Q4 2022 Movano Inc Earnings Call
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Operator 2: Hello, welcome to Movano Health's Q4 2022 Earnings Call. I would like to remind everybody that this call is being recorded, and a replay of the call will be available on Movano Health's website at ir.movano.com. I would like to hand the conference over to J. Cogan, Movano Health's Chief Financial Officer. Thank you. You may begin.
Speaker 2: Hello, and welcome to the MoVano Health fourth quarter 2022 earnings call. I would like to remind everybody that this call is being recorded and a replay of the call will be available on MoVano Health's website.
Speaker 2: I would like to hand the conference over to Jay Kogan, MoVano's Health Chief Financial Officer. Thank you. It is my pleasure to introduce and welcome you to the MOVano Nav Shop. Eight months or so ago, dashboard in four months, I would like to take to Mars in order to conclude my report. It is not just literally a project that threeasse.
J. Cogan: Thank you, operator. Good afternoon, everyone, and thank you for joining us today. Our CEO, John Mastrototaro, will open today's call with prepared remarks about the progress we've made during Q4 2022 and in recent weeks. Our Chief Marketing Officer, Tyla Bucher, will also join us to give an update on the upcoming launch of the Evie 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 Leabman, and Stacy Salvi, our Vice President of Strategy, will join John, Tyla, 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.
Speaker 3: Thank you, operator. Good afternoon, everyone, and thank you for joining us today. Our CEO , John Master-Totaro, will open today's call with prepared remarks about the progress we've made during the 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 new
Speaker 3: of the EV ring. Afterward, I'll cover the highlights of our quarterly operating results and provide perspective on our financial position.
Speaker 3: Finally, Movano Health's founder and chief technology officer, Michael Liebman, and Stacey Salvi, our vice president of strategy, will join John , Tyla, and me for the Q&A.
Speaker 3: 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.
J. Cogan: These 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 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. With that, I'd like to turn the call over to our CEO, John Mastrototaro.
Speaker 3: These risks and uncertainties are detailed in the risk factor section of our filings with the Securities and Exchange Commission, specifically in the company's forms 10-Q and 10-K.
Speaker 3: 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 Mastrototaro: Welcome, everyone. Thank you for joining us for Movano Health's Q4 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 US alone.
Speaker 3: John Mastrotutaro.
Speaker 4: 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.
Speaker 4: It's remarkable how far we've come and given our progress, I'm even more excited about our company's future potential.
Speaker 4: 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 MedTech and consumer devices, a market opportunity we believe is conservatively worth the cost of the product.
John Mastrototaro: We've made significant progress over the last quarter and early part of this year as we prepare for the commercial launch of the Evie 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 Evie Ring having accuracy well within the FDA standards. Ahead of the planned summer launch, we announced the Evie 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 Evie Ring.
Speaker 4: $50 billion in the US alone.
Speaker 4: 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.
Speaker 4: We successfully completed our pivotal hypoxia study, which resulted in the EV ring having accuracy well within the FDA standards.
Speaker 4: We successfully completed our pivotal hypoxia study, which resulted in the EB ring having accuracy well within the FDA standards. Ahead of the planned summer launch,
Speaker 4: We announced the EV ring at CES in January .
Speaker 4: and the media and consumer reception was and continues to be incredibly positive.
Speaker 4: 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.
John Mastrototaro: 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.
Speaker 4: and two additional leading global medical device companies.
Speaker 4: 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.
Speaker 4: What separates our company from the competition is that we're building Movano Health as a medical device company.
Speaker 4: We are going the extra mile to achieve a level of trust and credibility not offered by other consumer wearables.
Speaker 4: We have a quality management system run by our quality, regulatory, and clinical team to ensure appropriate product design and testing processes are followed.
John Mastrototaro: 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 multi-billion dollar FDA compliant contract manufacturer to assure the quality of the ring as a medical device. As a medical device company, we are on track to file our first 510K this spring for Evie's heart rate and SpO2 data after completing a successful hypoxia pivotal trial in Q4 of last year. In comparing the overall accuracy of the ring's data with data from the study's reference devices, Evie resulted in an approximate 2% margin of error, well below the FDA consensus standard of 3.5% for SpO2. Additionally, during the study, Evie's heart rate monitor had root mean square error of approximately 2 beats per minute, which is also in line with the FDA's requirements.
Speaker 4: We run formal clinical trials as mandated by FDA regulations, and we are using HIPAA-compliant systems to maintain data security.
Speaker 4: 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 SP02 data.
Speaker 4: after completing a successful hypoxia pivotal trial in Q4 of last year.
Speaker 4: In comparing the overall accuracy of the RINGS 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.
Speaker 4: Additionally, during the study, Evie's heart rate monitor had root mean square error of approximately 2 beats per minute, which is also in line with the FDA's requirements.
John Mastrototaro: 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 510K 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 Evie as a medical device. If not, we're prepared to launch Evie 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.
Speaker 4: 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.
Speaker 4: The submission requires hundreds of documents beyond data from our studies. Once the 510k is submitted in the spring timeframe, we expect the process with the FDA to take about three to four months.
Speaker 4: The timing of the launch may dovetail with the decision from the FDA, which will allow us to launch EV as a medical device.
Speaker 4: 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.
Speaker 4: Our pursuit of FDA clearances positions us well for both direct to consumer and business to business opportunities.
John Mastrototaro: 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 B2B partners is a leading global medical technology company that offers respiratory solutions for in-home use. Currently in the US, 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.
Speaker 4: with end-to-end solutions that give customers a comprehensive look at their health data, how 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.
Speaker 4: For example, one of our Beta-2 partners is a leading global medical technology company that offers respiratory solutions for in-home use.
Speaker 4: Currently in the US, 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.
Speaker 4: and the impact of one's daily activities on his or her oxygen requirements could be a game changer for those affected.
John Mastrototaro: Our expectation is that our beta programs will highlight the opportunity for integrated product partnerships with the Evie 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 Evie 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 Evie 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, Tyla Bucher, to update you on our marketing strategy leading up to the Evie launch.
