NASDAQ:MOVE Movano Q2 2023 Earnings Report $0.69 -0.10 (-12.66%) As of 04:00 PM Eastern ProfileEarnings HistoryForecast Movano EPS ResultsActual EPS-$2.55Consensus EPS N/ABeat/MissN/AOne Year Ago EPSN/AMovano Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AMovano Announcement DetailsQuarterQ2 2023Date8/14/2023TimeN/AConference Call DateMonday, August 14, 2023Conference Call Time5:00PM ETUpcoming EarningsMovano's Q1 2025 earnings is scheduled for Tuesday, August 12, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Movano Q2 2023 Earnings Call TranscriptProvided by QuartrAugust 14, 2023 ShareLink copied to clipboard.There are 5 speakers on the call. Operator00:00:00And welcome to the Movano Second 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. 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. Operator00:00:25Sir, please go ahead. Speaker 100:00:27Thank you, operator. Good afternoon, everyone, and thank you for joining us today. Our CEO, John Mastertitarra, will open today's call with prepared remarks about the progress we've made during the Q2 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 EviRing. Afterward, I'll cover the highlights of our quarterly operating results and provide a perspective on our financial position. Speaker 100:00:54Finally, Movano Health's Founder and Chief Technology Officer, Michael Liebmann and Stacy Salvi, our Vice President of Strategy will join John, Tyla and me for the Q and A. Movano Health issued a news release earlier this afternoon detailing our Q2 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 and A session, these forward looking statements are subject to inherent risks and uncertainties, and actual results may be materially different from such statements. Speaker 100:01:32These risks and uncertainties are detailed in the Risk Factors section of our filings with the Securities and Exchange Commission, specifically in the company's Forms 10Q and 10 ks. 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. So with that, I'd like to turn the call over to our CEO, John Masters Sitaro. Speaker 200:02:05Welcome, everyone. Thank you for joining us for Movado Health's 2nd 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. Speaker 200:02:45We 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. Speaker 200:03:25To that end, we have made a business decision to move out our launch date by an estimated 2 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. Evie is not just another wearable. It's a medical grade smart ring that meets FDA guidelines and is designed specifically for women. Speaker 200:04:10It's our belief that Evee 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 1st 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 range pulse oximeter. Speaker 200:05:09This 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 AB 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 the decision from the FDA by our planned launch date. Speaker 200:06:04We 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 2nd 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 constructs 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 3 partners, a global athletic apparel company, which is interested in our women's specific as well as a major health insurer and a leading remote patient monitoring company, each of which are keen to leverage the EB Ring's medical grade capabilities alongside their end market and future offerings. Speaker 200:07:09We expect the next set of data programs will enable us to perfect our end to end solution with a broad audience and presents us with 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 the skin temperature sensor as well as an accelerometer. This sensor suite enables the tracking of key health and wellness metrics such as sleep in 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. Speaker 200:08:36Evie helps women understand the unique bodies and how menstrual cycle, mood and energy levels relate to health with clear insights derived from women 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 3 beautiful finishes, gold, rose gold and silver for $2.69 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 evring directly from evring.com and have it shipped anywhere in the United States with plans for expansion to other territories in the future. Speaker 200:09:32It'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 three sixty degree marketing campaign. I'll now let our CMO, Tyler Bucher update you on how her team is preparing for launch. Speaker 300:10:28Thanks, John. Momentum for the Evring continues to build at a steady pace and we've been amping up our communications across social, content and email over the last 2 months. Since CES, we've had over 600,000 visitors to evring.com with more than 100,000 people signed up to receive updates about our release. Our engagement on social and email has been well beyond our internal expectations and we've continuously seen positive responses to close that highlight our unique benefits and product features. Next up will be the launch of our paid brand campaign, which brings ZV to life in a whole new way and really showcases the game changing solution for women that we're bringing to market. Speaker 300:11:04In addition to our paid and social efforts, we will shortly begin to see easy samples of influencers, celebrities and the media. The revised release date offers us the opportunity to place rings into the hands of individuals with enough time to complete thorough device evaluation and draft comprehensive reviews, which are critical to cultivating consumer trust and influencing buying decisions. The level of interest we have from press and consumers positions us well as a potential must have gift for the holiday season, as well as a choice for the New Year when people often turn their attention to new healthy habits. We'll also be showcasing EV at CES in January, where we will be exhibiting on the floor and sharing a sneak peek of new features we plan to release following launch. We're building a brand new commercial website to support our D2C plans that will allow users to purchase a ring directly from us and receive a Free Sizer kit to help find the perfect fit. Speaker 300:11:52The entire site is set up to provide an educational immersive and frictionless customer experience from consideration to the moment of purchase. We've also established a best in class customer service team to manage all aspects of customer care and create a positive first impression for the brand. We're also very excited to share that we've recently announced the establishment of our Medical Advisory Board, a group of subject matter experts and trusted advisors for our team. This women led board will help establish EV as a highly credible health and wellness resource and we plan to leverage their medical and scientific expertise to enhance EV's product roadmap and provide trusted content. I'd like to give you a brief overview of our esteemed inaugural members. Speaker 300:12:31Doctor. Mary Clare Haber is a Board certified OBGYN, who has helped thousands of women going through perimenopause and menopause actualize their health and wellness goals by creating an online program, the Galveston Diet. With the goal of empowering and educating women, her work focuses on the science of menopause, aging and inflammation. Doctor. Andrea Masamora is a sleep medicine specialist at the Oregon Clinic, who has helped thousands of people improve their sleep habits. Speaker 300:12:57Her current work is focused specifically on helping women improve their sleep and the recognition of how their patterns are different from men. Doctor. Ruth White is renowned for her work in stress management and diversity, equity and inclusion and has written for Modern Healthcare, Harvard Business Review and Fast Company. She is the author of several books, including The Stress Management Workbook, De stress in 10 Minutes or Less. And finally, we're preparing to launch our first white paper, titled Women and Biometrics: Harnessing the Potential of Gender Specific Health