From: To: Cc: Subject: Date: Attachments: Pat Gauny Shane Stevens; Hughson, Jane Debbie Woods; Henry Legere [EXTERNAL] RE: Covid-19 screenings/testing eventMonday, March 30, 2020 6:18:52 PM image001.png image002.png image003.png image004.png image005.png image006.png APMDBOX Info.pdf Afternoon Mayor Houghson,     I hope you and your family are doing well. I wanted to shoot you an update.  As Shane stated below, we recently received an Emergency Use Authorization (EUA) from Hay County to implement our COVID-19 Rapid tests and our Telehealth Platform that leverages artificial intelligence to screen patients. I have attached some information for your review. Shane and team recently held a press conference that you might see tonight on the news tonight. Here is a link to the CBS article.  We are also working with and providing tests for the Texas COVID Taskforce.  We would like to chat with you and your team to see how we can help “Flatten the Curve” in San Marcos.     Best   Patrick Gauny     Patrick Gauny Vice President Strategy and Innovations AnyPlace MD 512 905 1214 Pat.Gauny@AP-MD.com   https://www.ap-md.com/       From: Shane Stevens Sent: Sunday, March 29, 2020 10:37 AM To: JHughson@sanmarcostx.gov Cc: Pat Gauny ; Debbie Woods ; Henry Legere Subject: Covid-19 screenings/testing event  Good morning Mayor Houghson, One of my dear friends and brothers, Cory Morrow, passed along your contact information. We have an EUA for hays county to allow for in-home Covert testing with use of our telehealth platform. We have 50,000 of the test on hand and have 500,000 more tests coming. Hays counting will be the first county to roll out our R.A.P.I.D.  testing model and from there we will start applying it to other counties throughout the state.  There’s so much information to share and I can’t stop to share it with individual people. I’ve copied a couple of my close team members on here so they can help fill in the gaps. If it all possible, call me on my cell phone, 512-699-2815.  I could use your help connecting with the appropriate leaders in San Marcos for various needs. D. Shane Stevens http://www.usdentalsolutions.com http://www.capitaldentalequipment.com http://www.ap-md.com https://powerlaborusa.com https://www.mobiledentalsolved.com O-(512) 989-6990 X 100 Ephesians 6:10-20   CAUTION: This email is from an EXTERNAL source. Links or attachments may be dangerous. Click the Phish Alert button above if you think this email is malicious . onyploce md box The Future Of Healthcare Is Anywhere You Need It You've got a We've got the solution. Complete mobile medical visit. EXECUTIVE SUMMARY AnyPlace MD (APMDBOX) is requesting to deploy a Remote Assessment Platform for Infection Detection (RAPID) Project to protect frontline healthcare workers, prevent patients from falling through the cracks, stop the spread of COVID-19, and increase medical facility capacity. “According to Scientific America, the US is expected to have over 10 million infected by April 10th If no effective action is taken by April 10, the U.S.” --Scientific American The Challenge: The epidemic of the 2020 novel coronavirus (now called SARS-CoV2, causing the disease COVID-19) has expanded from Wuhan throughout China and is being exported to a growing number of countries around the world. Early efforts have focused on describing the clinical course, counting severe cases, and treating the sick. In less than a month, the global number of confirmed COVID-19 cases more than doubled from 75,000 cases on Feb. 20 to more than 200,000 on Mar. 18 and is expected to double every five days. According to Scientific America, the U.S. is expected to Figure 1 Scientific American, March 12, 2020 have over 10 million infected people by Apr. 10 if no effective action is taken by the U.S. Healthcare technology has the potential to provide easy solutions for high-impact infectious diseases like COVID-19. Technologies that lower barriers in providing the patient with information and treatment could reduce the severity and spread of infectious diseases while increasing capacity of brick and mortar facilities. Telemedicine, for example, is already playing a vital role by offering patients more convenient access to healthcare providers who may not be accessible for a variety of reasons at a traditional healthcare facility. “We face an urgent need to expand and enhance early identification and diagnosis to treat and isolate infected patients.” AnyPlace MDBox believes our Telehealth System is the force-multiplier that the U.S. needs to “Flatten the Curve”. Fully deployed, our system will lower the risk of infection in our healthcare workers, provide a mechanism to track patients of all risk levels, monitor and track those who have encountered the virus, and keep medical