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| Statement |
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| Portfolio with 70 issued patents and no in-licensing dependencies is a remarkable achievement for a company of our size and a testament to the innovation of ENDRA and the proprietary nature of our technology |
| The good news is that the new GLP-1 obesity drugs have demonstrated clinically significant reductions in liver fat and a rich pipeline of targeted therapies to treat SLD in both obese and nonobese patients is approaching commercialization with the first drug approval is expected in early 2024 |
| The de novo submission was a significant milestone for ENDRA as this regulatory pathway should strengthen our competitive position with distinctive patent-protected capabilities as a noninvasive point-of-care tool to aid in the characterization of liver fat |
| Since our FDA submission, we've had our second positive clinical data set reviewed and accepted for presentation by the European Association for the Study of the Liver |
| ENDRA's near-term focus is on the following four value-added catalysts: number one, securing the first commercial orders for our TAEUS technology in Europe, where we have the CE mark |
| In closing, we remain very excited about the value proposition for TAEUS as a noninvasive, cost-effective tool to assess liver fat especially as the clinical community prepares for the near-term arrival of the first treatments targeting the disease, which affects 2 billion people worldwide |
| I'm delighted by the momentum that's building for our Thermo Acoustic Enhanced Ultrasound liver system known as TAEUS |
| The most recent abstract includes 45 subjects comparing ENDRA's TAEUS liver measurements to MRI, and we're very pleased with the results |
| We're excited by the performance of the system and our aim is to continue to expand the collection of clinical data and to publish results from our clinical collaborations |
| This momentum checks a number of boxes, including clinical, regulatory and commercial along with the convergence of a number of factors that put ENDRA in the right place at the right time |
| We continue to bolster our portfolio and recently achieved a great new milestone of 70 issued patents with three additional patents issued during the third quarter and three more patents issued in Q4 thus far |
| We're very pleased to have submitted a de novo request to the FDA for our TAEUS system in August and to report that our file has advanced the substantive review stage |
| And congratulations, good job |
| Second, supporting the FDA through their review process with the goal of achieving a favorable de novo decision for ENDRA |
| And I wish you guys good luck |
| These newly issued patents protect and further differentiate ENDRA's thermal acoustic systems in areas of high unmet clinical need, such as the early detection of steatotic liver disease |
| Overall, the discussion with clinicians and the focus on issues directly addressed by TAEUS during the panel discussion, demonstrates not only a clear market need for our system but also an awareness and urgency from practitioners, which we are hopeful will soon translate into our first sales |
| market upon FDA approval, along with our Vietnam distribution agreement that is tied to the FDA approval; and fourth, continuing to grow and diversify our base of clinical evidence at clinical study partner sites in our target markets in Europe and the U.S |
| The Company is also actively exploring licensing opportunities in non-core indications with outside partners to augment the value of our growing intellectual property portfolio |
| Steatotic liver disease resonates with each of these specialties and there's a growing interest in the primary care arena as well |
| Our system generated a great deal of interest from both health care providers and industry attendees |
| As Francois mentioned, we recently participated in the American Association for the Study of Liver Disease Annual Meeting in Boston, where we showcased the TAEUS system and highlighted its capabilities |
| We look forward to keeping you informed of our accomplishments and to speaking with you again when we report our fourth quarter and full year financial results, and I wish you all a good evening |
| We believe our current capital position provides a runway into the first quarter of 2024 and we are currently evaluating alternatives to raise capital to provide for our future funding needs |
| They have a mix of public and private structures, but there's plenty of opportunity for ENDRA there |
| Edward Woo Congratulations on the progress |
| But we have to be as focused and effective and cost-effective as possible as well |
| The clinical data is the most critical element for getting commercial traction with clinical customers |
| Edward Woo Yes, that sounds good |
| And I would say, as we get closer to an FDA decision, we would replicate some of that approach and certainly leverage anything we've learned in Europe in terms of clinical and economic value propositions that support the product |
| Statement |
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| The negative predictive value, which is the probability that a negative test result is correct, was 95% |
| Net loss in the third quarter of 2023 was $3.1 million or $0.40 per share and this compares with a net loss of $3.4 million or $1.09 per share in the third quarter of 2022 |
| We maintain our asset-light operating model with pretty high risk in our operations and commercial team in anticipation of future growth |
| Our sales and marketing expenses decreased by approximately $177,000 mainly due to the departure of our Chief Commercial Officer |
| In other words, conventional tools for the assessment of steatotic liver disease are not capable of accurately assessing the wide range of possible patient body size and medical conditions which creates an urgent market need for a device like TAEUS |
| Conventional quantitative ultrasoft methods are not able to accurately estimate the liver fat fraction in individuals with high body mass index and often overestimate liver fat fraction in subjects with confirmed liver fibrosis |
| For the quarter ended September 30, 2023, our operating expenses decreased to $3.1 million from $3.4 million for the same period in 2022 |
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