OTC: BTCY
BIOTRICITY INC.CIK 0001630113 · Surgical & Medical Instruments
Biotricity Inc. (the “Company”, “Biotricity”, “we”, “us”, “our”) is a medical technology company focused on biometric data monitoring solutions. Our aim is to deliver innovative, remote monitoring solutions to the medical, healthcare, and consumer markets, with a focus on diagnostic and… About this business →
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About BIOTRICITY INC.
Source: Item 1 (Business) from the 10-K filed July 14, 2026. Description as filed by the company with the SEC.
ITEM
1. BUSINESS
Biotricity
Inc. (the “Company”, “Biotricity”, “we”, “us”, “our”) is a medical technology
company focused on biometric data monitoring solutions. Our aim is to deliver innovative, remote monitoring solutions to the medical,
healthcare, and consumer markets, with a focus on diagnostic and post-diagnostic solutions for lifestyle and chronic illnesses. We approach
the diagnostic side of remote patient monitoring by applying innovation within existing business models where reimbursement is established.
We believe this approach reduces the risk associated with traditional medical device development and accelerates the path to revenue.
In post-diagnostic markets, we intend to apply medical grade biometrics to enable consumers to self-manage, thereby driving patient compliance
and reducing healthcare costs. We first focused on a segment of the ambulatory diagnostic cardiac outpatient market, otherwise known
as Mobile Cardiac Outpatient Monitoring (“COM”), while also providing the capability to perform all types of ambulatory cardiac
studies.
We
developed our Bioflux® (“Bioflux”) COM technology, which has received clearance from the U.S. Food and Drug Administration
(“FDA”), comprised of a monitoring device and software components, which we made available to the market under limited release
on April 6, 2018, to assess, establish and develop sales processes and market dynamics. Full market release of the Bioflux device for
commercialization occurred in April 2019. The fiscal year ended March 31, 2021 marked our first year of expanded commercialization efforts,
focused on sales growth and expansion. In 2021, we commenced the initial launch of Bioheart, a direct-to-consumer heart monitor that
offers the same continuous heart monitoring technology used by physicians. In addition to developing and receiving regulatory approval
or clearance of other technologies that enhance our ecosystem, in 2022, we announced the launch of our Biocore Cardiac Monitoring Device
(“Biocore”, previously branded as Biotres), a three-lead device for ECG and arrhythmia monitoring intended for lower risk
patients, a much broader addressable market segment. Late in 2024, we launched the cellular version of that same device, the Biocore
Pro, which is now our flagship technology. We have since expanded our sales efforts to 35 states and intend
to expand further and compete in the broader US market using an insourcing business model. Our technology has a large potential total
addressable market, which can include hospitals, clinics and physicians’ offices, as well as other Independent Diagnostic Testing
Facilities (“IDTFs)”. Cardiac disease is ranked as the number one chronic care disease in the US and most markets globally,
making our technology useful across the globe. As such, we are pursuing and have achieved regulatory approvals in several key jurisdictions
in preparation of future distribution efforts outside of the US. We believe our technological and clinical advantage combined with our
solution’s insourcing model, which empowers physicians with state-of-the-art technology and charges technology service fees for
its use, has the benefit of a reduced operating overhead for us, and enables a more efficient market penetration and distribution strategy.
Read full description ↓
We
are a technology company focused on earning utilization-based recurring technology fee revenue. Our ability to grow this type of revenue
is predicated on the size and quality of our sales efforts and our ability to penetrate the market and place devices with clinically
focused, repeat users of our cardiac study technology. We plan to grow our sales force to address new markets and achieve sales penetration
in the markets currently served.
We
are incorporated in the State of Nevada and our headquarters are in Nevada and Ontario. Our principal executive office is located at 203
Redwood Shores Pkwy Suite 600, Redwood City, California, and our telephone number is (800) 590-4155. Our website address is
www.biotricity.com. The information on our website is not part of this Annual Report on Form 10-K.
Commercial
History
Full
market release of the Bioflux device for commercialization launched in April 2019, after receiving its second and final required FDA
clearance. To commence commercialization, we ordered device inventory from our FDA-approved manufacturer and hired a small, captive sales
force, with deep experience in cardiac technology sales; we expanded on our limited market release, which identified potential anchor
clients who could be early adopters of our technology. We then expanded our sales force and geographic footprint.
In
2021, we received a 510(k) clearance from the FDA for our Bioflux Software II System, engineered to improve workflows and reduce estimated
review time from 5 minutes to 30 seconds. This improvement in review time reduces operational costs and allows us to continue to focus
on excellent customer service and industry-leading response times to physicians and their at-risk patients. Additionally, these advances
mean we can focus our resources on high-level operations and sales.
During
2021 and the early part of 2022, we also commercially launched our Bioheart technology, which is a consumer technology whose development
was forged out of the clinical technologies that are already part of our technology ecosystem, the Biosphere. In recognition of our innovations,
in November 2022, Bioheart received recognition as one of TIME’s Best Inventions of 2022.
