Executing Tactical Elements of EU Commercial Plan to Support Initial Launch Activities
ANN ARBOR, MI / ACCESSWIRE / March 17, 2020 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announced more details today regarding its commercialization plan, which leverages the recent receipt of Conformité Européene ("CE") Mark approval for its TAEUS FLIP (Fatty Liver Imaging Probe) System.
"The CE Mark approval announced last week is a key milestone, and was earned earlier than anticipated," said Francois Michelon, CEO of ENDRA. "We have a solid foundation in place to move forward with initial launch activities in the EU, thanks to the pre-commercial activities we began implementing in 2018 and continue to execute as we move to commercialize the TAEUS liver device in our target markets. We are adapting our commercial plan where necessitated by COVID-19, but otherwise it does not materially affect our plan."
"We have been encouraged by the strong reception to date of our ongoing pre-commercial activities focused on the European clinical community, which have reinforced our excitement about the potential for TAEUS to address a significant clinical need and technology gap for a safe, non-invasive, and cost-effective point-of-care tool to the assess liver fat in patients with management of chronic liver conditions like NAFLD and NASH," said Renaud Maloberti, Chief Commercial Officer of ENDRA. "Our EU-based commercial team will work closely with EU clinical reference sites and our commercial partner GE to bring this exciting new technology to clinicians and their patients."
As a reminder, ENDRA is targeting over 200,000 global clinicians with an interest in liver health, specifically:
- Radiologists focused on abdominal and liver imaging;
- Gastro-Hepatologists focused on liver disease and treatment;
- Endocrinologists, Internal Medicine and Primary Care physicians, focused on metabolic disorders, diabetes, and obesity.
"Recall the landscape of NAFLD-NASH today," continued Michelon. "At the front end, you have over a billion people globally affected by these conditions. At the back end, you have the first ever therapies to reduce liver fat rapidly approaching commercial availability, including the recent approval of Zydus' saroglitazar in India. While the advent of available therapeutics for patients is exciting, the lack of a practical liver fat measurement tool to screen-in patients and monitor their response to therapy will be a substantial barrier to getting patients properly evaluated and onto the therapies they need. MRI and liver biopsy are completely impractical tools for the scale and profile of NAFLD-NASH, creating an opportunity for a technology like TAEUS to fill that clinical treatment gap."
ENDRA is implementing its EU commercial plan with the following key elements:
1H 2020
- Establish clinical evaluation reference sites in each target European market, including Germany, France, Switzerland and the U.K, to build clinical experience and serve as commercial springboards in each market.
- Add ENDRA clinical specialists to provide direct support to clinical reference site partners and work with commercial partner GE Healthcare's commercial teams at a local level.
- Initiate TAEUS product marketing communication campaign including direct marketing and social medial outreach to ENDRA's database of opt-in clinicians.
- Launch a liver-focused company website in multiple European languages highlighting the CE-approved TAEUS liver system, providing local country sales contact information, and helping to build the commercial pipeline.
- Mitigate COVID-19 related cancellation or rescheduling of trade shows (E.g., AIUM in New York and EASL in London) by creating digital education tools to maintain clinical relationships and continue generating interest in TAEUS.
2H 2020
- Participate in key European hepatology and radiology conferences including the EASL International Liver Congress (August, U.K) NAFLD Summit (September, Ireland), and Drei Lander (October, Austria).
- Deploy CE-approved commercial TAEUS systems to European evaluation sites, and support sites in their training, and clinical trialing of the device.
- Expand TAEUS product training of GE commercial teams in each European market, leveraging ENDRA's in-country clinical evaluation sites as training venues.
- Host a series of regional "lunch & learn" educational events in each key European market, targeting ENDRA's database of opt-in clinicians and local country introductions by GE, delivering hands-on group demonstrations of TAEUS.
ENDRA will provide additional details on EU commercial launch plans and activities on the previously announced Q4 and year-end report and conference call scheduled for Thursday, March 26th, 2020.
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.
Company Contact:
David Wells
Chief Financial Officer
(734) 997-0464
[email protected]
www.endrainc.com
Media & Investor Relations Contact:
MacDougall
Amanda Houlihan
(781) 235-3060
[email protected]
SOURCE: ENDRA Life Sciences Inc.