Good afternoon, and welcome to the Vivos Therapeutics, Inc. Second Quarter 2021 Earnings Conference Call. Please note, this event is being recorded. I would now like to turn the conference over to Edward Loew, Investor Relations Officer. Please go ahead.

Thank you, operator. Hello, everyone, and welcome to Vivos Therapeutics First Quarter 2021 Earnings Conference Call. A copy of the company's earnings press release is available on the Investor Relations section of our website at www.vivoslife.com. With us on today's call are Kirk Huntsman, Vivos' Chairman and Chief Executive Officer; and Brad Amman, Chief Financial Officer. Today, we'll review the highlights and financial results for the first quarter 2021 as well as recent developments. Following these formal remarks, we will be prepared to answer your questions. I would also like to remind everyone that today's call will contain certain forward-looking statements from our management made within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, concerning future events. Words such as may, should, projects, expects, intends, plans, believes, anticipates, hopes, estimates and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the company's control. Actual results, including the results of Vivos' growth strategies, operational plans, results of operations and other matters to be addressed by Vivos management in this conference call, may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the risk factors described in other disclosures contained in Vivos' filings with the Securities and Exchange Commission, including our first quarter 2021 10-Q, which is being filed today. Except to the extent required by law, Vivos assumes no obligation to update statements as circumstances change. Now at this time, it is my pleasure to introduce Kirk Huntsman, Chairman and CEO of Vivos. Kirk, please go ahead.

