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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported)
May 20, 2024
ENDRA Life Sciences Inc.
(Exact name of registrant as
specified in its charter)
Delaware
001-37969
26-0579295
(State or other
jurisdiction of incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
3600 Green Court
,
Suite 350
Ann Arbor
,
MI
48105
(Address
of principal executive offices)
(Zip Code)
Registrant's telephone number,
including area code
(
734
)
335-0468
___________________________________________
___
(Former name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-
commencement communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered
pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common stock, par value
$0.0001 per share
NDRA
The
Nasdaq
Stock Market LLC
Indicate by check mark
whether the registrant is an emerging growth company as defined in Rule 405 of
the Securities Act of 1933 ((s)230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 ((s)240.12b-2 of this chapter).
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 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On May
20, 2024, ENDRA Life Sciences Inc. (the "Company") issued a press release
regarding its in-person pre-submission meeting with the Food and Drug
Administration (the "FDA") related to the clinical trial design of its TAEUS
liver device in support of its planned de novo filing with the FDA. A copy of
the press release is being furnished as Exhibit 99.1 to this Current Report on
Form 8-K.
The information in Item 7.01 of this Current Report on Form 8-K and
Exhibit 99.1 attached hereto is intended to be furnished and shall not be
deemed "filed" for purposes of Section 18 of the Securities Exchange Act of
1934 (the "Exchange Act") or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933 or the Exchange Act, except as expressly set forth
by specific reference in such filing.
Item 8.01 Other Events.
The in-person
pre-submission meeting with the FDA occurred on May 16, 2024. The Company
currently anticipates completing the necessary clinical studies for its de
novo submission for its TAEUS liver device by the fourth quarter of 2024 or
first quarter of 2025 and submitting the new de novo filing to the FDA in the
first half of 2025.
Cautionary Note regarding Forward-Looking Statements
All
statements in this Current Report on Form 8-K that are not based on historical
fact are "forward-looking statements" within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements, which are based on certain assumptions and
describe future plans, strategies and expectations, can generally be
identified by the use of forward-looking terms such as "anticipates,"
"planned," and other comparable terms. Examples of forward-looking statements
include, among others, statements regarding the Company's plans to make a de
novo submission to the FDA relating to its TAEUS liver device and expectations
regarding timing of completion of related clinical studies and the submission
of such de novo request. The forward-looking statements made in this report
speak only as of the date of this report, and the Company assumes no
obligation to update any such forward-looking statements to reflect actual
results or changes in expectations, except as otherwise required by law.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.
Description
99.
1
Press Release dated May 20, 2024, furnished herewith.
104
Cover Page
Interactive Data File (embedded within the Inline XBRL document)
2
SIGNATURE
Pur
suant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ENDRA Life Sciences Inc.
May 20,
2024
By:
/s/ Francois Michelon
Name:
Francois Michelon
Title:
President and
Chief Executive Officer
3
EXHIBIT 99.1
ENDRA Provides Update Following In-person Meeting with
FDA
Increases clarity for ENDRA on regulatory path forward for TAEUS
ANN
ARBOR, Mich. (May 20, 2024) -
ENDRA Life Sciences Inc.
(NASDAQ: NDRA), a
pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS
(R)
), announced that it
has completed what it considers to be a highly informative pre-submission
meeting with the U.S. Food and Drug Administration (FDA) related to the
clinical trial design of the TAEUS liver device in support of its U.S. De Novo
filing .
Prior to the meeting, ENDRA provided the FDA with a detailed
description of the TAEUS technology to be used in clinical testing, along with
a clinical study synopsis outlining a prospective hypothesis-driven,
statistically powered multicenter clinical study spanning a fat fraction range
representative of steatotic liver disease in the U.S., ranging from healthy to
severe. In support of the proposed statistical analysis plan, ENDRA provided
background clinical data and statistical analyses from 45 historical study
participants.
The meeting was held at FDA's Maryland headquarters and focused
on ENDRA's proposed pivotal clinical study. During the meeting ENDRA also
demonstrated the TAEUS procedure using anatomical phantoms of the liver.
