Corvex, Inc.

Greetings, and welcome to the Movano Health Q1 2024 earnings call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jay Kogan. Thank you. You may begin.

Thanks, operator. Good afternoon, everyone, and thank you for joining us today. Milano Health CEO, John Master-Tataro, will open today's call with prepared remarks about the progress the company has made during the first quarter of 2024 in recent weeks. I will then provide highlights of the company's quarterly operating results and current financial position. Then we'll open up the call for Q&A. John and I will be joined by our Chief Marketing Officer, Tyler Booker, our Vice President of Business Development, Michael Soule, and Vice President of Product and Strategy, Stacey Salvi. Movano Health issued a news release this afternoon detailing first quarter 2024 financial results. Before we begin, I'd like to remind everyone that the company will make forward-looking statements during today's call based on current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risk and uncertainties, and actual results may be materially different from such statements. These risks and uncertainties are detailed in the risk factors section of Movano Health's filings with the Securities and Exchange Commission, specifically in the company's forms 10Q and 10K. Except as otherwise required by federal securities laws, Movano Health disclaims any obligation to update or make revisions to such forward-looking statements contained herein or elsewhere to reflect changes in expectations with regards to those events, conditions, and circumstances. And with that, I'll turn the call over to CEO John Mastrozzitaro.

Good afternoon, everyone. As you are aware, we reported our Q4 2023 earnings just over a month ago on April 4th. We were very excited to share the news of our recent $24 million private placement, which included a strategic seed investment from a Tier 1 multibillion-dollar medical device company. While we plan to be judicious with our capital spend and methodical in our approach to build out our EV ring direct to consumer and EV med business to business market opportunities, we are committed to establishing a solid foundation for both our B2C and B2B businesses so we can successfully serve all our customers. As such, our priorities are threefold. One, to prepare to take D2C orders again for the EV ring, two, to secure FDA 510 clearance for its pulse oximeter feature under the EV Med brand, and three, to refine our wrist-worn prototype with the millimeter wave RF system on a chip in preparation for additional blood pressure and glucose studies. As to the first priority, We are laser focused on preparing to take orders again for the EV ring, which requires that we deliver an excellent product experience, ensure a seamless delivery timeline for all orders, and provide an improved customer service response to any issue. From a product standpoint, we are diligently working to improve the customer experience across both hardware and software. We are developing more robust hardware with improved chemical, environmental, and physical resistance. In software, we are improving our heart rate and motion and sleep algorithms implementing a more comprehensive AI-driven suite of insights and are initiating the process to develop an Android version of the app. On the production side, we are enhancing our automation, tooling, and assembly and test processes to increase yield and throughput as we prepare for relaunch. We are also in conversations with our key production partner to implement a turnkey solution which would further increase our efficiencies. We have bolstered our customer service capacity and have implemented an AI-powered customer response chatbot on our site as well as onboarded a new head of customer service with over 25 years experience in the D2C space. All these efforts will ensure an enhanced customer experience whether users reach us through D2C or B2B channels. Regarding our second priority, we are working closely with the FDA in anticipation of a 510 clearance on the medical device version of the ring which we will launch under the brand name ED Med. We announced last week that we successfully submitted exemplary clinical trial results from a Q1 hypoxia trial to the FDA on April 22nd, 2024, which is a significant milestone for our organization. During the trial, each subject wore four ED Med rings, two on fingers and two held on fingertips. When evaluating accuracy versus arterial blood gas levels, the four EV Med rings achieved a root mean square error of 2.46%, well within the FDA guidance of 3.5%. In addition, our rings accurately exceeded that of the two commercially available hospital-grade reference pulse oxides, one of which failed to meet the FDA standard for accuracy. We continue to expect an FDA decision regarding our 510 in July 2024. In preparation for a positive FDA decision, we remain bullish on the enterprise opportunities that we believe a clearance will unlock for our organization. And as we get closer to securing this distinction, we are already engaged with our strategic partners in the pharmaceutical, medical device, and payer channels. These partners have all expressed the immediate challenge they face in obtaining continuous and secure medical-grade data and see our solution as an integral part of their future initiatives. We see opportunistic applications in chronic management of cardiovascular, metabolic, obesity, and pulmonary patients, which in aggregate we've identified as a $20 billion per year market opportunity. And finally, we continue to focus on the breakthrough technology of our ultra-compact and efficient health monitoring system on a chip, which measures just four by 6.7 millimeters and has yielded breakthrough advances in blood pressure monitoring, enabling accurate, helpless, and automated tracking. As you'll recall, we previously announced the results of a blood pressure clinical study in October 2023, where our prototype achieved an overall mean absolute difference, or MAD, of 5.9 millimeters of mercury below the 7 millimeter mercury MAD required for an FDA-recognized standard for wearable, cuffless blood pressure measuring devices. We have been making enhancements to this prototype we evaluated in that study, and we expect that our next blood pressure study will take place this June and will be the first study we've done with an arterial line, which is the precursor to an FDA pivotal study. Unlike a cuff, which provides only one blood pressure value, and arterial line will provide continuous data on a number of patients. In addition, we are also evaluating AI-based individual calibration methods to further enhance future performance of our platform. Ultimately, we expect blood pressure monitoring will be a significant addition to the suite of analytes currently offered in EV as over half the adults in the US over age 20 are prehypertensive or have hypertension. Continuous monitoring of blood pressure holds the promise of dramatically enhancing the management of these conditions. With that, I'll now hand the call over to Jay for the financial review.