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

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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

or regulators, may suspend or terminate our clinical trials because the participating patients are being exposed to unacceptable
health risks.

addition, changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these
changes, which could impact the cost, timing or successful completion of a clinical trial. If we experience delays in the commencement
or completion of our clinical trials, the commercial prospects for our product candidates will be harmed, and our ability to generate
product revenues will be delayed. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials
may also lead to the denial of regulatory approval of a product candidate.

Failures
or perceived failures in our clinical trials will delay and may prevent our product development and regulatory approval process, damage
our business prospects and negatively affect our reputation and competitive position.

Clinical
trials may be delayed, suspended or terminated for many reasons, which will increase our expenses and delay the time it takes to develop
new product candidates or seek new indications.

may experience delays in our ongoing or future preclinical studies or clinical trials, and we do not know whether future preclinical
studies or clinical trials will begin on time, need to be redesigned, enroll an adequate number of patients on time or be completed on
schedule, if at all. The commencement and completion of clinical trials for future product candidates or indications may be delayed,
suspended or terminated as a result of many factors, including:

●	the
FDA or other regulators disagreeing as to the design, protocol or implementation of our clinical trials;

●	the
delay or refusal of regulators or institutional review boards (“IRBs”) to authorize us to commence a clinical trial at
a prospective trial site;

●	changes
in regulatory requirements, policies and guidelines;

●	delays
or failure to reach agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical
trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial
sites;

●	delays
in patient enrollment and variability in the number and types of patients available for clinical trials;

●	the
inability to enroll a sufficient number of patients in trials to observe statistically significant treatment effects in the trial;

●	having
clinical sites deviate from the trial protocol or dropping out of a trial;

●	negative
or inconclusive results from ongoing preclinical studies or clinical trials, which may require us to conduct additional preclinical
studies or clinical trials or to abandon projects that we expect to be promising;

●	safety
or tolerability concerns that could cause us to suspend or terminate a trial if we find that the participants are being exposed to
unacceptable health risks;

●	reports
from preclinical or clinical testing of other similar therapies that raise safety or efficacy concerns;

●	regulators
or IRBs requiring that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance
with regulatory requirements or safety concerns, among others;

●	lower
than anticipated retention rates of patients and volunteers in clinical trials;

●	our
CROs or clinical trial sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely
manner, or at all, deviating from the protocol or dropping out of a trial;

●	delays
relating to adding new clinical trial sites;

●	difficulty
in maintaining contact with patients after treatment, resulting in incomplete data;

●	the
quality of the product candidates falling below acceptable standards;

●	the
inability to manufacture sufficient quantities of our product candidates to commence or complete clinical trials; and

●	exceeding
budgeted costs due to difficulty in accurately predicting costs associated with clinical trials.

could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or the Ethics Committees of institutions
at which such trials are being conducted, by the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities.
Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial
in accordance with regulatory requirements, including the FDA’s current Good Clinical Practice (“cGCP”), regulations,
or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the imposition of a clinical
hold, unforeseen safety issues or adverse side effects, failure to demonstrate safety and effectiveness, changes in governmental regulations
or administrative actions or lack of adequate funding to continue the clinical trial.

addition, we may encounter delays if the FDA concludes that our financial relationships with investigators result in a perceived or actual
conflict of interest that may have affected the interpretation of a study, the integrity of the data generated at the applicable clinical
trial site or the utility of the clinical trial itself. Principal investigators for our clinical trials may serve as scientific advisors
or consultants to us from time to time and receive cash compensation and/or stock options in connection with such services. If these
relationships and any related compensation to or ownership interest by the clinical investigator carrying out the study result in perceived
or actual conflicts of interest, or if the FDA concludes that the financial relationship may have affected interpretation of the study,
the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself
may be jeopardized, which could result in the delay or rejection by the FDA. Any such delay or rejection could prevent us from commercializing
any of our product candidates currently in development.

we experience delays in the commencement or completion of any clinical trial of our product candidates, or if any of our clinical trials
are terminated, the commercial prospects of our product candidates may be harmed, and our ability to generate revenue from sales may
be delayed or materially diminished.

do not know whether any of our future preclinical studies or clinical trials will begin as planned, will need to be restructured or will
be completed on schedule, or at all. Any delays in completing our clinical trials will increase our costs, slow down our product development
and approval process and jeopardize our ability to commence sales and generate associated revenue. Any of these occurrences may significantly
harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement
or completion of clinical trials may also ultimately lead to the denial, suspension or revocation of expanded regulatory clearance or
approval of our product candidates. Significant preclinical study or clinical trial delays also could shorten any periods during which
we may have the exclusive right to commercialize our product candidates or allow our competitors to bring product candidates to market
before we do and impair our ability to successfully commercialize our product candidates.

may be required to suspend or discontinue clinical trials due to side effects or other safety risks that could preclude approval of our
product candidates.

Our
clinical trials may be suspended at any time for a number of reasons. We may voluntarily suspend or terminate our clinical trials if
at any time we believe that they present an unacceptable risk to participants. In addition, regulatory agencies may order the temporary
or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance
with applicable regulatory requirements or that they present an unacceptable safety risk to participants.

Interim,
top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data
become available and are subject to audit and verification procedures that could result in material changes in the final data.