Q2 2024 Movano Inc Earnings Call
unknown: John Mastrototaro, John Mastrototaro, John Mastrototaro, John Mastrototaro, John Mastrototaro, John Mastrototaro, John Mastrototaro, [inaudible]. .. .. .. .. .. .. .. ...
Operator: John Mastrototaro, John Mastrototaro, John Mastrototaro, [inaudible] Greetings and welcome to Movano Health's Q2 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Jay Cogan, Chief Financial Officer. Thanks, Operator. Good afternoon, everyone.
Greetings and welcome to
Speaker Change: Movano Health Q2 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode.
Speaker Change: A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.
Jay Cogan: And thank you for joining us today. Movano Health CEO John Mastrototaro will open today's call with prepared remarks about the progress the company made during the second quarter of 2024 and in recent weeks. Our CMO, Tyla Bucher, will provide some remarks on the company's upcoming D to C plans, followed again by John, and then I'll provide highlights on the company's quarterly operating results and current financial position. Then we'll open the call for Q&A.
Jay Cogan: John, Jay, and Tyla will be joined by our Chief Technology Officer and Founder, Michael Leabman, Chief Commercial Officer, Michael Soule, and Vice President of Product and Strategy, Stacy Salvi. Movano Health issued a news release this afternoon detailing its second quarter 2024 financial results. Before we begin, I'd like to remind everyone that the company will make forward-looking statements during today's call based on current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties, and actual results may be materially different from those expressed.
Then we'll open the call for Q&A, John J in Thailand will be joined by our Chief Technology Officer, and founder Michael Liebman, Chief Commercial Officer, Michael and Vice President of product strategy Stacey Saudi.
Speaker Change: Novato Health issued a news release this afternoon detailing second quarter 2024 financial results.
Jay Cogan: These risks and uncertainties are detailed in the risk factors section of Movano Health's filings with the Securities and Exchange Commission, specifically in the company's forms 10-Q and 10-Q. 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 regard to those events, conditions, and circumstances. With that, I'll turn the call over to our CEO, John Mastrototaro. Good afternoon, everyone.
Speaker Change: Before we begin I'd like to remind everyone that the company will make forward looking statements. During today's call are based on current expectations whether.
Speaker Change: Whether in prepared remarks or during the Q&A session. These forward looking statements are subject to inherent risks and uncertainties and actual results may be materially different from such statements. These risks and uncertainties are detailed in the risk factors section of mobile health filings with the Securities and Exchange Commission.
Speaker Change: Typically in the company's forms 10-Q, and 10-K, except as otherwise required by federal Securities laws Novato 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.
Speaker Change: That I will turn the call over to our CEO John Masters Charl.
Speaker Change: Good afternoon, everyone. Since we last reported earnings in May we have been working diligently to prioritize the efficient use of our recent capital infusion, while continuing to make progress on our key business initiatives as follows.
John Mastrototaro: Since we last reported earnings in May, we have been working diligently to prioritize the efficient use of our recent capital infusion while continuing to make progress on our key business initiatives, such as preparing for the expansion of the direct-to-consumer launch at EV Ring and taking orders again starting September 17. Continuing to work with the FDA to secure 510k clearance for the EV med ring, delivering our first B2B commercial opportunities with healthcare partners, and lastly, preparing for upcoming blood pressure and glucose clinical trials using the most recent iteration of our wearable device incorporating our proprietary RF solution. We continue to be judicious with our capital and methodical in our approach to building out our direct-to-consumer and business-to-business market opportunities.
Speaker Change: Preparing for expansion of the direct to consumer launch at EV rang and taking orders again starting September 17th.
Speaker Change: Continuing to work with the F D. A to secure a five 10-K clearance for the E V Med ring.
Speaker Change: Delivering our first beta be commercial opportunities with health care partners.
Speaker Change: And lastly, preparing for upcoming blood pressure and glucose clinical trials using the most recent iteration of our wearable device incorporating our proprietary RF solution.
Speaker Change: We continue to be judicious with our capital and methodical in our approach to building out our direct to consumer and business to business market opportunities.
John Mastrototaro: I will provide an update on our progress with the FDA and preparations for the B-to-B launch of EVMed and will then turn the call over to our CMO, Tyla Bucher, to discuss plans for the D-to-C business, including our plan to begin taking orders again and shipping product in September. In preparation for the launch of EV-Med, we're working closely with the FDA to secure 510K clearance. As we highlighted in a press release last week, we plan to meet with the FDA this month. You'll recall the EVMed ring is designed to not only provide medical device functionality with its pulse oximetry feature but also offer numerous wellness metrics related to sleep activity and logging of mood, energy, and health symptoms.
Speaker Change: I will provide an update on our progress with the FDA and preparations for BTB launch it he be met and will then turn the call over to our CMO pilot Bucharest, you discussed plans for the D to C business, including our plan to begin taking orders again and shipping product in September.
Speaker Change: In preparation for the launch of D V. Med, we're working closely with the F D. A to secure a five 10-K clearance.
Speaker Change: That'd be highlighted in a press release last week, we plan to meet with the FDA. This month.
Speaker Change: You'll recall the E V. Med ring is designed to not only provide medical device functionality with its pulse oximetry feature but also offered numerous wellness metrics related to sleep activity and logging of mood energy and health symptoms.
Subsequent to our April five 10-K filing in May and early June the FDA review team requested two minor clarification Android teen promptly responded.
John Mastrototaro: Following our April 510K file, in May and early June, the FDA review team requested two minor clarifications, and our team promptly responded. In late June, the FDA review team requested some additional information related to the wellness aspects of EV med. Along with our regulatory advisors, Movano Health provided a draft response to the FDA's questions on July 10th and requested a meeting with the agency to review our draft response, which is now scheduled, as noted earlier.
Speaker Change: In late June the FDA review team requested some additional information related to the wellness aspects of EV met.
Mcdonnell help: Along with our regulatory advisors Mcdonnell help provided a draught response to the Fda's questions on July 10, and requested a meeting with the agency to review our draught response, which is now scheduled as I noted earlier.
John Mastrototaro: We look forward to meeting with the FDA and working towards resolving this issue in order to move forward with the review process. We remain steadfast in our commitment to the opportunity EVMED could unlock, given the clinical evidence provided as part of the filing related to the pulse proximity feature and our desire to work collaboratively with the agency. With regard to the BV opportunity, we have three new B2B commercial opportunities to highlight for you today.
Mcdonnell help: We look forward to meeting with the FDA and working towards resolving this issue in order to move forward with a review process.
Mcdonnell help: We remain steadfast in our commitment to the opportunity he met could unlock given the clinical evidence provided as part of the filing related to the pulse oximetry feature and our desire to work collaboratively with the agency.
Speaker Change: With regard to the be the opportunity we have three new beta be commercial opportunities to highlight for you today.
John Mastrototaro: In anticipation of an expected 510K clearance, we are engaged with two global pharmaceutical companies that could leverage EVMed in building unique solutions for both clinical and consumer applications. In the first case, we are in the agreement phase for a program that could begin in late 2024 and, assuming success, would be expected to develop into a larger commercial opportunity in 2025. In the second case, EVMed is expected to be evaluated this fall by a Tier 1 global pharmaceutical company for a clinical trial that is scheduled to commence in 2025.
Speaker Change: In anticipation of an expected five 10-K clearance we are engaged with two global pharmaceutical companies that could leverage EV bed and building unique sleep solutions for both clinical and consumer applications.
Speaker Change: In the first case, we are in the agreement phase for a program that could begin in late 'twenty 'twenty four and assuming success would be expected to develop into a larger commercial opportunity in 2025.
Speaker Change: In the second case EV Mad is expected to be evaluated this fall by a tier one global pharmaceutical company for a clinical trial that is scheduled to commence in 2025.
John Mastrototaro: We are also engaged with a large payer looking to better manage high-risk populations utilizing eVMED. This opportunity is expected to kick off around the new year, and, assuming a positive outcome, the commercial opportunity could build into 2025. All three of these strategic partners, as well as the others in our funnel, see EVMed as a game-changing solution that is not currently available in the market. This is in addition to our recent announcement of the partnership with the Taal Research Group at MIT to use EV rings for its maestro clinical study on the long-term health impacts of Lyme disease and COVID.
Speaker Change: We are also engaged with a large payer looking to better manage high risk populations utilizing easy met.
Speaker Change: This opportunity is expected to kick off around the new year, and assuming a positive outcome the commercial opportunity could build into 2025.
Speaker Change: All three of these strategic partners as well as the others in our funnel the E V med as a game changing solution that is not currently available in the market.
Speaker Change: This is in addition to our recent announcement of the partnership with the tall Research group at M. I T C U.
Speaker Change: E V rang spirits Maestro clinical study on the long term health impacts of Lyme disease and long Covid.
Speaker Change: To explain these health care opportunities in more depth. We recently hosted our first virtual event titled B to B. The next Wearables boom, we're managing director of a Lille capital, Matt Hughes moderated a panel that included myself, our chief commercial officer, Michael Soul.
