As
filed with the Securities and Exchange Commission on August 14, 2023
Registration
No. 333-273546
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Amendment No. 1
FORM
S-3
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
enVVeno
Medical Corporation
(Exact
name of registrant as specified in its charter)
Delaware |
|
33-0936180 |
(State
or other jurisdiction of |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
Identification
Number) |
70
Doppler
Irvine,
California 92618
(949)
261-2900
(Address,
including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Robert
A. Berman
Chief
Executive Officer
enVVeno
Medical Corporation
70
Doppler
Irvine,
California 92618
(949)
261-2900
(Name,
address, including zip code, and telephone number, including area code, of agent for service)
Please
send a copy of all communications to:
Barry
I. Grossman, Esq.
Matthew
Bernstein, Esq.
Ellenoff
Grossman & Schole LLP
1345
Avenue of the Americas
New
York, New York 10105-0302
(212)
370-1300
Approximate
date of commencement proposed sale to the public: From time to time after the effective date of this Registration Statement.
If
the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check
the following box. ☐
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following
box. ☒
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of the earlier effective registration statement for the same
offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If
this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective
upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If
this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional
securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:
Large
accelerated filer ☐ |
|
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
|
Smaller
reporting company ☒ |
|
|
Emerging
growth company ☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of Securities Act. ☒
The
Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the
Registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective
in accordance with Section 8(a) of the Securities Act, or until the registration statement shall become effective on such date as the
Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The
information in this prospectus is not complete and may be changed. We may not sell the securities until the Registration Statement filed
with the Securities and Exchange Commission, of which this prospectus is a part, is effective. This prospectus is not an offer to sell
these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED AUGUST 14, 2023
Prospectus
ENVVENO
MEDICAL CORPORATION
$75,000,000
COMMON
STOCK
PREFERRED
STOCK
PURCHASE
CONTRACTS
WARRANTS
SUBSCRIPTION
RIGHTS
DEPOSITARY
SHARES
DEBT
SECURITIES
UNITS
We
may offer and sell from time to time, in one or more series, any one of the following securities of our company, for total gross proceeds
of up to $75,000,000:
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● |
common stock; |
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● |
preferred stock; |
|
● |
purchase contracts; |
|
● |
warrants to purchase our
securities; |
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● |
subscription rights to
purchase any of the foregoing securities; |
|
● |
depositary shares; |
|
● |
secured
or unsecured debt securities consisting of notes, debentures or other evidences of indebtedness which may be senior debt securities,
senior subordinated debt securities or subordinated debt securities, each of which may be convertible into equity securities; or |
|
● |
units comprised of, or
other combinations of, the foregoing securities. |
We
may offer and sell these securities separately or together, in one or more series or classes and in amounts, at prices and on terms described
in one or more offerings. We may offer securities through underwriting syndicates managed or co-managed by one or more underwriters or
dealers, through agents or directly to purchasers. The prospectus supplement for each offering of securities will describe in detail
the plan of distribution for that offering. For general information about the distribution of securities offered, please see “Plan
of Distribution” in this prospectus.
Each
time our securities are offered, we will provide a prospectus supplement containing more specific information about the particular offering
and attach it to this prospectus. The prospectus supplements may also add, update or change information contained in this prospectus.
This
prospectus may not be used to offer or sell securities without a prospectus supplement which includes a description of the method and
terms of this offering.
Our
common stock is listed on the NASDAQ Capital Market under the symbol “NVNO.” The last reported sale price of our common stock
on the NASDAQ Capital Market on July 25, 2023 was $5.26 per share. The aggregate market value of our outstanding common stock held by
non-affiliates was $49,702,000 based on 9,471,932 shares of outstanding common stock, of which 9,449,134 shares are held by non-affiliates,
and a per share price of $5.26 which was the closing sale price of our common stock as quoted on the NASDAQ Capital Market on July 25,
2023. During the 12 calendar month period that ends on, and includes, the date of this prospectus, we have not offered and sold any
of our securities pursuant to General Instruction I.B.6 of Form S-3.
If
we decide to seek a listing of any preferred stock, purchase contracts, warrants, subscriptions rights, depositary shares, debt securities
or units offered by this prospectus, the related prospectus supplement will disclose the exchange or market on which the securities will
be listed, if any, or where we have made an application for listing, if any.
Investing
in our securities involves certain risks. See “Risk Factors” beginning on page 7 and the risk factors in our
most recent Annual Report on Form 10-K, which is incorporated by reference herein, as well as in any other recently filed quarterly or
current reports and, if any, in the relevant prospectus supplement. We urge you to carefully read this prospectus and the accompanying
prospectus supplement, together with the documents we incorporate by reference, describing the terms of these securities before investing.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed
upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this Prospectus is ___________, 2023.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission, or SEC, utilizing
a “shelf” registration process. Under this shelf registration process, we may offer and sell, either individually or in combination,
in one or more offerings, any of the securities described in this prospectus, for total gross proceeds of up to $75,000,000.
This prospectus provides you with a general description of the securities we may offer. Each time we offer securities under this prospectus,
we will provide a prospectus supplement to this prospectus that will contain more specific information about the terms of that offering.
We may also authorize one or more free writing prospectuses to be provided to you that may contain material information relating to these
offerings. The prospectus supplement and any related free writing prospectus that we may authorize to be provided to you may also add,
update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into
this prospectus.
We
urge you to read carefully this prospectus, any applicable prospectus supplement and any free writing prospectuses we have authorized
for use in connection with a specific offering, together with the information incorporated herein by reference as described under the
heading “Incorporation of Documents by Reference,” before investing in any of the securities being offered. You should rely
only on the information contained in, or incorporated by reference into, this prospectus and any applicable prospectus supplement, along
with the information contained in any free writing prospectuses we have authorized for use in connection with a specific offering. We
have not authorized anyone to provide you with different or additional information. This prospectus is an offer to sell only the securities
offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so.
The
information appearing in this prospectus, any applicable prospectus supplement or any related free writing prospectus is accurate only
as of the date on the front of the document and any information we have incorporated by reference is accurate only as of the date of
the document incorporated by reference, regardless of the time of delivery of this prospectus, any applicable prospectus supplement or
any related free writing prospectus, or any sale of a security.
This
prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the
actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some
of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration
statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section entitled
“Where You Can Find Additional Information.”
This
prospectus contains, or incorporates by reference, trademarks, tradenames, service marks and service names of enVVeno Medical Corporation
and its subsidiaries.
CAUTIONARY
NOTE REGARDING FORWARD LOOKING STATEMENTS
This
prospectus and the documents incorporated by reference herein contain or may contain forward looking statements that involve risks and
uncertainties. All statements other than statements of historical fact contained in this prospectus and the documents incorporated by
reference herein, including statements regarding future events, our future financial performance, business strategy, and plans and objectives
of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology
including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,”
“expects,” “intends,” “may,” “plans,” “potential,” “predicts,”
“should,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward
looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are
only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined under “Risk
Factors” or elsewhere in this prospectus and the documents incorporated by reference herein, which may cause our or our industry’s
actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover, we
operate in a highly regulated, very competitive, and rapidly changing environment. New risks emerge from time to time and it is not possible
for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or
combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements.
We
have based these forward-looking statements largely on our current expectations and projections about future events and financial trends
that we believe may affect our financial condition, results of operations, business strategy, short term and long term business operations,
and financial needs. These forward-looking statements are subject to certain risks and uncertainties that could cause our actual results
to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to such differences
include, but are not limited to, those discussed in this prospectus, and in particular, the risks discussed below and under the heading
“Risk Factors” and those discussed in other documents we file with the SEC. The following discussion should be read in conjunction
with the consolidated financial statements for the fiscal years ended December 31, 2022 and 2021 and notes incorporated by reference
herein. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, except
as required by law. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in
this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking
statement.
You
should not place undue reliance on any forward-looking statement, each of which applies only as of the date of this prospectus. Except
as required by law, we undertake no obligation to update or revise publicly any of the forward-looking statements after the date of this
prospectus to conform our statements to actual results or changed expectations.
Any
forward-looking statement you read in this prospectus, any prospectus supplement or any document incorporated by reference reflects our
current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations,
operating results, growth strategy and liquidity. You should not place undue reliance on these forward-looking statements because such
statements speak only as to the date when made. We assume no obligation to publicly update or revise these forward-looking statements
for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements,
even if new information becomes available in the future, except as otherwise required by applicable law. You are advised, however, to
consult any further disclosures we make on related subjects in our reports on Forms 10-Q, 8-K and 10-K filed with the SEC. You should
understand that it is not possible to predict or identify all risk factors. Consequently, you should not consider any such list to be
a complete set of all potential risks or uncertainties.
PROSPECTUS
SUMMARY
This
summary highlights selected information contained elsewhere in this prospectus. This summary does not contain all the information that
you should consider before investing in our Company. You should carefully read the entire prospectus, including all documents incorporated
by reference herein. In particular, attention should be directed to our “Risk Factors,” “Information With Respect to
the Company,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the
financial statements and related notes thereto contained herein or otherwise incorporated by reference hereto, before making an investment
decision.
As
used herein, and any amendment or supplement hereto, unless otherwise indicated, “we,” “us,” “our,”
the “Company,” or “enVVeno” means enVVeno Medical Corporation and its subsidiaries. Unless otherwise indicated,
all references in this prospectus to “dollars” or “$” refer to US dollars.
Overview
enVVeno
Medical Corporation is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based)
solutions to improve the standard of care for the treatment of venous disease. Chronic Venous Disease (CVD) is the world’s most
prevalent chronic disease, impacting approximately 71% of the adult population of the U.S. Chronic Venous Insufficiency (CVI), is a large
subset of CVD, which most often occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of
blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases,
venous ulcers that are difficult to heal. The Company is developing surgical and non-surgical replacement venous valves for patients
suffering from severe CVI of the deep venous system of the leg.