Speaker 4: 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.
Speaker 4: 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.
Speaker 4: representing a major inflection point for us.
Speaker 4: 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 .
Speaker 4: 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. Thanks, Jon. 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, The New York Times, and The New York Times.
Tyla Bucher: Thanks, John. As you mentioned, Evie 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 US alone. When you consider women make up more than half of the US population and control or influence 85% of the household spending, we see this as both a significant and a timely opportunity.
Speaker 5: that is made specifically for women, and particularly the misnomer that women are considered a niche market.
Speaker 5: The thumbtack space is set to grow to 48 billion dollars by 2030 in the US alone. And when you consider women make up more than half of the US population and control or influence 85% of the household spending, we see this as both a significant and a timely opportunity.
Tyla Bucher: Building off 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 and organic social media campaigns, and our monthly newsletter and blog.
Speaker 5: So building off 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.
Speaker 5: 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.
Speaker 5: We're focused on keeping these valuable leads engaged and are continuing to grow our user base with our email strategy, paid and organic social media campaign, 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.
Tyla Bucher: These leads constitute our early adopters, the foundation of our community, and our most likely brand ambassadors. 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 a 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 Evie 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.
Speaker 5: 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 EV entered the market. To that end, as we prepare for our commercial launch, please join us in a moment of silence.
Speaker 5: 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
Tyla Bucher: 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. 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.
Speaker 5: 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.
Speaker 5: 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.
Speaker 5: 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 data program.
Speaker 5: 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 .
Tyla Bucher: With that, I'll now turn it back over to John.
John Mastrototaro: Thanks, Tyla. From an operations standpoint, we feel prepared for our intended summer launch timeline and are building out our manufacturing line in accordance with FDA standards. Our supply chain partners, including our tier 1 contract manufacturer, distributors, direct manufacturers, custom component, and raw material suppliers, are in position to support our launch with contracts, forecasts, purchase orders, and material stocking agreements as dictated by lead times. Production capabilities, including process and test development, equipment automation, hard tooling, and packaging, are in the final stages and will be positioned to support our growth and capacity expectations. Additionally, our system integration with our domestic logistics and fulfillment partner is underway and will be fully operational for launch. In addition to working toward the launch of Evie, we are also moving at pace on our non-invasive glucose and cuffless blood pressure monitoring efforts using our patented system-on-a-chip.
Speaker 4: Thanks, Tyla. From an operations standpoint, we feel prepared for our intended summer launch timeline and are building out our manufacturing line in accordance with FDA standards. Our supply chain partners, including our Tier 1 contract manufacturer, distributors, and simple participants from our pacificile community.
Speaker 4: direct manufacturers, custom component and raw materials suppliers are in position to support our launch with contracts, forecasts, purchase orders, and material stocking agreements as dictated by lead times. Production capabilities, including process and test development, and production capabilities are in place.
Speaker 4: equipment automation, hard tooling, and packaging are in the final stages and will be positioned to support our growth and capacity expectations.
Speaker 4: Additionally, our system integration with our domestic logistics and fulfillment partners underway and will be fully operational for launch.
Speaker 4: In addition to working toward the launch of EV, we are also moving at pace on our non-invasive glucose and cuffless blood pressure monitoring efforts using our patented system on a chip.
John Mastrototaro: As you may recall, the chip is the smallest ever RF-enabled integrated circuit designed specifically for blood pressure or glucose monitoring. Over the last quarter, we implemented the system-on-a-chip into a new battery-powered wrist-worn device that is smaller than most wrist-worn wearables today. We are set to commence blood pressure and glucose clinical studies imminently using the single chip technology for the first time. In order to protect our innovation around our RF technology, we have been prolifically filing patents and have recently been issued 9 new US patents, including multiple foundational patents. Of note is a core patent related to enablement of measuring health metrics using amplitude and phase information from our proprietary system-on-a-chip.
Speaker 4: As you may recall, the chip is the smallest ever RF-enabled integrated circuit designed specifically for blood pressure or glucose monitoring.
Speaker 4: Over the last quarter, we implemented the system on a chip into a new battery-powered wrist-worn device that is smaller than most wrist-worn wearables today. We are set to commence blood pressure and glucose clinical studies imminently using the single-chip technology for the first time.
Speaker 4: In order to protect our innovation around our RF technology, we have been prolifically filing patents and have recently been issued nine new U.S. patents, including multiple foundational patents. Of note is a core patent related to enablement of measuring health metrics using amplitude and phase-
John Mastrototaro: The new patents validate our cutting-edge approach to RF-enabled glucose and blood pressure monitoring and extend our growing IP portfolio to 21 patents issued in the US, one patent issued in China, and 36 patents pending. In summary, this year is poised to be our most exciting and anticipated year yet. With the launch of Evie quickly approaching, we are preparing our manufacturing, marketing, and technology partners to be primed and ready for a summer 2023 launch. Our B2B initiatives, including our beta programs, are progressing and becoming more tangible every day, and our blood pressure and glucose monitoring solutions are consistently improving with each study. We have significant D2C and B2B business opportunities in front of us that we are ready for and excited to execute on. We look forward to sharing further updates soon.
Speaker 4: one patent issued in China, and 36 patents pending.
Speaker 4: In summary, this year is poised to be our most exciting and anticipated year yet. With the launch of EV quickly approaching, we are preparing our manufacturing, marketing, and technology partners to be primed and ready for a summer 2023 launch.
Speaker 4: Our B2B initiatives, including our beta programs, are progressing and becoming more tangible every day. And our blood pressure and glucose monitoring solutions are consistently improving with each study.
Speaker 4: We have significant D2C and B2B business opportunities in front of us that we are ready for and excited to execute on.
John Mastrototaro: With that, I'll turn it back to Jay to go over the financials.
Speaker 4: We look forward to sharing further updates soon. And with that, I'll turn it back to Jay to go over the financials.