3
We
continue to develop our telemedicine capabilities of real-time streaming of medical data. We are expanding our platform to include remote
patient monitoring, chronic care management, and implantable device management, creating a single unified cardiac platform for medical
facilities. Our focus has always been and continues to remain on developing technology that supports clinics while driving economic benefits
and costs savings to healthcare service providers within the traditional reimbursement and value based care payer models. Our goal is
to position ourselves as an all-in-one cardiac diagnostic and disease management solution. We continue to grow our data set of billions
of patient heartbeats, allowing us to further develop our predictive capabilities relative to atrial fibrillation and arrythmias.
In
January 2022, we received the 510(k) FDA clearance of our Biocore (previously named Biotres) patch solution, which is a novel product
in the field of Holter monitoring. This three-lead technology can provide connected Holter monitoring that is designed to produce more
accurate arrythmia detection than is typical of competing remote patient monitoring solutions. It is also foundational, since this platform
technology has a pipeline of development expansions focused on clinical applications which are currently unavailable in the market. In
October 2023, we launched the cellular version of this device, the Biocore Pro.
Since
then, we have launched Biocare, after successfully piloting this technology in two facilities that provide cardiac care to more than
60,000 patients. This technology and other consumer technologies and applications such as the Biokit and Biocare have been developed
to allow us to transform and use our strong cardiac footprint to expand into remote chronic care management solutions that will be part
of the Biosphere. The technology puts actionable data into the hands of physicians to assist them in making effective treatment decisions
quickly.
This
supports us in expanding our footprint within existing customer sites to provide full-cycle chronic care management solutions to our
clinic and patient network.
We
are also developing several other ancillary technologies, which will require application for further FDA clearances, which we anticipate
applying for within the next twelve months. Among these are:
●
advanced
ECG algorithms and analysis software for further improvements in sensitivity and specificity to analyze and synthesize patient ECG
monitoring data with the purpose of distilling it down to the important information that requires clinical intervention, while reducing
the amount of human intervention necessary in the process;
●
the
Biocore® Pro 2.0, which is the next generation of our award winning Biocore®
We
identified the importance of recent developments in accelerating our path to profitability, including the launch of important new products,
which have a ready market through cross-selling to existing customer clinics, and large new distribution partnerships that allow us to
sell into large hospital networks.
Our
mission is to innovate and create transformative healthcare products while ensuring financial discipline, to drive margin and revenue
growth while delivering value creation for our investors. Our commitment to innovation means that we harness data intelligently to explore
novel avenues for enhancing healthcare outcomes. Through cutting-edge research and development, we believe we are redefining medical
diagnostics and patient care by developing new innovative AI-driven solutions.
We
are expanding our AI technology development in remote cardiac care, leveraging proprietary AI technology to provide a suite of predictive
monitoring tools to enhance new disease profiling, improve patient management, and revolutionize the healthcare industry for disease
prevention.
We
have also strengthened relationships with Amazon and Google. The healthcare AI market opportunity is projected to grow to $208.2 billion
by 2030 according to Grand View Research. We have already established a strong foothold, having already built a powerful proprietary
cardiac AI model that combines Google’s TensorFlow, AWS infrastructure, big data and a continuous learning engine. This combination
allows us to rapidly improve our cardiac technology. In the near future, we believe the capabilities of our cardiac AI model will allow
us to support healthcare professionals in handling exponentially more patients while identifying the most critical data. This will enable
healthcare workers to elevate the quality of care while serving a larger number of patients. As growing patient numbers further stress
the shortage of healthcare professionals, our technology could help alleviate this pressing issue. We have engineered our technology
to not only improve patient care and outcomes, but to do so in a manner that supports more patients. This has led to increasing sales
of our remote cardiac monitoring devices and the ramp-up of our subscription-based service, increasing our recurring revenue over the
past few quarters and charting a clear path to profitability.
4
From
a market perspective, increasing interest and demand continue to drive the adoption of our suite of products, which are focused on chronic
cardiac disease prevention and management. Our efforts in commercialization and development have yielded tremendous progress in remote
monitoring solutions for diagnostic and post-diagnostic products.
Market
Overview
Chronic
diseases are the number one burden on the healthcare system, driving up costs year over year. Lifestyle related illnesses such as obesity
and hypertension are the top contributing factors of chronic conditions including diabetes and heart disease. Government and healthcare
organizations are focused on driving costs down by shifting to evidence-based healthcare where individuals, especially those suffering
from chronic illnesses, engage in self-management. This has led to growth in the connected health market, which according to an October
2023 report by MarketUs is projected to reach $150 billion by 2024 at a compound annual growth rate (CAGR) of 25%.
According
to the American Heart Association, the number one cost to the healthcare system is cardiovascular disease, estimated by the CDC Foundation
to be responsible for 1 in every 6 healthcare dollars spent in the US. Since cardiovascular disease is the number one cause of death
worldwide, early detection, diagnosis, and management of chronic cardiac conditions are necessary to relieve the increasing burden on
the healthcare infrastructure. Diagnostic tests such as ECGs are used to detect, diagnose and track certain types of cardiovascular conditions.
We believe that the rise of lifestyle related illnesses associated with heart disease has created a need to develop cost-effective diagnostic
solutions to fill a hole in the current ECG market. These solutions will not only deliver faster and earlier diagnoses but also build
the foundation for disease management, supporting the transition from diagnosis to disease management.