The
Company’s lead product is the VenoValve®, which is a first-in-class surgical replacement venous valve that is currently being
evaluated in a U.S. pivotal study. The Company is also developing a second product called enVVe®, which is a first-in-class,
non-surgical, transcatheter based replacement venous valve. The Company is currently waiting for regulatory approval to begin a first-in-human
study for enVVe. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins
of the leg, and back to the heart and lungs.
The
VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (FDA). We expect the VenoValve to
be eligible for FDA approval first, followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist,
with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although
we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA (see the section entitled “Risk
Factors” in our Annual Report on Form 10-K). There are currently no devices approved as surgical or non-surgical replacement venous
valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.
Our
team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that
have been commercially successful. We develop and manufacture our products in a 14,507 sq. ft. leased manufacturing facility in Irvine,
California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable
medical devices.
CVI
Background
Chronic
venous disease (“CVD”) is the world’s most prevalent chronic disease. CVD is generally classified using a standardized
system known as CEAP (clinical, etiological, anatomical, and pathophysiological). The CEAP system consists of seven clinical classifications
(C0 to C6) with C4, C5 and C6 being the most severe categories of CVD.
Chronic
Venous Insufficiency (“CVI”) is a large subset of CVD and is generally used to describe patients with C4 to C6 CVD. CVI is
a debilitating condition that affects the venous system of the leg causing pain, swelling, edema, skin changes, and ulcerations.
The
human leg contains three vein systems: the deep vein system, the superficial vein system, and the perforator vein system which connects
the deep system to the superficial system. The deep venous system is located below the muscle and facia in the center portion of the
leg and is responsible for approximately 90% of the blood flow. In order for blood to return to the heart from the foot, ankle, and lower
leg, the calf muscle serves as a pump and pushes the blood up the veins of the leg against gravity and through a series of one-way valves.
Each valve is supposed to open as blood passes through, and then close as blood progresses up the veins of the leg to the next valve.
CVI occurs when the one-way valves in the veins of the leg fail and become incompetent. When the valves fail, gravity causes the blood
to flow backwards and in the wrong direction (reflux). As blood pools in the lower leg, pressure inside the veins increases (venous hypertension).
Reflux, and the resulting venous hypertension, causes the leg to swell, resulting in debilitating pain, and in the most severe cases,
venous ulcers.
Severe
CVI sufferers experience a significantly reduced quality of life. Daily activities such as preparing meals, housework, and personal hygiene
(washing and bathing) become difficult due to reduced mobility. For many severe CVI sufferers, intense pain, which frequently occurs
at night, prevents patients from getting adequate sleep. Severe CVI sufferers are known to miss approximately 40% more workdays than
the average worker. A high percentage of venous ulcer patients also experience severe itching, leg swelling, and an odorous discharge.
Wound dressing changes, which occur several times a week, can be extremely painful. Venous ulcers from deep venous CVI are very difficult
to heal, and a significant percentage of venous ulcers remain unhealed for more than a year. Even if healed, recurrence rates for venous
ulcers are known to be high (20% to 40%) within the first year and as high as 60% after five years. Patients with severe CVI often become
housebound and experience social isolation due to difficulty with ambulation. As a result, studies have shown that patients with active
venous ulcers experience higher rates of anxiety and depression, with reported rates of anxiety of up to 30% and depression up to 40%.
Rates of depression caused by venous ulcers among the elderly are even higher, with 48% of elderly venous ulcer patients having severe
depressive symptoms.
Prevalence
is generally defined as the portion of the population that has a given condition. Estimates indicate that the prevalence of people in
the U.S. with severe, deep venous CVI (C4 to C6 disease) with reflux to be approximately 20 million. Incidence is generally defined as
the number of new cases of an ailment that develop in a given time period. We estimate that approximately 3.5 million new patients with
severe deep venous CVI are diagnosed each year in the U.S. including patients that develop venous leg ulcers (C6 patients). The average
patient seeking treatment of a venous ulcer spends as much as $30,000 a year on wound care, and the total direct medical costs from venous
ulcer sufferers in the U.S. has been estimated to exceed $3 billion a year.
VenoValve
The
VenoValve® is a porcine based replacement venous valve developed at enVVeno Medical to be surgically implanted
in the deep venous system of the leg to treat severe CVI. By reducing reflux and lowering pressure (venous hypertension) within the deep
venous system of the leg, the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the
potential to heal recurring venous leg ulcers. The VenoValve is implanted into the femoral vein of the patient in an open surgical procedure
via a 5-to-6-inch incision in the upper thigh. As our planned initial entrant to the replacement venous valve market, we estimate that
approximately 2.5 million people with severe deep venous CVI in the U.S. would be candidates for the VenoValve.
VenoValve
Clinical Status
After
consultation with the FDA, and as a precursor to the U.S. pivotal trial, in 2020 we conducted a small first-in-human study for the VenoValve
in Colombia which included eleven (11) patients. In addition to providing safety and efficacy data, the purpose of the first-in-human
study was to provide proof of concept, and to provide feedback to make any necessary product modifications or adjustments to our surgical
implantation procedure for the VenoValve prior to conducting the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal
trial. Endpoints for the VenoValve first-in-human study included safety (device related adverse events), reflux, measured by Duplex Ultrasound,
a rVCSS score used by the clinician to measure disease severity and progress, a VAS score used by the patient to measure pain, and quality
of life measurements.
Results
from the one year first-in-human study were presented at the Charing Cross International Symposium in April of 2021. Among the eleven
(11) patients in the study, reflux improved an average of 54%, Venous Clinical Severity Scores (“VCSSs”) improved an average
of 56%, and visual analog scale (VAS) scores, which are used by patients to measure pain, improved an average of 76%, all at one (1)
year when compared to pre-surgery levels. VCSS scores are commonly used by clinicians in practice and in clinical trials to objectively
assess outcomes in the treatment of venous disease, and include ten characteristics including pain, inflammation, skin changes such as
pigmentation and induration, the number of active ulcers, and ulcer duration. The improvement in VCSS scores is significant and indicates
the VenoValve patients who had severe CVI pre-surgery, had mild CVI or the complete absence of disease at one-year post surgery.
Related
safety incidences during the one year first-in-human study for the VenoValve included one (1) fluid pocket (which was aspirated), intolerance
from Coumadin anticoagulation therapy, three (3) minor wound infections (treated with antibiotics), and one occlusion due to patient
non-compliance with anti-coagulation therapy.
On
August 3, 2020, we announced that the FDA granted Breakthrough Device Designation status to the VenoValve. The FDA’s Breakthrough
Devices Program was established to enable priority review for devices that provide more effective treatment or diagnosis of life threatening
or irreversibly debilitating diseases or conditions. The goal of the FDA’s Breakthrough Devices Program is to provide patients
and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving
the FDA’s mission to protect and promote public health.
In
March 2021, we submitted an IDE application with the FDA and in April 2021, we received notification from the FDA that our IDE application
was approved. An investigational device exemption or IDE from the FDA is required before a medical device company can proceed with a
pivotal trial for a Class III medical device. This approval allowed us to proceed with our SAVVE study, a prospective, non-blinded,
single arm, multi-center study of seventy-five (75) CVI patients to be enrolled at up to 20 U.S. sites. We later received permission
from the FDA to increase the number of clinical sites to up to 30.
At
the end of the VenoValve first-in-human study, eight (8) study participants agreed to additional monitoring. In November of 2022, three-year
follow-up data was presented at the 49th Annual VEITH Symposium in New York city for this cohort of patients. That
data indicated no recurrences of the severe CVI that was present pre-VenoValve, including no ulcer recurrences for those patients who
had venous ulcers (C6 patients) prior to receiving the VenoValve. There were no reported safety issues from the end of one (1) year first-in-human
study to the end of the three (3) year reporting period. In addition, the patients continued to show improvements compared to pre-surgery
levels, reporting 62%, 64%, and 84%, average improvements in reflux, VCSS, and VAS scores, respectively, at an average of three (3) years
post VenoValve surgery. One deep vein thrombosis (DVT) occurred between year 2 and year 3 due to patient non-compliance with anti-coagulation
medication. In addition to presenting at leading academic and vascular conferences around the world, results from the VenoValve first-in-human
study and following observational period have been published in the Journal of Vascular Surgery Venous and Lymphatic Disorders,
the Journal of Vascular and Endovascular Surgery, and JAMA Surgery Journal.
In
November of 2022, we announced we had passed a preliminary safety review by the FDA for the first twenty (20) patients enrolled in the
SAVVE trial. The FDA had requested that we submit preliminary safety data at thirty (30) days post VenoValve® implantation
for the first twenty (20) patients enrolled in the study. The preliminary safety data included one (1) device related (mild) and two
(2) procedure related (moderate) adverse events. After review by the FDA, the study was cleared to continue without modification or interruption.
The
mass resignations and continuing turnover of healthcare workers following the COVID-19 pandemic put an enormous strain on hospital
resources, including their clinical staffing and research capabilities. These factors impact the rate at which clinical trials
such as SAVVE enroll and progress. We have taken several steps to help address the hospital staffing shortages, including our
hiring of 4 Clinical Technologists, with extensive and specialized experience in duplex sonography of the deep venous system, to assist
in training site personnel, proctoring Duplex Ultrasound examinations, and providing assistance for the SAVVE study. On July 5, 2023
we announced that that we have enrolled 57 subjects in the SAVVE trial and that we expect to achieve full enrollment (75 subjects) by
the end of 2023.
enVVe
On
September 21, 2022, we announced the development of a non-surgical transcatheter based replacement venous valve called enVVe®,
for the treatment of CVI of the deep veins of the leg. Preliminary bench testing and animal testing for enVVe were completed before
our announcement. We have filed an application seeking approval to begin an early feasibility study for enVVe. The trial
will be known as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis early feasibility study (TAVVE-EFS). The initial phase
of the TAVVE-EFS study will seek to enroll 3 to 5 patients across multiple sites.
