About ALR Technologies
ALR Technologies Inc. (ALRT), a data management company, develops diabetes care solutions for human and animal health in the United States. The company has developed its Diabetes Solution, which is a comprehensive approach to diabetes care consisting of data collection, predictive A1C, insulin dosage adjustment suggestions, performance tracking, remote monitoring and diabetes test supplies. The company is seeking commercial opportunities to deploy the Diabetes Solution in the United States (U.S.), Canada and Singapore. During 2011, the company received Food and Drug Administration (FDA) clearance and achieved Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance for an early version of its Diabetes Solution. The company subsequently completed a clinic trial and pilot programs, which led to the development of its Insulin Dosage Adjustment technology, for which it received FDA clearance in 2017, and its Predictive A1C technology, for which it has submitted a worldwide patent application under the Patent Cooperation Treaty (the PCT) to the World Intellectual Property Organization. Subsequently the company has continued making advancements to its Diabetes Solution technology by increasing functionality and capability to improve diabetes care for patients. In 2020, the company entered in an agreement with Bionime Corporation (Bionime) whereby it will bundle its Diabetes Solution application (or app) with Bionime BGM and diabetes test supplies and sell the bundle to diabetes patients of private medical clinics in Singapore; initiated a clinical pilot with Singapore General Hospital to prove the efficacy of the ALRT Diabetes Solution in insulin-treated diabetes patients; entered into a memorandum of understanding (MOU) to form a collaboration with Diabetes Singapore, a non-profit Singapore-based organization serving the Singapore Minister for Health and a member of the International Diabetes Federation, with the view of raising the diabetes management standard in Singapore; and advanced its Diabetes Solution to integrate with CGM devices. In 2021, the company announced it had advanced its Diabetes Solution for animal health purposes under the brand name GluCurve and the company announced its intent to redomicile to Singapore. Products ALRT Diabetes Solution ALRT has created the Diabetes Solution to address the diabetes marketplace globally. The Diabetes Solution utilizes internet-based technologies to facilitate the HCP’s ability to monitor their diabetes patients’ health and ensure adherence to health maintenance activities. The Diabetes Solution is a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA-compliant diabetes management system that collects data directly from BGM and CGM devices; a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. The Diabetes Solution system processes and converts each data set to a Predictive A1C value and shares it with the patient’s physician. The system provides the physician with therapy advancement suggestions based on current clinical practice guidelines. Patients receive therapy assessments and adjustments in much shorter cycles, keeping A1Cs at target, mitigating diabetes complications and lowering costs of care. In addition to insulin dosage adjustment, the ALRT Diabetes Solution offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives health care providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. The company focuses on diabetes and will expand its services to cover other chronic diseases anchored on verifiable data. The company’s Diabetes Solution consists of hardware, software and diabetes test supplies. The company designed the Diabetes Solution to be focused on the health care provider and is agnostic and proactive. The company’s software operates on iOS, Android, Windows and MacOS systems. Enrollment into the ALRT Diabetes Solution will include a branded glucose meter, diabetes test strips, lancets and a carrying case. The company’s technology collects all the blood glucose data from the glucose meters, uploads it to a secure account and ships diabetes test strips as required. The patient data is aggregated to a Predictive A1C value for a comprehensive view of the treatment plan and patient adherence to the plan, with the data available (and messaged) to authorized people. The ALRT Diabetes Solution addresses the five causes for not controlling diabetes with active patient monitoring; direct meter uploads; machine intelligent data processing; predictive A1C; and insulin dosage adjustment. Active Patient Monitoring The ALRT system monitors patient uploads and the underlying data providing more timely access to patient blood glucose data. The company’s system initiates interventions by notifying the Health care professional (HCP) of out-of-range results or failure to upload data in accordance with the requirements of the care plan. The ALRT system does not rely upon the patient for uploading data. The ALRT Diabetes Solution provides the