3/20/2023

speaker
Jay
Director of Investor Relations

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 fourth quarter of 2022 and in recent weeks. Our Chief Marketing Officer, Tyler Bucher, will also 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 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. Before we begin, I would like to remind everyone that we will make forward-looking statements during today's call. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties. 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. With that, I'd like to turn the call over to our CEO, John Mastrett-Tataro.

speaker
John Mastrett-Tataro
Chief Executive Officer

Welcome, everyone. Thank you for joining us from Avano Health's fourth quarter earnings call. We're quickly approaching our second anniversary as a publicly traded company. It's remarkable how far we've come and given our progress, I'm even more excited about our company's future potential. We're creating a new standard for the fast growing health wearables category, driven by our belief that health data should be more accessible, more actionable, and more accurate. We're forging new territory by developing products positioned at the intersection of med tech and consumer devices, a market opportunity we believe is conservatively worth $50 billion in the U.S. alone. We've made significant progress over the last quarter and early part of this year as we prepare for the commercial launch of the EV ring. And I wanted to briefly highlight some of the key milestones you'll be hearing more about in today's call. that give insight into our preparedness and potential demand for the smart ring, including the following. We successfully completed our pivotal hypoxia study, which resulted in the EV ring having accuracy well within the FDA standards. Ahead of the planned summer launch, we announced the EV ring at CES in January, and the media and consumer reception was and continues to be incredibly positive. We commenced our first round of beta programs with four previously announced partners to evaluate the EV ring. And given continued strong interest in our solution, today we announced a second beta program with a new slate of partners, among which are a global athletic apparel company and two additional leading global medical device companies. We also continue to make progress with our proprietary RF technology, which is the engine driving our glucose and blood pressure initiatives. We will be conducting blood pressure and glucose clinical studies imminently using the single chip technology for the first time. What separates our company from the competition is that we're building Movano Health as a medical device company. We're going the extra mile to achieve a level of trust and credibility not offered by other consumer wearables. We have a quality management system run by our quality regulatory and clinical team to ensure appropriate product design and testing processes are followed. We run formal clinical trials as mandated by FDA regulations, and we are using HIPAA compliant systems to maintain data security. We're also employing the services of a multibillion dollar FDA compliant contract manufacturer to assure the quality of the ring as a medical device. And as a medical device company, we are on track to file our first 510K this spring for EV's heart rate and SpO2 data after completing a successful hypoxia fibril trial in Q4 of last year. In comparing the overall accuracy of the ring's data with data from the study's reference devices, EV resulted in an approximate 2% margin of error, well below the FDA consensus standard of 3.5% for SpO2. Additionally, during the study, EV's heart rate monitor had root mean square error of approximately two beats per minute, which is also in line with the FDA's requirements. Now that we have achieved the accuracy benchmarks required by the FDA, we are gathering the documentation needed for the FDA submission, which is no small task. The submission requires hundreds of documents beyond data from our studies. Once the 510 is submitted in the spring timeframe, we expect the process with the FDA to take about three to four months. The timing of the launch may dovetail with the decision from the FDA which will allow us to launch EV as a medical device. If not, we're prepared to launch EV as a wellness device this summer and then leverage the FDA clearance as an opportunity to highlight the higher standard of accuracy our product delivers, which we believe is one of our competitive advantages. Our pursuit of FDA clearances positions us well for both direct-to-consumer and business-to-business opportunities. With end-to-end solutions that give customers a comprehensive look at their health data, our wearables are being designed to address accelerating consumer demand, as well as the unique needs of healthcare and other enterprises, such as medical device, pharmaceutical, payers, and more. For example, one of our Beta 2 partners is a leading global medical technology company that offers respiratory solutions for in-home use. Currently in the U.S., there are over 50 million people with various pulmonary conditions, and the ability to offer a wearable solution that monitors oxygen levels throughout the day and the impact of one's daily activities on his or her oxygen requirements could be a game changer for those affected. Our expectation is that our beta programs will highlight the opportunity for integrated product partnerships with the EV ring. to monitor a variety of specific medical conditions, improve patient outcomes, and act as a driver of innovation and growth. As you know, the EV Ring will be our first commercial product planned for launch this summer and will take us from a pre to a revenue generating company, representing a major inflection point for us. As the first medical grade smart ring designed uniquely for women, We believe EV delivers on a major unmet need, and this was validated by the outstanding reception to the unveiling of the ring at the Consumer Electronics Show in the first week of January. Let me now turn the call over to our Chief Marketing Officer, Kyla Bucher, to update you on our marketing strategy leading up to the EV launch.

speaker
Tyla Bucher
Chief Marketing Officer

Thanks, John. As you mentioned, EV made an impressive debut at the beginning of the year and came away with 11 best of CES awards from premium media publications, including CNN, USA Today, Wired, and Digital Trends. The media coverage really highlighted our focus on women, the open design of the ring, the portability of the charger, and the benefit of a sub $300 price point, particularly with no monthly subscription. We also had many conversations about the timeliness of a device that is made specifically for women. and particularly the misnomer that women are considered a niche market. The Femtech space is set to grow to $48 billion by 2030 in the U.S. alone. And when you consider women make up more than half of the U.S. population and control or influence 85% of the household spending, we see this as both a significant and a timely opportunity. So building up the strong momentum from CES and the corresponding launch of our website, we also recently began paid ad campaigns and are seeing impressive results to date. With a relatively modest investment and in just under 10 weeks, we've driven over 300,000 people to our website and more than 50,000 people have signed up to receive our emails. We also debuted our brand spot, which collectively is nearing 2 million views, and our social channels are reaching an average of almost 100,000 consumers a day through a combination of paid and organic posts with engagement rates that are exceeding platform benchmarks. We're focused on keeping these valuable leads engaged and are continuing to grow our user base with our email strategy, paid in organic social media campaigns, and our monthly newsletter and blog. These leads constitute our early adopters, the foundation of our community, and our most likely brand ambassadors. So we are thrilled to have such a strong number at this early stage. These figures and this level of engagement show both promise and demand for the launch of the female-first wearable. And we see and feel the enthusiasm everywhere we go, in the form of emails, comments on social, and personal interactions. We are hearing firsthand from women that it's about time a device like Eevee entered the market. To that end, as we prepare for our commercial launch, we are building out a phased marketing approach that began with identifying our target segments and is now focused on creating specific content across all our consumer channels with customized messaging for each of these segments. This includes partnering with influencers and creators, implementing an efficient paid media campaign, leveraging strategic PR opportunities, and, of course, establishing ourselves as thought leaders among our growing community of followers. From a sales standpoint, while we will launch as a D2C brand, our competitive price point with no subscription offers us the flexibility to engage with a number of exciting retail partners in the future. The retail landscape continues to evolve and change, and this requires that new brands such as ours find the right retail placement at the right time. As we look to the future and what the retail experience will be for our consumers, we are evaluating a variety of channels to ensure that our customer experience will be best in class. For example, we are thrilled to have announced today that a global athletic apparel company will be part of our second beta program. And with that, I'll now turn it back over to John.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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