About G Medical Innovations Holdings Ltd

G Medical Innovations Holdings Ltd., an early commercial stage healthcare company, engages in the development of next generation mobile health (or mHealth) and telemedicine solutions and monitoring service platforms. The company’s solutions and services can empower consumers, patients and providers to better monitor, manage and improve clinical and personal health outcomes, especially for those who suffer from cardiovascular disease (CVD), pulmonary disease and diabetes. Using its proprietary and patented suite of devices, software solutions, algorithms and monitoring services, the company intends to drive recurring revenue streams in two vertical markets, such as business to business (B2B): professional healthcare markets (including hospitals, clinics and senior care facilities); and business to business to customer (B2B2C) and business to customer (B2C): consumer healthcare market. The company’s product lines consist of its Prizma medical device (Prizma), a clinical grade device that can transform almost any smartphone into a medical monitoring device enabling both healthcare providers and individuals to monitor, manage and share a wide range of vital signs and biometric indicators, its Extended Holter Patch System, a multi-channel patient-worn biosensor that captures electrocardiography (or ECG) data continuously, including its QT Prolongation Syndrome Detection Capabilities Patch. In addition, the company is developing its Wireless Vital Signs Monitoring System (or VSMS), which will provide full, continuous and real time monitoring of a wide range of vital signs and biometrics. Its monitoring services include provision of Independent Diagnostic Testing Facility (or IDTF) monitoring services and private monitoring services. Product Lines The company’s product lines consist of its Prizma device, Extended Holter Patch System, and QT Patch. In addition, the company is developing its VSMS. Prizma Medical Device The Prizma is a ‘plug-and-play’ medical device that measures vital signs with electronic medical records functionality and clinical grade reporting standards. The company’s Prizma can transform almost any smartphone into a medical monitoring device using wireless Bluetooth connection. Prizma presents a comprehensive health profile of the user, measuring a wide range of vital signs and biometrics, including ECG, oxygen saturation, temperature, heart rate and stress levels. Blood pressure, body weight and blood glucose measurements may be entered via Bluetooth connection to the Prizma from an external device or manually entered and tracked on the Prizma app. All of the measurements are saved and tracked on the Prizma app and on the cloud portal. Users may generate reports and share with third-parties (i.e., medical providers and family members). The Prizma device has been designed as an invaluable tool to help manage an individuals’ health and wellness, and allow healthcare providers to analyze the collected data in order to make better treatment decisions for conditions, such as diabetes and heart disease, and vital signs functions for users with a range of health management needs. The Prizma app is available for download on the Apple Store and on Google Play. Prizma is powered by an independent battery, and activated by the user when needed, making usage and transport efficient and comfortable. The user simply places his or her index fingers on sensors embedded on the Prizma device, and the software seamlessly analyzes the data using various measurement methods and algorithms. Prizma can be used on almost any mobile phone, allowing the company to quickly adapt the application to new smartphones. Along with the company’s Prizma device, it offers a remote patient monitoring service (or RPM) for chronic patients. The Prizma device can record various vital signs as frequently as needed on the go and such recordings are being analyzed and presented on a monthly report for physicians to keep track of their patients’ vitals. This service can be provided as a monthly recurring service as long as prescribed by the physician. The Prizma platform provides clients with an one-stop, multi-function and multi-account platform providing secure access to a private cloud healthcare solution powered from a remote cloud infrastructure. The portal syncs all Prizma device measurements to the doctor’s dashboard automatically and notifies of any abnormalities. Patient reports can be generated and downloaded to integrate seamlessly within the physician’s Electronic Health Record. Prizma is compatible with iOS 11.0 or above, Android 6.0 or above and Smartphone Bluetooth BT SIG 4.2. This Prizma platform allows the company’s customers to enter and see all their medical information in a single platform. The information is stored on the platform and is also accessible to physicians. In addition, the system allows users to see and print reports with personal medical information and share such reports with third parties. This makes each interaction and use easy and simple. Prizma Next Generation