J. Cogan: Thanks, John. We detailed the financial results in today's Q4 earnings release, which you can find on our website. I'll share a few key line items. Movano Health reported an operating loss of $8 million in Q4 2022, compared to an operating loss of $6.3 million in the year ago period. The increase was primarily related to the accelerated R&D and commercialization initiatives described earlier in today's call. Our cash burn in the period was $6.3 million, in line with the prior four quarters. In Q4 2022, the burn was partially offset by $300,000 in net proceeds raised via our $50 million ATM facility.
Speaker 3: Thanks John . We detailed the financial results in today's fourth quarter earnings release, which you can find on our website, but I'll share a few key line items.
Speaker 3: Movano Health reported an operating loss of $8 million in the fourth quarter of 2022 compared to an operating loss of $6.3 million in the year-ago period.
Speaker 3: The increase was primarily related to the accelerated R&D and commercialization initiatives described earlier in today's call.
Speaker 3: Our cash burn in the period was $6.3 million in line with the prior four quarters.
Speaker 3: In the fourth quarter of 2022, the burn was partially offset by $300,000 in net proceeds raised via our $50 million ATM facility.
J. Cogan: As you recall, we executed our ATM agreement in August 2022 and raised more than $2.2 million in net proceeds at an average price of $2.83 per share over the last 5 months of 2022. We continue to view the ATM as an opportunistic source of capital and are pleased with the execution to date. In addition, in Q1 of this year, we raised another $7.5 million in gross proceeds, or $6.85 million net, through an underwritten public offering of shares of Movano Health common stock and warrants. At the end of Q4 2022, we had $10.8 million of cash equivalents, and short-term investments, and total assets of $13.2 million. On a pro forma basis, if one were to assume the aforementioned equity capital raise occurred on 31 December of last year, our pro forma cash on the balance sheet would've totaled $17.6 million.
Speaker 3: As you recall, we executed our ATM agreement in August of 2022 and raised more than $2.2 million in net proceeds and an average price of $2.83 per share over the last five months of 2022. As you recall, we executed our ATM agreement in August of 2022 and raised more than $2.83 per share over the last five months of 2022 and raised more than $2.83 per share over
Speaker 3: We continue to view the ATM as an opportunistic source of capital and are pleased with the execution to date.
Speaker 3: In addition, in the first quarter of this year, we raised another $7.5 million in gross proceeds, or $6.85 million net, through an underwritten public offering of shares of Movano Health, Comistock, and Warrens.
Speaker 3: At the end of the fourth quarter of 2022, we had $10.8 million of cash, cash equivalents, and short-term investments in total assets of $13.2 million.
Speaker 3: On a pro forma basis, if one were to assume the aforementioned equity capital raise occurred on December 31st of last year, our pro forma cash on the balance sheet would have totaled $17.6 million.
J. Cogan: Speaking of cash balances, I'd like to note that Movano Health does not have any current financial exposure to Silicon Valley Bank specifically, and we also partner with multiple multinational banking institutions to minimize the potential exposure to such systemic risks in general. We will not be providing specific financial guidance, but as you've heard in today's quarterly report, as well as through our commentary on previous quarterly calls, we're making great progress toward the direct-to-consumer launch of the Evie Ring in the summer of 2023, as well as our other B2B and clinical initiatives, and doing so on a capital-efficient basis. As that concludes our formal remarks, we'd be glad to take your questions. Operator, we're ready to begin the Q&A section of the call.
Speaker 3: Speaking of cash balances, I'd like to note that Movano Health does not have any current financial exposure to Silicon Valley Bank specifically, and we also partner with multiple multinational banking institutions to minimize the potential exposure to such systemic risks in general.
Speaker 3: We will not be providing specific financial guidance, but as you've heard in today's quarterly report, as well as through our commentary on previous quarterly calls, we're making great progress toward the direct-to-consumer launch of the EV ring in the summer of 2023, as well as our other B2B and clinical initiatives, and doing so on a capital-efficient basis.
Speaker 3: As that concludes our formal remarks, we'd be glad to take your questions. Operator, we're ready to begin the Q&A section of the call.
Operator 2: Thank you. We will now be conducting a question and answer session. If you dialed into the conference via phone and would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue, and for participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. If you have joined us from the webcast link, you can ask a question by clicking on the question mark icon and hitting send after you type in your question. One moment please while we poll for questions.
Speaker 2: Thank you. We will now be conducting a question and answer session. If you dialed into the conference via phone and would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.
Speaker 2: For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys.
Speaker 2: If you have joined us from the webcast link, you can ask a question by clicking on the question mark icon and hitting send after you type into your question. One moment please while we pull for questions.
J. Cogan: Okay. Operator, I can see in the webcast link that we have a few questions already in queue. While we're waiting for the phone lines, why don't we start with the webcast link, and I can go ahead and ask those questions, and then I'll come back to you when we're ready for the phones. John, the first question is for you. Remind us of why you're so excited for this next round of clinical trials. What do you think you're going to see? How's it related to the recent press around Apple and their progress towards bringing a non-invasive glucose monitor to market?
Speaker 3: Okay, operator, I can see in the webcast link that we have a few questions already in queue, while we're waiting for the...
Speaker 3: phone lines, why don't we start with a webcast link and I can go ahead and ask those questions and then I'll come back to you when we're ready for the phones.
Speaker 3: John , the first question is for you. Remind us of why you're so excited for this next round of clinical trials.
Speaker 3: What do you think you're going to see? How is it related to the recent press around Apple and their progress towards bringing a non-invasive glucose monitor to market?
John Mastrototaro: Thanks, Jay. Great question. First off, I just want to say that we're really excited about the robustness of our patent portfolio with nine new patents issued since our last earnings call. These patents cover a variety of topics, but primarily it's focused on the design of this RF chip, its use in healthcare, and making measurements of things like blood pressure and glucose. Lastly, around the algorithms that we use to convert the measurements that we take into the metric of interest. That is a really positive state for us right now, and we're very excited about that. The second thing is as it relates to clinical trials, every time we scale down the size of the technology, we've gotten improved fidelity and better accuracy with our platform.