Several
parameters will be evaluated over the course of the study including safety and technical success of the enVVe venous valve delivery system,
and the safety and clinical performance of the enVVe venous valve. enVVe is delivered into the femoral vein of the patient via a minimally
invasive procedure requiring no general anesthesia and no overnight hospital stay. Due to the minimally invasive nature of the procedure,
we expect to be able to reach patients with less severe CVI or who may otherwise not be good candidates for a surgical
device, and estimate the U.S. market for enVVe to be approximately 3.5 million patients.
Capital
We
finished 2022 with approximately $39.1 million of cash and investments and had approximately $29.8 million of cash and investments
at June 30, 2023. At our existing cash burn rate of approximately $4 - 5 million per quarter, we should have sufficient cash to fund
operations through the end of 2024 and into 2025. With primary endpoints following full enrollment in the SAVVE pivotal trial of thirty
(30) days for safety, and six (6) months for effectiveness, we expect to have primary endpoint data well in advance of the need to raise
additional capital.
Corporate
Information
We
were incorporated in Delaware on December 22, 1999. Our principal executive offices are located at 70 Doppler, Irvine, California, 92618,
and our telephone number is (949) 261-2900. Our corporate website address is www.envveno.com. The information contained on or accessible
through our website is not a part of this prospectus.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should carefully consider
the risk factors we describe in any prospectus supplement and in any related free writing prospectus for a specific offering of securities,
as well as those incorporated by reference into this prospectus and any prospectus supplement. You should also carefully consider other
information contained and incorporated by reference in this prospectus and any applicable prospectus supplement, including our financial
statements and the related notes thereto incorporated by reference in this prospectus. The risks and uncertainties described in the applicable
prospectus supplement and our other filings with the SEC incorporated by reference herein are not the only ones we face. Additional risks
and uncertainties not presently known to us or that we currently consider immaterial may also adversely affect us. If any of the described
risks occur, our business, financial condition or results of operations could be materially harmed. In such case, the value of our securities
could decline and you may lose all or part of your investment.
USE
OF PROCEEDS
Unless
otherwise indicated in a prospectus supplement, we intend to use the net proceeds from these sales primarily for the continued development
of our two lead products, VenoValve and enVVe, and for general corporate purposes, including working capital and investing in or acquiring
companies that are synergistic with or complementary to our technologies. We have no specific acquisition contemplated at this time.
The amounts and timing of these expenditures will depend on numerous factors, including the development of our current business initiatives,
the status of and results from clinical trials and any unforeseen cash needs. Pending these uses, we intend to invest the net proceeds
from this offering in short-term, investment-grade interest-bearing securities such as money market funds, certificates of deposit, commercial
paper and guaranteed obligations of the U.S. government.
PLAN
OF DISTRIBUTION
We
may sell the securities from time to time to or through underwriters or dealers, through agents, or directly to one or more purchasers.
A distribution of the securities offered by this prospectus may also be effected through the issuance of derivative securities, including
without limitation, warrants, rights to purchase and subscriptions. In addition, the manner in which we may sell some or all of the securities
covered by this prospectus includes, without limitation, through:
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a
block trade in which a broker-dealer will attempt to sell as agent, but may position or resell a portion of the block, as principal,
in order to facilitate the transaction; |
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purchases
by a broker-dealer, as principal, and resale by the broker-dealer for its account; or |
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ordinary
brokerage transactions and transactions in which a broker solicits purchasers. |
A
prospectus supplement or supplements with respect to each series of securities will describe the terms of the offering, including, to
the extent applicable:
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the
terms of the offering; |
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the
name or names of the underwriters or agents and the amounts of securities underwritten or purchased by each of them, if any; |
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the
public offering price or purchase price of the securities or other consideration therefor, and the proceeds to be received by us
from the sale; |
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any
delayed delivery requirements; |
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any
over-allotment options under which underwriters may purchase additional securities from us; |
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any
underwriting discounts or agency fees and other items constituting underwriters’ or agents’ compensation |
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any
discounts or concessions allowed or re-allowed or paid to dealers; and |
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any
securities exchange or market on which the securities may be listed. |
The
offer and sale of the securities described in this prospectus by us, the underwriters or the third parties described above may be effected
from time to time in one or more transactions, including privately negotiated transactions, either:
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at
a fixed price or prices, which may be changed; |
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in
an “at the market” offering within the meaning of Rule 415(a)(4) of the Securities Act of 1933, as amended, or the Securities
Act; |
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at
prices related to such prevailing market prices; or |
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at
negotiated prices. |
Only
underwriters named in the prospectus supplement will be underwriters of the securities offered by the prospectus supplement.
Underwriters
and Agents; Direct Sales
If
underwriters are used in a sale, they will acquire the offered securities for their own account and may resell the offered securities
from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or at varying prices
determined at the time of sale. We may offer the securities to the public through underwriting syndicates represented by managing underwriters
or by underwriters without a syndicate.
Unless
the prospectus supplement states otherwise, the obligations of the underwriters to purchase the securities will be subject to the conditions
set forth in the applicable underwriting agreement. Subject to certain conditions, the underwriters will be obligated to purchase all
of the securities offered by the prospectus supplement, other than securities covered by any over-allotment option. Any public offering
price and any discounts or concessions allowed or re-allowed or paid to dealers may change from time to time. We may use underwriters
with whom we have a material relationship. We will describe in the prospectus supplement, naming the underwriter, the nature of any such
relationship.
We
may sell securities directly or through agents we designate from time to time. We will name any agent involved in the offering and sale
of securities, and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus supplement
states otherwise, our agent will act on a best-efforts basis for the period of its appointment.
We
may authorize agents or underwriters to solicit offers by certain types of institutional investors to purchase securities from us at
the public offering price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery
on a specified date in the future. We will describe the conditions to these contracts and the commissions we must pay for solicitation
of these contracts in the prospectus supplement.
Dealers
We
may sell the offered securities to dealers as principals. The dealer may then resell such securities to the public either at varying
prices to be determined by the dealer or at a fixed offering price agreed to with us at the time of resale.
Institutional
Purchasers
We
may authorize agents, dealers or underwriters to solicit certain institutional investors to purchase offered securities on a delayed
delivery basis pursuant to delayed delivery contracts providing for payment and delivery on a specified future date. The applicable prospectus
supplement or other offering materials, as the case may be, will provide the details of any such arrangement, including the offering
price and commissions payable on the solicitations.
We
will enter into such delayed contracts only with institutional purchasers that we approve. These institutions may include commercial
and savings banks, insurance companies, pension funds, investment companies and educational and charitable institutions.
Indemnification;
Other Relationships
We
may provide agents, underwriters, dealers and remarketing firms with indemnification against certain civil liabilities, including liabilities
under the Securities Act, or contribution with respect to payments that the agents or underwriters may make with respect to these liabilities.
Agents, underwriters, dealers and remarketing firms, and their affiliates, may engage in transactions with, or perform services for,
us in the ordinary course of business. This includes commercial banking and investment banking transactions.
Market-Making;
Stabilization and Other Transactions
There
is currently no market for any of the offered securities, other than our common stock, which is quoted on the Nasdaq Capital Market.
If the offered securities are traded after their initial issuance, they may trade at a discount from their initial offering price, depending
upon prevailing interest rates, the market for similar securities and other factors. While it is possible that an underwriter could inform
us that it intends to make a market in the offered securities, such underwriter would not be obligated to do so, and any such market-making
could be discontinued at any time without notice. Therefore, no assurance can be given as to whether an active trading market will develop
for the offered securities. We have no current plans for listing of the debt securities, preferred stock, warrants or subscription rights
on any securities exchange or quotation system; any such listing with respect to any particular debt securities, preferred stock, warrants
or subscription rights will be described in the applicable prospectus supplement or other offering materials, as the case may be.
Any
underwriter may engage in over-allotment, stabilizing transactions, short-covering transactions and penalty bids in accordance with Regulation
M under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Over-allotment involves sales in excess of the offering
size, which create a short position. Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing
bids do not exceed a specified maximum price. Syndicate-covering or other short-covering transactions involve purchases of the securities,
either through exercise of the over-allotment option or in the open market after the distribution is completed, to cover short positions.
Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the securities originally sold by the dealer
are purchased in a stabilizing or covering transaction to cover short positions. Those activities may cause the price of the securities
to be higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.
Any
underwriters or agents that are qualified market makers on the Nasdaq Capital Market may engage in passive market making transactions
in our common stock on the Nasdaq Capital Market in accordance with Regulation M under the Exchange Act, during the business day prior
to the pricing of the offering, before the commencement of offers or sales of our common stock. Passive market makers must comply with
applicable volume and price limitations and must be identified as passive market makers. In general, a passive market maker must display
its bid at a price not in excess of the highest independent bid for such security; if all independent bids are lowered below the passive
market maker’s bid, however, the passive market maker’s bid must then be lowered when certain purchase limits are exceeded.
Passive market making may stabilize the market price of the securities at a level above that which might otherwise prevail in the open
market and, if commenced, may be discontinued at any time.
Fees
and Commissions
If
5% or more of the net proceeds of any offering of securities made under this prospectus will be received by a FINRA member participating
in the offering or affiliates or associated persons of such FINRA member, the offering will be conducted in accordance with FINRA Rule
5121.