and Wellness Data written by Doctor. Speaker 300:13:28Kristin Harlstotter with a focus on the impact of gender differences on health and wellness across sleep, heart health, activity and mental health. This detailed paper is a significant deep dive into these noted disparities and draws conclusions that we hope women will find helpful and informative. We'll be modifying the paper into blog and social posts so that this information will be accessible across multiple channels and drive traffic to our website and social media pages. The team is confident that our marketing efforts combined with the product's innovative features and pursuit of FDA clearance are setting Movano Health up for a successful and impactful launch of the EZ Ring. With that, I'd like to turn it back to John. Speaker 200:14:07Thank you, Tyla. To support all the activities we've just laid out, our operations team has been building the foundation of our supply chain and order fulfillment capabilities. With a well prepared supply chain and FDA compliant contract manufacturing sites, the team is prepping to handle increased demand and ensure a seamless production process. We're also finalizing manufacturing process and equipment automation, hard tooling and packaging as well as software integrations for order fulfillment and logistics. In addition to our commercial launch, we continue to move forward with testing our proprietary single chip radio frequency solution, which is the backbone of our coupless blood pressure and non invasive glucose initiatives. Speaker 200:14:56In May, we completed a 3 week IRB approved clinical study on 51 volunteers in the Movano Health clinical lab to evaluate the efficacy of our single chip prototype in estimating blood pressure. As you may recall, this was the very first time we've used our single chip solution in a clinical study. We analyzed the data and saw good signals. We learned a lot from this initial study and have made modifications to improve the prototype and measurement algorithms and plan to execute a follow-up blood pressure study on an additional 50 people in the coming weeks. We've also been conducting extensive testing to evaluate glucose data. Speaker 200:15:42As a result, we're optimizing antennas and the circuit board layout to improve signal sensitivity. Once complete, we'll leverage the modified platform in an upcoming glucose clinical trial. After almost 2 years of extensive research and development, we're looking forward to bringing the EV ring to market. The timing for such a product couldn't be better with increased interest in medical grade technologies for home use and a strong focus on women's health and empowerment. We believe we've designed an exceptional product and are excited to deliver it to our customers who are highly engaged and looking for a solution that aids them in their health journey. Speaker 200:16:28With that, I'll turn it back to Jay to go over the financials. Speaker 100:16:32Thanks, John. We detailed the financial results in today's Q2 earnings release, which you can find on our website, but I'll share a few key line items. Movano Health reported an operating loss of $7,400,000 the Q2 of 2023 and that compares to an operating loss of $6,800,000 in the year ago period. The increase was primarily related to the accelerated commercialization initiatives described earlier in the call. Our cash burn in the period was $7,900,000 a bit higher than the run rate for the prior 6 quarters given certain pre launch and FDA submission costs and other timing considerations. Speaker 100:17:09With regards to capital, we raised $9,200,000 in gross proceeds or $8,100,000 net through an underwritten public offering of shares of Movano Health common stock in the period. At the end of the Q2 of 2023, we had $14,500,000 of cash and cash equivalents and total assets of $17,600,000 As that concludes our formal remarks, we'd be glad to take your questions. Operator, we're ready to begin the Q and A section of the call. Operator00:17:40Thank Speaker 100:18:06And I think also operator, remind the participants that we can ask questions in the webcast link as well. Operator00:18:14Yes. You may ask also ask questions on the webcast link. Speaker 100:18:20Right. It looks like we've got several there. Just for those that are on the webcast, just as a reminder, you can click on the question mark icon and hit the send button after you've typed in your question and we'll do our best to address them all. So let me start with the webcast questions. I'll just ask them and a few of us on the call here will be happy to answer them. Speaker 100:18:41John, maybe the first one will be for you, just in terms of can you talk more about why you've delayed the launch date? Speaker 200:18:50Sure, Jay. Well, first off, I want to say that as a medical device company, the quality and accuracy of the data that we're providing is essential. And we had an opportunity to enhance our products by incorporating this new component that we spoke of into the ring. This new component is more accurate and addresses perfusion issues that could be within our target market. Essentially what the new component does is it has the ability to collect more of the signal that is being reflected from the finger. Speaker 200:19:24So with a female focused product and with the size of the ring going down to size 5 where you may have much smaller fingers, lower perfusion, less blood smaller blood vessels and therefore have less signal using this larger footprint component allows us to collect more of the data from the finger. And we've already started testing this. We have seen that it is able to get more of the signal than what we were able to do before. And so it increases our ability to provide more accurate data because we have a better signal that we're collecting. We're still using the same LEDs that we had before in terms of their wavelengths of light and whatnot, but this sensor allows us to basically collect more of the data that's emanating from the finger. Speaker 200:20:24So having this delay to put this part into the ring is something that we think is going to really pay off for us. And obviously, the delay gives us some more time to get in front of the media, influencers and others to really run it through the paces before we get to launch. At the end of the day, we want to be able to deliver a product that we can be really proud of and stand behind. And we believe that pushing back the launch date by a couple of months gives us time to assure just that. The other thing that I'll lastly mention is that by pushing it out for a couple of months, we can also make sure that we're set up with production and manufacturing and being able to build up a bit more inventory initially so that we can meet the demand that comes into the market. Speaker 100:21:14Okay. Jonathan, this next question is for you as well. What gives you confidence in your ability to meet the new launch date? Speaker 200:21:24It's a great question. Several things. First off, you should know that in order to submit to the FDA for the ring, we had to have produced the fully baked products. We had to have all of the testing done, environmental testing, biocompatibility testing, electrical testing, even cloud platform, cybersecurity testing, all done as part of the development process. And so all of that has already been in place. Speaker 200:21:53All of the testing is complete. All of that documentation is in with the agency. So that's one important note is that we really are at a point where we've done a lot of the heavy lifting to this product. The other thing that you should know is that we've been continuing to push forward with marketing, production readiness, as we mentioned on the call, customer service, etcetera. And so we feel pretty confident because we have been testing this new component. Speaker 200:22:20We've seen how it performs. We already we know that we're getting more signal collected from it. And so we feel really good about the fact that this isn't going to somehow not work at the end of the day because