In addition, the company is developing smart algorithms to measure mechanical respiratory function, which is essential for patients suffering from asthma and chronic obstructive pulmonary disease. The company is also developing AI (Artificial Intelligence) in order to improve its arrhythmia detection algorithm. The company estimates that the first version of the artificial intelligence it is developing will be implemented within the next 18 months, subject to U.S. Food and Drug Administration approvals. In the future, the company envisions additional applications for its 3rd generation Prizma device, including blood chemistry tests, such as glucose level measurement; cholesterol, triglyceride, and total cholesterol level; hemoglobin level (A1C); uric acid level; and Â-Ketone level In August 2017, the company received 510(k) clearance (under prescription) for its Prizma device from the U.S. Food and Drug Administration. In September 2017, the company received CE mark. These clearances were followed by approval received in November 2017 from the Therapeutic Goods Administration (or the TGA). In March 2020, the company received registration with the Italian Health Ministry’s database of medical products. In April 2020, the U.S. Food and Drug Administration granted the company OTC authorization based on an Emergency Use Authorization (or EUA) policy, which will remain in force during the public health emergency related to COVID-19 (novel coronavirus pandemic and related respiratory disease). This authorization will allow the company to sell the Prizma device directly to consumers without a physician’s prescription. In April 2020, the company received Taiwan Food and Drug Administration approval for its Prizma device. The company is also preparing its application to the Chinese National Medical Products Administration (or NMPA) for its Prizma device. Despite the fact that regulatory clearances and approvals were received in 2017, since the Prizma device is a novel and innovative product, and due to first to market penetration, the market acceptance of the product was slow. In addition, the Current Procedural Terminology codes covering Prizma RPM were only approved by the Centers for Medicare & Medicaid Services (or CMS) in November 2019. The company intends to continue its market education efforts for its Prizma device and other products, in order to enhance market acceptance. Extended Holter Patch System The company’s Extended Holter Patch System is a multi-channel patient-worn biosensor that captures ECG data continuously for up to 14 days. Multi-channel ECGs can deliver higher predictive values with more actionable data, which enables a more accurate diagnosis. In addition, the Extended Holter Patch System allows patients to capture any symptomatic event by tapping a button on the recorder and documenting their activity and symptom in the patient diary. This correlates the ECG activity and provides physicians with more contextual data to make a diagnosis. Following the monitoring session, the device is returned to the company and the data is uploaded to its secure cloud for analysis. A concise clinical report of preliminary findings is generated by certified cardiac technicians, validated through a quality assurance (or QA) process, and made available to the physicians on the company’s secure physician portal. The modular and easy-to-use patch solution utilizes a body worn sensor, a removable recorder, a secure cloud platform and a clinical reporting system. The patch has a very soft fabric format, and its water-resistant technology allows showering without removing the patch. These attributes encourage patients to wear the sensor all day long, resulting in more meaningful data, enabling more accurate diagnosis and timely treatment decisions. Clinical studies have demonstrated that wearable patch technologies can improve a physician’s ability to more accurately detect arrhythmia, allowing them to change the course of treatment. In November 2017, the company received the CE mark for its Extended Holter Patch System. In May 2020, the company received TGA approval. In May 2021, the company received emergency clearance from the United States Food and Drug Administration to use its Extended Holter Patch System for patients with suspected or identified QT prolongation syndrome. The company’s Patch recorder provides up to six channels of ECG and can be used for up to 14 days of ECG monitoring. The Patch records and transmits the ECG data to a smartphone, which acts as a gateway to its call center. The base line ECG signal, system and electrode status are verified before starting the enrollment process. The frequency of transmissions can be set by the healthcare provider while the default setting of the device is to record and transmit 10 minutes of ECG data every hour. The data is saved and wirelessly transmitted by the user’s smartphone to the company’s monitoring call center for QT prolongation syndrome detection capabilities analysis. The call center in turn sends the report to the prescribing physician at the hospital. In