DESCRIPTION
OF SECURITIES WE MAY OFFER
General
This
prospectus describes the general terms of our capital stock. The following description is not complete and may not contain all the information
you should consider before investing in our capital stock. For a more detailed description of these securities, you should read the applicable
provisions of Delaware law and our certificate of incorporation, as amended, referred to herein as our certificate of incorporation,
and our amended and restated bylaws, referred to herein as our bylaws. When we offer to sell a particular series of these securities,
we will describe the specific terms of the series in a supplement to this prospectus. Accordingly, for a description of the terms of
any series of securities, you must refer to both the prospectus supplement relating to that series and the description of the securities
described in this prospectus. To the extent the information contained in the prospectus supplement differs from this summary description,
you should rely on the information in the prospectus supplement.
The
total number of shares of capital stock we are authorized to issue is 260,000,000 shares, of which (a) 250,000,000 shares are common
stock and (b) 10,000,000 shares are preferred stock.
We,
directly or through agents, dealers or underwriters designated from time to time, may offer, issue and sell, together or separately,
up to $75,000,000 in the aggregate of:
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common stock; |
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preferred stock; |
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purchase contracts; |
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warrants to purchase our
securities; |
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subscription rights to
purchase our securities; |
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depositary shares; |
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secured or unsecured debt
securities consisting of notes, debentures or other evidences of indebtedness which may be senior debt securities, senior subordinated
debt securities or subordinated debt securities, each of which may be convertible into equity securities; or |
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units comprised of, or
other combinations of, the foregoing securities. |
We
may issue the debt securities exchangeable for or convertible into shares of common stock, preferred stock or other securities that may
be sold by us pursuant to this prospectus or any combination of the foregoing. The preferred stock may also be exchangeable for and/or
convertible into shares of common stock, another series of preferred stock or other securities that may be sold by us pursuant to this
prospectus or any combination of the foregoing. When a particular series of securities is offered, a supplement to this prospectus will
be delivered with this prospectus, which will set forth the terms of the offering and sale of the offered securities.
Common
Stock
As
of June 30, 2023, there were 9,471,932 shares of common stock issued and outstanding, held of record by approximately 71 stockholders.
Subject to preferential rights with respect to any outstanding preferred stock, all outstanding shares of common stock are of the same
class and have equal rights and attributes. Under the terms of certificate of incorporation, holders of our common stock are entitled
to one vote for each share held on all matters submitted to a vote of stockholders, including the election of directors, and do not have
cumulative voting rights. The holders of outstanding shares of common stock are entitled to receive dividends out of assets or funds
legally available for the payment of dividends of such times and in such amounts as our board of directors from time to time may determine.
Our common stock is not entitled to pre-emptive rights and is not subject to conversion or redemption. Upon liquidation, dissolution
or winding up of our company, the assets legally available for distribution to stockholders are distributable ratably among the holders
of our common stock after payment of liquidation preferences, if any, on any outstanding payment of other claims of creditors. The rights,
preferences and privileges of holders of common stock are subject to and may be adversely affected by the rights of the holders of shares
of any series of preferred stock that we may designate and issue in the future.
Preferred
Stock
Our
certificate of incorporation empowers our board of directors, without action by our shareholders, to issue up to 10,000,000 shares of
preferred stock from time to time in one or more series, which preferred stock may be offered by this prospectus and supplements thereto.
As of June 30, 2023, there were no shares of preferred stock designated, issued or outstanding.
We
will fix the rights, preferences, privileges and restrictions of the preferred stock of each series in the certificate of designation
relating to that series. We will file as an exhibit to the registration statement of which this prospectus is a part, or will incorporate
by reference from a current report on Form 8-K that we file with the SEC, the form of any certificate of designation that describes the
terms of the series of preferred stock we are offering before the issuance of the related series of preferred stock. This description
will include any or all of the following, as required:
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the
title and stated value; |
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the
number of shares we are offering; |
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the
liquidation preference per share; |
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the
purchase price; |
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the
dividend rate, period and payment date and method of calculation for dividends; |
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whether
dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate; |
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any
contractual limitations on our ability to declare, set aside or pay any dividends; |
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the
procedures for any auction and remarketing, if any; |
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the
provisions for a sinking fund, if any; |
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the
provisions for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and repurchase
rights; |
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any
listing of the preferred stock on any securities exchange or market; |
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whether
the preferred stock will be convertible into our common stock, and, if applicable, the conversion price, or how it will be calculated,
and the conversion period; |
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whether
the preferred stock will be exchangeable into debt securities, and, if applicable, the exchange price, or how it will be calculated,
and the exchange period; |
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voting
rights, if any, of the preferred stock; |
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preemptive
rights, if any; |
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restrictions
on transfer, sale or other assignment, if any; |
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whether
interests in the preferred stock will be represented by depositary shares; |
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a
discussion of any material or special United States federal income tax considerations applicable to the preferred stock; |
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the
relative ranking and preferences of the preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our
affairs; |
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any
limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the series of preferred stock
as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; and |
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any
other specific terms, preferences, rights or limitations of, or restrictions on, the preferred stock. |
If
we issue shares of preferred stock under this prospectus, after receipt of payment therefor, the shares will be fully paid and non-assessable.
The
Delaware General Corporation Law provides that the holders of preferred stock will have the right to vote separately as a class on any
proposal involving fundamental changes in the rights of holders of that preferred stock. This right is in addition to any voting rights
provided for in the applicable certificate of designation.
Our
board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting
power or other rights of the holders of our common stock. Preferred stock could be issued quickly with terms designed to delay or prevent
a change in control of our Company or make removal of management more difficult. Additionally, the issuance of preferred stock could
have the effect of decreasing the market price of our common stock.
Purchase
Contracts
We
may issue purchase contracts, representing contracts obligating holders to purchase from us, and us to sell to the holders, a specific
or varying number of common stock, preferred stock, warrants, depositary shares, debt securities, warrants or any combination of the
above, at a future date or dates. Alternatively, the purchase contracts may obligate us to purchase from holders, and obligate holders
to sell to us, a specific or varying number of common stock, preferred stock, warrants, depositary shares, debt securities, or any combination
of the above. The price of the securities and other property subject to the purchase contracts may be fixed at the time the purchase
contracts are issued or may be determined by reference to a specific formula set forth in the purchase contracts. The purchase contracts
may be issued separately or as a part of a unit that consists of (a) a purchase contract and (b) one or more of the other securities
that may be sold by us pursuant to this prospectus or any combination of the foregoing, which may secure the holders’ obligations
to purchase the securities under the purchase contract. The purchase contracts may require us to make periodic payments to the holders
or require the holders to make periodic payments to us. These payments may be unsecured or prefunded and may be paid on a current or
on a deferred basis. The purchase contracts may require holders to secure their obligations under the contracts in a manner specified
in the applicable prospectus supplement.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from a current
report on Form 8-K that we file with the SEC, forms of the purchase contracts and purchase contract agreement, if any. The applicable
prospectus supplement will describe the terms of any purchase contracts in respect of which this prospectus is being delivered, including,
to the extent applicable, the following:
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whether
the purchase contracts obligate the holder or us to purchase or sell, or both purchase and sell, the securities subject to purchase
under the purchase contract, and the nature and amount of each of those securities, or the method of determining those amounts; |
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whether the purchase contracts
are to be prepaid or not; |
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whether
the purchase contracts are to be settled by delivery, or by reference or linkage to the value, performance or level of the securities
subject to purchase under the purchase contract; |
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any
acceleration, cancellation, termination or other provisions relating to the settlement of the purchase contracts; and |
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whether the purchase contracts
will be issued in fully registered or global form. |
Warrants
We
may issue warrants to purchase our securities or other rights, including rights to receive payment in cash or securities based on the
value, rate or price of one or more specified commodities, currencies, securities or indices, or any combination of the foregoing. Warrants
may be issued independently or together with any other securities that may be sold by us pursuant to this prospectus or any combination
of the foregoing and may be attached to, or separate from, such securities. To the extent warrants that we issue are to be publicly-traded,
each series of such warrants will be issued under a separate warrant agreement to be entered into between us and a warrant agent.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from a current
report on Form 8-K that we file with the SEC, forms of the warrant and warrant agreement, if any. The prospectus supplement relating
to any warrants that we may offer will contain the specific terms of the warrants and a description of the material provisions of the
applicable warrant agreement, if any. These terms may include the following:
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the
title of the warrants; |
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the
price or prices at which the warrants will be issued; |
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the
designation, amount and terms of the securities or other rights for which the warrants are exercisable; |
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the
designation and terms of the other securities, if any, with which the warrants are to be issued and the number of warrants issued
with each other security; |
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the
aggregate number of warrants; |
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any
provisions for adjustment of the number or amount of securities receivable upon exercise of the warrants or the exercise price of
the warrants; |
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the
price or prices at which the securities or other rights purchasable upon exercise of the warrants may be purchased; |
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if
applicable, the date on and after which the warrants and the securities or other rights purchasable upon exercise of the warrants
will be separately transferable; |
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a
discussion of any material U.S. federal income tax considerations applicable to the exercise of the warrants; |
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the
date on which the right to exercise the warrants will commence, and the date on which the right will expire; |
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the
maximum or minimum number of warrants that may be exercised at any time; |
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information
with respect to book-entry procedures, if any; and |
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any
other terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the warrants. |
Exercise
of Warrants. Each warrant will entitle the holder of warrants to purchase the amount of securities or other rights, at the exercise
price stated or determinable in the prospectus supplement for the warrants. Warrants may be exercised at any time up to the close of
business on the expiration date shown in the applicable prospectus supplement, unless otherwise specified in such prospectus supplement.