we've tested it so thoroughly. And basically the majority of the system is the same as what it was before. And I'll stop there. Speaker 100:22:45Okay. Tyler, I think this next question is for you. Any concern about your ability to capitalize on holiday traffic with the launch ahead of Black Friday? Speaker 300:22:56Also a great question. And so, no, I mean, while the team is focused on ensuring that we maximize holiday timing in order to drive our sales, we really believe that our overall launch extends far beyond just the Q4. And I think it's important to state that the macro just the Q4. And I think it's important to state that the macro awareness around women and their health that we're seeing in the media and in business and in pop culture is a really clear signal that the time is now for a product like Evie Ring. So our launch date is really just the first step in a much bigger plan to serve our growing community of consumers for the long term. Speaker 300:23:28But feeling very confident that the momentum that we've generated so far will translate into purchase both during the holiday season and beyond. Speaker 400:23:37So yes. Speaker 100:23:39Okay. I'll take the next question regarding cash burn. Why does your cash burn increase in the quarter? Does the later launch affected? And what will the burn rate be after launch? Speaker 100:23:52So our cash burn has averaged about $6,500,000 per quarter for the last several quarters as we've been gearing up for launch. Not too surprisingly as you approach the launch date, there's some additional resources that you need to invest behind. For us, it includes raw materials, tooling, some FDA and product testing and also some marketing dollars that we've begun to put to work. We continue to be focused on being good stewards of our capital. You can count on us to continue to have that focus on a go forward basis. Speaker 100:24:26We view a launch prior to Black Friday as relatively immaterial to our cash burn. As any push out 8, 10 weeks or so of gross profits, we think will be offset by lower marketing spend and other launch related costs going into the events. So it's kind of a wash, something that we would rather be launching in September, but we are of the view that is relatively immaterial on an overall cash burn basis. There's also one more question that relates to cash, which I'll address here as well, which is we have enough cash to operate and execute your plan without going out to the capital markets and all that. I'd just basically say that as a reminder, we've raised $102,000,000 since inception in 2018. Speaker 100:25:17We had $14,500,000 on the balance sheet as of June 30. Our investors have been incredibly supportive over the years, including a couple of offerings that we did year to date in 2023, both in the Q1 and the Q2. And then also we've raised about $5,000,000 in net proceeds on the ATM over the past year as well. We've highlighted in our financial filings that we will need to raise additional capital over time. But we've also been seeing increased interest as we hit key milestones. Speaker 100:25:51For example, our FDA submission as well as getting closer and closer to the launch of our HeatView ring. Okay. Next question. Sean, this is for you. Can you give us some more insight to the FDA process? Speaker 100:26:10What are the next milestones? When do you expect to hear back from FDA? Speaker 200:26:15Yes, happy to Jay. Thank you for the question. And I see there's a couple of others very closely related to this. So I'll handle it all at once I hope. Operator00:26:25First, let Speaker 200:26:25me explain the process with the FDA for 510. Step 1 is actually making the filing. And the first thing that would happen after that is that the FDA acknowledged that they've received the filing. The next step is when they assess the entire package for completeness, They verify that all the sections that are required in a filing are there and that we have provided everything that they expect to see in that part of the filing. We've gone through that process as well. Speaker 200:26:56That's at least a 15 day review of the entire filing that we put in. And when we recently announced that we had done the 510, it was we waited until after that step or that milestone was beyond us. And so now the 510 is in the formal review. And the agency typically comes back with detailed questions after doing the detailed review at 60 days post filing date. And the filing date is the date when they gave the 15 day review and said, yes, you're past that, it's 15 days prior to that date. Speaker 200:27:39So basically, we are in the middle of the detailed review from the agency or probably the first part of the review with the agency and at 60 days, we'll get some feedback. Once we get the feedback with questions and typically in all the 510s that I've been affiliated with and filed, there's sure that we've got everything and provided them everything that they want to see. At the very end, there's final labeling materials that are reviewed assuming that they are going to clear it. There's no guarantees that they will clear it. But that's the basic process. Speaker 200:28:22And that's why on average, it's 3 to 6 months to get through this entire process assuming that you get cleared. So we feel pretty good about the completeness of our filing. We feel very good about the clinical data that we've collected to date. And so we're cautiously optimistic that things will go forward. But again, there are no guarantees that they will clear it. Speaker 200:28:45And I hope that that addresses all those questions fairly well. There was one other question about this new larger footprint detector sensor that we're using. Does that impact the FDA filing process? We're reviewing that right now. Again, it's one component of the entire platform that's being reviewed. Speaker 200:29:10But I will tell you this, that going through this first 510 getting completely done, getting to the process where we understand exactly what the FDA wants to see and what's necessary for clearance makes any subsequent filings incredibly easy. And in fact, 90% plus of what was already put together would basically be identical to what we would file if there was something else we needed to do. And there are different processes of assessing that Could be that we have what's called a special 510. It's more of a 30 day review, don't know. But those are some of the things that we're looking at right now and assessing and talking to our regulatory consultants about. Operator00:29:56That's it for that, Jay. Speaker 100:29:58Okay. And we've got one more from the webcast here. And Michael or John, I think this would be best answered by you. What were the results of your latest blood pressure study with your single chip technology? And what are you doing to make Speaker 200:30:14further progress? Go ahead, Michael. Speaker 400:30:17Sure. Yes. So the big change in our last study is we're finally using our single chip, which is much smaller, has a lot less heat impacts, it's more efficient and there's no exposed wires. It's all self contained in single chip. And we're able to get much cleaner data on that platform. Speaker 400:30:38That test was done like a little over a month or so ago. From that, we've done a couple of things that we think will really kind of take us to the next level in terms of optimizing our antenna. As we mentioned before, it's the millimeter wave system. So there's definitely a lot of innovation on our antenna side and we keep making and find more and more things as we go along. So we're making some changes there. Speaker 400:31:03And there's a couple of other things we're doing from the algorithm standpoint. And we hope that the next study, which John mentioned earlier, will start in a couple of weeks, will give us the data that we need to really fine tune our algorithms and hopefully get to the Holy Grail we're working on for the last couple of years. I think that also applies, as we mentioned, John mentioned earlier to glucose. So they kind of go hand in hand as we