notifications and audit trail needed for achieving best practice results. Its performance tracking allows care teams to identify areas in treatment plans that require change or improvement. Direct Meter Uploads Data is uploaded via Bluetooth directly from the glucometer into the ALRT application. This ensures that the data is accurate and reliable based on the results of testing. Machine Intelligent Data Processing The company’s machine intelligence processes large amounts of data, notifies relevant stakeholders and flags patients for review making collaboration real time. Across segments and populations, this also provides significant data points on use of diabetes test strips and insulin, which may be significant for businesses in those industries. Predicative A1C Predictive A1C is a patent-pending unique feature included into the ALRT Diabetes Solution for monitoring the effectiveness of care plans. This technology utilizes data diagnostics to compare targeted A1C with indicated results. Weekly patient blood glucose data is evaluated, and HCPs are notified as needed for care plan review when blood glucose values exceed parameters set by the HCPs. The company’s platform provides HCPs with patient prioritization reports and alerts based on the Predictive A1C measures and other related diagnostics. Predictive A1C was designed to assist HCPs in addressing clinical inertia in diabetes care. Insulin Dose Adjustment Insulin Dose Adjustment is an FDA-cleared feature that makes optimal insulin adjustment suggestions to HCPs based on dosing guidelines from organizations like the ADA. This ensures that HCPs are making timely insulin dosage assessments based on the blood testing results uploaded. ALRT’s next phase of technology advancement will produce an algorithm for advancing non-insulin diabetes therapies according to clinical practice guidelines. In October 2011, the company received 510(k) clearance from the FDA for this iteration of the Health-e-Connect System. This system offered remote monitoring of patients in support of effective diabetes management programs. The 510(k) clearance enabled the company to commence with the United States marketing and sales of its Health-e-Connect System. In September 2014, the company initiated its pilot program with one of the Kansas City Metropolitan Physician Association (KCMPA) clinics to deploy its Health-e-Connect System. Data from the KCMPA pilot program indicated that a number of patients had achieved reductions in their A1C levels. Furthermore, the data indicated that patients that left the pilot program had increases in A1C subsequent. On February 18, 2015, the company filed a 510(k) application with the FDA to add a remote insulin dosing recommendation feature to the company’s Diabetes Solution. The company utilized the publicly available algorithm of the American Association of Clinical Endocrinologists (AACE) and ADA. This feature allows the company to regularly run a patient’s blood glucose data (and other key data) through the AACE and ADA algorithm. On September 18, 2017, the company received clearance from the FDA for its Insulin Dosage Adjustment feature within the company’s Diabetes Solution. On June 20, 2017, the company filed a worldwide patent application under the PCT to the World Intellectual Property Office for the Predictive A1C feature. The company holds the rights to use the Predictive A1C feature. During 2019, the company added automated patient management to the Diabetes Solution. The company focuses on securing supply of CGM to bundle with the Diabetes Solution for the global marketplace. Also, during 2019, the company initiated support for CGM systems with the ALRT Diabetes Solution. CGM has become the standard of care for patients with Type 1 diabetes and is quickly gaining favor with Type 2 diabetes patients who use insulin. During 2020, the company advanced its ALRT Diabetes Solution to integrate with CGM. During 2021, the company enrolled a small number of patients with Diabetes Singapore into the Diabetes Solution, which provided for improved efficacy of the Diabetes Solution. The company is preparing for a clinical trial for its Diabetes Solution for human health utilizing CGM and to concurrently submit an FDA application for clearance to sell the Diabetes Solution in the United States submitted thereafter. The company is targeting to offer the ALRT Diabetes Solution for sale bundled with CGM in 2023. Continuous Glucose Monitoring (CGM) A CGM is a medical device that is worn on the body of a diabetic subject for up to 14 days and continually takes glucose (blood sugar) readings every 1-5 minutes. A CGM consists of three pieces, such as a sensor that measures glucose levels in the interstitial fluid that is attached to the skin of the subject via an adhesive pad; a Bluetooth transmitter that wirelessly sends the glucose readings to a mobile device or reader and can be integrated into the sensor or come as a separate piece that clips into the sensor; and