John Mastrototaro: To explain these healthcare opportunities in more depth, we recently hosted our first virtual event titled B2B, The Next Wearable Boom, where Managing Director of Allele Capital, Matt Hughes, moderated a panel that included myself, our Chief Commercial Officer, Michael Soule, and Stanford Cardiologist, Dr. Fatima Rodriguez. During the event, we identified and discussed the significant B2B possibilities that could be unlocked specifically for clinical trials and remote patient monitoring following As you'll recall, the clinical trials market we seek to address consists of pharmaceutical companies that need to gather data from FDA-cleared devices as part of their drug trials for FDA and other regulatory submissions. We've identified the TAM for FDA-cleared wearables in this market to be as much as $5 billion annually. Currently, trials are often cumbersome, expensive, and suboptimal, requiring in-person checkups which can result in poor compliance.
Fatima Rodriguez: And Stanford Cardiologists Doctor Fatima Rodriguez.
Speaker Change: During the event, we identified and discussed the significant b to b possibilities that could be unlocked specifically for clinical trials and remote patient monitoring following a five 10-K clearance.
Speaker Change: As Youll recall, the clinical trials market, we seek to address consists of pharmaceutical companies that need to gather data from FDA cleared devices as part of their drug trials for FDA and other regulatory submissions.
Speaker Change: We've identified the Tam for FDA cleared wearables in this market to be as much as 5 billion annually.
Speaker Change: Currently browser offering cumbersome expensive and suboptimal requiring in person checkups, which can result in poor compliance.
John Mastrototaro: We believe EVMED's unique offering and design aesthetic would improve compliance, lower costs significantly, and enable quicker enrollment, better data, and improved quality of results. Three examples I highlighted a few minutes ago speak to this need, and we are aggressively pursuing opportunities across clinical trials and post-market surveillance. The Remote Patient Monitoring, or RPM, market barely existed four years ago.
Speaker Change: We believe E V med unique offering and design aesthetic would improve compliance lower cost significantly and enable quicker enrollment better data and improved quality of results.
Speaker Change: The three examples I highlighted a few minutes to go speak to this need and we are aggressively pursuing opportunities across clinical trials and post market surveillance.
Speaker Change: The remote patient monitoring or R. P M market barely existed for years ago. However, COVID-19 unlocked the reality that our P. M can reduce the need for in office visits expand access and reduce costs. We believe D V med will be able to automate the collection of more complete and accurate data, resulting in an <unk>.
John Mastrototaro: However, COVID unlocked the reality that RPM can reduce the need for in-office visits, expand access, and reduce costs. We believe EVMed will be able to automate the collection of more complete and accurate data, resulting in an RPM solution with meaningful advantages over existing RPM products on the market today. During our conversation, Dr. Rodriguez also validated the need for RPM in her role as a physician, which would enable her to manage her patients between visits and easily identify patterns.
Speaker Change: P M solution with meaningful advantages over RPM products on the market today.
Speaker Change: During our conversation Doctor Rodriguez also validated the need for RPM in her role as a physician, which would enable her to manage our patients in between visits and easily identified patterns.
John Mastrototaro: We recently completed beta testing of our wearable technology with a leading US RPM company that serves over 450 healthcare organizations and is the exclusive platform for one of the largest medical device companies in the world. In anticipation of these partnerships and more, we are preparing our back-end operations to be able to meet our partners' requirements, including positioning the company to scale efficiently, establishing app and labeling modifications to support a medical device, and building our API and data sharing framework. I will now turn it over to our CMO, Tyla Bucher, to provide an update on our D2C plans for the EV ring. Thanks, John.
Speaker Change: We recently completed beta testing, our wearable technology with a leading U S. R. P. M company that serves over 450 health care organizations.
Speaker Change: As the exclusive platform, but one of the largest medical device companies in the world.
Speaker Change: In anticipation of these partnerships and more we are preparing our backend operations to be able to meet our partners' requirements, including positioning the company to scale efficiently, establishing app and labeling modifications to support a medical device and building, our API and data sharing framework.
Speaker Change: I will now turn it over to our CMO title Aboukir to provide an update on our D to C plants for the E V Ray.
Aboukir: Thanks, John as you all know we've been out of stock on the EV ranks since Q1, and we've been using this time to implement a series of improvements for our existing and prospective customers, including operational and delivery timelines better and more accurate rain functionality best in class customer service and finalizing some new and necessary features from them.
Tyla Bucher: As you all know, we've been out of stock on the EV ring since Q1, and we've been using this time to implement a series of improvements for our existing and prospective customers, including operational and delivery timelines, better and more accurate ring functionality, best-in-class customer service, and finalizing some new and necessary features. From an operations standpoint, we improved production yield and cycle time, as well as our logistics and warehouse management systems. This will result in greater efficiency on the production floor and allow us to keep more accurate real-time track of inventory and the flow of orders. From a software perspective, we updated our Ring algorithm, improving accuracy across sleep and wake times, sleep stages, heart rate measurements during activity, and steps.
Aboukir: Operation standpoint, we improved production yield and cycle times as well as higher logistics and warehouse management system. This will result in greater efficiency on the production floor and allowed us to keep more accurate real time tracking of inventory and the flow of orders.
Speaker Change: From a software perspective, we updated our rain algorithms improving accuracy across sleep and wake time sleep stages heart rate measurements rang up activity in stack. In addition, we expanded our proprietary AI generated insights engine with hundreds of new insights for either customized for their individual wellness journey and informed by a combination of tracks and log data.
Tyla Bucher: In addition, we expanded our proprietary AI-generated Insights Engine to include hundreds of new insights for our users, customized for their individual wellness journey and informed by a combination of tracked and logged data. An example of one of our newer insights would be that when you beat your average steps by more than a thousand, you tend to report a better mood. Regarding customer service, we built out a new team of representatives with a combined 25 plus years of service in the direct-to-consumer space who have a solid understanding of the pace and real-time knowledge delivery that a product like ours requires.
Speaker Change: An example of one of our newer insights would be when you'd be your average steps by more than a thousand you tend to report a pattern yet.
Speaker Change: Regarding customer service, we built out a new team of representatives with a combined 25 plus years of service and attract the consumer space, who have a solid understanding of the pace and real time knowledge delivery that a product like ours required.
Tyla Bucher: This team is currently responding live to all inquiries within 48 hours and has drafted a comprehensive library of useful articles and tips and tricks that can be shared with eV-Ring consumers as they work through any issues together, or the customers can use to self-serve if they prefer. In addition, these articles feed into our AI-powered chatbot, who can mitigate many easily solvable issues and get smarter as it ingests both the inquiries and our information, responding quickly and accurately to customers in a friendly and native language. In addition to all these enhancements, we are also working on an auto-activity detect workout feature that will allow you to understand that you're working out even if you have not started a workout on the app.
Speaker Change: Its team is currently responding lives all inquiries within 48 hours and it's drafted a comprehensive library of useful articles and tips and tricks that can be shared with you here in consumers as they work through any issues together or the customers can use to self serve if they prefer.
Speaker Change: These articles feed into our AI powered chatbot, who can mitigate many easily solvable issues and get smarter as it and Jeff both the increase and our information responding quickly and accurately to customers and friendly in native language.
Speaker Change: In addition to all of these enhancements. We are also working on an auto activity detect workout feature which will allow you to understand that you're working out even if you have not started to work out on the App and following the work out we'll be able to provide you with your resolved users will also be able to modify the he tells us that our workout after the fact.
Tyla Bucher: And following the workout, we'll be able to provide you with your results. Users will also be able to modify the details of their workout after the fact. And finally, we expect to have an Android version of the app ready for our prospective Android users, of which there are quite a few, to purchase by Black Friday in November of this year. We are pleased to announce that we'll be back in stock on September 17th. This is the post-summer season and the time when consumers begin turning their attention to the holidays and gift-giving.
Speaker Change: Finally, we expect to have an Android version of the App ready for a prospective Android users of which there are quite a few just purchased by Black Friday in November of this year.
Speaker Change: We are pleased to announce that we'll be back in stock on September 17th. This is total summer season and time for when consumers begin turning our attention to the holiday and gift, giving we have a full paid and organic social campaign prepare to support our launch which includes influencer and user generated content across Instagram Facebook Youtube and kicked off as well as Google search and shop, we also have herb.
Tyla Bucher: We have a full paid and organic social campaign prepared to support our launch, which includes influencer and user-generated content across Instagram, Facebook, YouTube, and TikTok, as well as Google Search and Shop. We also have a robust email lead list that has grown exponentially with consumers ready to buy, and we will be engaging them with a comprehensive outreach strategy. And we have a satellite press tour lined up with key tech and consumer press, as well as a pitch campaign for holiday gift guides across print and television.
Speaker Change: Email leads last it has grown exponentially if consumers ready to buy and we will be engaging them with a comprehensive outreach strategy and we have a satellite pressler a lineup of key tacking consumer press as well as the pitch campaign for holiday gift guide across print and television.