make fixes to our blood pressure system. A lot of those fixes also apply to glucose. Speaker 400:31:35And again, most of the I'd say most of the innovation in the last couple of months has been really trying to fine tune our antennas, which again are quite complicated this frequency to perfect. And I think now we're finally getting to the bottom of a lot of the performance improvements we'd like to get to. Speaker 100:31:57Okay. Operator, I think that does it for the Q and A from the webcast and I think also as I'm looking at the phone lines as well. So I'll turn it back to you. Operator00:32:12Thank you. We do have one question on the phone line from the line of Michael Grish with B. Riley. Please proceed with your question. Speaker 200:32:27Can you hear me? Speaker 400:32:29Yes, we can. Operator00:32:31Okay. Just a little aside, I some Facebook today, I saw an ad for a watch that does glucose monitoring that's non invasive. Is that something that's and I haven't had a chance to check it out, is that something that's FDA cleared or is it just like the blood pressure on the other ones? Speaker 200:32:56I will answer this real question real quick. Thanks for providing it. I'm not since I don't know the name specifically of the one you're referring to, I can't exactly answer it, but there was one recently that I did see talking about trying to make glucose measurements non invasively and they've talked about setting up for an FDA filing on that. So it's not something that is commercially available or that's been through the rigor of an FDA review process at this point. Doing glucose non invasively is obviously really challenging as we all know. Speaker 200:33:34We like the platform that we have in development for that. We've certainly seen some nice signals on the bench as well as in prior clinical studies. And as Michael mentioned, we're making some enhancements to our design so that we get even stronger signals for glucose and are excited about more clinical work coming up a little bit later in the year. Michael, do you have anything you'd like to add? Speaker 400:34:05No, no. I mean, I think one of the things that we've noticed is kind of related to either glucose or blood pressure. And now that we're using optical signals for things like blood oxygen in our ring is that our millimeter wave signal really has a lot less sensitivity to light and movement in sunlight and other things than optical. And it has a lot higher fidelity, which we need for measuring the different features we use for blood pressure. So I think we're the fact that we're using both domains on a range for different things and blood pressure with our chip, I think we feel even more strongly that our millimeter wave chip is really the right architecture and the right design for going after things like blood pressure and glucose. Speaker 100:34:53Great. And question. Operator00:34:55A little follow-up on that and that's it. I remember when the I can't remember what it's called, but anyway, the other fitness device that came out Fitbit or whatever. Some of the insurance, life insurance companies were offering them as part of the deal. Have you looked at insurance companies and trying to do partnerships with them as well? Thank you, by the way. Speaker 200:35:22Sure. So I'll start with this and Jade, maybe if you'd like to comment as well in a moment. Yes, in our beta evaluations, we've already completed in our beta-one study, a partnership with an integrated healthcare network. And in the next one, we are working with another entity that's payer like. And the bottom line is the product being a medical device really lowers the bar for us to get in and partner with them. Speaker 200:35:56It also provides us an opportunity to potentially seek reimbursement in the future, which would be really nice, especially for high risk populations who could benefit from this technology that we have. And so for those reasons, anything in the healthcare space really is a big opportunity for us, especially because of the fact that we're a medical device. The wellness devices on the market are specifically labeled against being used for medical purposes. Now that doesn't mean you can't use them in a certain capacity and certainly use them to monitor activity and sleep and those types of things. But we feel like having the FDA clearance, which we're seeking for heart rate SPO2 and then for future measures beyond that, I mean, our goal in the next 3 to 5 years is to maybe have 5 to 10 different measures or diagnoses that are all cleared within the one product. Speaker 200:36:56We're really looking to provide a comprehensive health solution, which would be very appealing we believe to the insurance companies as you mentioned. Speaker 100:37:08Yes. I would just basically just add on a broader basis. Our investors obviously know a lot about us and has been with us through the years. Still on a relative basis, we're a fairly under the radar company and with the launch of EV obviously we'll be coming much more onto the limelight. I think there's a few things that are very much underappreciated about us. Speaker 100:37:30One is you've seen just growing interest in other form factors besides bands or watches, rings and I think that's strategic. 2nd, I'd say that being a medical device company is definitely a differentiator. We continue to see significant interest from healthcare and other enterprises. And what we're doing is we highlighted, for example, we'll be working with a large insurer for our beta-two as well as a major remote patient monitoring company and also global athletic apparel retailer, as we talked about on today's call, we've talked about that in the past as well. And we've said that there are other healthcare and consumer entities that we've been talking to about possible partnerships, collaborations, etcetera. Speaker 100:38:13And as we move through the FDA process, we think that could provide meaningful opportunities over time. And then 3rd, obviously, the RF technology that Michael and John were highlighting with respect to being the engine behind our glucose and blood pressure initiatives. And so from our standpoint, we feel like we have a lot of opportunities to create value over time and looking forward to continuing that journey. Operator, I think that pretty much concludes the Q and A for us today. We'd like to thank everybody for your time. Speaker 100:38:53As a reminder, you can stay connected and up to date on Movano Health news and events by checking out our investor website at ir. Movano.com. Thank you. Operator00:39:06Thank you. This concludes today's conference. You may now disconnect your lines at this time. Thank you for your participation.Read morePowered by Key Takeaways Movano delayed the EviRing launch by about two months to November to integrate a new high-performance sensor, boosting data accuracy for smaller fingers and lower perfusion while building inventory and media momentum before the holidays. The company submitted its first 510(k) application to the FDA for the ring’s pulse oximeter after passing initial completeness screening, aiming for medical-grade clearance but prepared to launch as a wellness device if approval isn’t in hand. In its second beta program, Movano is partnering with a global athletic apparel firm, a major health insurer, and a leading remote patient monitoring company to refine the ring’s features and explore enterprise use cases for medical-grade data. The EV Ring tracks sleep stages, resting heart rate, HRV, SpO₂, respiration rate, skin temperature, activity metrics, and menstrual cycle data via an AI-enhanced app tailored to women’s health; it will retail for $269 with no subscription, sold direct-to-consumer in three finishes. In Q2 2023, Movano reported a $7.4 million operating loss (versus $6.8 million year-ago), a $7.9 million cash burn, raised $8.1 million net in a public offering, and ended the quarter with $14.5 million in cash to fund its commercialization plans. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallMovano Q2 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Movano Earnings HeadlinesHooker Furniture’s Earnings Call: Mixed Results and Strategic MovesJune 12 at 8:10 PM | tipranks.comTop Stock Movers Now: GM, GE Vernova, Lockheed Martin, and MoreJune 12 at 7:40 PM | finance.yahoo.comIs Elon's empire crumbling?The Tesla Shock Nobody Sees Coming While headlines scream "Tesla is doomed"... Jeff Brown has uncovered a revolutionary AI breakthrough buried inside Tesla's labs. One that is helping AI escape from our computer screens and manifest itself here in the real world all while creating a 25,000% growth market explosion starting as early as July 23rd.June 12, 2025 | Brownstone Research (Ad)A2Z Cust2Mate Sells Isramat Subsidiary in Strategic MoveJune 12 at 6:18 PM | tipranks.comMarkets Were On The Move In Thursday's Trade June 12 at 6:18 PM | talkmarkets.comOPEC+ Move To Defend Market ShareJune 12 at 3:46 PM | seekingalpha.comSee More Movano Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Movano? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Movano and other key companies, straight to your email. Email Address About MovanoMovano (NASDAQ:MOVE) engages in developing a platform to deliver healthcare solutions at the intersection of medical and consumer devices. The company is involved in the development of Evie Ring, which is a wearable designed specifically for women that combines health and wellness metrics comprises resting heart rate, heart rate variability (HRV), blood oxygen saturation (SpO2), respiration rate, skin temperature variability, period and ovulation tracking, and menstrual symptom tracking, as well as activity profile, including steps, active minutes and calories burned, sleep stages and duration, and mood tracking. It develops System-on-a-Chip (SoC) for blood pressure or continuous glucose monitoring (CGM) systems. The company was formerly known as Maestro Sensors Inc. and changed its name to Movano Inc. in August 2018. 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There are 5 speakers on the call. Operator00:00:00And welcome to the Movano Second 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. 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. Operator00:00:25Sir, please go ahead. Speaker 100:00:27Thank you, operator. Good afternoon, everyone, and thank you for joining us today. Our CEO, John Mastertitarra, will open today's call with prepared remarks about the progress we've made during the Q2 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 EviRing. Afterward, I'll cover the highlights of our quarterly operating results and provide a perspective on our financial position. Speaker 100:00:54Finally, Movano Health's Founder and Chief Technology Officer, Michael Liebmann and Stacy Salvi, our Vice President of Strategy will join John, Tyla and me for the Q and A. Movano Health issued a news release earlier this afternoon detailing our Q2 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 and A session, these forward looking statements are subject to inherent risks and uncertainties, and actual results may be materially different from such statements. Speaker 100:01:32These risks and uncertainties are detailed in the Risk Factors section of our filings with the Securities and Exchange Commission, specifically in the company's Forms 10Q and 10 ks. 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. So with that, I'd like to turn the call over to our CEO, John Masters Sitaro. Speaker 200:02:05Welcome, everyone. Thank you for joining us for Movado Health's 2nd 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. Speaker 200:02:45We 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. Speaker 200:03:25To that end, we have made a business decision to move out our launch date by an estimated 2 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. Evie is not just another wearable. It's a medical grade smart ring that meets FDA guidelines and is designed specifically for women. Speaker 200:04:10It's our belief that Evee 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 1st 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 range pulse oximeter. Speaker 200:05:09This 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 AB 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 the decision from the FDA by our planned launch date. Speaker 200:06:04We 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 2nd 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 constructs 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 3 partners, a global athletic apparel company, which is interested in our women's specific as well as a major health insurer and a leading remote patient monitoring company, each of which are keen to leverage the EB Ring's medical grade capabilities alongside their end market and future offerings. Speaker 200:07:09We expect the next set of data programs will enable us to perfect our end to end solution with a broad audience and presents us with 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 the skin temperature sensor as well as an accelerometer. This sensor suite enables the tracking of key health and wellness metrics such as sleep in 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. Speaker 200:08:36Evie helps women understand the unique bodies and how menstrual cycle, mood and energy levels relate to health with clear insights derived from women 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 3 beautiful finishes, gold, rose gold and silver for $2.69 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 evring directly from evring.com and have it shipped anywhere in the United States with plans for expansion to other territories in the future. Speaker 200:09:32It'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 three sixty degree marketing campaign. I'll now let our CMO, Tyler Bucher update you on how her team is preparing for launch. Speaker 300:10:28Thanks, John. Momentum for the Evring continues to build at a steady pace and we've been amping up our communications across social, content and email over the last 2 months. Since CES, we've had over 600,000 visitors to evring.com with more than 100,000 people signed up to receive updates about our release. Our engagement on social and email has been well beyond our internal expectations and we've continuously seen positive responses to close that highlight our unique benefits and product features. Next up will be the launch of our paid brand campaign, which brings ZV to life in a whole new way and really showcases the game changing solution for women that we're bringing to market. Speaker 300:11:04In addition to our paid and social efforts, we will shortly begin to see easy samples of influencers, celebrities and the media. The revised release date offers us the opportunity to place rings into the hands of individuals with enough time to complete thorough device evaluation and draft comprehensive reviews, which are critical to cultivating consumer trust and influencing buying decisions. The level of interest we have from press and consumers positions us well as a potential must have gift for the holiday season, as well as a choice for the New Year when people often turn their attention to new healthy habits. We'll also be showcasing EV at CES in January, where we will be exhibiting on the floor and sharing a sneak peek of new features we plan to release following launch. We're building a brand new commercial website to support our D2C plans that will allow users to purchase a ring directly from us and receive a Free Sizer kit to help find the perfect fit. Speaker 300:11:52The entire site is set up to provide an educational immersive and frictionless customer experience from consideration to the moment of purchase. We've also established a best in class customer service team to manage all aspects of customer care and create a positive first impression for the brand. We're also very excited to share that we've recently announced the establishment of our Medical Advisory Board, a group of subject matter experts and trusted advisors for our team. This women led