Corvex, Inc.

Greetings, and welcome to Movano's first quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press the number zero on your telephone keypad. As a reminder, this conference is being recorded. Now, my pleasure to introduce your host, Jay Kogan, Chief Financial Officer. Thank you. You may begin.

Thank you, Operator. Good morning, everyone, and thank you for joining us today. Our CEO, John Mastricitaro, will open today's call with prepared remarks about the progress we've made during the first 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 Stacey Salvi, our Vice President of Strategy, will join John, Tyler, and me for the Q&A session. Movano Health issued a news release earlier this afternoon detailing our first quarter financial results. This news release and today's presentation are available on our website at movanohealth.com. Before we begin, I would like to remind everyone that we will 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 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. Now, I'd like to turn the call over to our CEO, John Mastratitaro.

Welcome, everyone. Thank you for joining us for Mabano Health's first quarter earnings call. It's been 18 months since we made the strategic decision to commercialize a smart ring designed for women. To go from ideation to a well-designed wearable solution, at such a rapid pace has been no small feat, especially when considering all the macro forces at play. We're in the final stages of development before the commercial launch, and today we're excited to announce publicly for the first time that we plan to make the EV Ring available for purchase in September of this year for $269 with no subscription. We carefully considered the right time for a commercial launch, balancing product quality, speed to market, and seasonality. We believe a September launch will set us up for success for several reasons. First and foremost, there's no better time to be launching a health device for women. The global wearable health industry is exploding and projected to be worth $145 billion by 2027. This demand is driven by consumers' heightened awareness and desire to build healthier habits following the pandemic. This, in combination with the rise of femtech and a focus on women's health initiatives, has created a massive opportunity for a women-first wearable. From a seasonal standpoint, we believe a September launch is the perfect time to capture an engaged audience. Consumers are transitioning away from a vacation mindset and are settling back into their day-to-day routines. The back-to-school timeframe often comes with a desire to get organized and start fresh habits. In addition, people are starting to plan for holidays and gifting season, which will be just around the corner from our launch and a great opportunity for sales. By September, we will have also completed two beta programs with multiple strategic partners, enabling hundreds of consumers to test our solution. With usability data and enhancements to the product driven by feedback from potential customers, We believe our initial product will be primed for our target audience. The timing of the launch may or may not be in sync with an FDA clearance, which is consistent with our previous commentary. We announced today that we plan to file our first 510 in June for heart rate and blood oxygen. And whether or not we have a decision from the FDA in September, we are prepared to launch EV as a wellness device and then transition to a medical device when the time comes. I'll talk more about where we are with the FDA filing in just a moment. All in all, we remain very bullish on the market potential for EV and believe our strategy should position the company for a successful launch and beyond. Our CMO, Tyler Bucher, will join us later on to provide more details around our launch plans. In the meantime, I want to provide an update on a variety of important company initiatives. As it relates to the FDA submission in June, over the past two years, we've worked to ensure there is an established pathway through the regulatory approval process, but bringing a medical device to the market can be very challenging. One of the most critical aspects of the FDA submission is clinical performance. We previously presented the results of our hypoxia study where the EV ring demonstrated exceptional performance for both SpO2 and heart rate. Recently, we completed a more comprehensive heart rate evaluation on the bench for FDA guidelines to evaluate the system in measuring heart rates from 40 to 240 beats per minute. The results demonstrated excellent accuracy with errors of less than one beat per minute. Not only does the FDA submission require detailed reports on the performance of the device, but we also need to prepare thousands of pages of documentation regarding the design, safety, reliability, software, biocompatibility, labeling, and more, with many verification reports generated by external certified test laboratories. And before the submission, we must ensure the organization is structured as a medical device company. This requires a quality management team and system to assess the risk of every vendor and component we use, an FDA compliant contract manufacturer, and design control and risk management features, among other things. Fortunately, we're nearing completion of all the required documentation and plan to make the formal submission by the end of June. This first submission will set the stage for future FDA clearances on EV and our future wearables. The effort associated with becoming a medical device company presents significant opportunities with healthcare and other enterprises, and we believe it's a highly competitive differentiator as well as an underappreciated asset when compared to existing wellness solutions. In fact, it's been an influential factor in attracting partners to our beta programs. Since we last updated you in mid-March, we've completed our first round of beta programs with four partners, including Novant Health, Stanford University, a major global pharmaceutical company, and a leading patient-focused medical device company. These programs have proven to be a critical exercise in readying the EV ring for commercialization. Throughout the five to six-week programs, beta participants were given a ring and access to a beta version of our app. Each week, participants were asked to complete a series of activities and then answer questions related to their experience with the Ring. As a result, we gained a greater understanding about how and when people interact with and wear the Ring, and we are now armed with real usability data that showcased our strengths and presented us with opportunities to fine-tune the EV Ring and app experience. We're looking forward to incorporating our learnings into the next set of beta programs, which are set to commence in early July. During this round of betas, we'll be testing our technology with a global athletic apparel company and two additional leading global medical device companies. And as we've highlighted in prior calls, there are many more enterprises across healthcare, consumer, and tech that we're in discussions with, given the high interest in a solution like EV, which combines the best of consumer wearables with the quality of an FDA cleared device. During our last earnings call in March, we also shared that we were getting our single chip solution ready for its first blood pressure clinical trial, which has now effectively been completed. Over the course of three weeks ending tomorrow, we will have brought in over 50 volunteers from our local community to the Movano Health Clinical Lab to participate in an IRB-approved clinical study. Each participant wore a Movano Health wrist-worn wearable as well as a hospital-grade blood pressure system to compare the measurements. We've been very encouraged by the quality of the data signals that have been collected in the study with our single-chip solution, and we will continue to analyze the results over the next few weeks. We remain optimistic that our single-chip solution positions us to make further progress on algorithm development given the smaller size of the prototype. We plan to use the same single-chip prototype in a glucose clinical trial in the June-July timeframe. We continue to file patents to protect and validate our innovative approach to RF-enabled glucose and blood pressure monitoring. During the first quarter of this year, we were issued six new US patents including multiple foundational patents, extending our IT portfolio to 21 patents issued in the U.S., one patent issued in China, and 37 patents pending. Now I'd like to turn it over to our CMO, Tyler Bucher, for an update on our launch plans for the EV ring.