Tyla Bucher: And finally, we couldn't be more excited to share the introduction of our brand partnership with digital creator, wife, mom, and entrepreneur, Heidi D'Amelio. Heidi has been using the EV ring for several months and has really become a true fan. Allied with our mission of empowering women with better data and insights to help them live healthier lives, we have formed a strategic partnership with Heidi where we'll continue to grow the brand, drive awareness around women's health, and improve the ring experience together. We couldn't be more excited to welcome Heidi to the EV family.
And finally, we couldn't be more excited to share the introduction of our brand partnership with digital creator why mom and entrepreneur how do you familiar.
And he has been using the easier inked for several months and really become a true fan aligns with our mission of empowering women with better data and insights to help them live healthier lives. We have formed a strategic partnership with Heidi, where we will continue to grow their brands drive awareness around women's health and improves the range experience together, we couldn't be more excited to welcome hydro that AEP family.
John Mastrototaro: As you can see, we've been working around the clock to get the ring back in the hands of consumers, and we truly believe it will be worth the wait. And with that, I'll turn things back over to John. Thanks, Tyla.
Speaker Change: As you can see we've been working around the clock to get the rig back in the hands of consumers are we truly believe it will be worth the wait.
Speaker Change: With that I'll turn things back over to John.
Speaker Change: Yeah.
John: Thanks, Tyler as you are aware our product development plan extends far beyond E D and E be met we are deeply invested in multi analyte sensing and pursuing additional FDA clearances with further research and respiration rate core temperature and a solution to address sleep disturbances.
John Mastrototaro: As you are aware, our product development plan extends far beyond EV and EV med. We are deeply invested in multi-analyte sensing and pursuing additional FDA clearances with further research in respiration rate, core temperature, and a solution to address sleep disturbance. Some of these metrics may only require a software update, while others may require new hardware components or potentially different form factors.
Speaker Change: Some of these metrics may only require a software update while others may require new hardware components for potentially different form factors.
John Mastrototaro: We are in the planning stages now for several clinical trials related to these valuable analytes. As a follow-on to the successful blood pressure study we conducted in Q4-23, we completed our most recent blood pressure clinical study in June, which included the use of an arterial blood pressure line. We learned a great deal about improved ways to collect data, and we'll be redesigning for the next study with better placement of the sensors on the body to maximize their utility.
Speaker Change: We are in the planning stages now for several clinical trials related to these valuable analytes.
Speaker Change: A follow on to the successful blood pressure study, we conducted in Q4 23.
Speaker Change: We completed our most recent blood pressure clinical study in June which included the use of an arterial blood pressure line, we learned a great deal about improved ways to collect data and we'll be redesigning for the next study with bladder better placement of the sensors on the body to maximize their utility. We're also in the process.
John Mastrototaro: We're also in the process of designing a more consumer-friendly form factor as we focus on commercializing the solution. We will continue to develop this into Q4 with another study plan before year-end. In summary, we remain committed to improving health monitoring through the introduction of additional analyte sensing, including blood pressure and glucose, using our millimeter wave radio frequency and AI technology. With that, I'll now hand the call over to Jay for the financial report.
Speaker Change: Of designing a more consumer friendly form factor as we focus on commercializing the solution. We will continue to develop this into Q4 with another study planned before year end.
Speaker Change: In summary, we remain committed to improving health monitoring through the introduction of additional analyte sensing, including blood pressure and glucose using our millimeter wave radio frequency and AI technology.
Speaker Change: With that I'll now hand, the call over to Jay for the financial review.
Jay: Thanks, John.
John Mastrototaro: Thanks, John. We shipped 1,837 EV rings in the second quarter of 2024 as we completed fulfillment of our initial launch phase. You recall that we shipped approximately 5,300 rings in the first quarter and stopped taking orders and then said we're a given capital market king dish. The company did not report any revenue for the second quarter as previously deferred revenue was offset by receipts.
Jay: We shipped 1837 rigs in the second quarter of 2024, as we completed fulfillment of our initial launch phase.
Jay: You'll recall that we shipped approximately 5300 rings in the first quarter and stopped taking orders in that February given capital market conditions.
Speaker Change: These are not recording revenue for the second quarter as previously deferred revenues offset by refunds.
Jay Cogan: As we noted earlier in the call, we expect to begin taking orders and shipping rings again in September. We plan to have ample inventory prior to taking orders again in September. And, as Tyla highlighted, we have made important strides across product, manufacturing, and customer service that should position us well for both an expanded launch of the EV ring in D2C and the eventual launch of EV med in B2B upon FDA clearance.
Speaker Change: As we noted earlier in the call we expect to begin taking orders and shipping rings again in September.
Speaker Change: We plan to have ample inventory prior to taking orders again in September and as Taylor highlighted we have made important strides across product manufacturing and customer service that should position us well for both an expanded launch of reign in D C and eventual launch.
Speaker Change: Ned.
Speaker Change: Upon FDA clearance decision.
Jay Cogan: Following our successful private placement in April, where the company raised $24.1 million in gross proceeds, including strategic seed investment from a tier one multi-billion dollar medical device company. We recently executed a turnkey agreement with our production partner, which should free up both working capital and human resources for Movano Health. The company reported an operating loss of $6.4 million in the second quarter of 2024 versus an operating loss of $7.4 million in the year-ago period.
Speaker Change: Our successful private placement in April where the company raised $24 $1 million in gross proceeds including strategic investments in a tier one multibillion dollar medical device company.
Speaker Change: We recently executed a turnkey agreement with our production partner, which should free up both working capital and people resources for mobile health going forward.
Speaker Change: The company reported an operating loss of $6 $4 million in the second quarter of 2024 versus an operating loss of $7 4 million.
Speaker Change: Period.
Jay Cogan: And we had $16.9 million in cash and cash equivalents on our balance sheet at June 30th, which takes into account our catching up on more than $3 million of outstanding payables following the April private placement, putting us in good standing with our partners as we position the company to execute against key future models. Excluding the catch-up, our cash burn in the quarter was approximately $4.4 million, as managing resources continues to be a priority for us.
Speaker Change: And we had $16 9 million in cash and cash equivalents on our balance sheet at June 30th which takes into account are catching up on more than $3 million of outstanding payables. Following the April private placement.
Speaker Change: Putting us in good standing with our partners as we position the company to execute against key future milestones.
Speaker Change: Excluding the catch up our cash burn in the quarter was approximately $424 million as managing resources continues to be a priority for the company.
John Mastrototaro: Now I'll turn it back over to John for final approval. Thanks, Jay. The team and I couldn't be more excited about all of the progress we just highlighted. We are nearing an inflection point for the company as we close in on key EV and EV Med milestones. We are laser focused on the expansion of our D2C business, bullish on the B2B opportunities for EVMed, and optimistic about the potential of our RF chip. We look forward to continuing to share our progress as we head into the second half of the year. With that, we'd be happy to take your questions. Thank you.
Speaker Change: Now I'll turn it back over to John for final remarks.
John: Thanks, Jay the team and I couldn't we're excited about all of the progress. We just highlighted we are nearing an inflection point for the company as we close in on key E D and E V. Med milestones. We are laser focused on the expansion of our D to C business bullish on the B to b opportunities for E D.
John: And optimistic about the potential of our RF chip, we look forward to continuing to share our progress as we head into the back half of the year with that we'd be happy to take your questions.
Speaker Change: Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on the telephone keypad.
Operator: We will now be conducting a question and answer session. If you 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 Change: Confirmation tone will indicate your line is in the question queue.
Speaker Change: My best start to if you would like to remove your questions from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
Operator: Greetings and welcome to Movano Health, Q2, 2020 for earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation.
Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. You can also ask questions via the webcast. One moment, please, while we poll for questions. The first question comes from the line of Bruce Jackson with Benchmark Company.
Speaker Change: You can also ask questions via the webcast one moment, please while we poll for questions.
Speaker Change: The first question comes from the line of Bruce Jackson with.
Bruce Jackson: Please go ahead. Hi, good afternoon. Thank you for taking my questions. With the new EV that's going to launch with the autoactivity detect features, is that the same thing as the new heart rate and motion algorithm that you just developed? Michael Leabman, would you like to go ahead and respond to that question from Bruce? Yeah, sure. I think, you know, the first big fix we've added is that we've changed our heart rate algorithm to be really based on machine or deep learning to get much more accurate heart rate and motion if you're walking, jogging, running, et cetera. That's kind of a standalone algorithm.
Operator: If anyone should require operative assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.
Speaker Change: <unk> company. Please go ahead.
Michael Leabman: The autoactivity is really to, um, Thibault, Bruce Jackson, Unknown Executive, Jeremy Cogan, John Mastrototaro, Michael Leabman, Okay, great. And then moving over to the business-to-business side, with the provider organization where you've got an engagement, can you maybe go into a little bit more detail about that as to the depth of the engagement? Is it like parallel activities, or do they have any kind of minimum orders attached to the engagement?
