TAEUS Technology and Applications - The TAEUS technology platform aims to enhance clinical ultrasound capabilities, specifically targeting nonalcoholic fatty liver disease (NAFLD) and its progression, which can lead to serious conditions like NASH and liver cancer[25]. - The TAEUS technology uses radio frequency (RF) pulses, utilizing less than 1% of the energy required for an MRI scan, allowing for deeper tissue penetration and improved imaging capabilities[24]. - TAEUS technology enables ultrasound to distinguish fat from lean tissue, facilitating early identification and monitoring of NAFLD[44]. - The TAEUS platform will initially focus on quantifying fat in the liver and staging progression of Nonalcoholic Fatty Liver Disease (NAFLD), which affected over 1.4 billion people in 2015[51]. - The second generation product is expected to provide two-dimensional imaging with a multi-element transducer, allowing applications such as reading tissue composition and vascular flow[49]. - The company is developing TAEUS for incorporation into new ultrasound systems manufactured by companies such as GE Healthcare[41]. - The TAEUS technology is designed to enhance existing ultrasound systems, allowing healthcare providers to increase utilization and generate new revenue without significant capital investments[43]. - The company has conducted various internal ex-vivo laboratory experiments and limited in-vivo large animal studies to demonstrate the capabilities of the TAEUS platform[42]. Market and Financial Overview - The global ultrasound diagnostic equipment market was valued at approximately $4.4 billion in 2017, with an expected annual growth rate of about 4.4%[36]. - There are an estimated one million ultrasound systems in use globally, generating over 400 million annual diagnostic ultrasound procedures[36]. - The addressable market for TAEUS applications is approximately 365,000 cart-based ultrasound systems currently in use worldwide[36]. - The total annual direct medical costs for NAFLD in the United States are estimated to be $103 billion, with a median Medicare inpatient charge per NAFLD patient estimated at $36,000[57]. - The initial NAFLD TAEUS application is expected to be priced between $35,000 and $55,000, allowing purchasers to recoup their investment in less than one year[83]. - The worldwide market for RF surgical ablation procedures was estimated at $3.7 billion in 2015, growing at approximately 18% annually[66]. Regulatory Approvals and Compliance - The company has received CE mark approval for its NAFLD TAEUS application in March 2020 and completed the 510(k) Premarket Notification submission to the FDA in June 2020[25]. - The TAEUS device received CE mark approval for the NAFLD application in March 2020, following the completion of a study with 50 subjects[90]. - The company submitted its FDA application for the NAFLD TAEUS application in June 2020 under Section 510(k) of the FD&C Act, anticipating initial clearance for general imaging claims[92]. - The company plans to seek additional regulatory approvals in China after establishing a presence in the European Union and the United States[89]. - The Medical Device Regulation (MDR) will impose stricter requirements on clinical evidence and pre-market assessments starting in 2021, potentially affecting the company's existing and future products[91]. - The company is required to comply with various international regulations, including obtaining approvals from the FDA and the China Food and Drug Administration before launching new products[184]. - Recertification of products is generally required every five years in most countries outside the United States, which may involve additional testing and compliance evaluations[195]. Intellectual Property and Competition - The company has a patent portfolio consisting of 14 issued patents in the U.S. and 13 issued patents in foreign jurisdictions, with 21 pending applications in the U.S. and 26 pending applications abroad[79]. - The company faces challenges in policing unauthorized use of its intellectual property, which could lead to decreased market share if competitors exploit its technology[170]. - The company relies on a combination of patents, copyrights, and trade secret laws to protect its intellectual property, but challenges to its patents could allow competitors to market similar products[178]. - The company is the only entity developing RF-based thermoacoustic ultrasound products, facing competition from larger corporations in the CT, MRI, and NAFLD diagnosis markets[109]. - The company faces intense competition in the medical imaging market, requiring significant advantages over alternative products to succeed[151]. Financial Risks and Capital Requirements - As of December 31, 2020, the company had an accumulated deficit of $57,338,489, indicating a history of operating losses[114]. - The company requires additional capital to continue as a going concern and to commercialize its planned TAEUS applications[116]. - The company may need to raise funds through equity or debt financings, which could lead to dilution of existing stockholders' ownership[120]. - The company anticipates incurring significant costs related to research and development, marketing, and regulatory approvals for its TAEUS applications[116]. - The company may not remain commercially viable if there is inadequate reimbursement from governmental programs and third-party payors for its planned products[133]. Operational Challenges - The COVID-19 pandemic has adversely impacted the company's clinical trial activities, causing delays in patient visits and regulatory approvals[129]. - The company may face challenges in achieving market acceptance for its TAEUS applications among physicians, patients, and third-party payors[125]. - The company has limited data regarding the efficacy of its TAEUS platform applications, which may hinder successful commercialization if regulatory approved applications do not perform as expected[135]. - The company has limited commercial experience since its incorporation in 2007, making it difficult to predict future results or financial performance[137]. - The company relies on third parties for design, manufacturing, and regulatory approval of TAEUS applications, which poses a risk if these parties fail to meet expectations[143]. Internal Controls and Governance - The company is currently facing material weaknesses in its internal control over financial reporting, which may lead to misstatements in financial statements[219]. - The company has insufficient personnel resources within the accounting function, impacting the segregation of duties over financial transaction processing[219]. - The company’s ability to maintain effective internal controls is complicated and costly, potentially affecting financial reporting accuracy[220]. - The company is exposed to significant risks related to fraud and misconduct by employees and contractors, which could lead to increased compliance costs and potential fines[159]. Market Dynamics and External Factors - Changes in the healthcare industry may reduce market size or necessitate price reductions, adversely impacting financial performance[154]. - The United Kingdom's withdrawal from the European Union (Brexit) may disrupt trade and create legal uncertainties that could adversely affect the company's operations and financial results[164]. - Legislative changes in healthcare, such as the Affordable Care Act, may impact the company's revenues and profitability due to provisions affecting reimbursement and taxation[202]. - The company plans to market TAEUS applications globally, exposing it to various international business risks[156].

ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q3 2020 Earnings Conference Call November 16, 2020 4:30 PM ET Company Participants Kim Golodetz - LHA David Wells - CFO Francois Michelon - Chairman and CEO Renaud Maloberti - Chief Commercial Officer Michael Thornton - Chief Technology Officer Conference Call Participants Brooks O'Neil - Lake Street Capital Ed Woo - Ascendiant Capital Operator Good day, ladies and gentlemen. And welcome to your ENDRA Life Sciences Third Quarter 2020 Earnings Conference Call. All lines ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER 001-37969 ENDRA LIFE SCIENCES INC. (Exact name of registrant as specified in its charter) Delaware 26-0579295 (Registrant's telephone number, including area code) ...

ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q2 2020 Results Earnings Conference Call August 17, 2020 4:30 PM ET Company Participants David Wells - Chief Financial Officer Francois Michelon - Chairman and CEO Renaud Maloberti - Chief Commercial Officer Michael Thornton - Chief Technology Officer Conference Call Participants Brooks O'Neil - Lake Street Capital Vernon Bernardino - H.C. Wainwright Ed Woo - Ascendiant Capital Operator Good day, ladies and gentlemen. And welcome to your ENDRA Life Sciences Second Quar ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER 001-37969 ENDRA LIFE SCIENCES INC. (Exact name of registrant as specified in its charter) | Delaware | 26-0579295 | | --- | --- | | (State of incorporation) | (I.R.S. ...

ENDRA Life Sciences, Inc. (NASDAQ:NDRA) Q1 2020 Results Conference Call May 14, 2020 4:30 PM ET Company Participants Francois Michelon - Chairman and Chief Executive Officer David Wells - Chief Financial Officer Renaud Maloberti - Chief Commercial Officer Conference Call Participants Brooks O'Neil - Lake Street Capital Vernon Bernardino - H.C. Wainwright Ed Woo - Ascendiant Capital Operator Hello everyone and welcome to this ENDRA Life Sciences First Quarter 2020 Earnings Conference Call. During today's pre ...

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER 001-37969 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ENDRA LIFE SCIENCES INC. (Exact name of registrant as specified in its charter) Delaware 26-0579295 (State of incorporation) (I.R.S. Employer Identification ...

ENDRA Life Sciences, Inc. (NASDAQ:NDRA) Q4 2019 Earnings Conference Call March 26, 2020 4:30 PM ET Company Participants Francois Michelon - Chairman and Chief Executive Officer David Wells - Chief Financial Officer Michael Thornton - Chief Technology Officer Renaud Maloberti - Chief Commercial Officer Conference Call Participants Brooks O'Neil - Lake Street Capital Ed Woo - Ascendiant Capital Operator Good day, ladies and gentlemen and welcome to the ENDRA Life Sciences Fourth Quarter 2019 Financial Results ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number: 001-37969 ENDRA Life Sciences Inc. (Exact Name of Registrant as Specified in Its Charter) | Delaware ...

ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q3 2019 Results Earnings Conference Call November 13, 2019 4:30 PM ET Company Participants Francois Michelon - Chairman and Chief Executive Officer David Wells - Chief Financial Officer Michael Thornton - Chief Technology Officer Renaud Maloberti - Chief Commercial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets Kyle Bauser - Dougherty & Company Vernon Bernardino - H.C. Wainwright Ed Woo - Ascendiant Capital Operator Good afternoon. M ...