After the close of business on the expiration date, if applicable, unexercised warrants will become void. Warrants may be exercised in
the manner described in the applicable prospectus supplement. When the warrant holder makes the payment and properly completes and signs
the warrant certificate at the corporate trust office of the warrant agent, if any, or any other office indicated in the prospectus supplement,
we will, as soon as possible, forward the securities or other rights that the warrant holder has purchased. If the warrant holder exercises
less than all of the warrants represented by the warrant certificate, we will issue a new warrant certificate for the remaining warrants.
Subscription
Rights
We
may issue rights to purchase our securities. The rights may or may not be transferable by the persons purchasing or receiving the rights.
In connection with any rights offering, we may enter into a standby underwriting or other arrangement with one or more underwriters or
other persons pursuant to which such underwriters or other persons would purchase any offered securities remaining unsubscribed for after
such rights offering. In connection with a rights offering to holders of our capital stock a prospectus supplement will be distributed
to such holders on the record date for receiving rights in the rights offering set by us.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from a current
report on Form 8-K that we file with the SEC, forms of the subscription rights, standby underwriting agreement or other agreements, if
any. The prospectus supplement relating to any rights that we offer will include specific terms relating to the offering, including,
among other matters:
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the
date of determining the security holders entitled to the rights distribution; |
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the
aggregate number of rights issued and the aggregate amount of securities purchasable upon exercise of the rights; |
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the
exercise price; |
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the
conditions to completion of the rights offering; |
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the
date on which the right to exercise the rights will commence and the date on which the rights will expire; and |
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any
applicable federal income tax considerations. |
Each
right would entitle the holder of the rights to purchase the principal amount of securities at the exercise price set forth in the applicable
prospectus supplement. Rights may be exercised at any time up to the close of business on the expiration date for the rights provided
in the applicable prospectus supplement. After the close of business on the expiration date, all unexercised rights will become void.
Holders
may exercise rights as described in the applicable prospectus supplement. Upon receipt of payment and the rights certificate properly
completed and duly executed at the corporate trust office of the rights agent, if any, or any other office indicated in the prospectus
supplement, we will, as soon as practicable, forward the securities purchasable upon exercise of the rights. If less than all of the
rights issued in any rights offering are exercised, we may offer any unsubscribed securities directly to persons other than stockholders,
to or through agents, underwriters or dealers or through a combination of such methods, including pursuant to standby underwriting arrangements,
as described in the applicable prospectus supplement.
Depositary
Shares
General.
We may offer fractional shares of preferred stock, rather than full shares of preferred stock. If we decide to offer fractional shares
of our preferred stock, we will issue receipts for depositary shares. Each depositary share will represent a fraction of a share of a
particular series of our preferred stock, and the applicable prospectus supplement will indicate that fraction. The shares of preferred
stock represented by depositary shares will be deposited under a deposit agreement between us and a depositary that is a bank or trust
company that meets certain requirements and is selected by us. The depositary will be specified in the applicable prospectus supplement.
Each owner of a depositary share will be entitled to all of the rights and preferences of the preferred stock represented by the depositary
share. The depositary shares will be evidenced by depositary receipts issued pursuant to the deposit agreement. Depositary receipts will
be distributed to those persons purchasing the fractional shares of our preferred stock in accordance with the terms of the offering.
We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from a current
report on Form 8-K that we file with the SEC, forms of the deposit agreement, form of certificate of designation of underlying preferred
stock, form of depositary receipts and any other related agreements.
Dividends
and Other Distributions. The depositary will distribute all cash dividends or other cash distributions received by it in respect
of the preferred stock to the record holders of depositary shares relating to such preferred shares in proportion to the numbers of depositary
shares held on the relevant record date.
In
the event of a distribution other than in cash, the depositary will distribute securities or property received by it to the record holders
of depositary shares in proportion to the numbers of depositary shares held on the relevant record date, unless the depositary determines
that it is not feasible to make such distribution. In that case, the depositary may make the distribution by such method as it deems
equitable and practicable. One such possible method is for the depositary to sell the securities or property and then distribute the
net proceeds from the sale as provided in the case of a cash distribution.
Redemption
of Depositary Shares. Whenever we redeem the preferred stock, the depositary will redeem a number of depositary shares representing
the same number of shares of preferred stock so redeemed. If fewer than all of the depositary shares are to be redeemed, the depositary
shares to be redeemed will be selected by lot, pro rata or by any other equitable method as the depositary may determine.
Voting
of Underlying Shares. Upon receipt of notice of any meeting at which the holders of our preferred stock of any series are entitled
to vote, the depositary will mail the information contained in the notice of the meeting to the record holders of the depositary shares
relating to that series of preferred stock. Each record holder of the depositary shares on the record date will be entitled to instruct
the depositary as to the exercise of the voting rights represented by the number of shares of preferred stock underlying the holder’s
depositary shares. The depositary will endeavor, to the extent it is practical to do so, to vote the number of whole shares of preferred
stock underlying such depositary shares in accordance with such instructions. We will agree to take all action that the depositary may
deem reasonably necessary in order to enable the depositary to do so. To the extent the depositary does not receive specific instructions
from the holders of depositary shares relating to such preferred shares, it will abstain from voting such shares of preferred stock.
Withdrawal
of Shares. Upon surrender of depositary receipts representing any number of whole shares at the depositary’s office, unless
the related depositary shares previously have been called for redemption, the holder of the depositary shares evidenced by the depositary
receipts will be entitled to delivery of the number of whole shares of the related series of preferred stock and all money and other
property, if any, underlying such depositary shares. However, once such an exchange is made, the preferred stock cannot thereafter be
re-deposited in exchange for depositary shares. Holders of depositary shares will be entitled to receive whole shares of the related
series of preferred stock on the basis set forth in the applicable prospectus supplement. If the depositary receipts delivered by the
holder evidence a number of depositary shares representing more than the number of whole shares of preferred stock of the related series
to be withdrawn, the depositary will deliver to the holder at the same time a new depositary receipt evidencing the excess number of
depositary shares.
Amendment
and Termination of Depositary Agreement. The form of depositary receipt evidencing the depositary shares and any provision
of the applicable depositary agreement may at any time be amended by agreement between us and the depositary. We may, with the consent
of the depositary, amend the depositary agreement from time to time in any manner that we desire. However, if the amendment would materially
and adversely alter the rights of the existing holders of depositary shares, the amendment would need to be approved by the holders of
at least a majority of the depositary shares then outstanding.
The
depositary agreement may be terminated by us or the depositary if:
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all outstanding depositary
shares have been redeemed; or |
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there
has been a final distribution in respect of the shares of preferred stock of the applicable series in connection with our liquidation,
dissolution or winding up and such distribution has been made to the holders of depositary receipts. |
Resignation
and Removal of Depositary. The depositary may resign at any time by delivering to us notice of its election to do so. We may remove
a depositary at any time. Any resignation or removal will take effect upon the appointment of a successor depositary and its acceptance
of appointment.
Charges
of Depositary. We will pay all transfer and other taxes and governmental charges arising solely from the existence of any depositary
arrangements. We will pay all charges of each depositary in connection with the initial deposit of the preferred shares of any series,
the initial issuance of the depositary shares, any redemption of such preferred shares and any withdrawals of such preferred shares by
holders of depositary shares. Holders of depositary shares will be required to pay any other transfer taxes.
Notices.
Each depositary will forward to the holders of the applicable depositary shares all notices, reports and communications from us which
are delivered to such depositary and which we are required to furnish the holders of the preferred stock represented by such depositary
shares.
Miscellaneous.
The depositary agreement may contain provisions that limit our liability and the liability of the depositary to the holders of depositary
shares. Both the depositary and we are also entitled to an indemnity from the holders of the depositary shares prior to bringing, or
defending against, any legal proceeding. We or any depositary may rely upon written advice of counsel or accountants, or information
provided by persons presenting preferred shares for deposit, holders of depositary shares or other persons believed by us to be competent
and on documents believed by us or them to be genuine.
Debt
Securities
As
used in this prospectus, the term “debt securities” means the debentures, notes, bonds and other evidences of indebtedness
that we may issue from time to time. The debt securities will either be senior debt securities, senior subordinated debt or subordinated
debt securities. We may also issue convertible debt securities. Debt securities may be issued under an indenture (which we refer to herein
as an Indenture), which are contracts entered into between us and a trustee to be named therein. The Indenture has been filed as an exhibit
to the registration statement of which this prospectus forms a part. We may issue debt securities and incur additional indebtedness other
than through the offering of debt securities pursuant to this prospectus. It is likely that convertible debt securities will not be issued
under an Indenture.
The
debt securities may be fully and unconditionally guaranteed on a secured or unsecured senior or subordinated basis by one or more guarantors,
if any. The obligations of any guarantor under its guarantee will be limited as necessary to prevent that guarantee from constituting
a fraudulent conveyance under applicable law. In the event that any series of debt securities will be subordinated to other indebtedness
that we have outstanding or may incur, the terms of the subordination will be set forth in the prospectus supplement relating to the
subordinated debt securities.
We
may issue debt securities from time to time in one or more series, in each case with the same or various maturities, at par or at a discount.
Unless indicated in a prospectus supplement, we may issue additional debt securities of a particular series without the consent of the
holders of the debt securities of such series outstanding at the time of the issuance. Any such additional debt securities, together
with all other outstanding debt securities of that series, will constitute a single series of debt securities under the applicable Indenture
and will be equal in ranking.
Should
an Indenture relate to unsecured indebtedness, in the event of a bankruptcy or other liquidation event involving a distribution of assets
to satisfy our outstanding indebtedness or an event of default under a loan agreement relating to secured indebtedness of our company
or its subsidiaries, the holders of such secured indebtedness, if any, would be entitled to receive payment of principal and interest
prior to payments on the unsecured indebtedness issued under an Indenture.