Thanks, Ed, and thank you, everyone, for joining us today on our first quarter 2021 earnings conference call. This is our second quarterly call as a public company, and I'm excited to provide you with an update on our progress. Afterwards, our Chief Financial Officer, Brad Amman, will review the highlights of our first quarter financial results. Following that, we will be happy to take your questions. For those of you not familiar with Vivos, we are a growing revenue stage medical technology company focused on developing and commercializing innovative diagnostic products and therapeutic treatments for adult patients suffering from sleep disorder breathing, including obstructive sleep apnea or OSA. OSA is a chronic illness affecting nearly 1 billion people worldwide and over 54 million in the U.S. alone. OSA can also lead to many other debilitating and deadly health conditions such as high blood pressure, heart failure, stroke, diabetes, dementia and other debilitating or life-threatening diseases. This creates substantial societal and health care system costs, not to mention the personal toll it inflicts on people and their families. At Vivos, our mission is to rid the world of obstructive sleep apnea. We market and sell two primary innovative products, one diagnostic and the other therapeutic, each of which represents what we believe to be best-in-class technology. Together, we believe they give us a great competitive advantage in the market for the identification and treatment of OSA, consistent with our FDA approvals. Our flagship therapeutic product is the Vivos System, a multidisciplinary set of clinical therapies and protocols featuring our patented and customized mRNA oral appliance. Studies have shown that treatment with the Vivos System can reduce OSA severity, as measured by Apnea Hypopnea Index scores, by 67.4% on average. Our VivoScore product, which we gained access to and launched in the first quarter, is a comprehensive home sleep apnea test, to which we have exclusive distribution rights in the dental sleep markets in the United States and Canada. VivoScore consists of a single-sensor ring recorder that works with a mobile phone application and proprietary cloud-based algorithms to evaluate sleep quality and clinically diagnose sleep apnea. The primary market channel for the Vivos System and VivoScore are the estimated 165,000 general dentists and dental specialists in the United States and Canada. To date, we have trained over 1,200 dentists across North America and internationally in the use and application of the Vivos System. Our dentists are enrolled in our Vivos Integrated Practice or VIP program, which offers training and other value-added services in connection with using the Vivos System. Turning now to the first quarter. We continued to advance our strategic initiatives to introduce the benefits of the Vivos System treatment to members of the medical and dental communities. This includes the finalization of our licensing, marketing and distribution agreement for and the launch of VivoScore for home sleep testing in children and adults; the opening of our first Pneusomnia Center in Del Mar, California; and the launch of a new service called MyoCorrect, where trained therapists will provide Vivos-trained providers access to orofacial myofunctional therapy, otherwise known as OMT, via telemedicine technology. Before I review our first quarter highlights, I want to talk a little bit about the typical kind of activity we see this time of year and perhaps, more importantly, what we've been seeing here more recently. As you may recall, during the fourth quarter, we saw an uptick in both VIP enrollment as well as higher sales of our therapeutic products and services. The fourth quarter is typically a strong quarter for us. In addition to our continued organic growth in 2020, during Q4, we usually experience some seasonal activity related to people utilizing their dental insurance benefits prior to the calendar year-end. In line with our forecasts, our revenue recognition policies, the gradual post-pandemic reopening of our economy and the timing of our sales cycle, we did not expect to realize the full impact of the capital deployed from our December 2020 IPO and accelerated growth actions in the first quarter of 2021. This is consistent with what we've shared with the analysts who cover us and why we beat the consensus revenue numbers for the quarter. Related to this, during the first quarter, we typically see a sequential slowdown in product sales activity. This reflects a slight lull that often follows the higher activity we usually see in Q4 as dental offices overall are typically slower following the year-end rush when people are trying to utilize the remainder of their dental insurance benefits to their fullest extent. As a result of these factors I've discussed, while our VIP enrollment was up quarter-over-quarter for the first quarter, the overall growth was slower than what we've seen in Q4. Having said that, I'm happy to report that following the typical seasonality of the first quarter, we have been very pleased by the strong interest in our products and services within the dental community, which has increased our VIP sales funnel. This momentum has continued throughout May to date as many dentists have reopened their offices, more Americans get vaccinated, and we all move forward from the disruptions of the COVID-19 pandemic. The second quarter has been off to a very strong start with enrollments by new VIP dentists, along with increased levels of daily appliance sales. Demand for our new VivoScore diagnostic product and MyoCorrect therapy service, available via telemedicine during Q2, have also exceeded our expectations, although any material impact on our overall revenue from those two products is not expected to begin to be realized until the