board will help establish EV as a highly credible health and wellness resource and we plan to leverage their medical and scientific expertise to enhance EV's product roadmap and provide trusted content. I'd like to give you a brief overview of our esteemed inaugural members. Speaker 300:12:31Doctor. Mary Clare Haber is a Board certified OBGYN, who has helped thousands of women going through perimenopause and menopause actualize their health and wellness goals by creating an online program, the Galveston Diet. With the goal of empowering and educating women, her work focuses on the science of menopause, aging and inflammation. Doctor. Andrea Masamora is a sleep medicine specialist at the Oregon Clinic, who has helped thousands of people improve their sleep habits. Speaker 300:12:57Her current work is focused specifically on helping women improve their sleep and the recognition of how their patterns are different from men. Doctor. Ruth White is renowned for her work in stress management and diversity, equity and inclusion and has written for Modern Healthcare, Harvard Business Review and Fast Company. She is the author of several books, including The Stress Management Workbook, De stress in 10 Minutes or Less. And finally, we're preparing to launch our first white paper, titled Women and Biometrics: Harnessing the Potential of Gender Specific Health and Wellness Data written by Doctor. Speaker 300:13:28Kristin Harlstotter with a focus on the impact of gender differences on health and wellness across sleep, heart health, activity and mental health. This detailed paper is a significant deep dive into these noted disparities and draws conclusions that we hope women will find helpful and informative. We'll be modifying the paper into blog and social posts so that this information will be accessible across multiple channels and drive traffic to our website and social media pages. The team is confident that our marketing efforts combined with the product's innovative features and pursuit of FDA clearance are setting Movano Health up for a successful and impactful launch of the EZ Ring. With that, I'd like to turn it back to John. Speaker 200:14:07Thank you, Tyla. To support all the activities we've just laid out, our operations team has been building the foundation of our supply chain and order fulfillment capabilities. With a well prepared supply chain and FDA compliant contract manufacturing sites, the team is prepping to handle increased demand and ensure a seamless production process. We're also finalizing manufacturing process and equipment automation, hard tooling and packaging as well as software integrations for order fulfillment and logistics. In addition to our commercial launch, we continue to move forward with testing our proprietary single chip radio frequency solution, which is the backbone of our coupless blood pressure and non invasive glucose initiatives. Speaker 200:14:56In May, we completed a 3 week IRB approved clinical study on 51 volunteers in the Movano Health clinical lab to evaluate the efficacy of our single chip prototype in estimating blood pressure. As you may recall, this was the very first time we've used our single chip solution in a clinical study. We analyzed the data and saw good signals. We learned a lot from this initial study and have made modifications to improve the prototype and measurement algorithms and plan to execute a follow-up blood pressure study on an additional 50 people in the coming weeks. We've also been conducting extensive testing to evaluate glucose data. Speaker 200:15:42As a result, we're optimizing antennas and the circuit board layout to improve signal sensitivity. Once complete, we'll leverage the modified platform in an upcoming glucose clinical trial. After almost 2 years of extensive research and development, we're looking forward to bringing the EV ring to market. The timing for such a product couldn't be better with increased interest in medical grade technologies for home use and a strong focus on women's health and empowerment. We believe we've designed an exceptional product and are excited to deliver it to our customers who are highly engaged and looking for a solution that aids them in their health journey. Speaker 200:16:28With that, I'll turn it back to Jay to go over the financials. Speaker 100:16:32Thanks, John. We detailed the financial results in today's Q2 earnings release, which you can find on our website, but I'll share a few key line items. Movano Health reported an operating loss of $7,400,000 the Q2 of 2023 and that compares to an operating loss of $6,800,000 in the year ago period. The increase was primarily related to the accelerated commercialization initiatives described earlier in the call. Our cash burn in the period was $7,900,000 a bit higher than the run rate for the prior 6 quarters given certain pre launch and FDA submission costs and other timing considerations. Speaker 100:17:09With regards to capital, we raised $9,200,000 in gross proceeds or $8,100,000 net through an underwritten public offering of shares of Movano Health common stock in the period. At the end of the Q2 of 2023, we had $14,500,000 of cash and cash equivalents and total assets of $17,600,000 As that concludes our formal remarks, we'd be glad to take your questions. Operator, we're ready to begin the Q and A section of the call. Operator00:17:40Thank Speaker 100:18:06And I think also operator, remind the participants that we can ask questions in the webcast link as well. Operator00:18:14Yes. You may ask also ask questions on the webcast link. Speaker 100:18:20Right. It looks like we've got several there. Just for those that are on the webcast, just as a reminder, you can click on the question mark icon and hit the send button after you've typed in your question and we'll do our best to address them all. So let me start with the webcast questions. I'll just ask them and a few of us on the call here will be happy to answer them. Speaker 100:18:41John, maybe the first one will be for you, just in terms of can you talk more about why you've delayed the launch date? Speaker 200:18:50Sure, Jay. Well, first off, I want to say that as a medical device company, the quality and accuracy of the data that we're providing is essential. And we had an opportunity to enhance our products by incorporating this new component that we spoke of into the ring. This new component is more accurate and addresses perfusion issues that could be within our target market. Essentially what the new component does is it has the ability to collect more of the signal that is being reflected from the finger. Speaker 200:19:24So with a female focused product and with the size of the ring going down to size 5 where you may have much smaller fingers, lower perfusion, less blood smaller blood vessels and therefore have less signal using this larger footprint component allows us to collect more of the data from the finger. And we've already started testing this. We have seen that it is able to get more of the signal than what we were able to do before. And so it increases our ability to provide more accurate data because we have a better signal that we're collecting. We're still using the same LEDs that we had before in terms of their wavelengths of light and whatnot, but this sensor allows us to basically collect more of the data that's emanating from the finger. Speaker 200:20:24So having this delay to put this part into the ring is something that we think is going to really pay off for us. And obviously, the delay gives us some more time to get in front of the media, influencers and others to really run it through the paces before we get to launch. At the end of the day, we want to be able to deliver a product that we can be really proud of and stand behind. And we believe that pushing back the launch date by a couple of months gives us time to assure just that. The other thing that I'll lastly mention is that by pushing it out for a couple of months, we can also make sure that we're set up with production and manufacturing and being able to build up a