Each
prospectus supplement will describe the terms relating to the specific series of debt securities. These terms will include some or all
of the following:
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the
title of debt securities and whether the debt securities are senior or subordinated; |
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any
limit on the aggregate principal amount of debt securities of such series; |
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the
percentage of the principal amount at which the debt securities of any series will be issued; |
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the
ability to issue additional debt securities of the same series; |
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the
purchase price for the debt securities and the denominations of the debt securities; |
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the
specific designation of the series of debt securities being offered; |
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the
maturity date or dates of the debt securities and the date or dates upon which the debt securities are payable and the rate or rates
at which the debt securities of the series shall bear interest, if any, which may be fixed or variable, or the method by which such
rate shall be determined; |
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the
basis for calculating interest; |
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the
date or dates from which any interest will accrue or the method by which such date or dates will be determined; |
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the
duration of any deferral period, including the period during which interest payment periods may be extended; |
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whether
the amount of payments of principal of (and premium, if any) or interest on the debt securities may be determined with reference
to any index, formula or other method, such as one or more currencies, commodities, equity indices or other indices, and the manner
of determining the amount of such payments; |
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the
dates on which we will pay interest on the debt securities and the regular record date for determining who is entitled to the interest
payable on any interest payment date; |
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the
place or places where the principal of (and premium, if any) and interest on the debt securities will be payable, where any securities
may be surrendered for registration of transfer, exchange or conversion, as applicable, and notices and demands may be delivered
to or upon us pursuant to the applicable Indenture; |
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the
rate or rates of amortization of the debt securities; |
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any
terms for the attachment to the debt securities of warrants, options or other rights to purchase or sell our securities; |
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if
the debt securities will be secured by any collateral and, if so, a general description of the collateral and the terms and provisions
of such collateral security, pledge or other agreements; |
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if
we possess the option to do so, the periods within which and the prices at which we may redeem the debt securities, in whole or in
part, pursuant to optional redemption provisions, and the other terms and conditions of any such provisions; |
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our
obligation or discretion, if any, to redeem, repay or purchase debt securities by making periodic payments to a sinking fund or through
an analogous provision or at the option of holders of the debt securities, and the period or periods within which and the price or
prices at which we will redeem, repay or purchase the debt securities, in whole or in part, pursuant to such obligation, and the
other terms and conditions of such obligation; |
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the
terms and conditions, if any, regarding the option or mandatory conversion or exchange of debt securities; |
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the
period or periods within which, the price or prices at which and the terms and conditions upon which any debt securities of the series
may be redeemed, in whole or in part at our option and, if other than by a board resolution, the manner in which any election by
us to redeem the debt securities shall be evidenced; |
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any
restriction or condition on the transferability of the debt securities of a particular series; |
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the
portion, or methods of determining the portion, of the principal amount of the debt securities which we must pay upon the acceleration
of the maturity of the debt securities in connection with any event of default; |
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the
currency or currencies in which the debt securities will be denominated and in which principal, any premium and any interest will
or may be payable or a description of any units based on or relating to a currency or currencies in which the debt securities will
be denominated; |
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provisions,
if any, granting special rights to holders of the debt securities upon the occurrence of specified events; |
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any
deletions from, modifications of or additions to the events of default or our covenants with respect to the applicable series of
debt securities, and whether or not such events of default or covenants are consistent with those contained in the applicable Indenture; |
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any
limitation on our ability to incur debt, redeem stock, sell our assets or other restrictions; |
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the
application, if any, of the terms of the applicable Indenture relating to defeasance and covenant defeasance (which terms are described
below) to the debt securities; |
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what
subordination provisions will apply to the debt securities; |
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the
terms, if any, upon which the holders may convert or exchange the debt securities into or for our securities or property; |
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whether
we are issuing the debt securities in whole or in part in global form; |
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any
change in the right of the trustee or the requisite holders of debt securities to declare the principal amount thereof due and payable
because of an event of default; |
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the
depositary for global or certificated debt securities, if any; |
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any
material federal income tax consequences applicable to the debt securities, including any debt securities denominated and made payable,
as described in the prospectus supplements, in foreign currencies, or units based on or related to foreign currencies; |
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any
right we may have to satisfy, discharge and defease our obligations under the debt securities, or terminate or eliminate restrictive
covenants or events of default in the Indentures, by depositing money or U.S. government obligations with the trustee of the Indentures; |
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the
names of any trustees, depositories, authenticating or paying agents, transfer agents or registrars or other agents with respect
to the debt securities; |
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to
whom any interest on any debt security shall be payable, if other than the person in whose name the security is registered, on the
record date for such interest, the extent to which, or the manner in which, any interest payable on a temporary global debt security
will be paid; |
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if
the principal of or any premium or interest on any debt securities is to be payable in one or more currencies or currency units other
than as stated, the currency, currencies or currency units in which it shall be paid and the periods within and terms and conditions
upon which such election is to be made and the amounts payable (or the manner in which such amount shall be determined); |
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the
portion of the principal amount of any debt securities which shall be payable upon declaration of acceleration of the maturity of
the debt securities pursuant to the applicable Indenture; |
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if
the principal amount payable at the stated maturity of any debt security of the series will not be determinable as of any one or
more dates prior to the stated maturity, the amount which shall be deemed to be the principal amount of such debt securities as of
any such date for any purpose, including the principal amount thereof which shall be due and payable upon any maturity other than
the stated maturity or which shall be deemed to be outstanding as of any date prior to the stated maturity (or, in any such case,
the manner in which such amount deemed to be the principal amount shall be determined); and |
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any
other specific terms of the debt securities, including any modifications to the events of default under the debt securities and any
other terms which may be required by or advisable under applicable laws or regulations. |
Unless
otherwise specified in the applicable prospectus supplement, we do not anticipate the debt securities will be listed on any securities
exchange. Holders of the debt securities may present registered debt securities for exchange or transfer in the manner described in the
applicable prospectus supplement. Except as limited by the applicable Indenture, we will provide these services without charge, other
than any tax or other governmental charge payable in connection with the exchange or transfer.
Debt
securities may bear interest at a fixed rate or a variable rate as specified in the prospectus supplement. In addition, if specified
in the prospectus supplement, we may sell debt securities bearing no interest or interest at a rate that at the time of issuance is below
the prevailing market rate, or at a discount below their stated principal amount. We will describe in the applicable prospectus supplement
any special federal income tax considerations applicable to these discounted debt securities.
We
may issue debt securities with the principal amount payable on any principal payment date, or the amount of interest payable on any interest
payment date, to be determined by referring to one or more currency exchange rates, commodity prices, equity indices or other factors.
Holders of such debt securities may receive a principal amount on any principal payment date, or interest payments on any interest payment
date, that are greater or less than the amount of principal or interest otherwise payable on such dates, depending upon the value on
such dates of applicable currency, commodity, equity index or other factors. The applicable prospectus supplement will contain information
as to how we will determine the amount of principal or interest payable on any date, as well as the currencies, commodities, equity indices
or other factors to which the amount payable on that date relates and certain additional tax considerations.
Units
We
may issue units consisting of any combination of the other types of securities offered under this prospectus in one or more series. We
may evidence each series of units by unit certificates that we may issue under a separate agreement. We may enter into unit agreements
with a unit agent. Each unit agent, if any, may be a bank or trust company that we select. We will indicate the name and address of the
unit agent, if any, in the applicable prospectus supplement relating to a particular series of units. Specific unit agreements, if any,
will contain additional important terms and provisions. We will file as an exhibit to the registration statement of which this prospectus
is a part, or will incorporate by reference from a current report that we file with the SEC, the form of unit and the form of each unit
agreement, if any, relating to units offered under this prospectus.
If
we offer any units, certain terms of that series of units will be described in the applicable prospectus supplement, including, without
limitation, the following, as applicable
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the title of the series
of units; |
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identification and description
of the separate constituent securities comprising the units; |
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the price or prices at
which the units will be issued; |
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the date, if any, on and
after which the constituent securities comprising the units will be separately transferable; |
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a discussion of certain
United States federal income tax considerations applicable to the units; and |
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any other material terms
of the units and their constituent securities. |
Delaware
Anti-Takeover Law and Provisions of Our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws
Some
provisions of Delaware law, our certificate of incorporation and our bylaws contain provisions that could make the following transactions
more difficult: an acquisition of us by means of a tender offer; an acquisition of us by means of a proxy contest or otherwise; or the
removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or could
deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including transactions
which provide for payment of a premium over the market price for our shares.
These
provisions, summarized below, are intended to discourage coercive takeover practices and inadequate takeover bids. These provisions are
also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the
benefits of the increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal
to acquire or restructure us outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could
result in an improvement of their terms.
Delaware
Anti-Takeover Law
We
are subject to Section 203 of the DGCL. Section 203 generally prohibits a publicly traded corporation from engaging in a “business
combination” with an “interested stockholder” for a period of three years after the date of the transaction in which
the person became an interested stockholder, unless:
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prior to the
date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which
resulted in the stockholder becoming an interested stockholder; |
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upon consummation of the
transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of
the voting stock of the corporation outstanding at the time the transaction commenced, excluding specified shares; or |
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at or subsequent to the
date of the transaction, the business combination is approved by the board of directors and authorized at an annual or special meeting
of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3 % of the outstanding voting stock which is
not owned by the interested stockholder. |
Section
203 defines a “business combination” to include:
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any merger
or consolidation involving the corporation and the interested stockholder; |
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any sale, lease, exchange,
mortgage, pledge, transfer or other disposition of 10% or more of the assets of the corporation to or with the interested stockholder; |
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subject to exceptions,
any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; |
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subject to exceptions,
any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or
series of the corporation beneficially owned by the interested stockholder; or |
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the receipt by the interested
stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation. |
In
general, Section 203 defines an “interested stockholder” as any person that is:
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the owner of
15% or more of the outstanding voting stock of the corporation; |
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an affiliate or associate
of the corporation who was the owner of 15% or more of the outstanding voting stock of the corporation at any time within three years
immediately prior to the relevant date; or |
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the affiliates and associates
of the above. |
Under
specific circumstances, Section 203 makes it more difficult for an “interested stockholder” to effect various business combinations
with a corporation for a three-year period, although the stockholders may, by adopting an amendment to the corporation’s certificate
of incorporation or bylaws, elect not to be governed by this section, effective 12 months after adoption.
