ENDRA Life Sciences Inc. (Form: 8-K, Received: 03/10/2020 08:02:45)

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) March 10, 2020

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
Warrants, each to purchase one share of Common Stock	NDRAW	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 (§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 8.01 Other Events

On March 10, 2020, ENDRA Life Sciences Inc. issued a press release announcing the receipt of CE Mark approval for its TAEUS® clinical product targeting non-alcoholic fatty liver disease. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.		Description

99.1		Press Release dated March 10, 2020.

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.
March 10, 2020
	By:	/s/ Francois Michelon
	Name:	Francois Michelon
	Title:	President and Chief Executive Officer

ENDRA Life Sciences Receives CE Mark for its TAEUS® Clinical Product Targeting Non-Alcoholic Fatty Liver Disease

First regulatory clearance paves the way to commercialize TAEUS in European markets

U.S. FDA submission expected during H1:20

ANN ARBOR, MI / March 9, 2020/ ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announced today that it has received Conformité Européene (“CE”) Mark approval for its TAEUS FLIP (Fatty Liver Imaging Probe) System. TAEUS is initially focused on the non-invasive measurement of liver fat to identify and monitor Non-Alcoholic Fatty Liver Disease (“NAFLD”) and Non-Alcoholic Steatohepatitis (“NASH”), chronic liver conditions that affect over one billion people globally and are precursors to fibrosis, cirrhosis and cancer. The CE marking indicates that TAEUS FLIP System complies with all applicable European Directives and Regulations in the European Union and other CE Mark geographies, including the 27 EU member states. ENDRA will now notify the competent authorities that it has received the CE Mark, and register the TAEUS product in each of the initial target markets.

The company also provided an update on the status of its planned U.S. FDA regulatory submission, which is in preparation and expected to be submitted during the first half of 2020.

"CE Mark approval is a milestone achievement for ENDRA, as it marks our first regulatory approval for the TAEUS device, and paves the way for us to commercialize the TAEUS liver application in our initial international target markets, such as Germany and France," said Francois Michelon, Chairman and CEO of ENDRA.

"Our EU commercial team looks forward to working with our partners at GE Healthcare in Europe to introduce our TAEUS liver technology to clinicians in our initial target markets," said Renaud Maloberti, Chief Commercial Officer of ENDRA. “We will ramp up our supply chain near-term, and focus our efforts on getting the TAEUS systems into the hands of clinical influencers, an essential step in providing strong local references for our commercial team.”

ENDRA will provide additional information on its EU commercial plans for TAEUS, regulatory and other activities during the upcoming Q4, 2019 conference call on March 26th.

About ENDRA Life Sciences Inc.

ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to visualize tissue like CT or MRI, but at 1/50th of the cost, at the point of patient care. TAEUS is designed to work in concert with the over one million ultrasound systems in use globally today. TAEUS is initially focused on the measurement of fat in the liver, as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and inflammation (NASH), chronic liver conditions that affect over one billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS, including visualization of tissue temperature during energy-based surgical procedures. 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 expectations regarding the registration of our TAEUS device in European jurisdictions and the timing of a U.S. 510(k) regulatory submission for our TAEUS device; plans relating to our supply chain and commercialization of the TAEUS device, including its adoption by clinicians; and expectations concerning ENDRA's product development and 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.

Chief Financial Officer

investors@endrainc.com

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