SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-10-06
Accession Number: 0001493152-25-016953
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225016953/filename1.htm

Chunk 1 of 87
Word Count: 1463
Character Count: 9698

Document Content:

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 Benchmark, a StoneX Company The date of this prospectus is , 2025 TABLE OF CONTENTS Page Prospectus Summary 1 Risk Factors 10 Cautionary Note Regarding Forward-Looking Statements 57 Use of Proceeds 58 Dividend Policy 59 Capitalization 60 Dilution 61 Management’s Discussion and Analysis of Financial Condition and Results of Operations 63 Business 70 Management 86 Executive and Director Compensation 91 Principal Stockholders 100 Certain Relationships and Related Party Transactions 102 Description of Capital Stock 103 Shares Eligible for Future Sale 109 Material U.S. Federal Income Tax Consequences to Non-U.S. Holders 111 Underwriting 115 Legal Matters 124 Experts 124 Where You Can Find More Information 124 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 10, “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” beginning on page 63, 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.

The following terms, as used in
this prospectus shall have the following meanings:

ejection
fraction	The
percentage of blood the heart’s left ventricle pumps out with each beat calculated as the ratio of stroke volume to end-diastolic
volume.

mini-thoracotomy	A
less invasive surgical procedure using a small incision between the ribs in the chest wall, typically to access the heart or lungs,
that avoids the need for a full sternotomy (i.e., open heart surgery).

Elevated Myocardial Infarction
(or STEMI)	A
severe type of heart attack caused by a prolonged blockage of a coronary artery, characterized by ST-segment elevation on an electrocardiogram
(ECG) and resulting in damage to the heart muscle.

win-ratio	A
statistical measure comparing outcomes between two groups, typically in clinical trials, by pairing participants and counting how
often the treatment group has a superior outcome (a “win”) versus a worse outcome (a “loss”) based on a pre-defined
hierarchy of endpoints (i.e., the primary and secondary endpoints, or measures, of the trial).

PEEK	Polyether
ether ketone. A high-performance, biocompatible polymer commonly used in medical implants and devices due to its strength, stability,
and radiolucency.

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
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. Our goal is for the Revivent System to be the new standard of care for these patients.

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

Our Past and Current Clinical Trials
in the United States

November 2024, we received an investigational device exemption (“IDE”) from the U.S. Food and Drug Administration (the
“FDA”) under a Breakthrough Therapy Designation (“BTD”) 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 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.