Our
certificate of incorporation and bylaws do not exclude us from the restrictions of Section 203. We anticipate that the provisions of
Section 203 might encourage companies interested in acquiring us to negotiate in advance with our board of directors since the stockholder
approval requirement would be avoided if a majority of the directors then in office approve either the business combination or the transaction
that resulted in the stockholder becoming an interested stockholder.
Undesignated
Preferred Stock
The
ability of our board of directors, without action by the stockholders, to issue up to 10,000,000 shares of undesignated preferred stock
with voting or other rights or preferences as designated by our board of directors could impede the success of any attempt to change
control of us. These and other provisions may have the effect of deferring hostile takeovers or delaying changes in control or management
of our company.
Stockholder
Meetings
Our
certificate of incorporation and bylaws provide that a special meeting of stockholders may be called only by our chairman of the board,
chief executive officer or president, or by a resolution adopted by a majority of our board of directors.
Requirements
for Advance Notification of Stockholder Nominations and Proposals
Our
bylaws establish advance notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the nomination
of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee
of the board of directors.
Elimination
of Stockholder Action by Written Consent
Our
certificate of incorporation and bylaws eliminate the right of stockholders to act by written consent without a meeting.
Removal
of Directors
Our
certificate of incorporation provides that no member of our board of directors may be removed from office by our stockholders except
for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of the total voting power
of all of our outstanding voting stock then entitled to vote in the election of directors.
Stockholders
Not Entitled to Cumulative Voting
Our
certificate of incorporation does not permit stockholders to cumulate their votes in the election of directors. Accordingly, the holders
of a majority of the outstanding shares of our common stock entitled to vote in any election of directors can elect all of the directors
standing for election, if they choose, other than any directors that holders of our preferred stock may be entitled to elect.
Choice
of Forum
Our
certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for any derivative
action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us
arising pursuant to the DGCL, our certificate of incorporation or our bylaws; any action to interpret, apply, enforce, or determine the
validity of our certificate of incorporation or bylaws; or any action asserting a claim against us that is governed by the internal affairs
doctrine. The enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged
in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable or unenforceable.
Amendment
Provisions
The
amendment of any of the above provisions to our certificate of incorporation, except for the provision making it possible for our board
of directors to issue preferred stock, would require approval by holders of at least a majority of the total voting power of all of our
outstanding voting stock. The amendment of any of the above provisions to our bylaws would require the affirmative vote of 66 2/3 % of
the outstanding voting stock or our board of directors.
The
provisions of the DGCL, our amended and restated certificate of incorporation and our amended and restated bylaws could have the effect
of discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market
price of our common stock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect
of preventing changes in the composition of our board and management. It is possible that these provisions could make it more difficult
to accomplish transactions that stockholders may otherwise deem to be in their best interests.
FORMS
OF SECURITIES
Each
security may be represented either by a certificate issued in definitive form to a particular investor or by one or more global securities
representing the entire issuance of securities. Certificated securities in definitive form and global securities will be issued in registered
form. Definitive securities name you or your nominee as the owner of the security, and in order to transfer or exchange these securities
or to receive payments other than interest or other interim payments, you or your nominee must physically deliver the securities to the
trustee, registrar, paying agent or other agent, as applicable. Global securities name a depositary or its nominee as the owner of the
debt securities, warrants or units represented by these global securities. The depositary maintains a computerized system that will reflect
each investor’s beneficial ownership of the securities through an account maintained by the investor with its broker/dealer, bank,
trust company or other representative, as we explain more fully below.
Registered
Global Securities
We
may issue the securities in the form of one or more fully registered global securities that will be deposited with a depositary or its
nominee identified in the applicable prospectus supplement and registered in the name of that depositary or nominee. In those cases,
one or more registered global securities will be issued in a denomination or aggregate denominations equal to the portion of the aggregate
principal or face amount of the securities to be represented by registered global securities. Unless and until it is exchanged in whole
for securities in definitive registered form, a registered global security may not be transferred except as a whole by and among the
depositary for the registered global security, the nominees of the depositary or any successors of the depositary or those nominees.
The
specific terms of the depositary arrangement with respect to any securities to be represented by a registered global security will be
described in the prospectus supplement relating to those securities. We anticipate that the following provisions will apply to all depositary
arrangements.
Ownership
of beneficial interests in a registered global security will be limited to persons, called participants, that have accounts with the
depositary or persons that may hold interests through participants. Upon the issuance of a registered global security, the depositary
will credit, on its book-entry registration and transfer system, the participants’ accounts with the respective principal or face
amounts of the securities beneficially owned by the participants. Any dealers, underwriters or agents participating in the distribution
of the securities will designate the accounts to be credited. Ownership of beneficial interests in a registered global security will
be shown on, and the transfer of ownership interests will be effected only through, records maintained by the depositary, with respect
to interests of participants, and on the records of participants, with respect to interests of persons holding through participants.
The laws of some states may require that some purchasers of securities take physical delivery of these securities in definitive form.
These laws may impair your ability to own, transfer or pledge beneficial interests in registered global securities.
So
long as the depositary, or its nominee, is the registered owner of a registered global security, that depositary or its nominee, as the
case may be, will be considered the sole owner or holder of the securities represented by the registered global security for all purposes
under the applicable indenture, warrant agreement or unit agreement.
Except
as described below, owners of beneficial interests in a registered global security will not be entitled to have the securities represented
by the registered global security registered in their names, will not receive or be entitled to receive physical delivery of the securities
in definitive form and will not be considered the owners or holders of the securities under the applicable indenture, warrant agreement
or unit agreement. Accordingly, each person owning a beneficial interest in a registered global security must rely on the procedures
of the depositary for that registered global security and, if that person is not a participant, on the procedures of the participant
through which the person owns its interest, to exercise any rights of a holder under the applicable indenture, warrant agreement or unit
agreement. We understand that under existing industry practices, if we request any action of holders or if an owner of a beneficial interest
in a registered global security desires to give or take any action that a holder is entitled to give or take under the applicable indenture,
warrant agreement or unit agreement, the depositary for the registered global security would authorize the participants holding the relevant
beneficial interests to give or take that action, and the participants would authorize beneficial owners owning through them to give
or take that action or would otherwise act upon the instructions of beneficial owners holding through them.
Payments
to holders with respect to securities represented by a registered global security registered in the name of a depositary or its nominee
will be made to the depositary or its nominee, as the case may be, as the registered owner of the registered global security. None of
the Company, the trustees, the warrant agents, the unit agents or any other agent of the Company, agent of the trustees, the warrant
agents or unit agents will have any responsibility or liability for any aspect of the records relating to payments made on account of
beneficial ownership interests in the registered global security or for maintaining, supervising or reviewing any records relating to
those beneficial ownership interests.
We
expect that the depositary for any of the securities represented by a registered global security, upon receipt of any payment of principal,
premium, interest or other payment or distribution to holders of that registered global security, will immediately credit participants’
accounts in amounts proportionate to their respective beneficial interests in that registered global security as shown on the records
of the depositary. We also expect that payments by participants to owners of beneficial interests in a registered global security held
through participants will be governed by standing customer instructions and customary practices, as is now the case with the securities
held for the accounts of customers or registered in “street name,” and will be the responsibility of those participants.
If
the depositary for any of these securities represented by a registered global security is at any time unwilling or unable to continue
as depositary or ceases to be a clearing agency registered under the Exchange Act and a successor depositary registered as a clearing
agency under the Exchange Act is not appointed by us within 90 days, we will issue securities in definitive form in exchange for the
registered global security that had been held by the depositary. Any securities issued in definitive form in exchange for a registered
global security will be registered in the name or names that the depositary gives to the relevant trustee, warrant agent, unit agent
or other relevant agent of ours or theirs. It is expected that the depositary’s instructions will be based upon directions received
by the depositary from participants with respect to ownership of beneficial interests in the registered global security that had been
held by the depositary.
LEGAL
MATTERS
Unless
otherwise indicated in the applicable prospectus supplement, the validity of the securities offered by this prospectus will be passed
upon for us by Ellenoff Grossman & Schole LLP, New York, New York. If legal matters in connection with offerings made by this prospectus
are passed on by counsel for the underwriters, dealers or agents, if any, that counsel will be named in the applicable prospectus supplement.
EXPERTS
The
consolidated financial statements of enVVeno Medical Corporation and subsidiaries as of and for the years ended December 31, 2022 and
2021 have been incorporated by reference in the registration statement in reliance upon the report of Marcum LLP, independent registered
public accounting firm, and upon the authority of said firm as experts in accounting and auditing.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
We
file annual, quarter and periodic reports, proxy statements and other information with the Securities and Exchange Commission using the
Commission’s EDGAR system. The Commission maintains a web site that contains reports, proxy and information statements and other
information regarding registrants that file electronically with the Commission. The address of such site is http//www.sec.gov.
INCORPORATION
OF DOCUMENTS BY REFERENCE
We
are “incorporating by reference” in this prospectus certain documents we file with the SEC, which means that we can disclose
important information to you by referring you to those documents. The information in the documents incorporated by reference is considered
to be part of this prospectus. Statements contained in documents that we file with the SEC and that are incorporated by reference in
this prospectus will automatically update and supersede information contained in this prospectus, including information in previously
filed documents or reports that have been incorporated by reference in this prospectus, to the extent the new information differs from
or is inconsistent with the old information. We have filed or may file the following documents with the SEC and they are incorporated
herein by reference as of their respective dates of filing.