second half of 2021. We are very pleased with this recent momentum and expect it will continue throughout the remainder of the second quarter and for the rest of 2021. With that, let me provide some highlights from our first quarter results. I'm pleased to report that for the first quarter of 2021, we generated revenue of $3.4 million, an 8% increase compared to $3.2 million for the first quarter of 2020. We achieved gross profit of $2.7 million, an 11% increase compared to gross profit of $2.4 million for the same period in 2020. We also increased gross margin to 78% compared to a gross margin of 76% for the first quarter of 2020. We surpassed 17,000 in total cases treated with the Vivos System, and we ended the first quarter of 2021 with cash and cash equivalents of $14.1 million as of March 31, 2021. Brad will review our financial results with you shortly in more detail. I am very pleased with the results we're reflecting so far, which reflect Vivos' quarter-over-quarter growth, notwithstanding the onset of the COVID-19 pandemic. More than that, I'm particularly satisfied with our more recent performance. As I noted earlier, our business began to pick up considerably in April. And this has continued to date given the drivers, which include continued adoption of the Vivos System as well as accelerated growth in VIP enrollment. And where we are now in mid-May, we expect this momentum will continue throughout the balance of the second quarter. We continue to be encouraged by our recent activity and look forward to updating you further when we have our next quarterly call. In addition to these results, during the first quarter and in the weeks that have followed, we continued making considerable progress in advancing a number of our strategic initiatives designed to both increase awareness of our therapeutic products and services and adoption of the Vivos System throughout both the medical and dental communities as well as to broaden our scope of activities and potential revenue streams. To briefly recap some first quarter achievements I discussed on our last call, in January, we commercially launched our AireO2 software, a new patient and sleep practice management software platform that will enable our VIP doctors to more effectively manage, schedule, monitor and process their patients with OSA and its related conditions. Developed in collaboration with Lyon Dental, AireO2 contains features that enhance health care professionals' medical billing services and more, including practice management systems. We believe our AireO2 patient and practice management platform represents a significant improvement in how medical and dental professionals can effectively treat sleep disorders. We look forward to continuing to market AireO2 as a key value-added component, along with our existing billing intelligence service and to actively pursue AireO2 as a revenue source from other OSA-focused health care providers that are not affiliated with Vivos. I would note that we liked the Lyon Dental technology so much that this past April, for a relatively small spend, we acquired from Lyon Dental certain medical billing and practice management software licenses and contracts pertaining to the software underlying AireO2, thus eliminating all the middleman expenses to us. In February, we submitted a 510(k) Class II application to the U.S. Food and Drug Administration for our mmRNA oral appliance with indications to treat mild-to-moderate OSA, sleep-disordered breathing and snoring in adults. Our mmRNA oral appliance is a new version of our existing mRNA appliance, which is an FDA-cleared Class II oral appliance. Assuming the mmRNA receives 510(k) Class II approval, we would expect the mmRNA to be added to the Centers for Medicare and Medicaid Services' list of approved sleep apnea appliances. This achievement will allow our VIPs to bill Medicare and be reimbursed for their patients ages 63 and up that want the Vivos System. While the process with FDA is sometimes uncertain, we anticipate having this Class II approval later this year. This would be an important development for us, and we will keep you updated as this process continues. Later in February, as mentioned earlier, we gained access to and then launched our VivoScore diagnostic product. It is important to note that VivoScore's core technology from our partner, SleepImage, is the only FDA-cleared software as a medical device for establishing sleep quality and diagnosing and managing OSA in both children and adults. We believe this new technology will open the door for more patients to be diagnosed and eventually treated for sleep apnea. Further, we expect to generate increased revenue from VivoScore due to an anticipated rise in total patients being tested for sleep apnea, which has translated into a corresponding increase in patients enrolling in the Vivos System treatment. This conclusion is based on the results of an informal pilot study conducted with independent Vivos-trained dentists and other Vivos provider feedback, which may or may not prove reliable on a broader scale. But in its public or in this pilot study, 12 Vivos-trained dentists performed approximately 938 sleep tests over a 3-month period using VivoScore. 56% of the patients in the pilot study tested positive for obstructive sleep apnea and received a confirming diagnosis from a physician. 