an applicator that applies the sensor onto the subject. A CGM can be factory calibrated thus eliminating the need for diabetics to prick their finger to test blood on a strip inserted into a BGM throughout the day. A CGM works by utilizing glucose oxidase-based enzymes that are coated onto an electrode that is inserted into the subcutaneous tissue when the sensor is applied to the skin. The transmitter than securely sends the data wirelessly to a receiver, such as a mobile device, where the data is organized and displayed for the user. ALRT Pre-Diabetes System A prevention-based feature of the Diabetes Solution, the ALRT Prediabetes System, has been designed in direct response to discussions with government health care authorities for a scalable solution to the growing problem of prediabetes. The Prediabetes System provides patients with educational videos and supplemental content formatted for mobile devices and a private online community to discuss disease management (e.g., support, weight loss, diet, etc.). ALR GluCurve for Pets The company has developed the GluCurve Pet CGM to address an unmet need in diabetes care for felines and canines by combining the hardware of a CGM with the software of an adapted version of its Diabetes Solution platform for use by veterinarians in animal health. The GluCurve Pet CGM platform allows the blood glucose readings from the medical device placed on the pet to be uploaded to the Cloud where the data is processed and converted into daily glucose curve graphs and data sets that can be reviewed and compared by the veterinarian at any time. The system provides the doctor with insulin dose calculators and recommendations based on clinical practice guidelines. The company is starting validation and non-inferiority studies with a United States-based veterinary clinic on the GluCurve CGM app and the CGM supplies being bundled with the GluCurve app. The company has made the GluCurve app available on Google Play and the Apple Store for users of the validation and non-inferiority studies. Reimbursement for Health Professionals The company continues to work to obtain confirmation that the Diabetes Solution will allow for services to be provided by physicians that will be reimbursed by health insurance companies. The reimbursement will be a breakthrough, as physicians will be paid to provide these important new services to their patients with chronic conditions. Business Development and Marketing Strategy The company is focusing its efforts on introducing and marketing its Diabetes Solution and GluCurve products to medical clinics, veterinary clinics, hospitals, health care providers and pharmaceutical companies. The company has achieved collaborations with entities in Singapore and is targeting organizations with global operations in order to work with their sales network to distribute its products. Manufacturers The company has entered into an agreement with Bionime to market and sell the ALRT Diabetes Solution to diabetes patients of private physicians in Singapore. The ALRT Diabetes Solution offering in Singapore includes Bionime’s Rightest GM700SB blood glucose meter and test strips. The company is evaluating its options for diabetes hardware and supplies to be combined with the ALRT Diabetes Solution for the human health sector for the rest of the world. On December 7, 2021, the company entered into an MOU with Infinovo to assess how the parties can work towards entering into a global supply agreement for the Infinovo CGM for use by ALRT in the animal health sector. Selling Activities The company is actively seeking alliances with health care organizations, pharmaceutical companies, insulin providers and other health care companies that can act as catalysts to effect positive change for containing health care costs and improving health outcomes. The company will work with these types of organizations to introduce the ALRT Diabetes Solution and GluCurve product to their network and seek to start significant pilot projects that will lead to revenue-generating arrangements. Patents and Trademarks The company’s has the following patent applications under the PCT: CT/CA2017/050753 dated June 27, 2017. Title is method and system for monitoring a diabetes treatment plan. This patent application has been submitted to Canada, the United States, Europe, Singapore and Australia. The company holds an exclusive license to the patent applications. The company has submitted a trademark application in the United States for GluCurve dated July 15, 2021 under the serial number 90830675. Product Development The company’s product development and research costs were $499,000 in 2021. Competition The company’s competitors include Livongo, Glooko, WellDoc, Medtronics, iGlucose and Microsoft HealthVault. History The company was founded in 1987. It was incorporated under the laws of the state of Nevada in 1987. The company was formerly known as Mo Betta Corp. and changed its name to ALR Technologies Inc. in 1998.