facilities focused on critical cases at hand. APMD’s sophisticated platform offers the benefits of: 1 Page Benefit Feature Point of Care COVID-19 Testing • On-Demand and Scheduled Telehealth Encounters • Remote Patient Monitoring & Tracking System • • • COVID-19 point-of-care tests that leverage Artificial Intelligence, Computer Vision, and Machine Learning anytime and anywhere there is an internet connection. Anytime, anywhere there is an internet connection Keep your facility-based services focused on critical cases by monitoring suspected cases remotely Keep tabs on your most vulnerable and those with chronic conditions that are at higher risk Monitor those who have been directed to selfquarantine for adherence to tracking anyplace mdbox team Our team operates twenty-four hours a day, seven days a week three hundred sixty-five days a year. Anyplace MD (APMD) was founded in 2007 with the sole purpose of increasing access to healthcare with the belief that empowering patients via immediate on-demand telehealth medical services is the most efficient and effective way to improve patient outcomes and expand access to care while reducing overall health care costs. Last year, APMD partnered with MDBox to implement telehealth services for all Walmart and H.E.B. (largest grocery store in Texas) employees and customers. Our team operates twenty-four hours a day, seven days a week, three hundred sixty-five days a year with both immediate ondemand providers and “backup redundancy” overflow medical and behavioral health providers during high volumes. Our current provider network in Texas consists of over 1,000 registered medical professionals (both HIPPA and HITRUST certified) with specialties that include, but are not limited to, Audiology, Behavioral Health, Infectious Disease, Cardiology, Dermatology, Endocrinology, Orthopedics, and Rheumatology. March 2020, both companies felt a compelling need to come together to form Anyplace MDbox (APMDBOX) to combat the COVID-19 epidemic. 2 Page anyplace mdbox team APMDBOX has a uniquely experienced and dedicated team with a consistent track record of customization, flexibility, innovation, and value. Our team is committed to providing the best and most professional telehealth services to our clients and has over 100 years of combined experience in Health Care, Behavioral Health, Dental Care, Telehealth, Project Management, and Contract Management. Shane Stevens – Any Place MD, Any Place Audiology and Dental Health Management Solutions Founder and CEO Shane Stevens has over 20 years of experience in medical and dental operations, finance, marketing, staffing, and management. Shane is responsible for all aspects of Dental Health Management Solutions (DHMS), Any Place MD, and Any Place Audiology, which have created successful solutions in many areas of healthcare spanning a local as well as global reach. As the dynamic leader of DHMS, he has driven benchmarks in military readiness serving our nation’s soldiers across all 50 states and territories since its inception in 2004. In 2007, Shane founded Any Place MD with the vision of empowering patients with expanded access to healthcare providers and services through various delivery methods to include immediate, on-demand telehealth medicine in an efficient and effective way that directly improves not only their experience but also their overall health outcomes. Shane is a passionate player in the healthcare industry and an active philanthropist for many community-related causes. Dr. Henry Legere - MD Box Founder and CEO Dr. Henry Legere is the founder and CEO of Reliant Immune Diagnostics. He graduated medical school from Columbia University College of Physicians and Surgeons in New York City. After completing a residency at the University of California, Irvine, he completed an immunology fellowship at Harvard Medical School, Brigham and Women's Hospital. Dr. Legere founded one of the largest immunology practices in the United States and believes that patients should have greater access to healthcare at a more affordable price by utilizing technologies that we already use every day. Jovan Hutton Pulitzer – Innovator, MD Box Co-founder, Any Place MD Jovan Hutton Pulitzer, Award-Winning Inventor, created our patent portfolio for our unique and proprietary MPOC System and Platform (Mobile Point of Care). Our platform consists of over 60 patents filed to pioneer this technology breakthrough. Pulitzer is a highly active technology founder currently involved in the Augmented Reality, Artificial Intelligence, Machine Learning, Computer Vision, Health Care, Mobile Health Care, Engagement Technologies, and Data Analytics industries. Pulitzer is regularly one of the top inventors from month to month in the United States. Nicholas