May 2020, the U.S. Food and Drug Administration approved under EUA the use of the company’s Patch in order to detect QT prolongation syndrome in a hospital setting for remote monitoring of the QT interval prolongation of an ECG. The EUA policy will remain in force during the public health emergency related to COVID-19. Wireless Vital Signs Monitoring System (In Development) The company intends to use its proprietary diagnostic sensor technology to further develop a full monitoring and diagnostic ecosystem, which the company refers to as its VSMS. The VSMS is a simple, easy to use, low cost and affordable solution, which is designed to provide continuous real time monitoring of a wide range of vital signs and biometrics for patient in pre-hospitalization condition, during hospitalization or after their discharge. Subject to financing, the company is aiming to finalize the initial prototype of the VSMS by the end of the second quarter of 2022. The company is in the final stage of algorithm development, to be followed by development of the embedded software. At the same time, the company is working on the development of a backend system for the hospital segment, as well as for its monitoring call center. The system is designed to comprise four main elements, such as a six lead ECG patch utilizing an arrhythmia detection algorithm, body positioning algorithm, internal memory and wireless communication to communicate with the smartphone gateway and transmit data to the call center; a smartwatch (which is clinical grade), which integrates an optical sensor known as a photoplethysmography sensor for oxygen saturation, heart rate, respiration and blood pressure measurement; a small wireless thermometer sensor to monitor body temperature; and a central ‘Hub’, a cloud-based, user-friendly analytics platform, which is available on smartphones, tablets and personal computers. The six lead ECG patch is based on the company’s Extended Holter Patch System, but will require further development and internal clinical trials to integrate the patch with its VSMS. The company expects that these trials will be completed by the end of 2022. The smartwatch element of the product is under development and the company is targeting to have the smartwatch complete by the end of the first quarter of 2022. The company will be using an original equipment manufacturer smartwatch in order to develop the proprietary software and embedded parts of the software. For the wireless thermometer sensor, the company will use a third party with its embedded communication software. The company is targeting to have this element of the product completed by the end of the second quarter of 2022. The Hub is being designed to perform the following functions: Receives, displays and stores data from multiple patients; Analyses data using multiple algorithms to detect vital signs abnormalities and alerts in real time in the case of a threshold breach. Alternatively, in case of continuous transmission of data, algorithms are activated on the Hub and not on the sensors to optimize power consumption; and Generates reports from the raw data for user and healthcare professionals. The company is targeting to complete the development of the Hub by the end of the second quarter of 2022. Once all elements of the VSMS are complete, the company intends to pursue regulatory approvals, including with the U.S. Food and Drug Administration and the CE mark. Potential customers of the VSMS are hospitals and health care providers, nursing home and assisting living residences, nursing agencies for home visiting and post discharge patients. Monitoring Services The company’s monitoring services in the United States focus on two main verticals, such as IDTF Monitoring Services (B2B): Current Procedural Terminology (or CPT) based services; and Private Monitoring Services (B2B, B2C and B2B2C): services provided by a different entity, independent to the IDTF. Independent Diagnostic Testing Facility (IDTF) Monitoring Services The company’s provision of IDTF monitoring services is consisted of arrhythmia monitoring services for patients (including Mobile Cardiac Telemetry (or MCT), extended Holter and cardiac event monitor (or CEM)), and use its Prizma device’s RPM of vital signs on a daily basis and generating reports that allow physicians to track their patients’ health condition. An IDTF can sell services as a provider to physicians, hospitals, and patients. All services are provided according to physician’s prescription done through the enrollment form on the company’s proprietary website. After receiving an enrollment form, it will verify that the patient has an insurance coverage for the service requested by the physician and then will provide the patient, directly or through a physician, with the monitoring device. The patient will wear the monitoring device during the total service monitoring time, and the company will monitor and support the patient and send medical notifications to the patient’s physician, according to the type of service provided. Once service is completed, the