UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 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): January 30,
2018
|
|
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
Not Applicable
(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))
|
Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (§230.405 of
this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
(§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
1.01
Entry
into a Material Definitive Agreement
On
January 30, 2018, ENDRA Life Sciences Inc. (the
“Company”) entered into Amendment 2 (the
“Amendment”) to that certain Collaborative Research
Agreement between the Company and General Electric Company
(“GE”), dated as of April 22, 2016 and as amended on
April 21, 2017 (the “Agreement”). The Amendment extends
the term of the Agreement to January 22, 2020.
A copy
of the Amendment is filed herewith as Exhibit 10.1. The foregoing
description is qualified in its entirety by reference to the full
text of the Amendment, which is incorporated herein by
reference.
Item
7.01
Regulation
FD Disclosure
On
February 5, 2018, the Company issued a press release announcing its
entry into the Amendment. A copy of the press release is being
furnished as Exhibit 99.1 to this Current Report on Form
8-K.
The
information furnished in Item 7.01 of this Current Report on
Form 8-K, including Exhibit 99.1 attached hereto, 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 into any
filing under the Securities Act of 1933 or the Exchange Act, except
as expressly set forth by specific reference in such
filing.
Item
9.01
Financial
Statements and Exhibits
The
exhibits required to be filed as a part of this Current Report on
Form 8-K are listed in the Exhibit Index attached hereto and
incorporated herein by reference.
EXHIBIT
INDEX
|
Exhibit
No.
|
|
Description
|
|
|
|
|
|
|
|
Amendment
2 to Collaborative Research Agreement, dated January 30, 2018, by
and between the Company General Electric Company.
|
|
|
|
Press
Release dated February 5, 2018 issued by the Company, furnished
herewith.
|
SIGNATURES
Pursuant 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.
|
|
Date:
February 5, 2018
|
By:
|
/s/
Francois Michelon
|
|
|
Name:
|
Francois
Michelon
|
|
|
Title:
|
Chief
Executive Officer and Director
|
Exhibit 99.1
ENDRA Life Sciences Renews and Extends Term of
Collaboration
Agreement with GE Healthcare to Develop ENDRA’s TAEUS™
Clinical
Product Targeting Non-Alcoholic Fatty Liver Disease
2018 European Launch Remains on Track with Human Data Expected in
Second Quarter
of 2018 to Support ENDRA’s First Commercial Liver
Product
ANN ARBOR, Michigan – February 5, 2018 -
ENDRA Life Sciences
Inc.
(“ENDRA”) (NASDAQ: NDRA), a developer of
enhanced ultrasound technologies,
has renewed its
collaborative research agreement to develop ENDRA’s clinical
platform, Thermo-Acoustic Enhanced UltraSound (TAEUS™),
with
General
Electric Company
(NYSE: GE) acting
through its GE Healthcare unit, a leading provider of
transformational medical technologies and services, by extending
the agreement’s term to January 2020.
Under
the terms of the agreement, GE Healthcare will continue to support
ENDRA’s efforts to complete commercialization of its TAEUS
technology for use in a fatty liver application by, among other
things, providing equipment and technical advice, and facilitating
introductions to GE Healthcare clinical ultrasound customers. In
return for this assistance, ENDRA will afford GE Healthcare certain
rights of first offer with respect to manufacturing and licensing
rights for the target application.
In the
fourth quarter of 2017, ENDRA completed two major milestones
towards the commercial launch of its TAEUS clinical product in the
European Union, currently projected for the second half of
2018.
●
The first milestone
was the new partnerships with StarFish Medical and CriTech Research
to advance ENDRA’s current prototype TAEUS device into a
clinical product meeting CE regulatory requirements, followed by
FDA submission for the U.S. market.
●
The second
milestone was contracting with the Centre for Imaging Technology
Commercialization (CIMTEC) to commence human studies targeting
NAFLD involving both conventional ultrasound and TAEUS imaging,
along with relevant blood markers and magnetic resonance imaging
(MRI). ENDRA’s objectives are to obtain important insight
into clinical work flow and TAEUS’ quantitative
methodologies.
“2018
is off to an exciting start as evidenced by the accelerated renewal
of our collaboration agreement with GE Healthcare, the global
leader in clinical ultrasound,” said Francois Michelon,
ENDRA’s CEO. “Based on positive market trends in the EU
and our progress achieved on the development front in 2017, we and
GE Healthcare mutually agreed to extend our partnership by two
years to continue the development and commercialization of
ENDRA’s TAEUS fatty liver product in
Europe.”
Brian
McEathron, GE Healthcare’s Vice President and General Manager
for General Imaging Ultrasound added, “GE has a long history
of bringing meaningful healthcare innovation to market. We believe
that ENDRA’s technology has the potential to bring
significant new capabilities to ultrasound – which aligns
well with GE Healthcare’s mission of increasing access to
high-quality, cost-effective healthcare. We’re very excited
about completing the final steps towards commercialization of
ENDRA’s TAEUS fatty liver product.”
About ENDRA Life Sciences Inc.
ENDRA
Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA) is a developer of
enhanced ultrasound technologies. ENDRA's Photo-Acoustic Nexus-128
system is currently used by leading global medical researchers to
screen and modify disease models with high image quality and volume
scanning speed. ENDRA is developing next generation Thermo-Acoustic
Enhanced UltraSound (TAEUS
™
) system
to enable clinicians to visualize human tissue composition,
function and temperature in ways previously possible only with CT
& MRI -- at a fraction of the cost, and at the point-of-care.
ENDRA's first TAEUS application will focus on the quantification of
fat in the liver, for early detection and monitoring of
Non-Alcoholic Fatty Liver Disease, which affects over 1 billion
people globally, representing an estimated $13 billion global
ultrasound market opportunity. ENDRA's goal is to bring new
capabilities to ultrasound -- thereby broadening access to better
healthcare. For more information, please visit
www.endrainc.com
.
Forward-Looking Statements
All
statements in this 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
forward-looking terms such as "believe," "expect," "may," "will,"
"should," "could," "seek," "intend," "plan," "goal," "estimate,"
"anticipate," or other comparable terms. Examples of
forward-looking statements include, among others, statements we
make regarding the continuation of our agreement with GE
Healthcare, expectations concerning ENDRA's ability to secure
regulatory approvals; anticipated product pricing; expectations
with respect to current and future partnerships, including those
with GE Healthcare, CIMTEC, StarFish and CriTech; estimates of the
timing of future events and achievements; and expectations
concerning ENDRA's business strategy. Forward-looking statements
involve inherent risks and uncertainties which could cause actual
results to differ materially from those in the forward-looking
statements, as a result of various factors including, among others,
the following: our ability to develop a commercially feasible
technology; receipt of necessary regulatory approvals; our ability
to find and maintain development partners, market acceptance of our
technology, the amount and nature of competition in our industry;
our ability to protect our intellectual property; and the other
risks and uncertainties described in ENDRA's filings with the
Securities and Exchange Commission. The forward-looking statements
made in this release speak only as of the date of this release, 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:
David
Wells
Chief
Financial Officer
(734)
997-0464
investors@endrainc.com
www.endrainc.com
Media & Investor Relations Contact:
MZ North America
Chris Tyson
Managing Director
(949) 491-8235
NDRA@mzgroup.us
www.mzgroup.us