A
report by Grand View Research projects that the global ECG equipment market will grow at a CAGR of 6.5% from 2023 to 2030, with the US
market valued at $2.01 billion in 2022. The factors driving this market include an aging population, an increase in chronic diseases
related to lifestyle choices, improved technology in diagnostic ECG devices, and high growth rates of ECG device sales.
In
the US, COM tests are primarily conducted through outsourced IDTFs that are reimbursed at an estimated average rate of approximately
$850 per diagnostic test, based on pricing information provided by the Centers for Medicare & Medicaid Services, a part of the U.S.
Department of Health and Human Services, and weighted towards the largest markets of New York, California, Texas and Florida. Reimbursement
rates can be lower in smaller markets, although the national average is $801. Further, we believe private insurers provide for similar
or better reimbursement rates.
Our
initial device offerings intended to revolutionize the COM and Holter markets by providing convenient, cost-effective, integrated solutions,
inclusive of both software and hardware for physician providers and their patients. Biotricity, however, has a broader strategic vision
to offer an ecosystem of technologies that engage the patient-user and their medical practitioner(s) in sustained monitoring, diagnosis,
communication and pro-active treatment and management of chronic care conditions. Our core solution is designed as a platform to encompass
multiple segments of the remote monitoring market, and its future growth.
Market
Opportunity
Cardiac
Diagnostics
ECGs
are a key diagnostic test utilized in the diagnosis of cardiovascular disease, the number one cause of death worldwide. The American
Heart Association reported that there were approximately 128 million adults in the US living with cardiovascular disease in 2020.
The
US ECG market is divided into three major product segments:
1.
Event
monitoring systems;
2.
Stress
ECG systems; and
3.
Resting
(non-stress) ECG systems.
Event
monitoring systems are projected to grow the fastest due to a shift from in-hospital/clinic monitoring to outpatient monitoring. This
shift is expected to help reduce health care costs by limiting the number of overnight hospital stays for patient monitoring. We believe
that physicians prefer event monitoring systems over resting and stress ECG systems because they provide better insight to the patient’s
condition for diagnostic purposes.
5
The
event monitoring market is divided into the Holter/Extended Holter, Event Loop and COM product segments, of which Holter, and its variant
Extended Holter, and Event Loop are the current market leaders. Among event monitoring systems, we believe that the preferred choice
of physicians and cardiologists is COM, because of its ability to continuously analyze patient data and transmit, thereby speeding up
diagnoses. COM devices have built-in arrhythmia analysis and regular communication, which allow physicians to prescribe the device for
a longer period of time; thereby enabling prolonged data collection and delivering a more complete picture for diagnosis.
Typical
Holter/Extended Holter and Event Loop solutions lack the ability to alert the patient or provider in case of an anomaly. Holters are
typically used as a short-term solution, up to 3 days, whereas Event Loop is used for up to 30 days. Extended Holter, the long-term variant
of Holter can be used for up to 21 days. It is the most recent of the cardiac monitoring options and was created for longer term holter
recordings. Since Event Loop is also long term, reimbursement for Extended Holter and Event Loop are converging. Reimbursement for these
is much lower compared to COM due to the nature of the solution, recording vs monitoring. With Holter and Event Loop monitoring, ECG
data is not uploaded or transmitted regularly. Comparatively, if the patient were monitored through a COM device with regular ECG data
transfer and cellular connectivity, then in the event of cardiac anomalies, the monitoring center could send communication to the patient’s
physician.
Since
COM requires an FDA-cleared device (meaning for our purposes that it can be used to review medical ECG data from ECG devices), FDA-cleared
ECG reporting software, and remote monitoring capabilities, regulatory and development hurdles have resulted in relatively few companies
being able to successfully develop an all-encompassing solution. We believe that there are currently only 5 COM solutions within the
market. Some of these solutions are sold to the market through solutions providers that have not developed and do not manufacture their
own device.
Of
the COM systems currently available in the market, most are IDTFs who employ an outsourcing business model, focused on providing clinical
services for which they can earn reimbursement; this means that they would typically not sell their devices to physicians, but offer
their clinical services. Some COM providers choose to sell their solution by charging high prices for devices and upfront software costs,
as well as a per cardiac study monitoring fee. Among these are solutions that are not scalable; some lack monitoring software, requiring
a customer to acquire third party software and incur integration expenses. These would require an investment by the physician, to incur
upfront costs that would take time to recoup before profits are realized.
The
limited number of competitors makes this an attractive market for new entrants. However, entry into the market requires a hardware device
coupled with complex algorithms, ECG software and access to a monitoring center. Two of the five COM players have done so by building
their own monitoring infrastructure, developing their own ECG software and utilizing TZ Medical’s COM device. However, this is
capital intensive and we believe cost prohibitive for most hospitals and clinics. These barriers are in our opinion among the key reasons
as to why Holter and Event Loop have maintained a significant portion of the US event monitoring market despite the increase in patient
safety and improved outcomes with COM.