Speaker 4: Thanks Jay, great question. First off, I just want to say that we're really excited about the robustness of our patent portfolio with nine new patents issued since our last earnings call. These patents cover a variety of topics, but primarily it's focused on the design of this RF chip. You probably noticed that I forgot to take that yarn off theOutline But I just wanted to show you that it is not astand.
Speaker 4: its use in healthcare and making measurements of things like blood pressure and glucose, and lastly around the algorithms that we use to convert the measurements that we take into the metric of interest. So that is a really positive state for us right now and we're very excited about that. The second thing is as it relates to clinical trials,
Speaker 4: Every time we scale down the size of the technology, we've gotten improved fidelity and better accuracy with our platform. We went from a pizza box size device in the past, as you may recall, to an iPhone size device, then to a bulky wrist-worn device, and now we're down to something that is the size of a bracelet, which can be worn where we have really nice totes that machine-leonate as valid for everyone to see. And I also why we trying to exactly
John Mastrototaro: We went from a pizza box-sized device in the past, as you may recall, to an iPhone-sized device, then to a kind of bulky wrist-worn device, and now we're down to something that is the size of a bracelet, which can be worn, where we have really nice connection between the RF energy and the body to be able to make the accurate measurements. This improvement over time in terms of our hardware has been very meaningful. Every time we scale down that hardware, as I've said, we get better data. We're really excited about the start of this next clinical trial where we're using our integrated circuit chip. As it relates to Apple's recent press, they announced that they had started with a desktop device, and they're making optical measurements versus RF.
Speaker 4: connection between the RF energy and the body to be able to make the accurate measurements. And this improvement over time in terms of our hardware has been very meaningful. And every time we scale down that hardware, as I've said, we get better data. So we're really excited about the start.
Speaker 4: of this next clinical trial where we're using our integrated circuit chip. As it relates to Apple's recent press, they announced that they had started with a desktop device and they're making optical measurements versus RF. That desktop device, they've been trying now to scale down and they mentioned
John Mastrototaro: That desktop device, they've been trying now to scale down, and they mentioned in the article, and we see what you see. They mentioned that they were in the process with their engineers of trying to get it down to the size of a device that's about the size of an iPhone, which is where we were 2 revisions ago. From a hardware perspective and a scaled-down perspective, we believe we've got a very significant lead because now we're down to a chip that's 4mm by 6.7mm in size, which could even be put into a ring form factor. We're pretty excited about that.
Speaker 4: a scale down perspective, we believe we've got a very significant lead because now we're down to a chip that's four millimeters by 6.7 millimeters in size, which could even be put into a ring form factor. So we're pretty excited about that. And then as it relates to the technological differences between optical and RF, I want to turn the call over to Michael Liebman.
John Mastrototaro: As it relates to the technological differences between optical and RF, I want to turn the call over to Michael Leabman, who's our CTO and founder of the company, who's the expert in this space, and let him reply to that aspect of the question.
Michael Leabman: Yeah. Thanks, John. I think first to add to what John said, we've migrated this technology from what was before 4 IC to a single IC. I think we also mentioned before, that's at 22 nanometers, which is really the cutting edge of what GlobalFoundries, our chip partner, has developed. That's really improved our sensitivity by going to that process as well as combining all of our chips into a single IC. Our unique approach, which we now feel like we have a great moat of patents around, really focuses on millimeter wave, which has a lot of advantages from optical. A lot of people have tried optical over the last 10 years with issues primarily related to skin thickness, freckles
Speaker 6: was before 4 ICs to a single IC. I think we also mentioned before that's at 22 nanometers which is really the cutting edge what global foundry our partner our chip partner has developed and that's really improved our sensitivity by going to that process as well as combining all of our chips into you know a single IC. You know our unique approach which
Speaker 6: you know, we now feel like we have a great moat of patents around, really focuses on millimeter wave, which has a lot of advantages from obstacle. And a lot of people have tried obstacle over the last 10 years with issues primarily related to skin thickness, freckles.
Michael Leabman: tattoos, anything that light typically has issues with. The millimeter wave, as you know, really has those advantages by not being affected by those forementioned things, as well as being able to be extremely small. Typically, optical will take some size. You can't cover it with millimeter wave. We can cover it with plastic and other things and really embed it into any wearable, including our ring in the future. Thanks, John.
Speaker 6: Tattoos, anything that light typically has issues with. The millimeter wave, as you know, really has those advantages by not being affected by those four mentioned things. As well as being able to be extremely small, typically optical will take some size.
Speaker 6: You can't cover it with millimeter weight. We can cover it with plastic and other things and really embed it into any wearable including our ring in the future. Thanks John .
J. Cogan: We actually have a couple more questions, follow-ups on this point. I'm going to go ahead and ask those. John and Michael, if you want to just decide who's going to answer. One question is, are we able to talk a little bit more about the composition of the studies? Where are we doing the studies? How many subjects will be in the studies, et cetera? Another question is, when do we expect to generate some data from these studies or other future studies that we can share more broadly?
Speaker 3: You know we actually have a couple more questions follow-ups on this point so I'm going to go ahead and ask those and John and Michael if you want to just decide who's going to answer but one question is are we able to talk a little bit more about the composition of the studies you know where are we doing the studies how many subjects will be in the studies etc.
Speaker 3: And then another question is, you know, when do we expect to generate some data from these studies or other future studies that we can share more broadly? Well, I'll start. Typically, we initiate trials in-house.
John Mastrototaro: Well, I'll start. Typically, we initiate trials in-house, feasibility studies, and we're able to bring, for blood pressure studies, for example, bring in 100 people from our local community in and evaluate them over the course of a few weeks when we're looking at blood pressure. We compare to a hospital-grade blood pressure system when we're making those measurements. When we get to the point of conducting our pivotal trials, we will do those with third parties that are unbiased, obviously, and we want to evaluate the data like that, the same way that we did with our heart rate and SpO2 study that we conducted near the end of last year. That's how we do that. Then I know there's a question about the number of people we evaluate and whatnot.