50% of those patients who tested positive then entered into treatment for OSA with the Vivos System. We believe these pilot study results indicate that VivoScore may enable health care providers to more efficiently screen, diagnose and initiate treatment for OSA in their patients, which could result in more patients being treated with the Vivos System. In addition to VivoScore, during the first quarter, we continued to make advancements through our Medical Integration Division with March opening our first Pneusomnia Center. Our Medical Integration Division, or MID, was launched in 2020 with the goal of creating strategic alliances between the medical and dental communities so more medical doctors can work directly with Vivos-trained dentists for treating sleep disorders in patients. We believe this will further the diagnosis and treatment of OSA with the Vivos System. This first Pneusomnia Center is located in Del Mar, California and is owned and operated by an assorted group of local physicians led by Dr. Mimi Guarneri, a renowned cardiologist, Founder and President of The Academy of Integrative Health and Medicine and an award-winning physician and researcher. Additional Pneusomnia Centers are currently being developed in Nevada, Colorado, California and New Jersey. Later in March, we announced the launch of a new therapeutic service called MyoCorrect, where trained therapists will provide our VIP doctors and their patients with access to orofacial myofunctional therapy, or OMT, utilizing telemedicine technology as a component to OSA treatment for their patients using the Vivos System. OMT therapists work with patients to strengthen and improve function in the muscles of the lips, tongue, cheeks and face and their related roles in breathing, sucking, chewing, swallowing and some aspects of speech. Clinical research has shown OMT to be an effective component of OSA treatment. Further, Vivos-trained dentists who have actively incorporated OMT in their Vivos System treatment protocols report four primary benefits: one, higher case acceptance for Vivos System therapy; two, better patient compliance; three, shorter treatment times; and four, improved clinical outcomes. Despite these benefits, due to scarcity of trained OMT therapists in many areas of the country and other factors, too few dentists and patients have been able to access this important adjunctive therapy. MyoCorrect will provide every Vivos dentist and their patients with immediate and easy access via telemedicine to this valuable clinical resource at an attractive price point. Over time, we expect to see additional revenue from this new MyoCorrect service in the form of increased Vivos System case starts and direct therapeutic fees charged for the service. We expect this MyoCorrect service will become an important value-added component in the treatment of OSA as it is more fully integrated into the Vivos System. We further believe that offering a scalable and cost-effective OMT service via telemedicine will improve patient compliance, shorten overall treatment times and further improve clinical outcomes, thus providing Vivos with a further competitive advantage in the marketplace. More recently, in April, we announced the appointment of Dr. Mimi Guarneri as an independent consultant serving in the role of Medical Director of Clinical Education. As I mentioned earlier, Dr. Guarneri is one of several physician owners of Vivos' first Pneusomnia Center in Del Mar, California. In her newly created role, her duties for our company will include the promotion and expansion of our Medical Integration Division to her extensive network of medical colleagues. We are extremely excited to welcome Dr. Guarneri to Vivos. As a leading integrated cardiologist in North America, she is an incredibly valuable addition to our team. Her vast experience and expertise as an award-winning physician and researcher make her a logical choice to help inform other physicians about our breakthrough diagnostic and treatment technologies. We are happy to have her with us and look forward to her contributions to our rapidly growing organization. In summary, during the first quarter, we began to strategically deploy the capital from our IPO, laying the foundation for accelerated growth and performance throughout 2021 and beyond. At the same time, we achieved several significant milestones, including the commercial launch of AireO2; our 510(k) Class II application submission to the FDA for our mmRNA oral appliance; the finalization of our exclusive license, marketing and distribution agreement for our VivoScore sleep testing product and service; the opening of our first Pneusomnia Center; and the recent introduction of a new MyoCorrect service for orofacial myofunctional therapy. Looking ahead, as I noted earlier, in April, we began to see a substantial increase in activity throughout all facets of our business. This uptick has continued to date in May, and we believe it is further proof of the continued adoption of the Vivos System and the accelerating growth impact due to our VivoScore diagnostic product and MyoCorrect therapy services. Given this recent activity and the drivers of our business, we are hopeful that this momentum will persist throughout the remainder of the second quarter. The last month has also seen the publication of two important peer-reviewed papers, adding further validation and support to our core therapeutic technology, along with the long anticipated publication and arrival of a new textbook by our Founder and Chief Medical Officer, Dr. Dave Singh called Pneumopedics and Craniofacial Epigenetics with the foreword written by Dr. Clete Kushida, the Division Chief and Medical Director at Stanford Sleep Medicine and the Stanford Center for Human Sleep Research at Stanford University Medical Center. So with these achievements so far during our brief time as a public company and our current business momentum, we are extremely excited about our prospects. We look forward to updating you on our continued progress as we execute on our strategic initiatives to expand market share and increase awareness of our therapeutic products and services through our marketing initiatives and Medical Integration Division. This concludes my opening remarks. Now I'll pass the call on to Brad, who will review our financial results. Brad?