Bruce Jackson: Hi, good afternoon, and thank you for taking my questions.
Bruce Jackson: Thanks, Bruce. Michael Soll, do you want to go ahead and take that question? Yeah, so we are, as we said earlier, engaged with a number of different channels, providers, and, as one of them payers, for remote patient monitoring. In anticipation of our FDA approval, they are working with us in various formats through beta testing. We're also in initial agreement conversations with a number of folks, including providers, payers, and the remote patient monitoring channels as well. Okay, great. And then last question for me: any changes on the mid-August date for the meeting with the FDK? I'll take that one, Bruce.
Jay Cogan: It is now my pleasure to introduce your host, Mr. Jay Cogan, Chief Financial Officer. Thank you, Mr. Cogan. You may begin. Thanks, operator. Good afternoon, everyone, and thank you for joining us today.
Speaker Change: The the the new EV, that's going to launch with the auto activity detect features that the same thing as the new heart rate and motion Algo that you just developed.
Jay Cogan: Movano Health CEO, John Mastrototaro, will open today's call with prepared remarks about the progress the company made during the second quarter of 2024 and in recent weeks. Our CMO, Tyla Bucher, will provide some remarks on the company's upcoming D to C plans, followed again by John, and then I'll provide highlights on the company's quarterly operating results in current financial position.
Speaker Change: Michael would you like to go ahead and respond to that question from Bruce.
Michael: Yeah sure I think you know the first big fix we've added is you know we've changed our hardware or them to be really based on a machine or deep learning to get much more accurate heart rate emotion, if you're walking jogging running et cetera, that's kind of a standalone algorithm. The auto activity is really to.
Jay Cogan: Then we'll open the call for Q&A. John Jay and Tyla will be joined by our Chief Technology Officer and Founder, Michael Leabman, Chief Commercial Officer, Michael Soul, and Vice President of Product and Strategy, Stacy Salvi.
Speaker Change: She two fold one to kind of identify what activities, you're doing as well as pilot.
Speaker Change: Todd mentioned to be able to start to work out and you start collecting this data even if you don't tell your watch or your ring or are your app to start clustering, so they're kind of two separate things.
Unknown Executive: Movano Health issued a news release, a staff on the detailed in second quarter, 2024 financial results.
Unknown Executive: Before we begin, I'd like to remind everyone that the company will make forward-looking statements during today's call based on current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risk and uncertainties. And actual results may be materially different from such statements. These risks and uncertainties are detailed in the risk factors section of Movano Health's violence with the Securities and Exchange Commission, specifically in the company's forms 10Q and 10K.
Speaker Change: But that you now combine to give you much better results for for a workout.
Speaker Change: Okay great.
Speaker Change: And then moving over to the business to business side.
Speaker Change: With the provider organization, where you've got an engagement can you maybe go into a little bit more detail about that as to the depth of engagement is it like pearl activities or do they have any like minimum orders attached to the engagement.
Unknown Executive: Except as otherwise required by federal security laws, Movano Health disclaims any obligation, 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.
Speaker Change: Thanks, Bruce Michael sold do you want to go ahead and take that question.
Yeah. So we are and as we as we said earlier, we are engaged with a number of different channels providers is one of them payers remote patient monitoring in anticipation of our FDA approval are they are working with us in various formats through beta testing. We're also in the initial agreement.
Jay Cogan: With that, I'll turn the call over to our CEO, John, Mr. Storro.
John Mastrototaro: Good afternoon, everyone. Since we last reported earnings in May, we have been working diligently to prioritize the efficient use of our recent capital infusion while continuing to make progress on our key business initiatives as follows. Preparing for expansion of the Direct to Consumer Launch at EV Ring and taking orders again starting September 17th, continuing to work with the FDA to secure a 510K clearance for the EV Med Ring, delivering our first B2B commercial opportunities with healthcare partners, and lastly, preparing for upcoming blood pressure and glucose clinical trials using the most recent iteration of our wearable device incorporating our proprietary RF solution.
Speaker Change: Patients with a number of folks including providers payers and the remote patient monitoring channels as well.
Speaker Change: Okay great.
Speaker Change: And then last question for me any changes on the the mid August.
Speaker Change: For meeting with yesterday.
John Mastrototaro: Thanks for the question. No, there are no changes there. I'd just like to make a couple of comments about that. You know, we are still very optimistic with regard to our ability to work with the agency for a few reasons. First off, we've got a pretty seasoned and deep regulatory team in the company itself, but we've gone one step beyond that. In fact, we're also working with the leading regulatory firm in the U.S., and probably the principal of whom has probably had more meetings with the FDA than anyone ever, so far, in their career.
Speaker Change: I'll take that one Bruce thanks for the question no no changes there I'd just like to make a couple of comments about it you know we still are very optimistic with regard to our ability to work with the agency for a few reasons first off we've got a pretty seasoned and deep regulatory.
Speaker Change: <unk> came in the company itself, but we've gone one step beyond that and in fact, we're also working with the leading regulatory firm in the U S and probably the principle of whom has probably had more meetings with the FDA than anyone I ever so do their career. So we've really got the top team that we could possibly have working.
John Mastrototaro: We continue to be judicious with our capital and methodical in our approach to building out our Direct to Consumer and business-to-business market opportunities. I will provide an update on our progress with the FDA and preparations for B2B launch at EV Med, and we'll then turn the call over to our CMO, Hiloboomker, to discuss plans for the D2C business, including our plan to begin taking orders again and shipping product in September. In preparation for the launch of EV Med, we're working closely with the FDA to secure a 510K clearance.
Speaker Change: On this to assure that we're complying with all the FDA policies, you know when you're doing something new with our rang and we've got the wellness and medical devices are in the product. It can raise some new new questions of the agency, but we feel really good about where we stand we've had some already recent communication in <unk>.
John Mastrototaro: So, we've really got the top team that we could possibly have working on this to assure that we're complying with all the FDA policies. You know, when you're doing something new with our ring and we've got the wellness and medical devices in the product, it can raise some new questions for the agency, but we feel really good about where we stand. We've already had some recent communication in preparation for the meeting, and it's all trending in the right direction. So, that is all positive.
John Mastrototaro: As we highlighted in a press release last week, we plan to meet with the FDA this month. You'll recall the EV Med ring is designed to not only provide medical device functionality with its pulse-like symmetry feature, but also offer numerous wellness metrics related to sleep, activity, and logging of mood, energy, and health symptoms. Subsequent to our April 510K filing, in May and early June, the FDA review team requested two minor clarifications and our team promptly responded.
Speaker Change: Operations after the meeting.
Speaker Change: And it's all trending in the right direction. So that that is all positive and then lastly, one thing we always kind of remember is that the whole filing is is built on a really strong foundation of incredibly strong clinical data and results for the pulse oximetry features so because of all of these reasons.
Bruce Jackson: And then lastly, one thing we always kind of remember is that the whole filing is built on a really strong foundation of incredibly strong clinical data and results for the pulse oximetry feature. So, because of all of these reasons, we still feel really good about where we are and being able to work through the FDA and gain clearance. Okay, great. Congratulations on all of the progress, and thank you for taking the time to answer my questions. Thank you, Bruce.
We still feel really good about where we are in and being able to work through the F. D. A N and gain a clearance.
Speaker Change: Yeah.
Speaker Change: Okay, great congratulations on all the progress and thank you for taking my questions.
John Mastrototaro: In late June, the FDA review team requested some additional information related to the wellness aspects of EV Med. Along with our regulatory advisors, Movano Health provided a draft response to the FDA's questions on July 10th and requested a meeting with the agency to review our draft response, which is now scheduled as I noted earlier. We look forward to meeting with the FDA and working towards resolving this issue in order to move forward with the review process.
Bruce: Thank you Bruce.
Speaker Change: Yeah. Thanks, Bruce operator, it looks like we have some questions on the webcast I can go ahead and ask those and we'll see what happens with the phone lines thereafter.
Operator: Yeah, thanks, Bruce. Operator, it looks like we have some questions during the webcast. I can go ahead and ask those, and we'll see what happens with the phone lines thereafter.
Speaker Change:
Speaker Change: Okay.
Speaker Change: John I guess.
Jay Cogan: John, I guess if there's anything else, there's a question here about the 510k submission, if there's anything else you wanted to add in terms of our Confidence in Securing or just anything else beyond the press release that we issued last week. If there's anything to discuss, otherwise, we can move on to the next. Yeah, I saw that question. I saw that question online, and I tried to answer it at the same time that I answered Bruce's.
Speaker Change: If there's anything else. There's a question here about the five 10-K submission if theres anything else you wanted to add in terms of.
Speaker Change: Our.
John Mastrototaro: We remain steadfast in our commitment to the opportunity EV Med could unlock, given the clinical evidence provided as part of the filing related to the pulse-like symmetry feature and are desired to work collaboratively with the agency. With regard to the BV opportunity, we have three new B2B commercial opportunities to highlight for you today. In anticipation of an expected 510K clearance, we are engaged with two global pharmaceutical companies that could leverage EV Med in building unique solutions for both clinical and consumer applications.