Solter - Chief Technical Officer and Chief Information Security Officer Nicholas Solter studied Computer Science at Stanford University, where he earned a Bachelor of Science with distinction and a Master of Science with a focus in Systems. In his 20-year, wide-ranging industry career, Nicholas has led development of consumer products in a variety of spaces, including computer games, web apps, mobile apps, systems software, and payment systems. He has held engineering and product leadership roles in companies ranging from four-person startups to tech giants like Adobe Systems. Nicholas is also the lead author of two technical books: Professional C++ and the OpenSolaris Bible, has taught computer programming at the college level, and is the inventor of seven issued patents. Joseph Legere – Chief Compliance Officer Joseph E. Legere joined Reliant Immune Diagnostics in 2017 as the Chief Compliance Officer and was certified in December of 2017 as a CSF Practitioner by HITRUST. Mr. Legere has worked as an attorney in 3 Page the Dallas County District Attorney’s office, as a civil litigator, and as an adjunct professor with Collin College. Currently, in addition to his duties with Reliant Immune Diagnostics, Mr. Legere provides legal services to various financial institutions, politicians, associations, and non-profits with regards to compliance issues. Mr. Legere volunteers his free time with several non-profit entities including Susan G. Komen, Easter Seals, the American Cancer Society, MADD, the American Heart Association, and the Assist the Officer Foundation. Mr. Legere has been recognized for his legal work and volunteer work and has received numerous awards including the Back the Blue Award for his work following the shooting of five Dallas Police Officers in July of 2016 and was named a Champion for Healthcare by the Irving Healthcare Foundation. TECHNICAL APPROACH APMDBOX is committed to providing excellent end-to-end support and telehealth services for patients around the world while providing a fully secure and customizable Telehealth Platform and Provider Network. Our system allows providers to conduct COVID-19 testing and remote exams anytime, anywhere. Telehealth System Overview APMDBOX Telehealth Visit Flow Patient Downloads Application from Apple or Google Store Select Symptoms Experienced Sets up user account Up-To-Date Health Profile? User Performs Test No Complete General Health Profile User Captures Image of test results Yes Complete VisitSpecific Intake Questions Results Transferred to EMR Database Receive audio, visual and text instructions to complete the test Database upload initiates the Telemedicine Visit 4 Page Triple Redundant Telehealth Platform: APMDBOX’s Telehealth platform provides a live- streaming video examination experience that uses Artificial Intelligence, Computer Vision Validation, and Machine Learning to identify patients that exhibit signs and symptoms associated with COVID-19, chronic diseases, and infectious diseases in seconds. All tests and symptoms are validated through a global database. Because of this platform’s unique design, the process also reduces a provider’s need to repeat screening questions during the encounter and optimizes efficiency and indirectly costs. As a result of this increased encounter proficiency, the average patient encounter time has been reduced from an average of 15-21 minutes to 4 minutes. Additionally, if the selected provider does not respond within 120 seconds, a secondary provider is notified, minimizing wait times and expediting patient needs. We believe this process will expand and enhance early identification of patients with COVID-19 and other infectious diseases. COVID-19 Telehealth Encounter: During this global pandemic, telehealth is emerging as an effective and sustainable solution for precaution, prevention, and treatment to stem the spread of COVID19. Telehealth is bridging the gap between people, physicians, and healthcare systems, enabling everyone, especially symptomatic patients, to stay at home and communicate with medical providers through virtual channels. This approach reduces the spread of the virus to the public and exposure to medical staff on the frontlines. The telehealth encounter is a critical part of in-home COVID-19 testing. APMDBOX’s Telehealth System allows for patients to video chat with a healthcare provider on their phone, or other electronic device, from the comfort of their home. Patients can virtually visit with a licensed medical professional, receive prescriptions delivered from their pharmacy of choice, and gain comfort and knowledge as to what their next steps will be. Telehealth encounters can be used to triage patients to ensure that there is a need to test for COVID-19 and expedite