1.
Our Annual Report on Form
10-K for the year ended December 31, 2022, filed with the SEC on March 2, 2023;
2.
Our Quarterly Report on Form
10-Q for the quarter ended March 31, 2023, filed with the SEC on April 28, 2023; and
3.
Our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on July 31, 2023.
All
documents that we filed with the SEC pursuant to Sections 13(a), 13(c), 14, and 15(d) of the Exchange Act subsequent to the date of this
registration statement and prior to the filing of a post-effective amendment to this registration statement that indicates that all securities
offered under this prospectus have been sold, or that deregisters all securities then remaining unsold, will be deemed to be incorporated
in this registration statement by reference and to be a part hereof from the date of filing of such documents.
Any
statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus shall be deemed modified,
superseded or replaced for purposes of this prospectus to the extent that a statement contained in this prospectus, or in any subsequently
filed document that also is deemed to be incorporated by reference in this prospectus, modifies, supersedes or replaces such statement.
Any statement so modified, superseded or replaced shall not be deemed, except as so modified, superseded or replaced, to constitute a
part of this prospectus. None of the information that we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K or any corresponding
information, either furnished under Item 9.01 or included as an exhibit therein, that we may from time to time furnish to the SEC will
be incorporated by reference into, or otherwise included in, this prospectus, except as otherwise expressly set forth in the relevant
document. Subject to the foregoing, all information appearing in this prospectus is qualified in its entirety by the information appearing
in the documents incorporated by reference.
You
may requests, orally or in writing, a copy of these documents, which will be provided to you at no cost (other than exhibits, unless
such exhibits are specifically incorporate by reference), by contacting the Company at enVVeno Medical Corporation, at 70 Doppler, Irvine,
California 92618, attention: Corporate Secretary. Our telephone number is (949) 261-2900. Information about us is also available at our
website at https://envveno.com/. However, the information in our website is not a part of this prospectus and is not incorporated by
reference.
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and Distribution.
The
Company is paying all expenses of the offering. The following table sets forth all expenses to be paid by the registrant. All amounts
shown are estimates except for the registration fee.
SEC registration fee | |
$ | 8,265 | |
Printing | |
| * | |
Legal fees and expenses | |
$ | 35,000 | |
Accounting fees and expenses | |
$ | 30,000 | |
Trustees’ Fees and Expenses | |
| * | |
Warrant Agent Fees and Expenses | |
| * | |
Miscellaneous | |
| * | |
Total | |
$ | 73,265 | |
*
These fees are calculated based on the securities offered and the number of issuances and accordingly cannot be estimated at this time.
The applicable prospectus supplement will set forth the estimated amount of expenses of any offering of securities.
Item
15. Indemnification of Directors and Officers.
Section
145 of the DGCL inter alia, empowers a Delaware corporation to indemnify any person who was or is a party or is threatened to be made
a party to any threatened, pending or completed action, suit or proceeding (other than an action by or in the right of the corporation)
by reason of the fact that such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or agent of another corporation or other enterprise, against expenses (including
attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such
action, suit or proceeding if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests
of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful.
Similar indemnity is authorized for such persons against expenses (including attorneys’ fees) actually and reasonably incurred
in connection with the defense or settlement of any such threatened, pending or completed action or suit if such person acted in good
faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and provided further that
(unless a court of competent jurisdiction otherwise provides) such person shall not have been adjudged liable to the corporation. Any
such indemnification may be made only as authorized in each specific case upon a determination by the stockholders or disinterested directors
or by independent legal counsel in a written opinion that indemnification is proper because the indemnitee has met the applicable standard
of conduct.
Section
145 further authorizes a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee
or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another
corporation or enterprise, against any liability asserted against him and incurred by him in any such capacity, or arising out of his
status as such, whether or not the corporation would otherwise have the power to indemnify him under Section 145. We maintain policies
insuring our officers and directors against certain liabilities for actions taken in such capacities, including liabilities under the
Securities Act.
Section
102(b)(7) of the DGCL permits a corporation to include in its certificate of incorporation a provision eliminating or limiting the personal
liability of a director to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, provided
that such provision shall not eliminate or limit the liability of a director (i) for any breach of the director’s duty of loyalty
to the corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing
violation of law, (iii) under Section 174 of the DGCL (relating to unlawful payment of dividends and unlawful stock purchase or redemption)
or (iv) for any transaction from which the director derived an improper personal benefit.
Article
10 of the bylaws of the Company contains provisions which are designed to provide mandatory indemnification of directors and officers
of the Company to the full extent permitted by law, as now in effect or later amended. The bylaws further provide that, if and to the
extent required by the DGCL, an advance payment of expenses to a director or officer of the Company that is entitled to indemnification
will only be made upon delivery to the Company of an undertaking, by or on behalf of the director or officer, to repay all amounts so
advanced if it is ultimately determined that such director is not entitled to indemnification.
Item
16. Exhibits.
The
following exhibits are filed with this Registration Statement.
The
agreements included or incorporated by reference as exhibits to this registration statement contain representations and warranties by
each of the parties to the applicable agreement. These representations and warranties were made solely for the benefit of the other parties
to the applicable agreement and (i) were not intended to be treated as categorical statements of fact, but rather as a way of allocating
the risk to one of the parties if those statements prove to be inaccurate; (ii) may have been qualified in such agreement by disclosures
that were made to the other party in connection with the negotiation of the applicable agreement; (iii) may apply contract standards
of “materiality” that are different from “materiality” under the applicable securities laws; and (iv) were made
only as of the date of the applicable agreement or such other date or dates as may be specified in the agreement.
The
undersigned registrant acknowledges that, notwithstanding the inclusion of the foregoing cautionary statements, it is responsible for
considering whether additional specific disclosures of material information regarding material contractual provisions are required to
make the statements in this registration statement not misleading.
Item
17. Undertakings.
(a)
The undersigned Registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i)
to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii)
to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range
may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration
Fee” table in the effective registration statement; and
(iii)
to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or
any material change to such information in the registration statement;
provided
, however , that paragraphs (1)(i), (1)(ii) and (1)(iii) do not apply if the information required to be included in a post-effective
amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section
13 or 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained
in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
(2)
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
(3)
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the
termination of the offering.
(4)
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
(i)
Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the
date the filed prospectus was deemed part of and included in the registration statement; and
(ii)
Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on
Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required
by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier
of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the
offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date
an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the
registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is
part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or
modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in
any such document immediately prior to such effective date.
(5)
That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution
of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant
to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities
are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to
the purchaser and will be considered to offer or sell such securities to such purchaser:
(i)
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule
424;
(ii)
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by
the undersigned registrant;
(iii)
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant
or its securities provided by or on behalf of the undersigned registrant; and
(iv)
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
(b)
The undersigned registrant hereby undertakes that, for purposes of determining any liability of the registrant under the Securities Act
of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act
of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide
offering thereof.
(c)
The undersigned registrant hereby undertakes to supplement the prospectus, after the expiration of the subscription period, to set forth
the results of the subscription offer, the transactions by the underwriters during the subscription period, the amount of unsubscribed
securities to be purchased by the underwriters, and the terms of any subsequent reoffering thereof. If any public offering by the underwriters
is to be made on terms differing from those set forth on the cover page of the prospectus, a post-effective amendment will be filed to
set forth the terms of such offering.
(d)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of
the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses
incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding)
is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will,
unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction
the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933 and will be governed
by the final adjudication of such issue.
(e)
The undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to
act under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and regulations prescribed by the Commission
under Section 305(b)(2) of the Trust Indenture Act.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this Registration Statement to be signed
on its behalf by the undersigned, thereunto duly authorized, in the City of Irvine, State of California, on this 14th
day of August, 2023.
|
ENVVENO
MEDICAL CORPORATION |
|
|
|
By: |
/s/
Robert Berman |
|
|
Robert
Berman |
|
|
Chief
Executive Officer |
Pursuant
to the requirements of the Securities Act of 1933, as amended, this Registration Statement has been signed by the following persons in
the capacities and on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/
Robert A. Berman |
|
Chief
Executive Officer and Director |
|
August
14, 2023 |
Robert
A. Berman |
|
(Principal
Executive Officer) |
|
|
|
|
|
|
|
/s/
Craig Glynn |
|
Chief
Financial Officer and Treasurer |
|
August
14, 2023 |
Craig
Glynn |
|
(Principal
Financial Officer and Principal Accounting Officer) |
|
|
|
|
|
|
|
* |
|
Director |
|
August
14, 2023 |
Dr.
Francis Duhay |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
August
14, 2023 |
Dr.
Sanjay Shrivastava |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
August
14, 2023 |
Matthew
M. Jenusaitis |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
August
14, 2023 |
Robert
C. Gray |
|
|
|
|
*
By: |
/s/
Robert Berman |
|
Name: |
Robert
Berman
|
|
|
Attorney-in-fact |
|
Exhibit 23.1
Independent
Registered Public Accounting Firm’s Consent
We consent to the incorporation by reference in
this Registration Statement of enVVeno Medical Corporation on Amendment No. 1 to Form S-3 (File No. 333-273546) of our report dated March
2, 2023, with respect to our audits of the financial statements of enVVeno Medical Corporation as of December 31, 2022 and 2021 and for
the years ended December 31, 2022 and 2021 appearing in the Annual Report on Form 10-K of enVVeno Medical Corporation for the year ended
December 31, 2022. We also consent to the reference to our firm under the heading “Experts” in the Prospectus, which is part
of this Registration Statement.
/s/ Marcum LLP
Marcum LLP
New York, NY
August 14, 2023
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