ENDRA Life Sciences(US:NDRA)2019-03-12 02:15Financial Data and Key Metrics Changes - Revenue for the year ended December 31, 2018, totaled approximately $6,000, compared to approximately $350,000 for the year ended December 31, 2017, indicating a significant decrease in revenue [43] - Operating expenses increased to $8.9 million for the year ended December 31, 2018, up from $4.8 million for the same period in 2017, primarily due to research and development costs for the TAEUS product line [44] - The net loss for the year ended December 31, 2018, was $9.7 million or $2.16 per basic and diluted share, compared to a net loss of $5.4 million for the year ended December 31, 2017 [46] Business Line Data and Key Metrics Changes - The company secured approval from Health Canada to begin the first in-human feasibility study with the TAEUS reference system, designated as a class two device for the study [9] - The company expanded its intellectual property portfolio to 41 assets by the end of 2018, with six patent applications issued [9] Market Data and Key Metrics Changes - The company aims to address the unmet clinical need for diagnosing non-alcoholic fatty liver disease (NAFLD), which affects over 1 billion people globally [12] - The company has identified a strong market opportunity for TAEUS technology, particularly in the context of the upcoming pharmacological therapies for liver disease expected to be introduced in 2020 [19] Company Strategy and Development Direction - The company's strategy involves introducing new point-of-care technologies, focusing on high-value items such as fundamental research and intellectual property, and partnering with strategic partners to enable an asset-light business model [10][11] - The company plans to leverage its partnership with GE Healthcare to enhance the utility of ultrasound technology for liver disease assessment [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum heading into 2019, highlighting the importance of the upcoming CE mark application and the controlled launch of the TAEUS liver product in Europe [51] - The management noted that the current study at the Robarts Research Institute is on track, with findings expected to be reported at the end of March [30] Other Important Information - The company raised approximately $10 million in additional capital in 2018, which helped clean up its balance sheet and eliminate debt [9][47] - The company has implemented a formal quality management system encompassing key business processes, which is critical for securing ISO 1345 certification [29] Q&A Session Summary Question: Can you talk about internal plans to continue building clinical evidence beyond this initial CE mark application? - Management indicated that the Canadian study is the first of several sites for testing, with plans to achieve approximately 200 subjects scanned to develop a clinical value proposition [54] Question: Can you elaborate on the ability to go back and rescan patients after refining the algorithm? - Management explained that the feasibility study allows for understanding measurement variations and refining the system based on real patient data [58] Question: What is the outlook for regulatory approval in the United States? - Management anticipates filing a 510(k) for a class 2 device in the US mid-year, with a potential approval by the end of the year or early 2020 [67] Question: Are there plans to work with other partners besides GE? - Management confirmed that while they are committed to working with GE, they are open to exploring partnerships with pharmaceutical companies and other entities in the healthcare space [70] Question: What would it take for the test to become the standard of care? - Management emphasized the importance of building clinical evidence and advocacy from key clinical groups to influence guidelines and reimbursement [91]