Corvex, Inc.

Ladies and gentlemen, greetings and welcome to the Moana Health third quarter earnings conference 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 zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jay Kogan, Please go ahead, sir.

Thanks, operator. Good afternoon, everyone, and thank you for joining us today. Movano Health CEO John Master-Tataro will open today's call with prepared remarks about the progress the company made during the third quarter of 2024 and in recent weeks. Our CMO, Tyler Buecher, will provide some remarks on the company's D2C plans, followed again by John. And then I will provide highlights of the company's quarterly operating results and current financial position. Then we will open the call for a Q&A. John, Jay, and Tyler will be joined by our chief technology officer and founder, Michael Liebman, as well as our chief commercial officer, Michael Saul. Movano Health issued a news release this afternoon detailing third 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. 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 factors section of Movano Health's 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 to reflect changes in expectations with regards to those events, conditions, and circumstances. And with that, I'll turn the call over to our CEO, John Mastrititaro.

Good afternoon, everyone. Since we last reported earnings in August, we have continued to make progress on our key business initiatives as follows. First, is the ongoing successful sale and fulfillment of EV rings following our back in stock announcement on September 17th. Second, we're continuing to work closely with the FDA in anticipation of a 510 clearance for the EV Med ring. Third, We're preparing to deliver our first B2B commercial opportunities with healthcare partners shortly after gaining an FDA clearance. And lastly, we're analyzing the results of our recent blood pressure clinical trial utilizing our updated wearable device, which incorporates our proprietary radiofrequency solution. As mentioned previously, we continue to be judicious with our capital spending and methodical in our approach to building out our business strategies. And as we prepare for the opportunities that will emerge with a 510 clearance, I want to take a minute to reflect on what I see as a watershed moment at this critical intersection of wellness and medical devices. The wearables industry is growing rapidly and smart rings are quickly becoming the it form factor in the sector with almost 10 new players entering the market in the last 24 months, all making various claims about features, accuracy, and compatibility. Whereas major tech companies are selling more than 100 million wellness devices globally each year, we estimate there will be approximately 1 million smart rings sold in 2024, just 1 million. The leading smart ring competitor recently announced that it is on track to generate about $500 million in revenue in 2024. In our view, smart rings are a particularly attractive form factor compared to other wearables on the market as they can help improve engagement, especially at night while the user is sleeping where the collection of longitudinal baseline data is a big positive for both consumers and our B2B partners. Additionally, Our award-winning open ring design, which can flex to accommodate any swelling, also sets us apart from the competition in a very distinct way and caters effectively to both the D2C and B2B consumer. Movano Health has made significant strides over the last several months with our first commercial device, the EV ring, and we look forward to many more enhancements in the coming months, as well as future generations of EVs. With an upcoming launch of EB Med and the ongoing distribution of the EB Wellness Ring, Movano Health will be the only player in the space with a ring that effectively serves both B2C and B2B markets, built on the reliable foundation of a medical device company and providing a highly differentiated proposition for major healthcare partners across global pharma, med device, remote patient monitoring, and insurers, given our medical device routes, processes, and infrastructure. In our view, it would take years and many millions of dollars in investment for competitors to potentially transition from a wellness to medical device, which positions Movano Health as a very valuable asset in this emerging sector. And the progress we have made to date in blood pressure detection opens the door for yet a third device under the Movano Health umbrella, a cuffless blood pressure detection band. We have now completed our seventh cupless blood pressure clinical trial with our proprietary and highly patented RF technology, as well as several glucose studies. For the past six and a half years, we have steadily invested in our RF chip, wrist-worn prototypes, clinical evaluations, and algorithm development, and continue to work towards addressing these significant opportunities. The vast majority of our R&D investment dollars have been spent here. helping to improve the risk profile of our RF technology and related commercial opportunities going forward. As I mentioned earlier, we're in the final stages of the FDA 510K review process for the EV Med Ring. You'll recall the EV Med Ring is designed to not only provide medical device functionality with its pulse oximetry feature, but also offer numerous wellness metrics related to sleep, activity, and logging of mood, energy, and health symptoms. This is a unique combination of features and required some clarification with the FDA, which we resolved this past summer. We then received additional questions from the agency in September related to the medical aspects of EV Med, which we responded to the week of October 28th. Now, in the last stage of the process, we are standing by to answer any additional inquiries the agency may have. In anticipation of an expected 510K clearance, we have reengaged with a number of potential partners across the full spectrum of healthcare use cases, including condition management, remote patient monitoring, clinical trials, and corporate wellness. We are in active discussions with a major global pharmaceutical company looking to leverage EDMed in building unique solutions for both clinical and consumer applications. We have also entered into discussions with a clinical research organization or CRO that is looking to add our ring into their offering for large pharmaceutical companies and research organizations. Additionally, we have entered into the agreement phase with a large healthcare company who's preparing a pilot in Q1 of 2025 using the ED Med Ring as part of an overall metabolic solution to address chronic disease. All three of these strategic partners, as well as the others in our funnel, see EV Med as a game-changing solution with a number of potential applications. And finally, as we continue to deliver on our commitment to providing the most accurate data to all of our consumers, we are planning two third-party studies around sleep and menstrual cycle tracking in the coming months. I will now turn it over to our CMO, Tyler Bucher, to provide an update on our D2C plans for the EV rank.