Speaker Change: Confidence in securing or just anything else beyond the press release that we issued last week.
Speaker Change: Anything discussed otherwise they can move on to the next question.
Speaker Change: Yeah I saw that question I saw that question online and I tried to answer it at the same time that I can answer Bruce it. So I think that covered it pretty well bottom line is we still feel really confident and optimistic in where we stand and are very much looking forward to meeting with the agency.
John Mastrototaro: So I think that covers it pretty well. The bottom line is, we still feel really confident and optimistic about where we stand and are very much looking forward to meeting with the agency soon to resolve this and move on to the next topic. Okay, great. I think the next couple of questions can be for Tyler. Tyler, there are a couple questions about the press and marketing plan for the expanded launch of EV Ring, and then also, what are the biggest changes that we've made to the Ring and app header? Augustine St. John Mastrotaro, Sure.
Speaker Change: Soon to.
Speaker Change: To resolve this and move on to the next topic.
Tyler: Okay, Great I think the next couple of questions can be for Tyler Tyler. There's a couple of questions about the present marketing plan for the expanded launch of reign and then also.
John Mastrototaro: In the first case, we are in the agreement phase for a program that could begin in late 2024 and, assuming success, would be expected to develop into a larger commercial opportunity in 2025. In the second case, EV Med is expected to be evaluated this fall by a Tier 1 global pharmaceutical company for a clinical trial that is scheduled to commence in 2025. We are also engaged with a large payer looking to better manage high-risk populations utilizing EV Med.
Tyler Tyler: What are the biggest changes that we've made to the brain and app heading into this expanded launch.
Tyler Tyler: Sure. So I think you know as I.
Tyla Bucher: So I think, you know, as I noted on the call, we've obviously spent the last few months focusing on improvements across the board, including, you know, updating and fine-tuning the algorithms. I think the big focus has also been on our insights engine, because really, that is a key differentiator for us. And then, you know, I talked a little bit about our improved processes that we have on the operations side, but I think the other pieces are the auto activity detection that Bruce just mentioned, as well as an Android version of the app.
Tyler Tyler: As I noted on the call. We've obviously spent the last few months focusing on improvements across the board, including updating and fine tuning the algorithms.
Bruce: The Big focus has also been on our insights engine because really that is a key differentiator for US and then you know I talked a little bit about our improved processes that we have on the operation side, but I think the other pieces are the auto activity detect that Bruce just mentioned as well as an Android version of the App. Both of these are key features that consumers have been asking for it.
John Mastrototaro: This opportunity is expected to kick off around the new year and, assuming a positive outcome, the commercial opportunity could build into 2025. All three of these strategic partners, as well as the others in our funnel, the EV Med as a game-changing solution that is not currently available in the market.
Tyla Bucher: Both of these are key features that consumers have been asking for, and we really do want our community to know that we're listening. And we're really excited to actually roll out these enhancements. So those, I think, are the big pieces on the experience side.
Bruce: We really do you want her community to know that we're listening and we're really excited to actually rollout. These enhancements. So those I think are the big pieces.
Speaker Change: On the experience side and then as it relates to marketing we have a full campaign ready to go over that includes influencer and user generated content across Instagram Facebook Youtube all the other things I said, Google search and shop, and we have a really engage lead list in a comprehensive outreach strategy strategy.
John Mastrototaro: This is in addition to our recent announcement of the partnership with the TAL Research Group at MIT to use EV rings for its Maestro clinical study on the long-term health impacts of Lyme disease and long COVID. To explain these healthcare opportunities in more depth, we recently hosted our first virtual event titled B2B, the Next Wearables Boom, where managing director of a Leo Capital, Matt Hughes, moderated a panel that included myself, our Chief Commercial Officer Michael Sol, and Stanford Cardiologist Dr. Fatima Rodriguez.
Speaker Change: But above and beyond where we're just thrilled with the announcement of our partnership with Influencer and visual creator high eight she not only does she have a passion for it but she has a highly and wonderfully engaged audience and she really shares our vision of improving women's health with better data and insights.
Tyla Bucher: And then as it relates to marketing, we have a full campaign ready to go that includes, you know, influencer and user-generated content across Instagram, Facebook, YouTube, all the other things I said, Google search and shop. We have a really engaged lead list and a comprehensive outreach strategy. But above and beyond, we're just thrilled with the announcement of our partnership with, you know, influencer and digital creator Heidi D'Amelio. She not only has a passion for fitness, but she has a highly and wonderful engaged audience.
Speaker Change: I think the idea that we'll be able to work closely with someone like Heidi who you know again have such an engaged audience to drive awareness around the E V rang as well as the importance of a wellness device for women is a big step forward for us.
John Mastrototaro: Curtis. During the event, we identified and discussed the significant B2B possibilities that could be unlocked specifically for clinical trials and remote patient monitoring following a 510K clearance. As you'll recall, the clinical trials market we seek to address consists of pharmaceutical companies that need to gather data from FDA-cleared devices as part of their drug trials for FDA and other regulatory submissions. We've identified the TAM for FDA-cleared wearables in this market to be as much as 5 billion annually.
Speaker Change: Yeah.
Speaker Change: Great Alright, Michael So you might have answered some of this or most of this in the prior question from Bruce but a question on the webcast relates to taking a deeper dive into the person who led commercial opportunity.
Michael Soule: And she really shares our vision of improving women's health with better data and insights. I think the idea that we'll be able to work closely with someone like Heidi, who, you know, again, has such an engaged audience to drive awareness around the EV ring, as well as the importance of a wellness device for women, is a big step forward for us. Great. All right, Michael Soule, you might have answered some of this or most of this in the prior question from Bruce, but the question on the webcast relates to taking a deeper dive into the first eVMED commercial opportunities that we announced recently and how we positioned the company for growth with pharma and other health partners. Yeah, sure. Yeah. And I saw that as well online.
Speaker Change: That we've announced recently and how they position the company for growth with pharma and other health partners in the future.
Yeah sure Yeah and.
Speaker Change: I saw that as well online I think in the last call, we talked a little bit about our data partners right and we ran the gamut.
John Mastrototaro: Currently, trials are offering cumbersome, expensive, and sub-optimal requiring in-person checkups which can result in poor compliance. We believe EV meds unique offering and design aesthetic would improve compliance, lower cost significantly, and enable quicker enrollment, better data, and improved quality of results. The three examples I highlighted a few minutes ago speak to this need and we are aggressively pursuing opportunities across clinical trials and post-market surveillance.
Michael Soule: I think on the last call, we talked a little bit about our beta partners, right? And we ran the gamut across various channels with our beta partners. But since coming out of that beta phase, other large strategic partners have come to us looking to work with us.
Speaker Change: Ross various channels with our beta partners, but since coming out of that beta phase other large strategic partners have come to us looking to work with us and so.
Michael Soule: And so they range in channels from medical devices to pharma to payers who are looking forward to our FDA clearance. And so when that clearance comes, we expect to unlock a host of initiatives across clinical trials and remote patient monitoring. And we're also, as John mentioned earlier, building the backend systems required for these partnerships so we can hit the ground running. So in advance of that clearance, we've moved, as I said, into some agreement discussions with a number of folks. And we're very excited about the pace with which this is happening. Terrific. Next question from Michael Leabman: What did you learn in your most recent blood pressure clinical study? Yeah, great.
Speaker Change: They range in channels for medical device to pharma to payers, who are looking forward to our FDA clearance and so we win that clearance comes we expect to unlock a whole.
John: Initiatives across clinical trials remote patient monitoring and we're also as John had mentioned earlier building. The back end systems required for these partnerships. So we can hit the ground running so in advance of that clearance. We've moved as I said into some just agreement discussions with a number of folks and we're very excited about the pace with which this has happened.
John Mastrototaro: The remote patient monitoring or RPM market barely existed four years ago. However, COVID-19 locked the reality that RPM can reduce the need for in-office visits, expand access, and reduce costs. We believe EV med will be able to automate the collection of more complete and accurate data resulting in an RPM solution with meaningful advantages over RPM products on the market today. During our conversation, Dr. Rodriguez also validated the need for RPM in her role as a physician which would enable her to manage her patients in-between visits and easily identify patterns.
Speaker Change: <unk>.
Speaker Change: Terrific next question from Michael Lehman, What did you learn in your most recent blood pressure clinical studies.
Speaker Change: Yeah, great. So I think as John mentioned, we you know we completed our study in June and we've been analyzing the data using.
Michael Leabman: So I think, as John mentioned, we completed our study in June, and we've been analyzing the data using the arterial line, which is really new to us, giving us continuous data. And it's really allowed us to kind of fine-tune our device, including new antennas that we've already completed designing, as well as accommodating different wrist sizes with a smaller form factor, which gets us closer and closer to, you know, commercializing it.
Speaker Change: Using the arterial line, which is which is really neither of us giving us continuous data.