The
Biocore solution and business model attempts to address these complications with its complete, turn-key solution for providers to deliver
cardiac diagnostics directly. Technologically, the Biocore solution is superior as a one-piece solution as opposed to a two-piece and
collects 3 channels of ECG compared with 1 or 2, resulting in better data and higher quality diagnoses. It is also designed to be easy
to wear in a form factor that attains high patient compliance. Combined with our insourced business model, providers can deliver better
and faster care while also billing. This combination has led to our continued growth and high customer retention rates.
Chronic
Care and Remote Patient Monitoring
Chronic
diseases are the number one healthcare expense and are continuing to grow as the population ages. Lifestyle related illnesses such as
obesity, hypertension, cardiovascular diseases, and diabetes are the top contributing factors of chronic conditions. Government and healthcare
organizations are focused on driving costs down by shifting to holistic management where individuals, especially those suffering from
chronic illnesses, are supported outside of the clinic. This has led to growth in chronic care management market, which is projected
to reach $8.7 billion in the US by 2027 at a compound annual growth rate (CAGR) of 18% between 2021 and 2027, according to a January
2022 report by Precedence Research.
Remote
patient monitoring (RPM), one of the key areas of focus for disease-management and evidence-based practice, is projected by Research
and Markets to reach a market size of $96.67 billion by 2030 at a CAGR of 17.6%, according to a January 2024 report by Research and Markets.
Today, approximately 20% of large healthcare facilities in the US are already using remote monitoring with a projected 70 million US
patients utilizing remote monitoring by 2025, as reported by Strategic Market Research in July 2023.
6
Similar
to chronic care and RPM, lifestyle management is seeing increasing growth where stable patients are becoming more and more engaged in
lifestyle management. Grand View Research reported that the global wearable technology market has already reached $61.3 billion in 2022
with an expected CAGR of 14.6% from 2023 to 2030. In 2021, the US portion of that market was valued at $17.9 billion.
The
primary driver of each of these markets are individuals diagnosed with or at risk-for chronic conditions. Cardiac diseases are the number
one expense and the number one killer, making up the bulk of the individuals utilizing such solutions. Despite this, existing solutions
are not tailored for cardiac patients but for diabetes, obesity, and hypertension as these conditions are supported by medical or personal
devices that can track biometrics that support management. Up until now, there has been no solution available to support cardiac patients
as technology was limited to manual short term heart rhythm collection or heart rate monitors.
Biotricity
changed this with the creation of Bioheart and Biocare, which delivers the first cardiac tailored solution for disease management. The
engine of this solution is the Bioheart, the first-of-its-kind continuous heart rhythm monitor that autonomously and continuously collect
heart rhythm data with no limitation on duration, a necessity for cardiac issues. Just as diabetic patients have continuous glucose monitoring,
individuals with cardiac issues now have continuous heart monitoring.
Combining
our technological innovation with our business model delivers a solution that is not only industry leading technologically and clinically,
but one that also supports providers to deliver better care while creating a new revenue stream. We believe this leap in innovation will
help us compete with the more generic solutions as well as those limited by shorter duration data collection. The leap in innovation
created by Bioheart was also recognized by TIME, where they named Bioheart one of the Best Inventions of the World in 2022.
Market
Strategy
Cardiac
Diagnostics
Our
cardiac diagnostics strategy is focused on the target addressable market of approximately 34,000 cardiologist physician offices in the
U.S. (approximately 6% of all specialty physician offices in the U.S.), approximately 780 hospitals that specialize in cardiology, heart
and vascular surgery (approximately 13% of all hospitals in the U.S.), and 300 IDTFs that provide cardiac monitoring services (an estimated
10% of all IDTFs in the U.S.). To do this, we invested in the hiring of top caliber sales professionals with a proven track record in
cardiac technology and device sales, and strong business relationships with providers of cardiac medical services. To further expand
our market reach, we have partnered with leading distributors and GPOs.
COM
The
Bioflux and Biocore Pro solutions are deployed into physicians’ offices, clinics, hospitals, and IDTFs. For the prescribing physician,
the COM diagnostic read is a reimbursable service from payers such as Medicare and insurance companies. In the United States, billing
codes for an COM diagnostic read are available under the American Medical Association Current Procedural Terminalogy, with a current average
reimbursement rate of $850 per read (a read is between 1 and 30 days long).
We
believe that Biotricity’s revenue model, which is a platform or technology as a service model (PAAS or TAAS),
is a significant and disruptive departure from the pricing and reimbursement strategies of the existing competitors in the COM market,
which apply an outsourced model to COM diagnostics, where the entire procedure and reimbursement is outsourced; the COM solutions provider
takes over the clinical responsibilities and earns the reimbursement and pays the physician a small administrative stipend. Biocore’s
technology, revenue and insourced business model entail differentiators that are expected to create barriers to entry for other competitors
seeking to emulate our strategy.
We
also believe our solutions are not only financially superior but also clinically superior. Existing COM solutions are two-piece solutions
with 2 channel ECGs. Comparatively, Biocore is a one-piece solution with 3 channels of ECG, delivering more and higher quality data with
better patient compliance. This is a significant barrier to entry for existing and new competitors as they would need to develop an entirely
new solution that encompasses multiple channels and integrated cellular connectivity to compete with the Bioflux or Biocore.
