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

Chunk 1 of 82
Word Count: 1288
Character Count: 8592

Document Content:

the total underwriting discounts and commissions will be $ and the additional proceeds to us, before expenses, from the over-allotment option exercise will be $ The underwriters expect to deliver the shares of common stock to purchasers on or about The Benchmark Company The date of this prospectus is , 2025 TABLE OF CONTENTS Page Prospectus Summary 1 Risk Factors 9 Cautionary Note Regarding Forward-Looking Statements 56 Use of Proceeds 57 Dividend Policy 58 Capitalization 59 Dilution 60 Management’s Discussion and Analysis of Financial Condition and Results of Operations 62 Business 69 Management 85 Executive and Director Compensation 90 Principal Stockholders 99 Certain Relationships and Related Party Transactions 101 Description of Capital Stock 102 Shares Eligible for Future Sale 108 Material U.S. Federal Income Tax Consequences to Non-U.S. Holders 110 Underwriting 114 Legal Matters 123 Experts 123 Where You Can Find More Information 123 Index to Consolidated Financial Statements F-1

Neither
we nor the underwriters have authorized anyone to provide you with any information or to make any representation other than those contained
in this prospectus and in any free writing prospectus prepared by or on behalf of us and delivered or made available to you. Unless otherwise
indicated, information contained in this prospectus concerning our industry and the regions in which we operate, including our general
expectations and market position, market opportunity, market share and other management estimates, is based on information obtained from
various independent publicly available sources and other industry publications, surveys and forecasts, which we believe to be reliable
based upon our management’s knowledge of the industry. We assume liability for the accuracy and completeness of such information
to the extent included in this prospectus. We are offering to sell, and seeking offers to buy, shares of our common stock only in jurisdictions
where offers and sales are permitted. The information contained in this prospectus or any free writing prospectus is accurate only as
of its date, regardless of its time of delivery or of any sale of shares of our common stock. Our business, financial condition, operating
results, and prospects may have changed since that date.

For
investors outside the United States: Neither we nor any of the underwriters have done anything that would permit this offering or
possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United
States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any
restrictions relating to, this offering of the shares of common stock and the distribution of this prospectus outside of the United States.

INDUSTRY
AND MARKET DATA

Unless
otherwise indicated, information in this prospectus concerning economic conditions, our industry, our markets and our competitive position
is based on a variety of sources, including information from third-party industry analysts and publications and our own estimates and
research. Some of the industry and market data contained in this prospectus are based on third-party industry publications. This information
involves a number of assumptions, estimates and limitations.

The
industry publications, surveys and forecasts and other public information generally indicate or suggest that their information has been
obtained from sources believed to be reliable. None of the third-party industry publications used in this prospectus were prepared on
our behalf. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including
those described in “Risk Factors” in this prospectus. These and other factors could cause results to differ materially from
those expressed in these publications.

TRADEMARKS

own or have rights to trademarks or trade names that we use in connection with the operation of our businesses, our corporate names,
logos and website names. This prospectus contains references to our trademarks and service marks and to those belonging to other entities.
Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the ® or ™
symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent possible under
applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or
display of other companies’ trade names, trademarks, or service marks to imply a relationship with, or endorsement or sponsorship
of us by any other companies. All other trademarks are the property of their respective owners.

PROSPECTUS
SUMMARY

This
summary highlights certain information appearing elsewhere in this prospectus. Because it is only a summary, it does not contain all
of the information that you should consider before investing in shares of our common stock and it is qualified in its entirety by, and
should be read in conjunction with, the more detailed information appearing elsewhere in this prospectus. This summary contains forward-looking
statements that involve risks and uncertainties, such as statements about our plans, objectives, expectations, assumptions, or future
events. These statements involve estimates, assumptions, known and unknown risks, uncertainties and other factors that could cause actual
results to differ materially from any future results, performances or achievements expressed or implied by the forward-looking statements.
See “Cautionary Note Regarding Forward-Looking Statements.” Before you decide to invest in our common stock, you should also
read the entire prospectus carefully, including “Risk Factors” beginning on page 9, “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” beginning on page 62, and the financial statements and related notes
included in this prospectus.

Unless
the context indicates otherwise, as used in this prospectus, the terms “we,” “us,” “our,” “our
company,” “BioVentrix” and “our business” refer to BioVentrix, Inc. and its consolidated subsidiaries.

Overview

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.

Our Clinical Trial

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 JACC ALIVE 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).