Speaker Change: And it's really allowed us to kind of fine tune, our device, including new antennas that that.
John Mastrototaro: We recently completed beta testing our wearable technology with a leading U.S. RPM company that serves over 450 healthcare organizations and is the exclusive platform for one of the largest medical device companies in the world. In anticipation of these partnerships and more, we are preparing our backend operations to be able to meet our partner's requirements, including positioning the company's scale efficiently, establishing app and labeling modifications to support a medical device, and building our API and data sharing framework.
Speaker Change: We've already completed designing as well as accommodating.
Speaker Change: [noise] different risk sizes, with a smaller form factor, which gets us closer and closer to you now.
Speaker Change: Commercializing it.
Michael Leabman: I think all these changes will really allow us to, you know, begin testing with B2B customers when we're ready. And the expected new design, we expect to arrive somewhere at the end of September or early October, as we get ready for our next clinical arterial line study in November. And I think everything's kind of coming together nicely with this first study, and we really look forward to getting this hardware back and taking the next step. Okay, Michael.
Speaker Change: All of these changes will really allow us to you know.
Speaker Change: Began testing with ETT customers are already and they expected a new design, we expect to arrive somewhere in the end of September early October as we get ready for our next clinical arterial line study in November and I think everything's kind of coming together nicely with this first study and we didn't really look forward to getting this hardware back and I'm taking the next.
Tyla Bucher: I will now turn it over to our CMO Tyler Booker to provide an update on our D to C plans for the EV ring. Thanks, John. As you all know, we've been out of stock on the EV ring since Q1 and we've been using this time to implement a series of improvements for our existing and prospective customers, including operational and delivery timelines better and more accurate ring functionality, best in class customer service, and finalizing from new and necessary features.
Speaker Change: Step.
Speaker Change: Okay, Thanks, Michael or John can Tyler, there's a question about the company, taking the path of being a medical device company.
John Mastrototaro: John and Tyla, there's a question about the company taking the path of being a medical device company, and with blood pressure and glucose on the horizon, not specific to, but is Movano planning to expand its marketing to target beyond women? Yeah, from the med device perspective, I'll take that aspect. Certainly, as you're aware and alluded to for direct to consumer, we have had a female focus, and Tyler can expand upon that in a moment. But for these opportunities that we have in the healthcare space, there are some that are products that are specific to women. So this dovetails in very nicely.
Speaker Change: And with blood pressure and glucose a horizon.
Speaker Change: Specific to them.
Speaker Change: Gender.
Speaker Change: His novato planning to expand its marketing could target.
Speaker Change: Beyond women.
Speaker Change: Okay.
Tyla Bucher: From an operations standpoint, we improved production yield and cycle time as well as our logistics and warehouse management systems. This will result in greater efficiency on the production floor and allow us to keep more accurate real-time track of inventory and the flow of orders. From a software perspective, we updated our ring algorithms, improving accuracy across sleep and wake times, sleep stages, heart rate measurements during activity and steps. In addition, we expanded our proprietary AI-generated insight engine to include hundreds of new insights for our users, customized for their individual wellness journey, and informed by a combination of track and log data. An example of one of our newer insights would be when you beat your average steps by more than a thousand, you tend to report a better move.
Speaker Change: Yes from the med device perspective, I'll I'll take that aspect certainly as you're aware and alluded to for BD.
Speaker Change: Direct to consumer we have had a female focus and Tyler can expand upon that in a moment, but for these opportunities that we have in the health care space. There are some which are products that are specific for women. So this dovetails in very nicely, but many of the opportunities that we've been.
John Mastrototaro: But many of the opportunities that we've been looking at are for anyone. And just because we've targeted women with some aspects of the app experience and design and whatnot doesn't mean that it's not of tremendous value for anyone. And so all of our partners, no one said, oh, well, you know, this won't suit all of our customers or subscribers to a plan or whatever it may be. They're looking at using it universally.
Tyler Tyler: And looking at art for anyone and just because we targeted women with with some aspects of the app experience and design and whatnot. It doesn't mean that it's not a tremendous value for for anyone and so are all of our partners No one said Oh well.
Tyla Bucher: We're guarding customer service. We built out a new team of representatives with a combined 25 plus years of service in the direct to consumer space who have a solid understanding of the pace and real time knowledge delivery that a product like ours requires. This team is currently responding live to all inquiries within 48 hours and has drafted a comprehensive library of useful articles and tips and tricks that can be shared with EV ring consumers as they work through any issues together or the customers can use to self serve if they prefer.
Tyler Tyler: You know this this won't suit all of our all of our customers are subscribers to a plant or whatever it may be a theyre looking at using it universally in and you're right, whether it's a work related to continuous glucose monitoring in the future.
John Mastrototaro: And you're right, whether it's work related to continuous glucose monitoring in the future or blood pressure and what we have today with heart rate and SpO2 and other future analytes, they're important to measure in everybody. And, you know, we're all suffering from chronic conditions, and in the U.S., it's a major problem. We've got, you know, half of people over age 20 in the U.S. have high blood pressure or prehypertensive, and diabetes is about a third of them.
Tyler Tyler: Or the blood pressure or and what we have today with heart rate S. P O two and other future analytes. They are important to measure and everybody in and you know, we're all suffering from chronic conditions and in the U S. A it's a major problem. We've got you know half of people over age 20 in the U S that have.
Tyla Bucher: In addition, these articles feed into our AI power chatbot who can mitigate many easily solvable issues and get smarter as it ingest both the increase and our information, responding quickly and accurately to customers and friendly and native language. In addition to all these enhancements, we're also working on an auto activity detect workout feature which will allow EV to understand that you're working out even if you have not started workout on the app and following the workout will be able to provide you with your results users will also be able to modify the details of their workout after the fact. And finally, we expect to have an Android version of the app ready for our perspective Android users of which there are quite a few to purchase by Black Friday in November of this year.
Tyler Tyler: High blood pressure or pre hypertensive and diabetes is about a third of the people are.
John Mastrototaro: And so having products like this that can be worn and used at home in a very user-friendly way that feel good and look good on the finger, something that doesn't interfere with your lifestyle and is able to collect just a wealth of important data and can bring to light changes in your health are needed. And I think it's going to change the way healthcare is delivered in the future to bring more of this into the home with folks. And I think we're all more aware of our health than ever before after what happened during the course of COVID and whatnot.
Tyler Tyler: And so having products like this that can be worn and used at home in a very user friendly way that feel good and look good on the fingers something that doesn't interfere with your lifestyle and is able to collect just a wealth of important data and can you bring to light changes in your in your health are needed.
Tyla Bucher: We're pleased to announce that we'll be back in stock on September 17th. This is post summer season and time for when consumers begin turning their attention to the holidays and just giving. We have a full paid and organic social campaign prepared to support our launch, which includes influencer and user generated content across Instagram, Facebook, YouTube and TikTok as well as Google search and shop. However, robust email leads us that has grown exponentially with consumers ready to buy and we will be engaging them with a comprehensive outreach strategy. And we have a satellite press to align up with key tech and consumer press as well as the pitch campaign for holiday gift guys across print and television.
Tyler Tyler: And I think it's going to change the way health care is delivered in the future.
Tyler Tyler: Bring more of this into the home with folks and I think we're all more aware of our health than ever before after what's happened through the course of Covid and whatnot. So it's it's a we're finding it to just be a massive opportunity quite frankly and are speaking to all of the who's who in the health care space.
John Mastrototaro: So we're finding it to just be a massive opportunity, quite frankly, and are speaking to all the who's who in the healthcare space about products like this that can be leveraged seamlessly and help support the health and wellness of people. Kyla, do you have anything to add specifically about D2C and the female focus there that you want to comment on? Sure, I mean, I think you captured it really well.
Tyler Tyler: About products like this that can be leveraged seamlessly and helps support the health and wellness with people.
Tyla Bucher: And finally, we couldn't be more excited to share the introduction of our brand partnership with digital creator, wife, mom and entrepreneur Heidi DiMilio. Heidi has been using the EV ring for several months and has really become a true fan. Alive with our mission of empowering women with better data and insights to help them live healthier lives.
Tyler Tyler: Tyler do you have anything to add specifically about the.
Tyler Tyler: The D to C and the female focus there that you.
Tyler Tyler: Do you want to comment on.
Tyler Tyler: Sure I mean, I think you captured it really well I think the only comment that I would make is just sort of echo. Your your notes about we didn't design the EV ring to the exclusion of the male gender, but rather to really.
John Mastrototaro: I think the only comment that I would make is to sort of echo your notes about how we didn't design the EV ring to the exclusion of the male gender, but rather to really, you know, be present for an opportunity that we see among women who prioritize their health, prioritize the health of their family, control the purse strings, make decisions for the family, and really come up with a solution for them to make sure that they're taking good care of themselves You can wear the EV ring now if you are, you know, whatever gender you are.