Speaker 4: feasibility studies and we're able to bring for blood pressure studies, for example, bring in a hundred people from our local community in and evaluate them over the course of a few weeks when we're looking at blood pressure. We compare to a hospital grade blood pressure system.
Speaker 4: when we're making those measurements. When we get to the point of conducting our pivotal trials, we will do those with third parties that are unbiased, obviously, and we want to evaluate the data like that. The same way that we did with our heart rate and SPO2 study that we conducted near the end of last year.
John Mastrototaro: For a pivotal trial for both probably glucose and blood pressure, you're looking at somewhere between 60 and 100 people participating in the trial. This will be Class 2 filings, 510. When we talk about these filings, typically on a 510, the FDA provides you feedback within 60 days of your filing. Then you work to answer any questions that they may have. If things go well, these can be cleared in three to four months. My last company I was with, this is after the start of COVID, we got two 510s cleared. One was done in 90 days, one in 108 days. Part of that depends upon how comprehensive your package is when you file it and the amount of questions that the agency may have in evaluating your filing.
Speaker 4: So that's how we do that. And then I know there's a question about the number of people we evaluate and whatnot. For a pivotal trial for both probably glucose and blood pressure, you're looking at somewhere between 60 and 100 people participating in the trial. This is a, will be class two filings, 510K. When we talk about these filings typically,
On a 510K, the FDA provides you feedback within 60 days of your filing, and then you work to answer any questions that they may have. If things go well, these can be cleared in three to four months. My last company I was with, and this is after the start of COVID.
We've got two 510Ks cleared. One was done in 90 days, one in 108 days. Part of that depends upon how comprehensive your package is when you file it and the amount of questions that the agency may have in evaluating your filing. I will pause there and see, Michael, do you have anything else you'd like to add? Yeah, I think the only thing to add there is, you know, we...
John Mastrototaro: I will pause there and see, Michael, do you have anything else you'd like to add?
Michael Leabman: Yeah, I think the only thing to add there is, we typically start in the lab in a controlled environment, so we can really start optimizing, which we are doing now, our algorithms, our antennas, and really perfect that before we go live with patients. That's usually the first step before we go with patients.
J. Cogan: Okay. I think the next question is probably for Tyla. How are you building awareness of Evie ahead of launch? How are most people discovering you?
How are you building awareness of Eevee ahead of the launch? How are most people discovering you?
Tyla Bucher: Yeah. Hi. CES was a really excellent ignition point for us, and we're continuing to build on that amazing organic press and awareness that we received following the announce of Evie. We're also continuing to amplify that sort of post-show momentum through a strong paid and organic social campaign that's currently running across multiple channels, and it's driving ongoing traffic to our site, and then these are leads that we're hoping to convert into emails that we can then retarget once we get ready for launch. In addition, we're seeing new growth on our social channels every day, not only with likes, but very positive comments and a lot of questions about when the device will be available.
Yeah, hi. So CES was a really excellent ignition point for us, and we are continuing to build on that amazing organic press and awareness that we received following the announcement of EV. We are also continuing to amplify that post show momentum through a strong paid and organic social campaign that is currently running across multiple channels. And it is driving ongoing traffic to our site. And then these are leads that we are hoping to convert into email.
Tyla Bucher: In addition to that, we're driving engagement through our 50,000-person-strong newsletter list, and we're really encouraging our early adopters not only to follow us on social, but to share the news and excitement of the brand with others in their network. Yeah, that's it.
and share the news and excitement of the brand with others in their network. And yeah, that's it.
J. Cogan: Thanks, Tyla. That's awesome.
J. Cogan: I'm going to turn it over to the operator. I see there is a question on the phone lines, and so we can do that first, then we'll come back to the webcast questions.
Thanks, Dyla. That's awesome. I'm going to turn it over to the operator. I see there is a question on the phone lines. So we can do that first, and then we'll come back to the webcast questions.
Operator 2: Our question is from Bruce Jackson with The Benchmark Company. Please proceed.
Our question is from Bruce Jackson with the Benchmark Company. Please proceed.
Bruce Jackson: Hi. Good morning, thank you for taking my questions. I wanted to focus on the system-on-a-chip study that's about to start. From the time that you start the study, how long do you think it's going to take to complete it and get the package ready for the FDA?
Hi, good morning and thank you for taking my questions. I wanted to focus on the system on a chip study that's about to start.
From the time that you start the study, how long do you think it's going to take to complete it and get the package ready for the FDA?
John Mastrototaro: Well, thanks for the question, Bruce. Typically, we evaluate somewhere between 50 to 100 folks when we first evaluate in our facility. In our upcoming study, we plan to have numbers in that range. It takes us about three weeks to collect that data. Now, after we get that data, after we evaluate how well our algorithms are measuring blood pressure, for example, we will then look to partner with a third party, and we have third parties in mind who would conduct the formal study for us. That formal study could take two to three months. Typically to put our package together for the FDA, because we're already putting together the package for the heart rate and SpO2, we've got the bones of a package set up.
Well, thanks for the question, Bruce. We evaluate somewhere between
50 to 100 folks when we first evaluate in our facility. In our upcoming study, we plan to have numbers in that range. It takes us about three weeks to collect that data. Now after we get that data and after we evaluate how well our algorithms are...
measuring blood pressure, for example, we will then look to partner with a third party, and we have third parties in mind, who would conduct the formal study for us. And that formal study could take two to three months.
And then typically to put our package together for the FDA, because we're already putting together the package for the heart rate and SPO2, we've got the bones of a package set up and naturally we're looking at some different form factors with this and obviously we've got a new clinical trial report. But overall, you're talking about a filing that would occur, assuming...
John Mastrototaro: Naturally, we're looking at some different form factors with this, and obviously, we've got a new clinical trial report. Overall, you're talking about a filing that would occur, assuming we have the appropriate level of clinical accuracy, a filing that would occur within two, three months of that. Then as we said before, the FDA review process can take another three to four months.
Bruce Jackson: Okay, great. With the glucose measurement specifically, what is the measurement that you're using, and do you have a target performance value that you're going after?
using and do you have like a target performance value that you're going after?