bit more inventory initially so that we can meet the demand that comes into the market. Speaker 100:21:14Okay. Jonathan, this next question is for you as well. What gives you confidence in your ability to meet the new launch date? Speaker 200:21:24It's a great question. Several things. First off, you should know that in order to submit to the FDA for the ring, we had to have produced the fully baked products. We had to have all of the testing done, environmental testing, biocompatibility testing, electrical testing, even cloud platform, cybersecurity testing, all done as part of the development process. And so all of that has already been in place. Speaker 200:21:53All of the testing is complete. All of that documentation is in with the agency. So that's one important note is that we really are at a point where we've done a lot of the heavy lifting to this product. The other thing that you should know is that we've been continuing to push forward with marketing, production readiness, as we mentioned on the call, customer service, etcetera. And so we feel pretty confident because we have been testing this new component. Speaker 200:22:20We've seen how it performs. We already we know that we're getting more signal collected from it. And so we feel really good about the fact that this isn't going to somehow not work at the end of the day because we've tested it so thoroughly. And basically the majority of the system is the same as what it was before. And I'll stop there. Speaker 100:22:45Okay. Tyler, I think this next question is for you. Any concern about your ability to capitalize on holiday traffic with the launch ahead of Black Friday? Speaker 300:22:56Also a great question. And so, no, I mean, while the team is focused on ensuring that we maximize holiday timing in order to drive our sales, we really believe that our overall launch extends far beyond just the Q4. And I think it's important to state that the macro just the Q4. And I think it's important to state that the macro awareness around women and their health that we're seeing in the media and in business and in pop culture is a really clear signal that the time is now for a product like Evie Ring. So our launch date is really just the first step in a much bigger plan to serve our growing community of consumers for the long term. Speaker 300:23:28But feeling very confident that the momentum that we've generated so far will translate into purchase both during the holiday season and beyond. Speaker 400:23:37So yes. Speaker 100:23:39Okay. I'll take the next question regarding cash burn. Why does your cash burn increase in the quarter? Does the later launch affected? And what will the burn rate be after launch? Speaker 100:23:52So our cash burn has averaged about $6,500,000 per quarter for the last several quarters as we've been gearing up for launch. Not too surprisingly as you approach the launch date, there's some additional resources that you need to invest behind. For us, it includes raw materials, tooling, some FDA and product testing and also some marketing dollars that we've begun to put to work. We continue to be focused on being good stewards of our capital. You can count on us to continue to have that focus on a go forward basis. Speaker 100:24:26We view a launch prior to Black Friday as relatively immaterial to our cash burn. As any push out 8, 10 weeks or so of gross profits, we think will be offset by lower marketing spend and other launch related costs going into the events. So it's kind of a wash, something that we would rather be launching in September, but we are of the view that is relatively immaterial on an overall cash burn basis. There's also one more question that relates to cash, which I'll address here as well, which is we have enough cash to operate and execute your plan without going out to the capital markets and all that. I'd just basically say that as a reminder, we've raised $102,000,000 since inception in 2018. Speaker 100:25:17We had $14,500,000 on the balance sheet as of June 30. Our investors have been incredibly supportive over the years, including a couple of offerings that we did year to date in 2023, both in the Q1 and the Q2. And then also we've raised about $5,000,000 in net proceeds on the ATM over the past year as well. We've highlighted in our financial filings that we will need to raise additional capital over time. But we've also been seeing increased interest as we hit key milestones. Speaker 100:25:51For example, our FDA submission as well as getting closer and closer to the launch of our HeatView ring. Okay. Next question. Sean, this is for you. Can you give us some more insight to the FDA process? Speaker 100:26:10What are the next milestones? When do you expect to hear back from FDA? Speaker 200:26:15Yes, happy to Jay. Thank you for the question. And I see there's a couple of others very closely related to this. So I'll handle it all at once I hope. Operator00:26:25First, let Speaker 200:26:25me explain the process with the FDA for 510. Step 1 is actually making the filing. And the first thing that would happen after that is that the FDA acknowledged that they've received the filing. The next step is when they assess the entire package for completeness, They verify that all the sections that are required in a filing are there and that we have provided everything that they expect to see in that part of the filing. We've gone through that process as well. Speaker 200:26:56That's at least a 15 day review of the entire filing that we put in. And when we recently announced that we had done the 510, it was we waited until after that step or that milestone was beyond us. And so now the 510 is in the formal review. And the agency typically comes back with detailed questions after doing the detailed review at 60 days post filing date. And the filing date is the date when they gave the 15 day review and said, yes, you're past that, it's 15 days prior to that date. Speaker 200:27:39So basically, we are in the middle of the detailed review from the agency or probably the first part of the review with the agency and at 60 days, we'll get some feedback. Once we get the feedback with questions and typically in all the 510s that I've been affiliated with and filed, there's sure that we've got everything and provided them everything that they want to see. At the very end, there's final labeling materials that are reviewed assuming that they are going to clear it. There's no guarantees that they will clear it. But that's the basic process. Speaker 200:28:22And that's why on average, it's 3 to 6 months to get through this entire process assuming that you get cleared. So we feel pretty good about the completeness of our filing. We feel very good about the clinical data that we've collected to date. And so we're cautiously optimistic that things will go forward. But again, there are no guarantees that they will clear it. Speaker 200:28:45And I hope that that addresses all those questions fairly well. There was one other question about this new larger footprint detector sensor that we're using. Does that impact the FDA filing process? We're reviewing that right now. Again, it's one component of the entire platform that's being reviewed. Speaker 200:29:10But I will tell you this, that going through this first 510 getting completely done, getting to the process where we understand exactly what the FDA wants to see and what's necessary for clearance makes any subsequent filings incredibly easy. And in fact, 90% plus of what was already put together would basically be identical to what we would file if there was something else we needed to do. And there are different processes of assessing that Could be that we have what's called a special 510. It's more of a 30 day review, don't know. But those are some of the things that we're looking at right now and assessing and talking to our regulatory consultants about. Operator00:29:56That's it for that, Jay. Speaker 100:29:58Okay. And we've got one more from the webcast here. And Michael or John, I think this would be best answered by you. What were