, and other healthcare
providers that purchase or use medical devices generally rely on third-party payors to pay for all or part of the costs and fees associated
with the procedures performed with these devices.

Adequate
coverage and reimbursement for procedures performed with our product candidates is central to the acceptance of our current and future
product candidates. We may be unable to sell our product candidates on a profitable basis if third-party payors deny coverage, continue
to deny coverage or reduce their current levels of payment, or if our costs for the product increase faster than increases in reimbursement
levels.

Many
private payors refer to coverage decisions and payment amounts determined by the Centers for Medicare and Medicaid Services (“CMS”)
which administers the Medicare program, as guidelines for setting their coverage and reimbursement policies. Private payors that do not
follow the Medicare guidelines may adopt different coverage and reimbursement policies for procedures performed with our product candidates.
Future action by CMS or third-party payors may further reduce the availability of payments to physicians, outpatient surgery centers,
and/or hospitals for procedures using our product candidates.

The
healthcare industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control
healthcare costs. Payors are imposing lower payment rates and negotiating reduced contract rates with service providers and being increasingly
selective about the technologies and procedures they choose to cover. There can be no guarantee that we will be able to provide the scientific
and clinical data necessary to overcome these policies. Payors may adopt policies in the future restricting access to medical technologies
like ours and/or the procedures performed using such technologies. Therefore, we cannot be certain that the procedures performed with
each of our product candidates will be reimbursed. There can be no guarantee that, should we introduce additional product candidates
in the future, payors will cover those product candidates or the procedures in which they are used.

Conducting
successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify
and recruit.

Patient
enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the
patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with, the treatments
received by enrolled subjects; the availability of appropriate clinical trial investigators; support staff; and the proximity of patients
to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient
compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo
extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our product candidates or if they determine
that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts. Patients may
also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive product candidates.

may be difficult to identify and enroll patients due to clinical trial inclusion-exclusion criteria or other factors, which has in the
past, and may in the future, lead to delays in enrollment and in generating clinical data for our trials.

Our
clinical trials have had, and may have in the future, strict inclusion criteria for patient enrollment. These criteria could present
significant obstacles to the timely recruitment and enrollment of a sufficient number of eligible patients into our trials. We may experience
slower than expected patient enrollment in our existing or future clinical trials. Any inability to successfully enroll the number of
patients meeting the criteria for any of our clinical trials could cause significant delays in the trial and increase the costs associated
with the trial, which could materially harm our business and prospects.

Patient
enrollment in a clinical trial may be affected by many factors, including:

●	the
severity of the disease under investigation;

●	the
design of the study protocol;

●	the
eligibility criteria for the study;

●	the
perceived risks, benefits and convenience of administration of the product candidate being studied;

●	the
existence of infectious disease outbreaks;

●	the
competitive disease space with many trials for patients to select from;

●	the
availability of approved alternate treatments; and

●	the
proximity and availability of clinical trial sites to prospective patients.

and our investigators may also face challenges in enrolling patients to participate in our clinical trials due to the novelty of procedures.
Some patients may have concerns regarding our procedure that may negatively affect their perception of our therapies and their decision
to enroll in our trials. Enrollment delays in our clinical trials may result in increased development costs for our product candidates,
and our inability to enroll a sufficient number of patients for any of our current or future clinical trials would result in significant
delays or may require us to abandon one or more clinical trials altogether.

our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed.

Clinical
development is a long, expensive and uncertain process and is subject to delays and the risk that product candidates may ultimately prove
unsafe or ineffective in treating the indications for which they are designed. Completion of clinical trials may take several years or
more. Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory approval to commence a trial,
in reaching an agreement on acceptable clinical trial terms with prospective sites, in obtaining institutional review board approval
at each site, in recruiting patients to participate in a trial or in obtaining sufficient supplies of clinical trial materials.

cannot provide any assurance that we will successfully, or in a timely manner, enroll our clinical trials, that our clinical trials will
meet their primary or other endpoints or that such trials or their results will be accepted by the FDA or foreign regulatory authorities.

may experience numerous unforeseen events during, or because of, the clinical trial process that could delay or prevent us from receiving
regulatory clearance or approval for new product candidates or modifications of existing product candidates, including new indications
for existing product candidates, including:

●	enrollment
in our clinical trials may be slower than we anticipate, or we may experience high screen failure rates in our clinical trials, resulting
in significant delays;

●	our
clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional
clinical and/or preclinical testing which may be expensive and time-consuming;

●	trial
results may not meet the level of statistical significance required by the FDA or other regulatory authorities;

●	the
FDA or similar foreign regulatory authorities may find the product is not sufficiently safe for investigational use in humans;

●	the
FDA or similar foreign regulatory authorities may interpret data from preclinical testing and clinical trials in different ways than

●	there
may be delays or failure in obtaining approval of our clinical trial protocols from the FDA or other regulatory authorities;

●	there
may be delays in obtaining institutional review board approvals or governmental approvals to conduct clinical trials at prospective
sites;

●	the
FDA or similar foreign regulatory authorities may find our or our suppliers’ manufacturing processes or facilities unsatisfactory;

●	the
FDA or similar foreign regulatory authorities may change their review policies or adopt new regulations that may negatively affect
or delay our ability to bring a product to market or receive approvals or clearances to treat new indications;

may have trouble in managing multiple clinical sites;

may have trouble finding patients to enroll in our trials;

may experience delays in agreeing on acceptable terms with third-party research organizations and trial sites that may help us conduct
the clinical trials; and