company will send the physician an end-of-session report with a summary of all relevant information detected during the service period. The company will also send the bill out to the relevant insurance company and collect the money according to the specific CPT code and monitoring services that were provided. Under the IDTF umbrella, the company offers four types of services for remote cardiac monitoring: MCT: A 24/7 remote cardiac monitoring and transmission in near-real time of specific arrhythmias recognized by the algorithm. This service can be provided to patients for up to 30 days and is reimbursed for up to twice a year per patient. Extended Holter (AECG): Cardiac monitoring 24/7 for up to 14 days. Analysis is done off-line when the device is returned to the call center. This service is reimbursed multiple times a year per patient. Cardiac Event Monitor (CEM): Cardiac monitoring and recording only when the patient has an arrhythmia. This service is available for up to 30 days and reimbursed per patient multiple times a year. 24/48 Hours Holter Monitoring: Cardiac monitoring for up to 24-48 hours only. This service can be provided per patient, multiple times per year. The company entered the U.S. arrhythmia monitoring services industry through its December 2017 acquisition of G Medical Diagnostic Services, Inc., an IDTF based in Austin, Texas. The IDTF provides physicians and hospitals with 24/7 remote cardiac monitoring services, which utilize the company’s Holter, extended Holter, MCT and event monitoring devices. G Medical Diagnostic Services, Inc. (GMedDx) is expected to serve as a platform for introducing its suite of clinical-grade products into outpatient settings, physician practices, hospitals and senior care facilities in the United States. In November 2018, the company acquired a second IDTF, Telerhythmics, LLC, based in Memphis, Tennessee. Telerhythmics, LLC operates mainly across the Southeastern United States, and provides hospitals and physicians with cardiac monitoring services, including MCT, Holter and event monitoring. In addition to its traditional activities, Telerhythmics, LLC will utilize the Prizma device for RPM services. Telerhythmics, LLC and GMedDx have entered into approximately 140 commercial payor agreements across local, regional and national markets, as well as an agreement with CMS, which provides health coverage to more than 100 million people. In May 2019, GMedDx entered into provider participation agreements with Prime Health Services, Inc. and Ancillary Care Services, Inc. The provider participation agreements have further and significantly increased the company’s footprint in the healthcare delivery system of cardiac monitoring and provide more exposure to its future patient base and third-party payer populations. The company has adopted a three-phase approach for the deployment of its IDTF platform, which includes evaluation, implementation, and treatment phases. Ten university hospitals in the United States are in the treatment phase, another seven hospitals are near completion of the implementation phase and the company is witnessing an increase in patient enrolment that it expects to continue. The company has been approved and CPT-coded with more than 150 healthcare insurance providers to be reimbursed by its services. Private Monitoring Services In addition to IDTF monitoring services, the company will provide private monitoring services, utilizing its Prizma device. Under the private service umbrella, the company offers three main lines of services: Prizma OTC: The sale of the Prizma device to consumers with a user portal service, which will allow them to save their medical tests and create their own medical information reports and share such reports remotely or when visiting their physicians. Prizma Concierge Medicine Services: A 24/7 call center service that allows subscribers to speak directly with a physician regarding the collected data. Prizma Care Facility/Nursing Home Services: A 24/7 service that assists care facilities and nursing homes to track diagnostic information for patients and residents. Ecosystem The company anticipates that its next generation mobile technologies will empower both users and businesses to better utilize their business processes by merging them into a coherent ecosystem. It plans to provide users (individuals or families) products and services, and collects valuable data and monetary inflows at the same time. It also plans to serve businesses (including hospitals, pharmacies, elderly care institutions, research institutions, etc.) by establishing a direct linkage using mobile technology to maximize the value of user data, which is more than ever needed by businesses. Strategy The company’s strategic commercial activities are focused on investing in cardiac monitoring service centers in the United States; commercializing the Prizma device and Patch Extended Holter Patch System monitoring solution in the United States, China, and other markets; the development of its VSMS; and cultivating various channels of distribution. Such