the results of your latest blood pressure study with your single chip technology? And what are you doing to make Speaker 200:30:14further progress? Go ahead, Michael. Speaker 400:30:17Sure. Yes. So the big change in our last study is we're finally using our single chip, which is much smaller, has a lot less heat impacts, it's more efficient and there's no exposed wires. It's all self contained in single chip. And we're able to get much cleaner data on that platform. Speaker 400:30:38That test was done like a little over a month or so ago. From that, we've done a couple of things that we think will really kind of take us to the next level in terms of optimizing our antenna. As we mentioned before, it's the millimeter wave system. So there's definitely a lot of innovation on our antenna side and we keep making and find more and more things as we go along. So we're making some changes there. Speaker 400:31:03And there's a couple of other things we're doing from the algorithm standpoint. And we hope that the next study, which John mentioned earlier, will start in a couple of weeks, will give us the data that we need to really fine tune our algorithms and hopefully get to the Holy Grail we're working on for the last couple of years. I think that also applies, as we mentioned, John mentioned earlier to glucose. So they kind of go hand in hand as we make fixes to our blood pressure system. A lot of those fixes also apply to glucose. Speaker 400:31:35And again, most of the I'd say most of the innovation in the last couple of months has been really trying to fine tune our antennas, which again are quite complicated this frequency to perfect. And I think now we're finally getting to the bottom of a lot of the performance improvements we'd like to get to. Speaker 100:31:57Okay. Operator, I think that does it for the Q and A from the webcast and I think also as I'm looking at the phone lines as well. So I'll turn it back to you. Operator00:32:12Thank you. We do have one question on the phone line from the line of Michael Grish with B. Riley. Please proceed with your question. Speaker 200:32:27Can you hear me? Speaker 400:32:29Yes, we can. Operator00:32:31Okay. Just a little aside, I some Facebook today, I saw an ad for a watch that does glucose monitoring that's non invasive. Is that something that's and I haven't had a chance to check it out, is that something that's FDA cleared or is it just like the blood pressure on the other ones? Speaker 200:32:56I will answer this real question real quick. Thanks for providing it. I'm not since I don't know the name specifically of the one you're referring to, I can't exactly answer it, but there was one recently that I did see talking about trying to make glucose measurements non invasively and they've talked about setting up for an FDA filing on that. So it's not something that is commercially available or that's been through the rigor of an FDA review process at this point. Doing glucose non invasively is obviously really challenging as we all know. Speaker 200:33:34We like the platform that we have in development for that. We've certainly seen some nice signals on the bench as well as in prior clinical studies. And as Michael mentioned, we're making some enhancements to our design so that we get even stronger signals for glucose and are excited about more clinical work coming up a little bit later in the year. Michael, do you have anything you'd like to add? Speaker 400:34:05No, no. I mean, I think one of the things that we've noticed is kind of related to either glucose or blood pressure. And now that we're using optical signals for things like blood oxygen in our ring is that our millimeter wave signal really has a lot less sensitivity to light and movement in sunlight and other things than optical. And it has a lot higher fidelity, which we need for measuring the different features we use for blood pressure. So I think we're the fact that we're using both domains on a range for different things and blood pressure with our chip, I think we feel even more strongly that our millimeter wave chip is really the right architecture and the right design for going after things like blood pressure and glucose. Speaker 100:34:53Great. And question. Operator00:34:55A little follow-up on that and that's it. I remember when the I can't remember what it's called, but anyway, the other fitness device that came out Fitbit or whatever. Some of the insurance, life insurance companies were offering them as part of the deal. Have you looked at insurance companies and trying to do partnerships with them as well? Thank you, by the way. Speaker 200:35:22Sure. So I'll start with this and Jade, maybe if you'd like to comment as well in a moment. Yes, in our beta evaluations, we've already completed in our beta-one study, a partnership with an integrated healthcare network. And in the next one, we are working with another entity that's payer like. And the bottom line is the product being a medical device really lowers the bar for us to get in and partner with them. Speaker 200:35:56It also provides us an opportunity to potentially seek reimbursement in the future, which would be really nice, especially for high risk populations who could benefit from this technology that we have. And so for those reasons, anything in the healthcare space really is a big opportunity for us, especially because of the fact that we're a medical device. The wellness devices on the market are specifically labeled against being used for medical purposes. Now that doesn't mean you can't use them in a certain capacity and certainly use them to monitor activity and sleep and those types of things. But we feel like having the FDA clearance, which we're seeking for heart rate SPO2 and then for future measures beyond that, I mean, our goal in the next 3 to 5 years is to maybe have 5 to 10 different measures or diagnoses that are all cleared within the one product. Speaker 200:36:56We're really looking to provide a comprehensive health solution, which would be very appealing we believe to the insurance companies as you mentioned. Speaker 100:37:08Yes. I would just basically just add on a broader basis. Our investors obviously know a lot about us and has been with us through the years. Still on a relative basis, we're a fairly under the radar company and with the launch of EV obviously we'll be coming much more onto the limelight. I think there's a few things that are very much underappreciated about us. Speaker 100:37:30One is you've seen just growing interest in other form factors besides bands or watches, rings and I think that's strategic. 2nd, I'd say that being a medical device company is definitely a differentiator. We continue to see significant interest from healthcare and other enterprises. And what we're doing is we highlighted, for example, we'll be working with a large insurer for our beta-two as well as a major remote patient monitoring company and also global athletic apparel retailer, as we talked about on today's call, we've talked about that in the past as well. And we've said that there are other healthcare and consumer entities that we've been talking to about possible partnerships, collaborations, etcetera. Speaker 100:38:13And as we move through the FDA process, we think that could provide meaningful opportunities over time. And then 3rd, obviously, the RF technology that Michael and John were highlighting with respect to being the engine behind our glucose and blood pressure initiatives. And so from our standpoint, we feel like we have a lot of opportunities to create value over time and looking forward to continuing that journey. Operator, I think that pretty much concludes the Q and A for us today. We'd like to thank everybody for your time. Speaker 100:38:53As a reminder, you can stay connected and up to date on Movano Health news and events by checking out our investor website at ir. Movano.com. Thank you. Operator00:39:06Thank you. This concludes today's conference. You may now disconnect your lines at this time. Thank you for your participation.Read morePowered by