John Mastrototaro: Yeah, this is a great topic. First off, when we look at glucose, it is important for us to understand how this product is going to be used. In our clinical trials, we actually evaluate the product in people who have type 1 diabetes, and we recruit people who are on a continuous glucose monitor today. When we conduct those trials, we have the continuous CGM waveform. We also have intermittent finger sticks that are measured for glucose, and then we have our device. We've got all three of those, and our goal in those trials is to assess how well and how accurate we're able to track trends in glucose levels in these people with type 1 diabetes who have more lability in terms of glucose in general.
Yeah, this is a great topic. First off... Get that text out, wanna read?
When we look at glucose, it is important for us to understand how this product is going to be used. In our clinical trials, we actually evaluate the product in people who have type 1 diabetes, and we recruit people who are on a continuous glucose monitor today. So when we conduct those trials, we look at the products that are going to be used in the clinical trials.
We have the continuous CGM waveform. We also have intermittent finger sticks that are measured for glucose. And then we have our device. And so we've got all three of those. And our goal in those trials is to assess how well and how accurate we're able to
track trends in glucose levels in these people with type 1 diabetes who have more liability in terms of glucose in general. And so we may track them through the course of many hours, maybe after they've had a meal or they've delivered insulin, and we can track the changing glucose levels which may go from normal range up to an elevated level and then back down again and we want to evaluate whether we're able to...
John Mastrototaro: We may track them through the course of many hours, maybe after they've had a meal, or they've delivered insulin, and we can track the change in glucose levels, which may go from normal range up to an elevated level and then back down again. We want to evaluate whether we're able to track those changes. When we think about CGM devices on the market today in terms of accuracy, they all started with accuracies around 20% or 20-plus%. Dexcom and Abbott, who are maybe the gold standards today with accuracies within 8% of the truth. Dexcom, for example, started, I don't know, 15 years ago with 26% average errors, and Medtronic was at 21 and has gotten down to maybe 10 or nine. It's taken them many years to improve the accuracy from the 20s down to sub-10% average error.
for example, started 15 years ago with 26% average errors and Medtronic was at 21 and have gotten down to maybe 10 or 9. It's taken them many years to improve the accuracy from the 20s down to sub 10% average error. When we're evaluating our product we will not be although we are although we're testing
John Mastrototaro: When we're evaluating our product, although we're testing it in people with type 1 diabetes, our real focus in the future will be for people who have pre-diabetes or type 2 diabetes, not on insulin. The 1.5 people with type 1 diabetes, a million people, and the 4 million people who are type 2 on insulin, we're going to leave those folks to the Dexcoms, Abbotts, Medtronics of the world, and Senseonics. We're going to focus on the rank and file type 2 and pre-diabetes people who are many tens of millions of folks. What we're looking at in that population is really trying to identify major excursions in glucose levels, drawing people's attention to those excursions, helping them understand why they're occurring, and what they could do to mitigate those moving forward. That's a lot about what we're focused on.
We're going to leave those folks to the Dexcoms and Abbotts and Medtronics of the world and Senseonics. And we're going to focus on the rank and file type 2 and prediabetes people who are many tens of millions of folks. What we're looking at in that population is really trying to identify major excursions in glucose levels. You've seenolphakif, I mean he had other survey done to continue to diagnose betterlast series and because of the age issues of hormones, he decided to finish off his student prison two months before the
drawing people's attention to those excursions, helping them understand why they're occurring and what they could do to mitigate those moving forward. That's a lot about what we're focused on. And so accuracy—
John Mastrototaro: Accuracy is going to be something that needs to allow us to be able to detect those excursions, and we will be working with the agency the same way I did 20-plus years ago when we got the first CGM cleared through the agency. I am expecting that accuracy will not be equivalent to where the current invasive sensors have gotten, but they will be closer to where they used to be. Their utility will be really focused on people with type 2 or pre-diabetes, or folks who do not have even that at all, but just want to make sure that they are living an appropriate lifestyle so that they do not become someone with type 2. I hope that answers the question, Bruce.
is going to be something that needs to allow us to be able to detect those excursions. And we'll be working with the agency the same way I did.
20 plus years ago when we get the first CGM cleared through the agency. But I'm expecting that accuracy will not be equivalent to where the current invasive sensors have gotten, but they'll be closer to where they used to be and their utility will be really focused on people with type 2 or pre-diabetes.
or folks who don't have even that at all but just want to make sure that they're living an appropriate lifestyle so that they don't become someone with type 2. So I hope that answers the question Bruce. It does and congratulations on all of the progress and thank you again for taking my questions. Thanks Bruce.
Bruce Jackson: It does. Congratulations on all of the progress, and thank you again for taking my questions.
John Mastrototaro: Of course.
J. Cogan: Thanks, Bruce. Operator, let's go back to the webcast Q&A. Stacy, I think the next question or two can be for you. What are the goals for these product partnerships that you've launched? Can you tell us a little bit more about the Evie user experience? How are you differentiating Evie from the competition?
Operator, let's go back to the webcast Q&A. Stacey, I think the next question or two can be for you. What are the goals for these product partnerships that you've launched? And can you tell us a little bit more about the Eevee user experience? How are you differentiating Eevee from the competition?
Stacy Salvi: Sure. Thanks, Jay. I'll start with the first question. Just initially, the goals for the product partnerships are really just to expand our pool of testers to make sure everything is working as expected and as best as possible. More fundamentally, there's really a rich landscape for us when it comes to product partnerships. Of course, partners want to look at what we're building and conceptualize it, how it fits in with their offering. This reflects not just consumer retail interest, but very importantly, how the Evie Ring can serve as a complement to existing in-market medical solutions. This doesn't only raise user awareness of their own biometrics, but specifically enhances the efficacy of current treatments. Really, this is a win-win-win, right? It provides us with a robust partner channel. It provides partners with an innovation and growth story.
possible. But more fundamentally, there's really a rich landscape for us when it comes to product partnerships.