Thank you, Kirk, and good afternoon, everyone. Today, I'll review our first quarter 2021 financial results. We reported total revenue of $3.4 million for the first quarter of 2021 compared to $3.2 million for the first quarter of 2020. The 8% quarter-over-quarter increase was related to revenue from VIP enrollments, billing intelligence service subscriptions and a small amount of initial management fees from our Medical Integration Division or MID program. During the first quarter, we enrolled 53 VIPs and recognized revenue of approximately $1.8 million compared to 32 VIPs and recognized revenue of $1.5 million during the same period last year. Additionally, our billing intelligence service revenues increased from $156,000 in the first quarter of 2020 to $203,000 for the first quarter of 2021. During the first quarter of 2021, we sold 2,570 oral appliance arches compared to 2,099 total oral appliance arches during last year's first quarter with revenues slightly higher in 2021 due to volume increases. Gross profit was $2.7 million for the first quarter of 2021, up 11% compared to gross profit of $2.4 million for the first quarter of 2020. For the first quarter of 2021, gross margin was 78%, an increase of 2 percentage points compared to 76% for the first quarter of 2020. We continue to see improvement as our business continues to be driven by high-margin service revenues, including VIP enrollments and billing intelligence service revenues during the period. General and administrative expenses were $5.1 million for the first quarter of 2021 compared to $4.2 million for the first quarter of 2020. This increase was due to additional personnel that were hired during the course of 2020 and early 2021 to support our continued growth and new status as a public company. The net loss was $3.4 million for the first quarter of 2021 compared to $2.6 million for the first quarter of 2020. The quarter-over-quarter increase was mainly due to higher G&A expenses due to the factors that I discussed earlier. Turning to our balance sheet. At March 31, 2021, our cash and cash equivalents were $14.1 million compared to cash and cash equivalents of $18.2 million at December 31, 2020. To strengthen our balance sheet, we recently closed a follow-on public offering of 4.6 million shares of common stock at a public offering price of $6 per share. Aggregate gross proceeds from this offering were $27.6 million prior to deducting underwriting discounts, commissions and other operating expenses. These proceeds, in addition to the proceeds from our December IPO, should give us the considerable financial flexibility to continue executing on our growth strategy. As for the reasons for this raise, our Board of Directors and management were pleased by the initial demand of our VivoScore and MyoCorrect products and services and concluded that the additional capital could be highly beneficial, allowing Vivos to staff up significantly to meet the demand and potentially accelerate revenue growth. Before I go to Q&A, I want to provide an update on the coronavirus pandemic as it relates to our company. As we noted on our last conference call, the COVID-19 pandemic created a global disruption in economic activity. Due to this decrease in global economic activity as well as local restrictions, temporary business shutdowns and social distancing practices, many of our VIPs and potential VIPs closed their offices during 2020. While revenues growth flattened during March and April of 2020, our expenses were also reduced due to our disciplined management of expenses. At the same time, we aggressively expanded our network of health care providers familiar with our products by offering online continuing education courses, which introduced many in the medical and dental communities to our product line. As businesses and the general economy have continued to reopen during 2021, the impact of COVID-19 on our business continues to diminish. Our VIP program continues to grow, while sales of Vivos appliances have steadily increased. Additionally, we have continued to work to improve cash flow and manage our working capital. Given these factors as well as our recently priced secondary offering, we believe our existing cash resources will be sufficient to meet our capital requirements and fund our operations for at least the next 24 months. Moving forward, we will continue to aggressively expand our network of health care providers familiar with Vivos products by offering online continuing education courses, which have proven to be both successful as well as cost effective in introducing new members of the medical and dental communities to our services and products. We continue to see greater awareness and adoption of the Vivos System throughout both the dental and larger health care communities. Given our continued momentum in 2021, we expect this trend will continue throughout 2021 and into next year. That concludes our prepared remarks. Now I would like to open the call for questions. Operator, please go ahead.