Tyla Bucher: We have formed a strategic partnership with Heidi where we'll continue to grow the brand, drive awareness around women's health and improve the ring experience together. We couldn't be more excited to welcome Heidi to the EV family.
Tyler Tyler: The precedent for an opportunity that we see among women, who prioritize their house prioritizes the health of their family control. The purse strings makes decision for the family and really coming up with a solution for them too.
Tyla Bucher: As you can see, we've been working around the clock to get the ring back in the hands of consumers and we truly believe it will be worth the wait.
John Mastrototaro: And with that, I'll turn things back over to John. Thanks, Tyler. As you are aware, our product development plan extends far beyond EV and EV med. We are deeply invested in multi-analytic sensing and pursuing additional FDA clearances with further research and respiration rate core temperature and a solution to address sleep disturbances. Some of these metrics may only require a software update while others may require new hardware components or potentially different form factors.
Tyler Tyler: To make sure that theyre, taking good care of themselves and that they are prioritizing their wellness you can wear the ring now. If you are you know whenever gender you are and I think what we tried to do is really take into consideration how women with like to received the data how they want to see it displayed in their app are comfortable fit and make sure that we're delivering insights that.
Tyla Bucher: And I think what we tried to do was really take into consideration how women would like to receive the data, how they want to see it displayed in their app, a comfortable fit, and make sure that we're delivering insights that make them feel like this is a worthwhile endeavor and that they understand what to do with that data. So I think as we move forward, you know, nothing is necessarily off the table, but certainly, the priority was to make something available to women where we see a tremendous, tremendous opportunity. But again, having said that, anyone can wear the ring, and it will still work, and it will still track your health and well-being.
Tyler Tyler: That.
Speaker Change: It makes them feel like this is a worthwhile endeavor and that they understand what to do with that data. So I think as we move forward you know nothing is done necessarily off the table, but certainly the priority was to makes.
John Mastrototaro: We are in the planning stages now for several clinical trials related to these valuable analytes. As a follow on to the successful blood pressure study we conducted in Q423. We completed our most recent blood pressure clinical study in June, which included the use of an arterial blood pressure line. We learned a great deal about improved ways to collect data and will be redesigning for the next study with better placement of the sensors on the body.
Speaker Change: It makes something available to women, where we see a tremendous tremendous opportunity, but again, having said that and even come out of the range and it will still work and it was still check that your health and wellbeing.
Speaker Change: Thanks, Tyler Thanks, John I'll take the last question.
Tyla Bucher: Thanks, Tyler. Thanks, John. I'll take the last question.
Speaker Change: So it looks like you've made some good progress on reducing our quarterly burn rates, how do we see the trend in our.
Jay Cogan: It looks like you've made some good progress on reducing the quarterly burn rates, and we see the trend in our expanded launch of EV Ring and eventually EVNet. We appreciate the feedback. We continue to be focused as an organization on the highest and best use of our capital and the marginal profile of the D2C and B2B businesses that we're rolling out. We believe the product manufacturing and customer service improvements that we've implemented over the past few months should definitely help position us for growth and cash flow.
John Mastrototaro: To maximize their utility. We are also in the process of designing a more consumer friendly form factor as we focus on commercializing the solution. We will continue to develop this into Q4 with another study plan before year-end.
Speaker Change: Standard launch of maybe ring and eventually even that are we.
Speaker Change: We appreciate the feedback.
Speaker Change: We continue to be focused as an organization on the highest and best use of our capital in the margin profile of the D to C and b to B businesses that we're rolling out.
John Mastrototaro: Grant. In summary, we remain committed to improving health monitoring through the introduction of additional analyte sensing, including blood pressure and glucose, using our millimeter-wave radio frequency and AI technology.
We believe the product manufacturing and customer service improvements that we've implemented over the past few months should definitely help position us for growth and cash flow in.
Jay Cogan: In addition, the turnkey agreement, which we've mentioned a couple of times over the last few calls and which we've now executed with our contract manufacturing partner, should very much improve our company's cash flow profile, better aligning sales and the actual cost of goods.
Speaker Change: In addition, the turnkey agreement, which we've mentioned a couple of times over the last few calls, which we've now executed.
Jay Cogan: With that, I'll now hand the call over to Jay for the financial review. Thanks, John. We shipped 1,837 EV rings in the second quarter of 2024 as the completed fulfillment of our initial launch phase. You recall that we shipped approximately 5,300 rings in the first quarter and stopped taking orders in that February given capital market conditions.
Speaker Change: With our contract manufacturing partner that should very much improve our company's cash flow profile better aligning up sales and the actual cost of goods.
Speaker Change: Operator.
Operator: Operator, I'm just saying in closing, if investors would like to stay up to date on Movano Health, please continue to check into ir.movano.com. We look forward to staying in touch. We'll see you next quarter. And thank you for your support. Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. John Mastrototaro, Michael Leabman, Tyla Bucher, Michael Leabman, John Mastrototaro, Michael Leabman, Tyla Bucher, Michael Leabman, Tyla Bucher, Michael Leabman, Tyla Bucher, Michael Leabman, Tyla Bucher, Michael Leabman, Tyla Bucher, Michael Leabman, Tyla Bucher, Michael Lea
Speaker Change: Just say in closing.
Speaker Change: Investors like to stay up to date on mobile health.
Jay Cogan: The company did not report any revenue for the second quarter as previously deferred revenues offset by refunds. As we noted earlier in the call, we expected to begin taking orders and shipping rings again in September. We plan to have ample inventory prior to taking orders again in September and as Tyla highlighted, we have made important strides across product and manufacturing and customer service that should position us well for both an expanded launch of the EV ring in D to C and eventual launch of EV med in D to D upon an FDA clearance decision.
Speaker Change: Please continue to check into IR marrano Dot com.
Speaker Change: We look forward to staying in touch with you next quarter and thank you for your support.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: [music].
Jay Cogan: Following our successful private placement and people where the company raised $24.1 million in gross proceeds, including a strategic seed investment from a tier 1 multibillion-dollar medical device company, we recently executed a turnkey agreement with our production partner, which should free up both working capital and people resources for the mobile health going forward. The company reported an operating loss of $6.4 million in the second quarter of 2024 versus an operating loss of $7.4 million in a year ago period and we had 16.9 million cash and cash equivalents on our balance sheet at June 30, which takes into account our catching up on more than $3 million about standing payables following the April private placement, putting us in good standing with our partners as we position the company to execute against key future milestones. Excluding the catch up, our cash burden in the quarter was approximately $4.4 million as managing resources continues to be a priority for the company.
John Mastrototaro: Now I'll turn it back over to John for our final remarks. Thanks, Jay.
John Mastrototaro: The team and I couldn't are excited about all of the progress we just highlighted. We are nearing an inflection point for the company as we close in on key EV and EV med milestones. We are laser focused on the expansion of our D to C business, bullish on the B2B opportunities for EV med and optimistic about the potential of our RF chip. We look forward to continuing to share our progress as we head into the back half of the year.
Unknown Executive: With that, we'd be happy to take your questions. Thank you.
Operator: We will now be conducting a question and answer session. If you would like to ask a question, please press star one on the 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 questions from the queue. For participants using streakal equipment, it may be necessary to pick up your handset before pressing the star keys. You can also ask questions via the webcast. One more please, value poll for questions.
Bruce Jackson: The first question comes from the line of Bruce Jackson with benchmark company. Please go ahead. Hi, good afternoon.
Bruce Jackson: Thank you for taking my questions. With the the new EV that's going to launch with the auto activity detect features that the same thing as the new heart rate and motion algo that you just developed.
Michael Leabman: Michael, would you like to go ahead and respond to that question from Bruce? Yeah, sure. I think, you know, the first big fix we've added is, you know, we've changed our heart rate algorithm to be really based on on machine or deep learning to get much more accurate heart rate and motion if you're walking, jogging, running, etc.
Michael Leabman: That's kind of a standalone algorithm. The auto activity is really to to full one to kind of identify what activities you're doing as well as Tyler mentioned to be able to start to work out and start collecting this data even if you don't tell all your watch or your ring or your app to start collecting. So they're kind of two separate things that, you know, combined to give you much better results for a workout.
Michael Leabman: Okay, great. And then moving over to the business to business side with the provider organization where you've got an engagement. Can you maybe go into a little bit more detail about that as to the depth of the engagement is sit like pearl activities, or do they have any like minimum orders attached to the engagement? Thanks, Bruce.
Michael Leabman: Michael, so do you want to go ahead and take that question? Yeah, so we are, as we said earlier, we are engaged with a number of different channels providers is one of them payers remote patient monitoring. In the anticipation of our FDA approval, they are working with us in various formats through beta testing, or also in the initial agreement conversations with a number of folks, including providers, payers and the remote patient monitoring channels as well.
Bruce Jackson: Okay, great. And then last question for me, any changes on the mid-August date for for meeting with the FDA?
John Mastrototaro: I'll take that one, Bruce. Thanks for the question. No, no changes there.