Course partners want to look at what we're building and conceptualize it, how it fits in with their offering. And this reflects not just consumer retail interests, but very importantly, how the EZ Ring can serve as a complement to existing in-market medical solutions.
This doesn't only raise user awareness of their own biometrics, but specifically enhances the efficacy of current treatment. And really this is a win-win-win, right? It provides us with a robust partner channel.
Stacy Salvi: Of course, most importantly, it provides end users with a better chance at improved health outcomes. I guess I'll go ahead and jump right into the second question. The second question was about how we're differentiating from competitors. This is probably one of my favorite questions, in fact. Fundamentally, when we think about competitors in the space, we have a lot of the same metrics and all of the same metrics that they have brought to market. We really differentiate out of the gate by ensuring that the device is medical grade. We know that accuracy is something that has been difficult for consumers in the past. Yeah, trend data is helpful, but we really want to make sure that we are providing the best in metrics. Of course, also really important is that form factor.
It provides partners with an innovation and growth story. And of course, most importantly, it provides end users with a better chance at improved health outcomes.
And then I guess I'll go ahead and jump right into the second question. The second question was about how we're differentiating from competitors.
This is probably one of my favorite questions, in fact. But fundamentally, when we think about competitors in this space, we have a lot of the same metrics and all the same metrics that they have brought to market. But we really differentiate out of the gate.
by ensuring that the device is medical grade. So we know that accuracy is something that has been difficult for consumers in the past. And, yeah, trend data is helpful, but we really want to make sure that we are providing the best in metrics. And then, of course, also really important is that form factor.
Stacy Salvi: The form factor being slightly flexible, fits over the finger without discomfort. It accommodates for swelling over the course of a day or over a month. The charging case is a major delighter that goes without saying. The experience itself is really aimed at insights and meeting the user where she is in any given day, rather than that standard 10,000 steps a day, which we all know and love, but I think doesn't appeal to a majority of consumers.
The form factor being slightly flexible, fits over the finger without discomfort. It accommodates for swelling over the course of a day or over a month. And then the charging case is a major delighter that goes without saying. So the experience itself.
is really aimed at insights and meeting the user where she is in any given day rather than kind of that standard 10,000 steps a day, which we all know and love, but I think doesn't appeal to a majority of consumers. Great, thanks, Stacey.
J. Cogan: Great. Thanks, Stacy.
Stacy Salvi: Sure.
J. Cogan: We have a couple questions related to the launch of Evie. John, maybe you can start, and if anybody else wants to add as well. One has to do with, just getting some clarification again, if we're going to file for the, or if we've already filed for FDA clearance for the Evie Ring, has that actually happened yet? Will it be a class 1 or a class 2 filing? Would we launch Evie in the summer without the FDA approval? How long do you think it'll take to get an answer from the FDA? I know, John, you covered some of this already, but just maybe just to reiterate that. Also along the same lines, what other major tasks beyond an FDA filing are still to be completed prior to launch?
We have a couple questions related to the launch of the EV. John , maybe you can start, and if anybody else wants to add as well. One has to do with if we're going to file, just getting some clarification again, if we're going to file for the, or if we've already filed.
for FDA clearance for the EV ring, has that actually happened yet? Will it be a Class I or Class II filing? Would we launch EV in the summer without the FDA approval? How long do you think it'll take to get an answer from the FDA? I know, John , you covered some of this already, but just maybe just to reiterate that. And then also along the same lines,
you know, what other major tasks beyond an FDA filing are still to be completed prior to launch? All right. There's several questions in there, but let me start at the beginning. We have not filed yet with the FDA. We're planning to file this spring. Be clear about your
John Mastrototaro: All right. There's several questions in there. Let me start at the beginning. We have not filed yet with the FDA. We're planning to file this spring. Once we file, it will be a 510 class 2 device. There were many pulse oximeters on the market that were cleared to provide heart rate and SpO2. That's what we're going after with the first filing. I expect to get some feedback from the agency within 60 days after the filing. If things go well, I would expect a clearance within three to four months.
Once we file with it, it will be a 510k class 2 device. There were many pulse oximeters on the market that were clear to provide heart rate and sp02 and that's what we're going after with the first filing.
I expect to get some feedback from the agency within 60 days after the filing and if things go well I would expect a clearance within three to four months. If for some reason the FD has more questions about a product like this, which is new in terms of form factor and it takes longer, we are prepared to launch the product.
John Mastrototaro: If for some reason the FDA has more questions about a product like this, which is new in terms of form factor, and it takes longer, we are prepared to launch the product as a wellness device first, and then later on, assuming we do gain FDA clearance, we would then at that point, be able to have an announcement to that effect at a later date. That's our current strategy. At this juncture, if things go according to plan, we do think that the timing of an FDA clearance may work out very well with where we are with setting up all the manufacturing we mentioned earlier in the call, getting that established and ready to go for the launch. That's that process. I guess the second part of that question may be any risks associated with the product coming to the market.
wellness device first and then later on when we do if assuming we do getting FDA clearance we would then at that point be able to have an announcement to that effect at a later date. So that's our current strategy at this juncture if things go according to plan.
we do think that the timing of an FDA clearance may work out very well with where we are with setting up all the manufacturing we mentioned earlier in the call, getting that established and ready to go for the launch. That's that process. Then, I guess the second part of that question may be any risks associated with the product coming to the market.
John Mastrototaro: We have a very talented contract manufacturing firm we're working with, and they're a large firm. They've done this before. Our product will be manufactured in a medical device manufacturing facility. We feel pretty confident that we are developing the right processes to be able to manufacture the product in large quantities. We also have done a really great job in terms of sourcing the raw materials that we need. We have an incredibly seasoned VP of operations who, from day one, was really focused on supply chain, recognizing the Shipageddon challenges that persisted through the course of COVID. We feel like we're in a really good place as it relates to all of the components.
talented contract manufacturing firm we're working with and they're a large firm. They've done this before. Our product will be manufactured in a medical device manufacturing facility and so we feel pretty confident that we are developing the right processes to be able to manufacture the product.
in large quantities. We also have done a really great job in terms of sourcing the raw materials that we need. We have an incredibly seasoned VP of operations who from day one was really focused on supply chain, recognizing the chippagettin challenges that persisted through the course of COVID.