The first question comes from Alex Nowak with Craig-Hallum Capital.

Just over the last 6 months or so, we've seen Vivos build out a pretty nice portfolio of products treating OSA at the dental office. You got the Pneusomnia clinics, the VivoScore, the OMT telemedicine app and then the patient management software. Are there any other areas you'd like to bring on to round out that portfolio?

So thanks, Alex. Good question there. We are always looking opportunistically for the right kind of platform to leverage, whether it's a technology or some other means of accessing the marketplace. So I would say there's not anything directly. We've pretty well assembled what we have today, and now it's a matter of execution. But we're always looking at different platforms and other opportunities to extend the reach.

Okay. No, that makes sense. And perhaps expand on the ways to leverage the investment dollars from the IPO to expand the sales and marketing strategy here for Vivos. The press release today mentioned it looks like there's a new marketing firm. So just expand how you're looking to change the marketing of the appliances, how you're going to change the marketing or expand the marketing for the VIP enrollments? And yes, I guess I'll leave it there, and I'll ask a separate question.

Yes, another good question. We validated a model for our sales force before the IPO, where instead of having independent sales reps operating solo, we formed teams. We had one complete team with various functions and roles. Since the IPO, we've replicated that second team and now a third team. Previously, our capacity and resources were limited, which hindered our ability to add more marketing personnel. Now, we're scaling up by replicating these teams across the country, with the second and third teams fully established by June 1st. Additional teams will be added as necessary throughout the year. This is our approach to enrollment. On the VivoScore side, we had to create an entire department. The demand for the VivoScore product surged quickly and unexpectedly, capturing attention globally. We received inquiries from around the world, which indicated significant interest, prompting us to expand the company and ensure we had a capable division led by experienced individuals. We've made new hires and established the VivoScore division, implementing various programs. I recently returned from a conference in Dallas, and we also had a successful conference in Florida. I refer to the VivoScore product as the tip of the spear, which accurately reflects its role in our outreach. It's the first exposure that doctors have to our offerings, and it operates so effectively that we provided devices for doctors to test overnight. They returned the next morning, and it was rare to find a doctor without some concerns about their sleep results. This experience was quite revealing for them and initiated important conversations about the need for these products in their practices and the opportunity that Vivos represents. By leading with VivoScore, we are engaging with many more professionals in both the dental and medical fields, facilitating more open discussions with their patients.

No. That's great. And just a follow-up to the sales point. On those teams that you've established here, is there a focus as well to improve same-store sales? And I guess what I'm trying to get at, you have some VIPs that are doing a high number of cases. You mentioned those in the prepared remarks, but then the average is lower. So just curious, where are you focusing the sales side to improve the same-store sales performance?

That's okay. Yes, so alongside our enrollment teams, we also have practice analysts. These analysts are experienced professionals from the dental industry who have significant experience in implementing products in dental offices. They are assigned to new enrollees. However, during COVID, many dental practices closed for some time, and while they managed to enroll, they struggled to complete their onboarding and training, which made starting their first few cases challenging. To address this, we have hired and are continuing to hire practice advisers, which has significantly reduced the number of practices that have yet to engage. Although I don't have the exact figure at hand, I recall being quite pleased with it, as over 88% of doctors have started cases with us recently. This contrasts with the situation during COVID, when the completion rate was around 50%. Engagement from our doctors has notably improved as they emerge from COVID and fully participate in training. Part of their training requires them to come to Denver; it used to be entirely in-person, but now it is mostly online, with some sessions in Denver. They need to experience the appliances firsthand to understand how they work and feel comfortable enough to recommend them to patients. We are optimistic about the progress here. We are working on two fronts: increasing new enrollments and another initiative focused on improving same-store sales.

Okay. Understood. That makes sense. And then just last question, just an update on the Stanford study and then any other data readouts we should be watching for.

Yes. So Stanford, I think, Brad, are we signing it this week? We should be signing it.

Yes. It's ready to be launched.

Yes. It's ready to be executed. We've resolved all the back-and-forth issues with Stanford regarding the final documents. I believe we are set to sign the deal and begin. The Stanford study will start immediately, which is very exciting. Additionally, we have other studies ongoing. I want to remind you that other IRB studies currently in progress are expected to conclude in the next few months, and we will report the results and publish those papers later this year.

