4/4/2024

speaker
John
Chief Executive Officer

including a $3 million strategic seed investment from a tier one multi-billion dollar global medical device company. This is a pivotal moment in our company's journey. We're thrilled to partner with this leader in healthcare and look forward to potential future collaborations. As we highlighted in our press release earlier this week, this strategic investor is keenly interested in the EV ring and our proprietary millimeter wave radio frequency technology And this event underscores the vast potential of our innovative approach to delivering medical grade data to both consumers and enterprises. We're also fortunate to have had the broad participation in the private placement from Havana Health's management team and board of directors, totaling more than $3.6 million. Now, with the new financing, we are set up to scale commercial production proceed further along the regulatory pathway and pursue multiple market opportunities that should deliver shareholder value. Our goal is to deliver both the consumer and FDA cleared wearable that combines accessibility, personalization, and style with the recognized capabilities of a medical device. Our highest priorities are as follows. One, to achieve our first FDA clearance for pulse rate and blood oxygen monitoring, which sets the stage for our brand expansion to EV Med. Two, on the heels of this clearance to bring key B2B opportunities to fruition. And three, to accelerate our clinical trials for cupless blood pressure and noninvasive glucose monitoring, establishing the foundation to develop additional commercial products leveraging our proprietary technology. Movano Health is using EV to set new standards for the possibilities of what wearable health technology can do. We plan to serve consumers through both D2C and B2B channels, where regardless of the access point, our user is ultimately always a consumer wearing a ring. As such, the EV Ring Wellness product is a valuable step on our path to broader commercialization. We're already learning what consumers like and want, and this critical information will help us achieve higher adoption and engagement from future users. Based on early feedback, we've made several software updates to improve the overall experience, including minimizing use of the green LED light and improving the accuracy of our sleep tracking. In March, we launched our Insights Engine, which is the first step to offering our customers personalized insights which leverage an AI-based framework correlate disparate data types. We plan to be judicious with our capital position and methodical in our approach to build out our direct-to-consumer and business-to-business market opportunities. In preparation for our B2B launch, we must secure FDA clearance and improve our scale and volume production capabilities. We also plan to execute several initiatives in the next few months, developing an Android version of the app, building sufficient finished inventory to ensure a quick order fulfillment, and bolstering our customer service capacity. Regarding the FDA pathway, we've been strategically focused on pulse rate and blood oxygen saturation monitoring, often referred to as SpO2. In the first quarter of 2024, we used our commercial ring in a second hypoxia trial with UCSF in which each subject wore four EV rings, two on fingers and two held on fingertips. When evaluating accuracy versus arterial blood gas levels, the four EV rings achieved a root mean square error of 2.46%, well within the FDA guidance of 3.5%. In addition, Our rings accuracy also exceeded that of two commercially available hospital-grade reference pulse oximeters, one of which failed to meet the FDA standard for accuracy. Later this month, we plan to present this confirmatory data and address the outstanding FDA comments from our prior submission. We believe taking these steps will put Movano Health on track to receive a decision regarding the 510 clearance in July 2024. We look forward to continuing to work closely with the FDA throughout the review process. In preparation for a positive FDA decision, we have been planning the launch of EV Med, the medical device version of the ring. It's important to note that because the EV ring and EV Med will be the same physical ring, production costs remain the same. The primary difference is that EV Med will include labeling for the FDA cleared features, as well as some modifications to the app experience. As mentioned earlier, our EV user base and customer feedback support sizable B2B opportunities. I'll now hand the call over to Michael Soule, our VP of Business Development, to discuss our efforts.

speaker
Michael Soule
VP of Business Development

Thank you, John. As noted, there are numerous B2B opportunities for EVMed. We are actively engaged with potential partners that are performing various beta tests with EV to assess form and function. Today, I will review three of the distinct market segments beyond the medical device partnership that we announced earlier this week. First, the clinical trials market 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 are poised to dominate the $2 billion market annually of FDA-cleared wearables with minimal competition. Currently, trials are in-person, cumbersome, expensive, and suboptimal as they don't capture the subjects in actual real-life situations. We believe EV Med would improve compliance, lower costs significantly, and enable quicker enrollment, better data, and improved quality of results. Presently, we are in discussions with five top tier pharma companies, one of which has beta tested EV. All of these potential partners are excited about the prospects for an FDA cleared, low cost and convenient wearable to take the place of other devices presently used. Second, the payer market consists of insurers that represent more than 130 million patients with chronic diseases, often with comorbidities who have poor and or unreliable monitoring options. EV Med would provide an easy to implement solution for early detection of dangerous health risks and for the prevention that could greatly reduce costly disease interventions. Already, we have traction with one of the top three US payers that covers approximately 50 million lives. If EV Med is used by just 1% of this insurer's population, that equates to more than a half a million rings. The third market I wanted to highlight is the rapidly growing remote patient monitoring channel, or RPM. This market barely existed four years ago. However, COVID unlocked the reality that healthcare can reduce the need for in-office visits, expand access, and reduce costs. We believe EVMed will be able to automate more complete and accurate data, resulting in an RPM solution with meaningful advantages over RPM products in the market today. Our wearable technology is in beta testing 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. This is just the tip of the iceberg. Other large B2B opportunities include applications in condition management for cardiovascular, metabolic, obesity, and pulmonary patients, which in aggregate we've identified as a $20 billion per year market opportunity. and corporate wellness with an identified TAM of $14 billion. Additionally, we fully anticipate the EV Med introduction will drive more consumer awareness leading to greater D2C adoption.

speaker
John
Chief Executive Officer

I'll now turn the call back to John. Thanks, Michael. Our product development plan extends far beyond EV and EV Med. we're deeply invested in multi-analyte sensing and pursuing additional FDA clearances with further research in respiration rate, for 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. Our commitment to innovation in improving health monitoring and intervention has fueled six years of intensive R&D work in millimeter wave radio frequency and AI technology. Through these efforts, we created our ultra-compact and efficient health monitoring system on a chip, or SOC, which measures just four by 6.7 millimeters in size. Use of this chip yielded breakthrough advances in blood pressure monitoring, enabling accurate, coupless, and automated tracking. We announced the results of a blood pressure clinical study in October 2023, where our prototype achieved an overall mean absolute difference, or MAD, of 5.9 millimeters of mercury, well below the 7 millimeter mercury MAD required for an FDA-recognized standard for wearable cuffless blood pressure monitoring devices. The results of this clinical trial were a clear catalyst for investment by the Tier 1 Medical Device Company. Looking ahead, We're also evaluating AI-based individual calibration methods to further enhance the future performance of our prototype. Ultimately, we expect blood pressure monitoring will be a significant addition to incorporate into a new product that supplements the suite of analytes we currently offer in EV. In addition, we believe our single chip technology can be implemented in products designed to aid in the treatment of patients with multiple chronic conditions, including diabetes, where our platform is being evaluated for non-invasive blood glucose monitoring. Our studies demonstrated that our millimeter wave RF technology surpasses traditional optical sensors and provides high fidelity data and reliable readings with the ease of continuous data collection. We look forward to additional clinical testing later this year, leveraging the RF chip. With that, I'll now hand the call over to Jay for the financial review.

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