John Mastrototaro: As we continue to execute the way we have before, and we've got a very seasoned team, I don't see at this moment anything that's going to cause us to have a problem as it relates to our ability to execute and get this product out in the summer.
we feel like we're in a really good place as it relates to all of the components and so you know as we if as we continue to execute the way we have before and we've got a very seasoned team I don't see at this moment anything that's going to cause us to have a problem as it relates to our ability to execute and get this product out in the summer.
J. Cogan: Great. Thanks, John. We've got a couple more, and I can probably take those, at least from the webcast, and then maybe operator will see if there's any more on the phones. One question is, what unit production capacity are we planning for the initial summer launch of the ring? As we have mentioned on numerous occasions, we're not going to provide financial guidance, but I think as you heard in John's comments just now and also how we were kind of characterizing this in the script for today, we're going to be well prepared in terms of parts and capabilities to deliver thousands and thousands of units initially. We have plans for how we think that this is going to play out from an overall demand standpoint. We're getting positioned for that. We feel good about it, and we're looking forward to the launch, obviously.
Great. Thanks, John .
We've got a couple more, and I can probably take those at least from the webcast, and then maybe operator will see if there's any more on the phones.
One question is, what unit production capacity are we planning for the initial summer launch of the ring? As we have mentioned on numerous occasions, we're not going to provide financial guidance, but I think as you heard in John's comments just now and also how we were kind of characterizing this in the script for today.
we're going to be well prepared in terms of parts and capabilities to deliver, you know, thousands and thousands of units initially, and we have plans for how we think that this is going to play out from an overall demand standpoint. So, you know, we're getting positioned for that, we feel good about it, and...
J. Cogan: Another question about when we might be able to announce the partners' names for both studies, or I guess betas this questioner is referring to. We've announced the partners that we can thus far. Obviously, we'd like to be able to announce more partners as we move through time, and certainly as soon as we're able to, we will keep you posted. As we have mentioned, we've been working with Stanford and their athletic department. We're working with Novant Health, who is an integrated health network down in the Southeast, in the Carolinas and Georgia. They have 6 million annual patient visits a year. They generate $7 billion in revenue. We're working with three global medical device companies, one major pharmaceutical company, one global athletic apparel retailer, which we announced today as well.
We're looking forward to the launch, obviously. And then another question about when we might be able to announce the partners' names for both studies, or I guess betas this questioner is referring to. We've announced the partners that we can thus far. We'd like to be able to announce more partners as we move through time.
And certainly as soon as we're able to, we will keep you posted. As we have mentioned, we've been working with Stanford and their athletic department. We're working with Novant Health, who is an integrated health network down the southeast in the Carolinas and Georgia. They have six million annual patient visits a year. They generate seven billion in revenue. And we're working with three global...
medical device companies, one major pharmaceutical company, one global athletic apparel retailer, which we announced today as well. And so that pretty much fills out the others that we are working with.
J. Cogan: That pretty much fills out the others that we are working with. Finally, at least in terms of the webcast questions, there's a question about future capital raising and all that. The question says, first COVID, then supply shocks, inflation, and now banks in crisis mode. How does this affect your efforts to raise capital as you look out over the next six to 12 months? Well, obviously, we've been navigating some choppy macro waters, and as noted earlier in the call, we have no material exposure to Silicon Valley Bank or the regional banks in general. We're working with multiple multinational banks to help mitigate these types of systemic risks, as we mentioned earlier. In regards to future financings, I guess what we'd say is that we have several catalysts in front of us.
And then finally, at least in terms of the webcast questions, there's a question about, you know, future capital raising and all that. The question says, first COVID, then supply shocks, inflation, and now banks in crisis mode. How does this affect your efforts to raise capital as you look out over the next 6 to 12 months?
Well, obviously we've been navigating some choppy macro waters and as noted earlier in the call, we have no material exposure to Silicon Valley Bank or the regional banks in general. We're working with multiple multinational banks to help mitigate these types of systemic risks as we mentioned earlier.
In regards to future financings, I guess what we'd say is that we have several catalysts in front of us. Obviously, going from pre-revenue to revenue is a big deal with the launch of the EV ring. We're very excited about that. We're also partnering, as noted on multiple occasions now on this call, with seven major players across health and consumer.
J. Cogan: Obviously, going from pre-revenue to revenue is a big deal with the launch of the Evie Ring. We're very excited about that. We're also partnering, as noted on multiple occasions now on this call, with seven major players across health and consumer in regards to our betas, which is quite exciting for us and shows there's a lot of interest in what we're doing. We'll also be filing for our first FDA clearances, as we talked about, this spring. We're looking forward to bringing this wearable medical device to the market, which will certainly be a differentiator. Obviously, we're moving forward with our single chip clinical studies, as we talked about earlier as well, trying to solve for the holy grails of glucose monitoring on a non-invasive basis and blood pressure monitoring without a cuff.
in regards to our betas, which is quite exciting for us and shows there's a lot of interest in what we're doing. We'll also be filing for our first FDA clearances, as we talked about, this spring. And we're looking forward to bringing this wearable medical device to the market, which will certainly be a differentiator. And then obviously we're moving forward with our single-chip clinical studies as we talked about.
J. Cogan: We've had great support from our investors to date, obviously, and we're just focused on what's in our control and executing. We know that we're obviously going after quite a significant opportunity. Okay, let's see. Operator, are there any more questions from the phone lines?
in executing and we know that we're obviously going after quite a significant opportunity.
Okay, let's see. Operator, are there any more questions from the phone lines? There are no more further questions at this time.
Operator 2: There are no more further questions at this time.
J. Cogan: Okay. Well, I think that pretty much wraps it up for us for today. Thank you for your time, everyone. As 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.
Okay, well I think that pretty much wraps it up for us for today. Thank you for your time everyone. As 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.
Operator 2: Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.
Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.
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