7
Holter/Extended
Holter
The
Biocore solution is purpose-built for the holter and extended holter market and is deployed into physicians’ offices, clinics,
hospitals, and IDTFs. For the prescribing physician, the Holter/Extended Holter diagnostic read is a reimbursable service from payers
such as Medicare and insurance companies. In the United States, billing codes for a Holter and Extended Holter diagnostics are available
under the American Medical Association Current Procedural Terminalogy, with a current blended average reimbursement rate of $200 per test,
where a test is between 1 and 21 days long.
We
believe that Biocore’s revenue model, which is a platform or technology as a service model (PAAS or TAAS),
is a significant and disruptive departure from the pricing and reimbursement strategies of the existing competitors in the Holter market,
which apply an outsourced model to Holter diagnostics, where the entire procedure and reimbursement is outsourced; the Holter solutions
provider takes over the clinical responsibilities and earns the reimbursement and pays the physician a small administrative stipend.
Biocore’s technology, revenue and insourced business model entail differentiators that are expected to create barriers to entry
for other competitors seeking to emulate our strategy.
Additionally,
we believe the Biocore solution is not only financially superior but also clinically superior. Existing holter patch solutions are 1
channel devices that lack connectivity. This leads to cardiac diagnostic results taking up to 2 weeks. Biocore is a connected 3 channel
patch solution, delivering more and higher quality data while reducing the time to diagnosis from 2 weeks to 3 days or less. This is
a significant barrier to entry for existing and new competitors as they would need to develop an entirely new solution that encompasses
connectivity and multiple channels to compete with the Biocore.
Chronic
Care Management (CCM) and Remote Patient Monitoring (RPM)
Our
chronic care management and remote patient monitoring strategy is focused on the same target addressable market of approximately 34,000
cardiologist physician offices (approximately 6% of all physician offices in the U.S.), approximately 780 hospitals that specialize in
cardiology, heart and vascular surgery (approximately 13% of all hospitals in the U.S.), and 300 IDTFs that provide cardiac monitoring
services (an estimated 10% of all IDTFs in the U.S.) that we are targeting for our diagnostics. The difference in our strategy here is
a focus on selling into existing accounts and new diagnostic accounts as opposed to building out a new channel strategy. These solutions
are complementary to our diagnostics solution and can be sold as part of a complete platform to target new and existing customers.
Product
and Technology
Bioflux
and Biocore Pro
Bioflux
and Biocore Pro are advanced, integrated ECG device and software solutions for the COM market. The device attaches like a patch into
utilizes wet electrodes that are applied to a patient’s chest. The Biocore ECG reporting software allows doctors and labs to view
a patient’s ECG data for monitoring and diagnostic purposes.
The
Biocore Pro device has been developed, among other things, with the following features:
●
3
channels
●
Built-in
cellular connectivity for global cellular network compatibility;
●
Extended
battery size for up to 5 days of battery life.
The
Bioflux and Biocore Pro platform has a built-in cellular chipset and a real-time embedded operating system which allows for our technology
to be utilized as an Internet of Things (IoT) platform. This technology can be leveraged into other applications and industries by utilizing
the platform and OS side of our technology.
8
Biocore
Holter
and Extended Holter monitors are significantly simplified versions of cardiac diagnostics that lack connectivity and analysis. Holter
and Extended Holter monitors require data to be downloaded manually, resulting in diagnostic results taking up to 2 weeks or longer.
The Biocore device has been designed to address the limitations of existing solutions while providing the same disruptive business model
as the Bioflux. Responding to our customer needs, the Biocore was developed with the following features:
●
3
channels
●
Connectivity
●
Rechargeable
●
Reusable
The
Biocore is also a platform technology that can be leveraged and used to enter other markets and support future product enhancements.
The company has already developed a number of enhancements for Biocore that will be available in the next generation of the solution.
Biocare,
Bioheart and Biokit
It
is widely reported that chronic illnesses related to lifestyle diseases are on the rise, resulting in increased healthcare costs. This
has caused a major shift in the US healthcare market, emphasizing a need for evidence-based healthcare system focused on overall health
outcomes. Patient compliance is a critical component in driving improved health outcomes, where the patient adheres to and implements
their physician’s recommendation. Unfortunately, poor patient compliance is one of the most pressing issues in the healthcare market.
One of the key contributing factors to this is the lack of a feedback mechanism to measure improvement and knowledge. Studies show that
poor patient compliance costs the US healthcare system $100 to $289 billion annually1, representing 3% to 10% of total US
healthcare costs2 . Studies have proven that regular monitoring of chronic care conditions improves patient outcomes in the
form of lower morbidity rates and reduce the financial burden on the healthcare system by empowering preventative care.
The
Company has developed Biocare to support medical practitioners as they gather data and regularly monitor and treat patients with two
or more chronic care conditions. We expect that Bioheart combined with our Biocare platform, our fourth product, is focused on filling
this need by providing a clinically relevant, preventative care and disease management solution for the consumer. A key underlying component
of Bioheart is the ability to measure patient improvements—with clinical accuracy—helping to drive feedback and support patient
compliance. This approach is implemented in our development process by focusing on a disease/chronic illness profile, as opposed to a
customer profile. We are focused on cardiovascular disease for our first preventative care solution since Bioflux is aimed at the same
health segment.
