Biotricity Stock

Biotricity Inc., a medical technology company, focuses on biometric data monitoring solutions.

The company’s focus is to deliver remote monitoring solutions to the medical, healthcare, and consumer markets, with a focus on diagnostic and post-diagnostic solutions for lifestyle and chronic illnesses. Its major focus is on the diagnostic mobile cardiac telemetry market (MCT).

The company is a technology company focused on earning recurring technology fee revenue in the form of technology-as-a-service. It has also developed or is developing various other ancillary technologies, which would require application for further FDA clearances, which it focuses applying for within the next to twelve months. Among these are an advanced ECG analysis software that could analyze and synthesize patient ECG monitoring data with the purpose of distilling it down to the major information that requires clinical intervention, while reducing the amount of human intervention necessary in the process; the Biotres patch solution, which would be a novel product in the field of Holter monitoring; the Bioflux 2.0, which is the next generation of the company’s Bioflux. During the year ended March 31, 2021, the company announced that it received a 510(k) clearance from the FDA for its Bioflux Software II System, engineered to improve workflows.

During the year ended March 31, 2021, the company announced that it is developing telemedicine technology that also provides capabilities of real-time streaming of medical devices. Telemedicine offers patients the ability to communicate directly with their health care providers without the need of leaving their home. The introduction of a telemedicine solution is intended to align with the company’s Bioflux product and facilitate remote visits and remote prescriptions for cardiac diagnostics, but it would also serve as a means of establishing referral and other synergies across the network of doctors and patients that use the technologies it is building within the its ecosystem.

Product and Technology

Bioflux is an integrated ECG device and software solution for the MCT market. The Bioflux device includes a wet electrode and worn on a belt clip around the waist. The Bioflux ECG reporting software would allow doctors and labs to view a patient’s ECG data for monitoring and diagnostic purposes. Both the device and software are in accordance with MCT billing code standards, compliant with arrhythmia devices and alarms as defined by the FDA, and require 510(k) clearance, which has been obtained.

The Bioflux device is developed, among other things, with various features, such as GSM mobile chip for global cellular network compatibility; touch-screen LCD viewer; and extended battery pack for an additional 48 hours of battery life.

The Bioflux platform has a built-in cellular chipset and a real-time embedded operating system, which allows for its technology to be utilized as an Internet of Things platform. This technology could be leveraged into other applications and industries by utilizing the platform and OS side of Bioflux.

Future Markets

The company intends to expand the use of its technology platform with medical-grade solutions for the monitoring of blood pressure, diabetes, sleep apnea, and chronic pain, as well as fetal monitoring, and other adjacent healthcare and lifestyle markets.

Preventative Care: The company has developed a technology that would support medical practitioners as they gather data and regularly monitor and treat patients with two or more of the major ten chronic care conditions that plague individuals. The company focuses that Bioheart, its planned third product, would focus on filling this need by developing a clinically relevant, preventative care and disease management solution for the consumer. A key underlying component of Bioheart focuses on the ability to measure patient improvements. This approach is implemented in the company’s development process by focusing on a disease/chronic illness profile, as opposed to a customer profile. The company focuses on cardiovascular disease for its first preventative care solution as Bioflux focuses on the same health segment.

Adjacent Chronic Healthcare Markets and Prenatal Care: The company intends to expand its reach with medical-grade solutions for diabetes, sleep apnea, fetal monitoring, and other adjacent healthcare and lifestyle markets.

Holter and Event Monitoring: The Bioflux MCT device software has been adjusted to be able to be used as a Holter/Extended Holter or an Event loop monitor, which has already opened up the Holter and Event Loop monitor markets, by combining with Bioflux’s global cellular chipset to become a 4 in 1 device that is applicable to the global event monitoring market. However, the company is also developing new technology that is applicable to this space, which would continue to adhere to the company’s revenue model of deriving income from technology fees.

The key major technologies in the Holter market are patch devices that take the form of a large band-aid and could be mailed back or returned to the physician for data retrieval. They lack connectivity, have one channel of data, and cannot be charged but are convenient for low-risk patients. Responding to its customer needs, the company has developed a new technology that is applicable to this space, which would continue to adhere to its revenue model of deriving income from technology fees. This product is known as the Biotres and it addresses the shortcomings of existing solutions by adding connectivity, the ability to charge, and improved data through 3 channels, while maintaining patient convenience. The Biotres is awaiting FDA clearance.

The company relies on various principal suppliers for the components that make up its products and proposed products, which include Digikey Corporation and Mouser Electronics for electronics and connectors; Telit/Stollmann for Bluetooth modules; Yongan Innovations for batteries; Dongguan Bole RP&M Cp. Ltd. for plastics; Unimed Medical and Conmed for ECG cables and electrodes; and Medico Systems for touch-panel LCD displays.

Research and Development

The company incurred research and development costs of $2.1 million for the year ended March 31, 2021.

Government Regulation

The company’s proposed product is subject to regulation by the U.S. Food and Drug Administration and various other federal and state agencies, as well as by foreign governmental agencies. The company received 510(k) clearance for both the software and hardware components of its Bioflux product. Suppliers of components and products used to manufacture the company’s devices must also comply with FDA regulatory requirements, which often require significant resources and subject it and its suppliers to potential regulatory inspections and stoppages.

Competition

The company’s primary competitors in the MCT market are BioTelemetry; Preventice; ScottCare; and Infobionic.