The next question is from Scott Henry with ROTH Capital.

A couple of questions. First, I know you recently brought in that second sales force team. Can you talk about where they are in the cycle? Are they productive at this point? Are they generating new VIPs at this point?

Yes. They are. So yes, I'll just tell you that we're very happy with the way that they are ramping up. And they're not quite to the same productivity level as our first team. But I think we're really happy with the way that's come along. So yes, the answer is yes.

Okay. Great. It sounds like a lot of positive leading indicators in this first quarter. Would you expect to see sequential upticks throughout the year on a kind of quarter-to-quarter basis in total revenues and perhaps on the VIP front as well, although you might get some choppiness here or there?

Our forecasts indicate that we anticipate an increase in enrollments and appliance sales throughout the year. There is nothing occurring currently that would lead us to change that outlook. We are setting daily records for appliance orders, which is very encouraging for our recurring revenue streams and new enrollments. Based on the current momentum we've discussed today, we feel confident in achieving our long-term targets.

Excellent. And G&A, a little higher in Q1. Do you think Q1 is representative of what we should expect throughout the year?

On G&A, yes, we do have some infrastructure-type expenditures. We have an ERP system that we're planning on bringing on here later this quarter. And we do have, certainly, sales and marketing expenditures or plan to increase to help drive top line revenue.

What happens is that, similar to many businesses, we need to hire before people actually start generating revenue. For the added marketing expenses in the current quarter, we won't see any benefits right away. Instead, we’ll be investing in the marketing assets and personnel needed, such as hiring and training for the VivoScore department, which all requires capital upfront before we begin to see a return on investment. That’s why we’re making these investments now. The funds from our IPO and secondary offering are being carefully allocated to areas where we expect to see results starting in the second half of this year, particularly in Q3 and Q4, with some improvements expected in Q2. Although we are experiencing slightly higher general and administrative costs, this is all aimed at achieving future growth in the business.

Okay. Final question, just with regards to the mmRNA, let's say you get that approval later this year. How long does it take from approval to being able to get Medicare reimbursement? And what are the steps in that process to make that happen?

There are several steps involved in this process. We need to obtain approval from CMS, which requires what is known as PDAC clearance. This necessitates a third party evaluating the mechanics of the product. This should not pose a problem, as we have already completed all necessary biomechanical work. We're essentially changing one type of hinge for another, with no functional alterations. The new hinge is what Medicare requires, although the reasoning for this is unclear. There are multiple steps we need to take, and we cannot predict the timing or the reactions from all parties involved. However, we anticipate the approval process to be relatively straightforward. If we can secure FDA release within the next couple of months, we expect to receive clearance within six to eight weeks afterward.

This concludes our question-and-answer session. I would like to turn the conference back over to Kirk Huntsman for any closing remarks.

Thank you, operator. We feel like with the capital, the much-needed capital that we obtained through our IPO and our secondary, that we have positioned this company to be a disruptive force in the market. As we move forward, as we begin to get the name Vivos and our brand out there using Osmond Marketing, our new marketing group that we have, they have just embraced this full tilt. And they are aggressively creating marketing assets and helping us with the rollout. We're very pleased with that. We're very pleased with the way our medical division is rolling out and the exposure that we've seen. Some of these new papers that I've referenced here that have come to market that Dr. Singh has published and others have published give us great hope for being able to continue to make the case that Vivos has a game-changing technology from a therapeutic standpoint and certainly from the diagnostic standpoint, something that's already showing some disruptive capabilities in the market. So I think we've positioned this very well. I always say, if the world knew what we really had here, it would be a much different story for us. But we are gradually and judiciously putting this thing together and putting it out in a way that we think will optimize the growth opportunities that we have and maximize shareholder value. So with that, we'll close this out. I appreciate everybody's support of the company and our team here, and we look forward to having you on board and see you again next quarter. Thank you.

Thanks, everybody.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.