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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actual initial public offering price and other terms of this offering. Assuming the underwriters’ over-allotment option is not exercised, each $1.00 increase (decrease) in the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) our pro forma as adjusted net tangible book value after giving effect to this offering by $ , or by approximately $ per share of common stock and the dilution to new investors purchasing our common stock in this offering by approximately $ per share, assuming the number of shares offered by us remains the same and after deducting the estimated underwriting discount and estimated offering expenses payable by us. In addition, to the extent any stock options that we granted to certain of our officers, directors, employees and permitted consultants, new investors would experience further dilution.

The
following table illustrates our pro forma proportionate ownership, upon completion of this offering by present stockholders and investors
in this offering, compared to the relative amounts paid by each. The table reflects payment by present stockholders as of the date the
consideration was received and by investors in this offering at the public offering price. The table further assumes no changes in net
tangible book value other than those resulting from this offering.

Shares
Purchased Total
Consideration Average
Price

Number Percent
(%) Amount
($) Percent
(%) Per
Share ($)

Existing stockholders [  ] [  ]	% [  ] [  ]	% $	[  ]

New investors [  ] 10	% [  ] [  ]	% $	[  ]

Total [  ] 100	% [  ] [  ]	% $	[  ]

The
table above assumes no exercise of the underwriters’ over-allotment option to purchase additional shares in this offering. If the
underwriters’ over-allotment option to purchase additional shares is exercised in full, the number of shares of our common stock
held by existing stockholders would be reduced to               % of the total number of shares of our common stock outstanding after this offering,
and the number of shares of common stock held by new investors participating in this offering would be increased to % of the total number
of shares outstanding after this offering.

The
number of shares of our common stock to be outstanding upon completion of this offering will be shares assuming no exercise of the over-allotment
by the underwriters, which is based on 5,674,143 shares of our common stock outstanding as of March 31, 2025, which includes
5,697,138 shares of common stock being issued upon the closing of this offering in connection with the conversion of: (i) 1,565,000
shares of our existing Series A Preferred Stock into 1,565,000 shares of common stock and (ii) $5,719,152 of our existing convertible
notes into 4,132,138 shares of our common stock, and excludes, as of March 31, 2025:

●	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 2024 Equity Incentive 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 our 2025 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

We are a clinical-stage 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”). In HFrEF patients with left ventricular dilation due to large
anterior heart attack scars, cardiac surgeons elect to utilize our product, the Revivent system (the “Revivent System”),
in order to restore left ventricular function by reducing the size of the left ventricle. The Revivent System does so by folding the
scar onto itself and fastening it together in a less invasive mini-thoracotomy procedure. Absent the Revivent System, patients suffer
the grim prognosis of 50-60% five-year mortality rates when treated with the standard of care, currently consisting of a combination
of medications used to treat HFrEF.

November 2024, we received an investigational device exemption (“IDE”) from the U.S. Food and Drug Administration (the “FDA”)
under Breakthrough Therapy Designation (“BTD”) to begin a pivotal trial (the “RELIVE Trial”). The FDA grants
BTD 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 prior trial, which was completed 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 our primary efficacy endpoint. However, as reported in the Journal of the American College
of Cardiology (“JACC”) ALIVE Trial publication, the failure of the other two measures 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 JACCALIVE Trial publication, the authors noted that (1) 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 (2) the external anchor placement (surgical only approach) was safer than the internal RV-LV anchor
placement (hybrid procedure). 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 for
approval. 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, surgeon experience, and trial expense. We anticipate first subject treatment
in August 2025.

the event we receive FDA PMA approval for our Revivent System, which we anticipate could be by mid-2028, we intend to expand from the
20 or more cardiac surgery centers participating in the trial to the top 340 United States cardiac surgery centers which represent 30%
of hospitals performing cardiac surgeries and 51% of cardiac surgery volume. Ultimately, through the approximately 1,120 U.S.
cardiac surgery centers, we will seek to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible
patients in the U.S. Based on leading cardiac surgery device companies averaging 60% of their total revenue in the U.S.,
we estimate an additional 213,000 identifiable and appropriate patients which have similar unmet needs outside the U.S. Approximately
28,000 and 32,000 Revivent System-eligible patients are added each year to U.S. and ex-U.S. prevalence, respectively,
and a similar number are lost each year to mortality.

Principal
Factors Affecting Our Financial Performance

Our
operating results are primarily affected by the following factors:

●	the
ability to obtain regulatory approval to market our product candidates;

●	the
timing, costs and results of clinical trials and other development activities versus expectations;

●	the
ability to manufacture product candidates successfully;

●	competition
from product candidates sold or being developed by other companies;

●	the
price of, and demand for, our product candidates once approved;

●	the
ability to negotiate favorable licensing or other manufacturing and marketing agreements for our product candidates;

●	patent
reinforcement and prosecution; and

●	changes
in laws or the regulatory environment affecting our company.

Our
Status as an Emerging Growth Company and Smaller
Reporting Company

qualify as an “emerging growth company” under the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions
from certain disclosure requirements. For so long as we are an emerging growth company, we will not be required to:

●	have
an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;