The
ENDRA team in attendance included key technical staff, a regulatory/clinical
lead with over 20 years of first-of-a-kind medical device experience, a senior
biostatistician familiar to the FDA, and liver ultrasound and MRI radiology
experts.
Management believes that the meeting was highly informative and views
the FDA's feedback as very constructive. Based on the feedback received as
well as the Meeting Minutes expected in June, ENDRA will update its pivotal
clinical study protocol and statistical plan for submission to the FDA as a
next step prior to initiating the study.
"ENDRA's new regulatory approach is
focused on close engagement with the FDA to ensure alignment on our pivotal
study design and statistical plan, in support of a future De Novo submission,"
said Michael Thornton, ENDRA's Chief Technology Officer. "We believe this
in-person meeting with the FDA helped clarify the path forward for ENDRA. We
look forward to maintaining close collaboration with the FDA throughout the
process."
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of
Thermo Acoustic Enhanced UltraSound (TAEUS
(R)
), a ground-breaking technology
that characterizes tissue similar to an MRI, but at 1/40
th
the cost and at
the point of patient care. TAEUS
(R)
is designed to work in concert with the
more than 700,000 ultrasound systems in use globally today. TAEUS
(R)
is
initially focused on the non-invasive assessment of fatty tissue in the liver.
Steatotic liver disease (SLD, formerly known as NAFLD-NASH) is a chronic liver
disease spectrum that affects over two billion people globally, and for which
there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring
several other clinical applications of TAEUS
(R)
, including non-invasive
visualization of tissue temperature during energy-based surgical procedures.
For more information, please visit
www.endrainc.com
.
Forward-Looking
Statements
All statements in this press release that are not based on
historical fact are "forward-looking statements" within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. Forward-looking statements, which are based on certain
assumptions and describe our future plans, strategies and expectations, can
generally be identified by the use of terms such as "approximate,"
"anticipate," "attempt," "believe," "could," "estimate," "expect," "forecast,"
"future," "goal," "hope," "intend," "may," "plan," "possible," "potential,"
"project," "seek," "should," "will," "would," or other comparable terms
(including the negative of any of the foregoing), although some forward-looking
statements are expressed differently. Examples of forward-looking statements
for ENDRA include, among others: expectations with respect to FDA requirements
regarding its clinical trials and de novo submission for its TAEUS liver
device; estimates of the timing of future events and anticipated results of
its development efforts, including the timing of submission for and receipt of
required regulatory approvals and product launches and sales; statements
relating to future financial position and projected costs and revenue;
expectations concerning ENDRA's business strategy; and statements regarding
ENDRA's ability to find and maintain development partners. Forward-looking
statements involve inherent risks and uncertainties that could cause actual
results to differ materially from those in the forward-looking statements as a
result of various factors including, among others: the ability to raise
additional capital in order to continue as a going concern; the ability to
obtain FDA and other regulatory approvals necessary to sell ENDRA medical
devices in certain markets in a timely manner, or at all; the ability to
develop a commercially feasible technology and its dependence on third parties
to design and manufacture its products; ENDRA's ability to maintain compliance
with Nasdaq listing standards; ENDRA's dependence on its senior management
team; market acceptance of ENDRA's technology and the amount and nature of
competition in its industry; ENDRA's ability to protect its intellectual
property; and the other risks and uncertainties described in the Risk Factors
and Management's Discussion and Analysis of Financial Condition and Results of
Operations sections of the company's most recent Annual Report on Form 10-K
and in subsequent Quarterly Reports on Form 10-Q filed with the Securities and
Exchange Commission. You should not rely upon forward-looking statements as
predictions of future events. The forward-looking statements made in this
press release speak only as of the date of issuance, and ENDRA assumes no
obligation to update any such forward-looking statements to reflect actual
results or changes in expectations, except as otherwise required by
law.
Company Contact:
Irina Pestrikova
Senior Director, Finance
investors@endrai
nc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor
Relations
(310) 691-7100
ybriggs@lhai.com
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