channels include hospitals, insurance companies, chronic care management companies, concierge medicine groups, telecommunications companies, specialized mobile virtual network operators (or MVNOs) distribution houses, original design manufacturer (or ODM) handsets, and wireless design centers. Heartbuds Collaboration In 2021, the company entered into a joint development, licensing and distribution agreement with Heartbuds AK, LLC (Heartbuds). Heartbuds is a medical device company that developed a medical device used with a smart phone to enable doctors and others to listen to and record a patient’s heart and lungs (or HB1). Pursuant to the joint development agreement, the company and Heartbuds will jointly develop a newer, enhanced model or generation of the HB1 to be included with the sale and distribution of its Prisma (or HB2). According to the agreement, Heartbuds has the right to develop, promote, market, license, sell, and distribute the HB1, the HB2 and any other newer models and generations thereafter (or collectively the HB Devices), independent of the Prisma. The company’s strategy is to distribute its products in Italy through two vertical lines: E-commerce B2C: The company will offer its Prizma system directly through e-commerce platforms, including Mediwebnet or Amazon. The company plans to promote the Prizma device using social media platforms. In addition, it will offer two models of use for its Prizma device in Italy: Personal Use Model – The patient will only have access to the user portal, without access to any call center services; and Call Center Model – In addition to access to the use portal, the patient will register to Mediwebnet’s medical call center. In this model, the users’ data will be automatically available to the physician at the call center. B2B Market: The company is promoting the Prizma system to all those clinics and facilities interested in managing their own mobile health service by integrating the Prizma user portal data into their health management system, using the application programming interface provided by the company, such as insurance companies, companies that offer it as a benefit for their managers and employees, public and private healthcare facilities, telemedicine service centers, and mobile phone operators. The company plans to sell its Prizma device and charge a monthly fee for the use of the user portal. Intellectual Property The company’s intellectual property portfolio consists of eleven patent applications and three granted patents, which have either the PCT pending status or have entered national stage and are under examination by national authorities. Other Intellectual Property In 2016, the company’s subsidiary, G Medical Innovations Ltd. (Israel), and Mennen Medical Ltd. (or Mennen) (a company incorporated in Israel), entered into a software licensing agreement pursuant to which the company was granted a worldwide, perpetual, irrevocable (other than in case of breach), royalty-free, non-exclusive license to use the arrhythmia software and high risk detection application (including all existing preprocessing) and respiration module manufactured and developed by Mennen (including subject to certain conditions, any updates, upgrades, modification and customizations, if requested by the company, which shall be priced separately) and to incorporate and integrate the arrhythmia software and high risk detection application with the company’s ECG wireless devices. Trademarks The company owns one U.S. trademark and one U.S. trademark application: PRIZMA – US trademark 87815896 allowed April 9, 2019. PRIZMA-CARE – US trademark application filed December 22, 2021 serial number 97/184615. Competition The company’s arrhythmia monitoring service primary competitors in the U.S. include BioTelemetry, Inc.; iRhythm Technologies, Inc.; Preventice Solutions, Inc.; and Bardy Diagnostics, Inc. The company’s competitors in the mHealth space include, among others, AliveCor (ECG only), Qardia (more geared to fitness) and Tytocare (home care device with various attachments for examining ears, throat, heart, lungs, abdomen, skin, and capturing heart rate and temperature data). Government Regulation The company’s devices are classified as medical devices and are subject to regulation by numerous agencies and legislative bodies, including the U.S. Food and Drug Administration, and its foreign counterparts. Clinical Laboratory Improvement Amendments of 1988 requires that the company holds a certificate applicable to the type of laboratory examinations it performs and that the company complies with various standards with respect to personnel qualifications, facility administration, proficiency testing, quality control and assurance and inspections. The company’s products fall under Class II (non-invasive) devices. Research and Development Expenses The company’s research and development expenses amounted to $1,315,000 for the year ended December 31, 2020. History G Medical Innovations Holdings Ltd. was founded in 2014. The company was incorporated in 2014 under Cayman Island law.