The
focus on cardiovascular disease states make the combination of Bioheart and Biocare a unique offering within the chronic care management
space which is primarily focused on diabetes. With no long term consumer solution for heart patients, chronic care management has focused
on those conditions that do have personal devices, mainly diabetes, hypertension, and COPD. This is why we developed Bioheart, a consumer
solution for personal use for individuals with cardiac issues. Combined with our Biocare platform, it is one of the first disease management
solutions capable of delivering holistic chronic care management to cardiovascular patients.
Taking
it a step further, we developed Biokit to support cardiac patients that had other chronic conditions such as hypertension or COPD. Biokit
is a remote patient monitoring kit that combines a blood pressure cuff, an pulse oximeter and a digital thermometer into the Biocare
platform to support the collection of additional biometrics for those patients with multiple conditions. Biocare was developed with the
following features:
●
Integration
with cardiac diagnostics: Bioflux and Biocore
●
Bioheart
●
Biokit
●
Virtual
Clinic
●
Automated
biometric reporting
●
Patient
Dashboards
●
Automated
time tracking
●
Built-in
patient reminders and calling
●
Asynchronous
chat
●
Monthly
data summaries
9
Biocare
is also a platform technology that can be leveraged and used to enter other chronic condition markets and support future product enhancements.
The company has already developed a number of enhancements for Biocare that will be available in the next generation of the solution.
Future
Markets
In
the next few years, we intend to expand use of our technology platform with medical-grade solutions for the monitoring of implantable
cardiac devices, diabetes, sleep apnea, chronic pain, as well as fetal monitoring, and other adjacent healthcare and lifestyle markets.
Bionatal
is a proposed product for monitoring fetus’ health by remote cardiac telemetry. In the US, there were approximately 24,073 fetal
deaths at 20 or more weeks gestation in 20123. The rise of older mothers and mothers with chronic conditions have driven high-risk
pregnancies to a new high; high-risk complications now occur in 6 to 8 percent of all pregnancies4.
The
Company has also received an NIH grant to investigate cardiac anomalies in chronic kidney disease patients, which is designed to be a
predictive or early detection tool for CKD patients. This and other new technology that the Company is developing is applicable to the
market segments that the Company intends to serve and will continue to adhere to the Company’s revenue model of deriving income
from technology fees.
Competition
Cardiac
Diagnostics
Cardiac
Outpatient Monitoring
The
medical technology equipment industry is characterized by strong competition and rapid technological change. There are a number of companies
developing technologies that are competitive to our existing and proposed products, many of them, when compared to our Company, having
significantly longer operational history and greater financial and other resources.
Within
the US event monitoring systems market, we are aware of six main competitors in the COM product segment. These competitors have increased
market presence and distribution primarily by working through existing IDTFs. The existing competitors have maintained a competitive
advantage within the market by controlling the distribution of all available COM devices and software solutions. Our primary competitors
in the COM market are:
●
Philips Biotel - Biotelemetry (formerly CardioNet), recently acquired by Philips for a reported $2.8B. We believe that BioTelemetry,
Inc. has the largest network of IDTFs within the COM market. BioTelemetry is considered a complete solution provider as it produces and
distributes its own COM device, software solution, and COM monitoring centers. The company acquired its COM device through the acquisition
of a COM manufacturer, Braemar. Upon acquisition of Braemar, BioTelemetry offered limited support to other clients utilizing Braemar’s
technology. This resulted in BioTelemetry increasing the use of its device and software solution, enabling wide market penetration. We
believe that BioTelemetry business model is focused on providing the COM diagnostic service, as opposed to selling COM solutions to other
IDTFs or service providers, which enables a perpetual per-read fee as opposed to one time device or software sales. Equity research analysts
categorize BioTelemetry as a clinical health provider, because of its business model, rather than as a medical device company. As such,
we believe that BioTelemetry market cap is limited by the low multiples associated with that type of business, and, as a clinical health
provider, BioTelemetry has significant overhead and fixed costs associated with monitoring centers and health professionals.
●
Boston Scientific – Preventice Preventice (formerly eCardio.), recently acquired by Boston Scientific for a reported $1.2B.
Preventice is a private company, based in Houston, Texas. Preventice’s device is manufactured by a third party medical device
company, TZ Medical. Preventice has integrated TZ Medical’s device with its software solution to create a complete COM solution.
Similar to Biotelemetry, we believe eCardio follows the same business model of offering the COM service and acting as a clinical health
provider.
●
ScottCare. ScottCare is a private company in the US and a subsidiary of Scott Fetzer Company, a division of Berkshire Hathaway.