it. Telehealth medicine provides additional benefits of: • • • • Promoting Social Distancing Expediting timely care Remotely monitor patients Aid patients with limited mobility • • Decreasing strain and exposure to our healthcare system Providing valuable data that can be used to identify emerging hotspots and predict when others will dissipate 5 Page Enhanced Telemedicine Diagnostic Testing: Our platform leverages Computer Vision, Artificial Intelligence Machine Learning, and Artificial Intelligence (AI) for all of our diagnostic Point of Care (POC) testing. Computer Vision is an AI field that takes and develops advanced image processing software for near limitless uses. Computer Vision is more efficient and accurate than the human eye. By training computers to effectively analyze the real and virtual world through images and photos, vast amounts of high-yield information can be gathered at a greater pace than humans can on their own. Machine Learning Computer Vision Machine Learning uses Computer Vision technology to analyze environmental objects and systems and make an educated, information-based deduction based on the data collected. Our patented system references thousands of positive, negative, and questionable results in order to accurately make a determination 99.9% of the time. APMDBOX’s system can take any current Point of Care (POC) test that requires visual validation and automate it. Why our AI is different: Image analysis can be complicated by many factors. The type of light (natural, LED, fluorescent, etc.), intensity of light, camera variations (white balancing, compression), shadow and glare can impact results. Our team solved this problem by utilizing Curve Filter Transformation. We have pioneered one of the most advanced diagnostic image systems/platforms in the world based on existing mobile camera technologies. Our system recognizes signals that are virtually undetectable, thus producing a quantum leap in image analysis. We have even evolved beyond the need for significant colorimetry blooms and signatures. 6 Page FDA Approved POC Tests: Our POC tests utilize Lateral Flow Immunoassay Testing (LFT). This is a simple to use diagnostic device used to confirm the presence or absence of a target analyte, such as pathogens or biomarkers in humans. The most commonly known rapid LFT strip is a pregnancy test. LFTs typically contains a control line to confirm the test is working properly, along with one or more target or test lines. They are designed to incorporate intuitive user protocols and require minimal training to operate. APMDBOX’s Telehealth Platform integrates a variety of FDA approved diagnostic POC LFT tests with a Mobile Device Application (MDA). Once a test is completed, the MDA triggers a connection to further cater options through a telemedicine video visit. All tests are tethered to Computer Vision for image analysis that can be easily administered onsite and reviewed by our telemedicine providers. All tests and symptoms are validated through a global database and can be customized to the Army’s (or public’s) needs. Some of the current tests available include influenza A and B, strep, and pinkeye. COVID19 rapid tests will be available March 2020. Traditional POC urinalysis tests only utilize 4-6 markers. Below is an example of our advanced diagnostic tests that currently utilize up to 36 markers which can identify over 4,000 underlying conditions related chronic diseases, infectious diseases, drug use, urinary tract infections, and pregnancy status—all from a simple urine test. 7 Page COVID-19 Rapid Test: Many laboratory test kits have been developed and used in testing patient specimens for COVID-19 by the Chinese Centers for Disease Control, the U.S. Centers for Disease Control, and other private companies. The virus nucleic acid RT-PCR test has become the current standard method for diagnosing COVID-19. Yet these real-time PCR test kits suffer from many limitations: 1. These tests have long turnaround times and are complicated in operation; they generally take an average of over 2 to 3 hours to generate results. 2. The PCR tests require certified laboratories, expensive equipment, and specially trained technicians to operate. 