SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1
Document Type: S-1
Date Filed: 2026-02-12
Accession Number: 0001493152-26-006407
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/forms-1.htm

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(i) 1,565,000 shares of our existing Series A Preferred Stock into 1,565,000 shares of common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00) and (ii) $11,333,146 of our existing convertible notes into 6,099,998 shares of our common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00), and excludes, as of the date of this prospectus: ● shares of common stock issuable upon the exercise of the Representative’s Warrant; shares of our common stock reserved for issuance under stock option agreements issued pursuant to the 2024 Plan; and shares of our common stock (which is equal to % of our issued and outstanding common stock immediately after the consummation this offering) reserved for future issuance under the 2026 Equity Incentive Plan, which will become effective as of the closing of this offering.

MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL

CONDITION AND RESULTS OF OPERATIONS

The
following discussion and analysis summarize the significant factors affecting our operating results, financial condition, liquidity and
cash flows of our company as of and for the periods presented below. The following discussion and analysis should be read in conjunction
with our financial statements and the related notes thereto included elsewhere in this prospectus. The discussion contains forward-looking
statements that are based on the beliefs of management, as well as assumptions made by, and information currently available to, our management.
Actual results could differ materially from those discussed in or implied by forward-looking statements as a result of various factors,
including those discussed below and elsewhere in this prospectus, particularly in the sections titled “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements”.

Overview

are a medical device company focused on developing, manufacturing and commercializing proprietary devices to restore left ventricular
function in heart failure patients with reduced ejection fraction (“HFrEF”).

Our lead device
program, the Revivent System, has a CE mark in Europe and is in its pivotal trial in the United States. In Europe (where we have
obtained approval but are currently not commercially operating in order to preserve capital) or through an authorized U.S. clinical site
(as we have not received FDA approval), heart failure specialists refer HFrEF patients with left ventricular dilation due to large anterior
heart attack scars to cardiac surgeons who elect to utilize our product to restore left ventricular function by reducing the size of
the left ventricle. The Revivent System accomplishes this reduction by folding the scar onto itself and fastening it together in a less
invasive mini-thoracotomy procedure.

Based
on our analysis of publicly available data and according to a 2016 New England Journal of Medicine article, patients with heart failure
with HFrEF continue to face poor outcomes under the current standard of care, with multiple studies reporting an approximately 50–60%
five-year mortality rate. Our goal is for the Revivent System to be the new standard of care for these patients.

also have ownership rights to Alginate, a hydrogel-based device treatment for HFrEF patients without anterior scarring.

In November 2024, we received
an investigational device exemption (“IDE”) from the U.S. Food and Drug Administration (the “FDA”) under a Breakthrough
Device Designation (“BDD”) to begin a pivotal trial of the Revivent System (called the “RELIVE Trial”). We began
enrolling patients in the RELIVE Trial in September 2025. An IDE authorizes the use of a significant-risk investigational medical device
in a clinical study in order to collect safety and effectiveness data but does not constitute FDA clearance or approval to market or
commercialize the device. The FDA grants BDD if preliminary clinical evidence suggests the procedure may improve substantially upon at
least one clinically significant endpoint for a serious or life-threatening condition compared to existing therapies.

Our
company, under prior management, previously conducted a clinical trial of the Revivent System (called the “ALIVE Trial”),
which ended in 2023. The ALIVE Trial achieved statistical significance upon secondary analysis on functional status and Quality-of-Life
(“QoL”) measures, three of the five measures in the trial’s primary efficacy endpoint. The functional status and QoL
endpoints included change in 6-minute walk test (“6MWT”), change in Minnesota Living with Heart Failure questionnaire score
(“MLHF”), and change in New York Heart Association (“NYHA”) functional classification assessed at 12 months.
However, as reported in the Journal of the American College of Cardiology (“JACC”) ALIVE Trial publication, the failure of
the other two measures, cardiovascular mortality and heart failure hospitalization, were in part a result of the comparison of our trial
results with a control group that was healthier than the treatment group. This was a result of prior management’s decision to not
randomize the ALIVE Trial. In the JACC ALIVE Trial publication, the authors noted that (i) the control group was healthier than the treated
group as evidenced by heart failure treatments and hospitalizations in the twelve months prior to the trial and better baseline left-ventricle
function; and (ii) the external anchor placement (surgical only approach) produced fewer major adverse events than the internal right
ventricle-left ventricle (RV-LV) anchor placement (hybrid procedure). The composite primary safety endpoint through 30 days was met.
Major adverse events occurred in 15 of 84 patients (17.9%) of which 12 out of 60 patients (20%) were in the hybrid procedure and 3 out
of 23 (13.0%) were in the surgical only approach. In one patient, the device procedure was attempted but aborted before device anchor
placement. While the ALIVE trial met its safety endpoints inclusive of the hybrid procedure and surgical only approach, we have decided
to test the surgical only approach only in the RELIVE trial due to the fact that fewer major adverse events could indicate that it has
a more favorable safety profile, which would ultimately be determined by the FDA.

Our
current management team is following the JACC article authors’ recommendations by designing a randomized control trial using the
external anchor placement approach. We proposed and were approved by the FDA via an IDE for the RELIVE Trial for 84 treated patients
and 42 control patients, for a total of 126 trial patients (135 randomized patients starting the trial to account for trial patient attrition)
to support our Revivent Therapy Pre-Market Approval (“PMA”) application. We are actively engaged with approximately half
of the sites needed for the RELIVE Trial, providing confidence to management on their estimates on site initiation, recruitment rates,
heart failure specialist referral rates, surgeon experience, and trial expense.

The
Revivent System is classified by the FDA as a Class III medical device and requires PMA approval. In the event we receive FDA PMA approval
for our Revivent System, which we believe could be by mid-2028, we intend to expand from the 20 or more cardiac surgery centers participating
in the trial to the top 336 United States cardiac surgery centers which represent approximately 30% of hospitals performing cardiac surgeries
and 51% of cardiac surgery volume according to data published in The American Journal of Accountable Care. Ultimately, through the approximately
1,545 U.S. heart failure specialist and 1,120 U.S. cardiac surgery centers, our goal is to deploy the Revivent System in the market
to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. based on our estimations.

While
our priority is conducting the RELIVE Trial, we intend to support post-market surveillance to maintain our Revivent System CE mark and may
build a small European commercial organization if funding from this offering or otherwise becomes available in excess of our trial expenses.
In addition, we expect to conduct post-approval studies to support marketing and to satisfy any ongoing regulatory requirements.

There
is no guarantee that the RELIVE Trial will be sufficient for FDA approval, and in such case, we may be required to conduct additional
trials for the Revivent System. See “Risk Factors – If our clinical trials are unsuccessful or significantly delayed,
or if we do not complete our clinical trials, our business may be harmed.” and “Risk Factors – The FDA regulatory
approval, clearance and license process is complex, time-consuming and unpredictable.”