ScottCare provides equipment for cardiovascular clinics and diagnostic technicians. ScottCare has built its own COM device and software
solution, and white-labeled TZ Medical’s device. Unlike the others, ScottCare offers its solution in an insourced model, where
the physician has the opportunity to bill. This model requires the physician to purchase a minimum number of devices at an approximate
average cost of $2,000 and their software at a cost of $25,000 to $40,000. After this initial upfront cost, ScottCare charges an additional
per test fee for monitoring. We believe the above model creates a long return on investment for the physician. In our opinion, this has
resulted in little market penetration for ScottCare as compared to the others.
10
●
Infobionic. Infobionic is a private company located in Waltham, Massachusetts. It follows a leasing model where it leases its
technology at a fixed monthly rate, whether technology is used or not. They have a complete solution, comprised of a device and software.
We believe that they have a good model that will enable them to be competitive in the market. In our opinion, there is room for both
Biotricity and Infobionic within the marketplace, though we believe that our solution is superior in two ways. 3 channels and built in
cellular technology.
●
VitalConnect. VitalConnect is a private company that has expanded into the COM space by offering a disposable patch coupled with
a cellphone. They have adopted the same model as Boston Sci and Philips. They are well funded and are growing but continue to lose money
and have integrated various third party technologies to build their solution. Operationally, a disposable patch is expensive to manage
and increases COGS. Long term we think our solution is superior as it is clinically better with 3 channels and built in cellular technology
alongside industry leading operational workflows. Economically, we know that solutions like this cannot compete with us when it comes
to costs and margins.
In
addition, we note that:
●
Medtronic. Medtronic is a major medical device conglomerate. It has an COM solution by the name of SEEQ that was added to their
portfolio through the acquisition of Corventis. We have seen no significant activity or usage with SEEQ in our market analysis. We also
note that SEEQ is a patch based COM solution that only collects data on 1 lead. As such, it has strong competition from 3 lead systems
which are the standard for COM. In early 2018, Medtronic withdrew SEEQ from the marketplace. We do not view Medtronic as a primary competitor,
but, given the size and reach of Medtronic, they are an organization that we must continuously watch and be aware of.
●
TZ Medical. TZ Medical is a medical device company that focuses on manufacturing a variety of medical devices. We do not consider
TZ Medical to be a direct competitor as they produce a COM device that is available for purchase, and sold to competitors such as to
Scottcare and Preventice, described above. However, we do not believe that TZ Medical has a software solution, requiring any new entrant
to either acquire or build out a software solution and then integrate that with the TZ Medical device. This creates a requirement for
a large upfront capital investment. As a result, we believe this approach only works for organizations looking to become COM solution
providers with the same business model as the others.
We
believe that our Bioflux COM solution will successfully compete because:
●
it
is designed as a platform to encompass all segments of the event monitoring market;
●
of
the insourcing business model which we believe is applicable to a significantly larger portion of the total available market and
enable more efficient strategic penetration and distribution; and
●
for
the other reasons described earlier under “Market Opportunity.”
Holter/Extended
Holter
Within
the US event monitoring systems market, we are aware of three main competitors in the Holter patch product segment. These competitors
have increased market presence and distribution primarily by working with Hospitals. The existing competitors have maintained a competitive
advantage within the market by a first mover advantage. Our primary competitors in the Holter patch market are:
●
iRhythm
Technologies: iRhythm is the leader in holter patch technology with the largest footprint. They are primarily hospital focused and
operate as an IDTF, much like our COM competitors. Their core product is the Zio patch, which is a 1 channel holter with no connectivity
and is not rechargeable
●
BardyDx
(Recently Acquired by Hilrom): BardyDx is the second largest player in the holter space. They operate as an IDTF as well.
Their core product is a 1 channel patch with no connectivity with a removable chip for data uploads.
●
VitalConnect:
is a small player in the holter space. They have a disposable patch monitor that can be used for a limited time, making it unusable
for long term studies. They operate as an IDTF.
11
Cardiac
Disease Management
Within
the US cardiac disease management market, we are aware of three main competitors in the cardiac care management segment. These competitors
have different approaches, solutions, and technologies but we still regard them as competitors. Technologically we have a number of differentiators
as we are the only company that has a continuous heart monitor. Our primary competitors in the cardiac disease management market are:
Bioheart:
●
Alivecor
is a direct to consumer cardiac monitoring company. They are the biggest brand in consumer cardiac care and have a simple to use
handheld cardiac device. They operate as a service provider, providing cardiac insights direct to individuals.
Biocare:
●
Optimize
Health: Optimize health is a chronic care and RPM platform for a variety of chronic conditions. Thought it is platform with no focus
on cardiac specifically, it provides a complete platform for clinics and hospitals to utilize and build out a chronic disease management
program.
●
HelloHeart:
Hello Heart is a disease management program focused on hypertension. It is one of the few disease management programs that is focused
on a heart related chronic disease
In
the digital health space, we have noticed that we have competitors for different products but not a single competitor that has the entire
product portfolio that we have. This adds a layer of differentiation and competitive advantage as customer can deal with one vendor as
opposed to multiple vendors that they have to integrate.
Intellectual
Property
We
primarily rely on trade secret protection for our proprietary information. No assurance can be given that we can meaningfully protect
our trade secrets. Others may independently develop substantially equivalent confidential and proprietary information or otherwise gain
access to, or disclose, our trade secrets.