John Mastrototaro: I just like to make a couple comments about it. You know, we still are very optimistic with regard to our ability to work with the agency for a few reasons. First off, we've got a pretty seasoned and deep regulatory team in the company itself, but we've gone one step beyond that. In fact, we're also working with the leading regulatory firm in the U.S. And probably the principle of whom has probably had more meetings with the FDA than anyone ever.
John Mastrototaro: So do their career. So we've really got the top team that we could possibly have working on this to assure that we're complying with all the FDA policies. You know, when you're doing something new with our ring, and we've got the wellness and medical devices in the product, it can raise some new questions of the agency, but we feel really good about where we stand. We've had some already recent communication in preparation for the meeting, and it's all trending in the right direction.
John Mastrototaro: So that that is all positive. And then lastly, one thing we always kind of remember is that the whole filing is built on a really strong foundation of incredibly strong clinical data and results for the Pulsak Symmetry feature. So because of all of these reasons, we still feel really good about where we are and being able to work through the FDA and gain a clearance.
Bruce Jackson: Okay, great. Congratulations on all of the progress, and thank you for taking my questions. Thank you, Bruce. Yeah, thanks, Bruce.
Unknown Executive: Operator, it looks like we have some questions in the webcast. I can go ahead and ask those, and we'll see what happens with the phone lines thereafter.
John Mastrototaro: John, I guess there's anything else there's a question here about the 510K submission. If there's anything else you wanted to add, in terms of our confidence in securing or just anything else beyond the pressure release that we issued last week, if there's anything discussed, otherwise it could move on to the next question. Yeah, I saw that question. I saw that question online and I tried to answer it at the same time that I answered Bruce's.
John Mastrototaro: So I think I've covered it pretty well. Bottom line is, we still feel really confident and optimistic and where we stand, and I were very much looking forward to meeting with the agency soon to resolve this and move on to the next topic. Okay, great.
Tyla Bucher: I think the next couple of questions can be for Tyla. Tyla, there's a couple of questions about the press and marketing plan for the expanded launch of ED ring, and then also one of the biggest changes that we've made to the ring and app heading into this expanded launch. Sure. So I think, as I noted on the call, we've obviously spent a few months focusing on improvements across the board, including updating and finding the algorithms.
Tyla Bucher: I think the big focus has also been on our insights engine, because really that is a key differentiator for us. And then I talked a little bit about our improved processes that we have on the operation side, but I think the other pieces are the auto activity detect that Bruce just mentioned, as well as an Android version of the app. Both of these are key features that consumers have been asking for. And we really do want our community to know that we're listening, and we're really excited to actually roll out these enhancements.
Michael Soul: So those I think are the big pieces on the experience side. And then as it relates to marketing, we have a full campaign ready to go that includes influencer and user generated content across Instagram, Facebook, YouTube, all the other things I said, Google search and shop. We have a really engaged lead list and a comprehensive outreach strategy. But above and beyond, we're just thrilled with the announcement of our partnership with influencer and digital creator Heidi D'Amelio.
Michael Soul: Not only does she have a passion for fitness, but she has a highly and wonderfully engaged audience, and she really shares our vision of improving women's health with better data and insights. I think the idea that we'll be able to work closely with someone like Heidi who, again, has such an engaged audience to drive awareness around the EV ring, as well as the importance of a wellness device for women. Is a big step forward for us. Great.
Michael Soul: All right, Michael Soul. You might have answered some of this or most of this in the prior question from Bruce, but question on the webcast relates to taking a deeper dive into the first EV med commercial opportunities that we've announced recently, and how they've positioned the company for growth with Pharma and other health partners in the future. Yeah, sure. Yeah, and I saw that as well online. I think in the last call, we talked a little bit about our beta partners, right?
Michael Soul: And we ran the gamut across various channels with our beta partners. But since coming out of that beta phase, other large strategic partners have come to us looking to work with us. And so they range in channels from medical device to Pharma to payers who are looking forward to our FDA clearance. And so when that clearance comes, we expect to unlock a host of initiatives across clinical trials, remote patient monitoring. And we're also, as John had mentioned earlier, building the backend systems required for these partnerships, so we can hit the ground running. So in advance of that clearance, we've moved, as I said, into some agreement discussions with a number of folks, and we're very excited about the pace with which this has happened. Thank you. Terrific.
Michael Leabman: Next question, Michael Leabman. What did you learn in your most recent blood pressure clinical study? Yeah, great. So, I think as John mentioned, we, you know, we concluded our study in June, and we've been analyzing the data using the arterial line, which is, which is really new to us, giving us continuous data. And it's really allowed us to kind of fine tune our device, including new antennas that, that, we've already completed designing, as well as accommodating different sizes with a smaller form factor, which gets us closer and closer to, you know, commercializing it.
Michael Leabman: I think all these chains will really allow us to, you know, begin testing with BDG customers when we're ready. And they expected new design. We expect to arrive somewhere in the end of September, early October, as we get ready for our next clinical arterial line study in November. And I think everything's kind of coming together nicely with this first study.
Michael Leabman: And we really look forward to getting this hardware back and taking the next step. Okay, thanks, Michael.
John Mastrototaro: John, can Tyler, there's a question about the company taking the path of being a medical device company, and with blood pressure and glucose on horizon, not specific to, you know, gender. His Movano planning to expand its marketing to target beyond women. Yeah, from the med device perspective, I'll take that aspect. Certainly, as you're aware and alluded to for BDG, for direct to consumer, we have had a female focus, and Tyler can expand upon that in a moment.
John Mastrototaro: But for these opportunities that we have in the healthcare space, there are some, which are products that are specific for women. So, this dovetails in very nicely. But many of the opportunities that we've been able to take care of, you know, is very important. That we've been looking at are for anyone. And just because we've targeted women with some aspects of the app experience and design and whatnot doesn't mean that it's not of tremendous value for anyone.
John Mastrototaro: And so all of our partners, no one said, oh, well, you know, this, this won't suit all of our customers or subscribers to a plan or whatever it may be. They're looking at using it universally and and you're right, whether it's work related to continuous glucose monitoring in the future, or the blood pressure, or and what we have today with heart rate, SPO 2 and other future analyte. They're important to measure in everybody and, you know, we're all suffering from chronic conditions.
John Mastrototaro: And in the US, it's a major problem. We've got, you know, half of people over age 20 in the US have have high blood pressure are prehypertensive and diabetes is about a third of the people. And so having products like this that can be worn and used at home in a very user friendly way, that feel good and look good on the finger, something that doesn't interfere with your lifestyle and is able to collect just a wealth of important data and can bring to light changes in your health are needed.
John Mastrototaro: And I think it's going to change the way health care is delivered in the future to bring more of this into the home with folks. And I think we're all more aware of our health than ever before after what's happened through the course of COVID and whatnot. So it's we're finding it to just be a massive opportunity quite frankly and are speaking to all the who's whom in the health care space about products like this that can be levered seamlessly and help support the health and wellness of People.
Tyla Bucher: Tyla, do you have anything to add specifically about the D to C and the female focus there that you want to comment on? Sure. I mean, I think you you captured it really well.
Tyla Bucher: I think the only comment that I would make is to sort of echo your your notes about we didn't design the EV ring to the exclusion of the mill gender, but rather to really, you know, be present for an opportunity that we see among women who prioritize their health, prioritize the health of their family, control the purse strings, make decisions for the family, and really coming up with a solution for them to to make sure that they're taking good care of themselves and that they're prioritizing their wellness. You can wear the EV ring now, if you are, you know, whatever gender you are.
Tyla Bucher: And I think what we try to do is really take into consideration how women would like to receive the data, how they want to see it displayed in their app, a comfortable fit, and make sure that they're delivering insights that make them feel like this is a worthwhile endeavor and that they understand what to do with that data.
Tyla Bucher: So I think as we move forward, you know, nothing is necessarily off the table, but certainly the priority was to make something available to women where we see a tremendous tremendous opportunity. But again, having said that, anyone can wear the ring. And it will still work and it will still track your health and well being.
Unknown Executive: Thanks, Alex. Thanks, John.
Unknown Executive: I'll take the last question. It looks like you've made some good progress on reducing the quarterly burn rates, how we see the trend in our expanded launch of the EV ring and eventually even that we appreciate the feedback. We continue to be focused as an organization on the highest and best use of our capital and the larger profile of the D to C and B to B businesses that were rolling out.
Unknown Executive: We believe the product, manufacturing and customer service improvements that we've implemented over the past few months should definitely help position us for growth and cash flow. In addition, the turn to agreement, which we've mentioned a couple of times over the last few calls and which we've now executed with our contract manufacturing partner. That should very much improve our company's cash flow profile better lining up sales and the actual costs and goods.
Unknown Executive: Operator, I'm just saying closing, investors like to stay up to date on Movano Health, please continue to check into ir.movano.com. We look forward to staying in touch. We'll see you next quarter. And thank you for your support. Thank you.
Operator: This concludes today's city conference. You may disconnect your lines at this time. Thank you for your participation. Thank you very much.