Corvex, Inc.

Greetings and welcome to the Movano Second Quarter 2023 Earnings Call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Jay Kogan, Chief Financial Officer.

Sir, please go ahead. Thank you, Operator. Good afternoon, everyone, and thank you for joining us today. Our CEO, John Master Totaro, will open today's call with prepared remarks about the progress we've made during the second quarter of 2023 and in recent weeks. Our Chief Marketing Officer, Tyler Bucher, will join us to give an update on the upcoming launch of the EV Ring. Afterward, I'll cover the highlights of our quarterly operating results and provide a perspective on our financial position. Finally, Movano Health's founder and chief technology officer, Michael Liebman, and Stacy Salvi, our vice president of strategy, will join John, Tyler, and me for the Q&A. Movano Health issued a news release earlier this afternoon detailing our second quarter financial results. This news release and today's presentation are available on our website at movanohealth.com. Before we begin, I'd like to remind everyone that we'll make forward-looking statements during today's call based on our current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties and actual results may be materially different from such statements. These risks and uncertainties are detailed in the risk factor section of our filings with the Securities and Exchange Commission, specifically in the company's forms 10-Q and 10-K. 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 reflect changes in expectations with regards to those events, conditions, and circumstances. So with that, I'd like to turn the call over to our CEO, John Mastricitaro.

Welcome, everyone. Thank you for joining us for Movano Health's second quarter earnings call. As you know, preparing for the commercial release of a product as innovative and complex as the EV ring requires a focused roadmap and dedication to delivering a high-quality health solution. At our last earnings call, we announced the planned launch date of September. Over the past few months, we have demonstrated significant progress with the development of our production ring, as well as through fulfilling the requirements of our FDA submission, which I'll speak to in more detail in a minute. We recently validated a new high-performance sensor with increased sensitivity that has materially improved the efficacy of the EV ring. With the new sensor, testing shows we're getting better, more accurate data across a wider group of people, particularly those with smaller fingers or lower perfusion. As a company pursuing medical device clearance, prioritizing data quality from the start is essential. We believe this new sensor could be critical to EV's long-term success. However, it naturally requires more time to test. To that end, we have made a business decision to move out our launch date by an estimated two months. That said, we are still planning to launch ahead of Black Friday, and this extra time will significantly benefit us in several ways. It enables us to expand upon the capabilities of the EV ring for launch, complete a critical round of testing with the new sensor, and better position the ring for significant media and influencer exposure ahead of the holiday season. EV is not just another wearable. It's a medical grade smart ring that meets FDA guidelines and is designed specifically for women. It's our belief that EV has the potential to be a game changing solution that ushers in a new era of women's health with actionable insights and a personalized experience for our users. We want to ensure that we're delivering on that promise from the onset. While we're not the first technology company to experience a delay leading up to a planned launch date, we don't take it lightly. and the team is working tirelessly to prepare for launch in November. We are taking the long view here and believe these actions will help us deliver a health solution that women deserve and respond positively to, while simultaneously bolstering value for our shareholders. Obtaining FDA clearance has always been a top priority for Movano Health. and we're very excited to have successfully submitted our first 510 application to the FDA for the EV rings pulse oximeter. This is a monumental milestone as it makes EV one of the first consumer wearables to seek FDA clearance and demonstrates the company's commitment to meeting the highest standards of safety and accuracy. As we highlighted in a recent press release, The submission has passed the initial screening for completeness and is now under full review by the FDA. We'll be working closely with the FDA throughout their review process. While there is no guarantee the AV ring will receive clearance, we're cautiously optimistic based on the clinical performance achieved by the ring and the quality of our submission. As we've noted on past earnings calls, we are prepared to launch the EV ring as a wellness device if we have not received a decision from the FDA by our planned launch date. We also continue to believe that obtaining FDA clearance could be a catalyst for commercial agreements with healthcare and other enterprises over time. We look forward to keeping you posted on our progress in this area. To that end, we're preparing for our second round of beta programs, Since our first initial set of beta evaluations in the spring, we've made major enhancements to the ring, adding several new features related to our app, sensor configuration, mechanical construct, and firmware. We had significant interest from a wide variety of health and fitness companies to participate in our next beta round and have chosen to work with three partners. a global athletic apparel company, which is interested in our women-specific, as well as a major health insurer and a leading remote patient monitoring company, each of which are keen to leverage the EV Ring's medical-grade capabilities alongside their in-market and future offerings. We expect the next set of beta programs will enable us to perfect our end-to-end solution with a broad audience. and presents us with an opportunity to get more rings on the fingers of more people, which is important to ensure commercial success. Outside of these beta evaluations, we continue to dialogue with numerous potential partners, given the broad interest in continuous, accessible, medical-grade data packaged in a highly attractive form factor and combined with a differentiated app experience. As you'll recall, The EV ring uses a PPG sensor to read heart rate and SpO2 and a skin temperature sensor as well as an accelerometer. This sensor suite enables the tracking of key health and wellness metrics such as sleep stages and duration, resting heart rate, heart rate variability, SpO2, respiration rate, calories burned, skin temperature variability, and steps in active minutes. The companion app enables the logging of period and ovulation, menstrual symptoms, mood, and workouts. All of this data, including the medical-grade heart rate and SpO2 data, are aggregated in the mobile app, which is personalized for the user based on her specific health goals. Evie helps women understand their unique bodies. and how menstrual cycle, mood, and energy levels relate to health with clear insights derived from women's specific research. Daily, weekly, and monthly views of key body metrics also help women identify trends between all aspects of their health. The ring will be available in three beautiful finishes, gold, rose gold, and silver. for $269 with no subscription and free shipping. The water resistant ring is lightweight and has an open design to accommodate any swelling that may occur throughout the day or night. At launch, consumers will be able to purchase the EV ring directly from EVring.com and have it shipped anywhere in the United States with plans for expansion to other territories in the future. It's notable that our app also harnesses the positive advancements offered by artificial intelligence. Utilizing both machine learning and deep learning techniques, we are training the EV app to not only derive more accurate metrics around sleep and activity, but also to suggest original correlations that we can leverage to offer our users a more comprehensive look at their health. Initially, the app will be compatible with iOS devices, and we expect to release an Android version in early 2024. In order to ensure there is excitement and awareness of the EV Ring at launch, the marketing team has been building and executing against the full 360-degree marketing campaign. I'll now let our CMO, Tyler Bucher, update you on how her team is preparing for launch.