3. There are some number of false negatives for RT-PCR of COVID-19. These limitations make RT-PCR unsuitable for use in the field for rapid and simple diagnostics and screening of patients and limits the outbreak containment effort. Therefore, there is an urgent need for a rapid, simple to use, sensitive, and accurate test to quickly identify infected patients of COVID-19 to prevent further virus transmission and to assure timely treatment of patients. The new COVID-19 rapid test provides an accurate COVID-19 infection diagnosis in only 15 minutes. This is the world’s first rapid point-of-care lateral flow immunoassay (LFT) for the diagnosis of COVID-19. The test has been used widely by the Chinese CDC to combat infections and is now available globally. It is widely accepted that IgM tests provides the first line of defense during viral infections, followed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory. Therefore, testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid diagnosis of COVID-19 infection. Furthermore, detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, whereas detection of COVID-19 IgG antibodies indicates a later stage of infection. Thus, this combined antibody test could also provide information on the stage of infection. 8 Page The new COVID-19 rapid test can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic. Recent data suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important. The test is ideally suited for hospitals, clinics, and test laboratories. However, the test, used within APMDBOX’s Telehealth System can also be effectively deployed in homes, churches, businesses, schools, airports, seaports, and train stations, etc., increasing the range of testing and reducing the threat of transmission. The diverse application of this test gives it the potential to become a profound force in the fight against this global threat. This COVID-19 test is faster than anything currently on the market, requiring only 15 minutes for results. Results can be validated through both an intuitive visual interpretation and by supplicated Computer Vision and machine learning systems, which automatically deliver the testing information, users’ data, and a symptoms screen to a medical practitioner though a live audio/video session via the users own mobile device (smartphone). No special equipment or lab is needed and the test and telehealth system works seamlessly with a user’s own mobile phone or device. COVID-19 rapid test can be completed in 4 simple steps. • • • • • • • Easy to use Tests for 2 antibodies No special equipment needed Results in 15 minutes Results validated with AI Connects patient to provider within 2 minutes No sample transport required 9 Page Innovative Provider Network: APMDBOX’s Provider Network is custom-built for each state with highly skilled medical and behavioral health professionals. They are qualified, licensed, certified, credentialed, and/or registered in compliance with applicable state and federal requirements through our credentialing staff and proprietary software. Once fully trained, their duties are governed by a detailed job description and our Quality Assurance program. We are dedicated to a forward-thinking and technologically advanced healthcare provider approach that delivers care where it is needed regardless of geographical limitations. APMDBOX’s unique provider network is truly innovative. Our network is a modern scheduled and on-demand telehealth service that is revolutionizing the healthcare industry. Our virtual provider network is analogous to an “Uber-style” network of doctors. The patients are the passengers, and the doctors are the drivers. Instead of relying solely on a strict number of providers and specialty providers on-call at a scheduled time, we have hundreds of providers at the ready when they receive a notification on their mobile application that their services are needed. The Network is a creative on-demand telehealth service which is revolutionizing the telehealth industry. APMDBOX’s Provider Network is driven by proprietary technology that populates patients into a dynamic self-organizing virtual waiting room, in which healthcare providers accept patients on a first-come-first-served basis, rather than matching patients with providers. APMDBOX runs its own algorithms and formulas to ensure that there are ample providers participating on the network at all times in order to service 24/7/365 patient demand for telemedicine services. Competition among providers to serve patients in the virtual waiting room also minimizes patient waiting time. This staffing structure allows our Provider Network to operate at an estimated 200% improved efficiency when compared to other telehealth provider networks. Currently, the industry-standard response times can range from 15 to 21 minutes (not inclusive of date forward scheduling for times past 24 hours). However, our system is built to provide immediate provider to patient connection at the touch of a button in no longer than 2.5 to 3.9 minutes. All medical providers will be familiar with the signs and symptoms of COVID-19. After each telemedicine session has concluded, the application asks the patient if they would like a follow-up text in the next few days to check on their treatment progress, after which the patient can opt for another telemedicine session. We built our system with scalability and flexibility in mind. We currently have over 1,000 participating providers and have the ability to bring other networks on in days. The U.S. government would have the option of utilizing our network or facilitating patient encounters with their own network as well. 10 P a g e Remote Patient Monitoring & Tracking System: APMDBOX is smart device-driven with exceptional technical merit in a modern healthcare market. With that in mind, we have built our platform to be 100% integratable with wearables and remote diagnostic devices. According to guidance from the Centers for Disease Control and Prevention (CDC), the hallmark symptoms of COVID-19 include fever, cough, and shortness of breath. Our Tyto suite of devices allows people without any medical background or experience to carry out examinations of the heart, lungs, throat, ears, skin, abdomen, heart rate, and body temperature. The tests can be conducted by the patient themselves as well. As for the lungs, one of the most sensitive areas to detect possible symptoms of COVID-19, the tool offers a digital stethoscope that can auscultate the respiration and detect possible signs of infection. Tyto allows patients to perform an examination independently to collect data, including images and sounds, through the smartphone application with easy to follow instructions and options to repeat the test if needed. On Friday, Mar. 20, the FDA stated that “one of the agency’s goals is to expand the use of these technologies during the coronavirus outbreak to help get non-infected patients out of hospitals and clinics and free-up resources.” Our platform is immediately available to address this goal. Our integrated Tyto suite empowers people on the frontlines of this health crisis to: • • • • Triage individuals, monitor health metrics, and codify next steps Automate measurement reminders via text and or email Trigger alerts that will notify program administrators or clinicians as a person's symptoms worsen, improve, or remain static – or as a quarantine period ends with no symptoms present Keep facility-based services focused on critical case monitoring of suspected cases remotely 11 P a g e Additional Platform Features: • • Multilingual: Our multilingual platform can engage patients both visually and verbally in English and Spanish. Our system works if the patient cannot read the information. Other visual aids such as icons and pictographs are used to enhance communication. Authorizations and consents are automated as with recommendations and treatment plans. All screening and menu options are customizable to governmental medical standards. Electronic Health Record: We have an exclusive customizable EHR for storing each soldier’s information securely. Our EHR is completely compatible with the Army’s legacy and future EHRs and other medical systems as directed by the government. APMDBOX’s EHR also features a state-of-the-art reporting platform that makes capturing trends and identifying patients as easy as a click of the button. • Remote Pharmacy Ordering. Each APMDBOX provider will have the ability to order prescriptions electronically. Some locations may have the ability to deliver prescriptions to the patient as well. • Remote Lab Ordering. Each APMDBOX provider will have the ability to order additional diagnostic lab tests that can completed at local labs. All lab results will be sent electronically to APMDBOX’s EHR. include Gap Assessments, Facilitated Self Assessments, Interim Assessments, Validation & Re-Certification, Continuous Monitoring, and Bridge Assessments. Security: APMDBOX’s Telehealth Platform is HIPAA compliant and has achieved the Health Information Trust Alliance Community Security Framework Certification (HITRUST CSF/FEDRamp). HITRUST provides a comprehensive CSF that enables organizations to integrate compliance with a wide range of regulations, standards, and best practices to 12 P a g e onyploce md box FDA: From: Shane Stevens Sent: Friday, March 27, 2020 2:33 PM To: Whitaker, Kathleen Cc: Henry Legere Amy Altman Subject: RE: Information regarding your EUAEDUD4D Ms. Whitaker, Thank you for the time on the phone and thank you for all the FDA is doing to expedite EUA waive rs. I have copied in two of my colleagues, Dr. Hank Lege re and Amy Altman who would like to join our Webex. Per the option cited in your file, we will move forward with providing Notification of our platformg'reader with the requested information so we can begin use while continuing to pursue an EUA waiver for use with in home testing. I understand the questions about in home testing and we look forward to the opportunity to share more information about the platform, how it works and how it will help save lives. lam confident once you and your team will at a minimum be impressed by the technology and will HDPEFULLT be confident enough to provide an EUA waiver. 1 ii?ery respectfully, From: Whitaker, Kathleen Sent: Thursday, March 26, 2020 8:29 PM To: Shane Stevens Subject: Information regarding your EUA200040 Thank-you for your EUA submission. Please see the attached file regarding additional information regarding the pre?EUA process. We anticipate your response as requested in the attachment. Regards, Kathleen (Kat) Whitaker, 301-796-6208 Kathleenwhitaker?fda.hhs.g? Excellent customer service is important to us. Please take a moment to provide feedback regarding the Customer service you have received Thank You! 14 Page onyploce md box Hoys County Texos Emergency Use Authorizotion: 15 Page COVID-19 Rapid Manufacture FDA Test Approval: From the Manufacture: On March 16, 2020, FDA issued the guidance document, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff”. Section D of the guidance is for “commercial manufacturer development and distribution and laboratory development and use of serology tests without an EUA”. In this section, the guidance states that “considering the serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports: • This test has not been reviewed by the FDA. • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. According to the above guidance document, we (Guangzhou Wondfo Biotech Co., Ltd) notified FDA about our intention to distribute our validated Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) on March 16, 2020. We also clearly state above mentioned points in the test instruction for use. Then on March 20, 2020, we successfully listed Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) under product code QKO and obtained the listing number D376561. 16 P a g e onyploce md box Rapid Test Orders: Ratio Holdings Limited 1ill-lest Chicago DBETIZDZD To: Henry Legere MD Reliant Immune Diagnostics, CEID Riyerplace Blvd, Elldg 4, Suite 102 Austin, Tilt Dear Sir, This letter is to confirm your ?rst order of 5001MB Coyid??l El rapid test kits. I would like also to con?rm: 1} We are able to ful?ll order of Coyid?1E kits weekly. 2} We can assLIe that we will follow up withl customs procedure for kits leaving China, and we con?rm that there is no limit on product going out of the Chinese ten'itory as per the Chinese goyemment. 3} In the remote case that the shipment leaving China will he stopped from the Chinese goyemment at Shanghai airport, we will retiJnd the money wired to us to your company. 4} For the following weekly orders of Coyid?1E kits, we would like to payments for each shipment as follows: 25% down payment wired on each new invoice sight- 25% wired when shipment is ready to ship to Dallas airport. 50% wired when shipment will he released from USA. custom and FDA screening. Regards, Fabiizio Rallo CECI Hallo Holdings ljm'rled Rallo Holdings ljmil'ed 135 Rooseyelt: Fld, Suite 11g. Wat Chimgo, IL 50135 nimcom Ph 17 Page SUMMARY APMDBOX is the only telehealth company in the market with a platform that combines COVID-19 rapid testing with Computer Vision, Artificial Intelligence, Machine Learning, a provider network that delivers a real on-demand patient experience, and a fully customizable EHR that is a HiTrust/FedRamp certified. Our Telehealth System is the force-multiplier the U.S needs to “Flatten the Curve”. Fully deployed, our system will lower the risk of infection for our healthcare workers, provide a mechanism to track patients of all risk levels, monitor and track those who have encountered the virus, and keep medical facilities focused on critical cases at hand. Benefit Point of Care COVID-19 Testing • On-Demand and Scheduled Telehealth Encounters • Remote Patient Monitoring & Tracking System • • • Feature COVID-19 point-of-care tests that leverage Artificial Intelligence, Computer Vision, and Machine Learning anytime and anywhere there is an internet connection Anytime, anywhere there is an internet connection Keep your facility-based services focused on critical cases by monitoring suspected cases remotely Keep tabs on your most vulnerable and those with chronic conditions that are at higher risk Monitor those who have been directed to selfquarantine for adherence to tracking At APMDBOX, we take tremendous pride in our ability to adapt to meet the needs of our clients. We operate twenty-four hours a day, seven days a week, three hundred sixty-five days a year. When we enter into a contract, we take all obligations and responsibilities seriously and commit ourselves to not only fulfilling our contractual obligations to the letter but to exceeding each client’s expectations. Sincerely, Shane Stevens Shane.Stevens@AP_MD.com 512-989-6990 18 P a g e