We
have and generally plan to continue to enter into non-disclosure, confidentiality and intellectual property assignment agreements with
all new employees as a condition of employment. In addition, we intend to also generally enter into confidentiality and non-disclosure
agreements with consultants, manufacturers’ representatives, distributors, suppliers and others to attempt to limit access to,
use and disclosure of our proprietary information. There can be no assurance, however, that these agreements will provide meaningful
protection or adequate remedies for our trade secrets in the event of unauthorized use or disclosure of such information.
We
also may from time to time rely on other intellectual property developed or acquired, including patents, technical innovations, laws
of unfair competition and various other licensing agreements to provide our future growth and to build our competitive position. We have
filed an industrial design patent in Canada, and we may decide to file for additional patents as we continue to expand our intellectual
property portfolio. However, we can give no assurance that competitors will not infringe on our patent or other rights or otherwise create
similar or non-infringing competing products that are technically patentable in their own right. We fully intend to vigorously defend
our intellectual property and patents.
Currently,
we have a number of registered trademarks; we may obtain additional registrations in the future.
Research
and Development
Our
research and development programs are generally pursued by engineers and scientists employed by us in California and Toronto on a full-time
basis or hired as per diem consultants or through partnerships with industry leaders in manufacturing and design and researchers and
academia. We are also working with subcontractors in developing specific components of our technologies. In all cases, we ensure that
all areas of IP are owned and controlled by the Company.
12
The
primary objective of our research and development program is to advance the development of our existing and proposed products, to enhance
the commercial value of such products.
We
incurred research and development costs of $2.7 million for the fiscal year ended March 31, 2026 and $2.2 million for the fiscal year
ended March 31, 2025.
Government
Regulation
General
Our
medical device products are subject to regulation by the U.S. FDA and various other federal and state agencies, as well as by foreign
governmental agencies. These agencies enforce laws and regulations that govern the development, testing, manufacturing, labeling, advertising,
marketing and distribution, and market surveillance of our medical device products.
In
addition to those indicated below, the only other regulations we encounter are regulations that are common to all businesses, such as
employment legislation, implied warranty laws, and environmental, health and safety standards, to the extent applicable. We will also
encounter in the future industry-specific government regulations that would govern our products, if and when developed for commercial
use. It may become the case that other regulatory approvals will be required for the design and manufacture of our products and proposed
products.
U.S.
Regulation
The
FDA governs the following activities that Biotricity performs, will perform, upon the clearance or approval of its product candidates,
or that are performed on its behalf, to ensure that medical products distributed domestically or exported internationally are safe and
effective for their intended uses:
●
product
design, and development;
●
product
safety, testing, labeling and storage;
●
record
keeping procedures; and
●
product
marketing.
There
are numerous FDA regulatory requirements governing the approval or clearance and subsequent commercial marketing of Biotricity’s
products. These include:
●
the
timely submission of product listing and establishment registration information, along with associated establishment user fees;
●
continued
compliance with the Quality System Regulation, or QSR, which require specification developers and manufacturers, including third-party
manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects
of the manufacturing process;
●
labeling
regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;
●
clearance
or approval of product modifications that could significantly affect the safety or effectiveness of the device or that would constitute
a major change in intended use;
●
Medical
Device Reporting regulations (MDR), which require that manufacturers keep detailed records of investigations or complaints against
their devices and to report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned
in a way that would likely cause or contribute to a death or serious injury if it were to recur;
●
adequate
use of the Corrective and Preventive Actions process to identify and correct or prevent significant systemic failures of products
or processes or in trends which suggest same;
●
post-approval
restrictions or conditions, including post-approval study commitments;
●
post-market
surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness
data for the device; and
●
notices
of correction or removal and recall regulations.
13
Depending
on the classification of the device, before Biotricity can commercially distribute medical devices in the United States, it had to obtain,
either prior 510(k) clearance, 510(k) de-novo clearance or premarket approval (PMA), from the FDA unless a respective exemption applied.
The FDA classifies medical devices into one of three classes based on the degree of risk associated with each medical device and the
extent of regulatory controls needed to ensure the device’s safety and effectiveness:
●
Class
I devices, which are low risk and subject to only general controls (e.g., registration and listing, medical device labeling compliance,
MDRs, Quality System Regulations, and prohibitions against adulteration and misbranding) and, in some cases, to the 510(k) premarket
clearance requirements;
●
Class
II devices, which are moderate risk and generally require 510(k) or 510(k) de-novo premarket clearance before they may be commercially
marketed in the United States as well as general controls and potentially special controls like performance standards or specific
labeling requirements; and
●
Class
III devices, which are devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable
devices, or devices deemed not substantially equivalent to a predicate device. Class III devices generally require the submission
and approval of a PMA supported by clinical trial data.
The
custom software and hardware of our products are classified as Class II. Class II devices are those for which general controls alone
are insufficient to provide reasonable assurance of safety and effectiveness and there is sufficient information to establish special
controls. Special controls can include performance standards, post-market surveillance, patient histories and FDA guidance documents.
Premarket review and clearance by the FDA for these devices is generally accomplished through the 510(k) or 510(k) de-novo premarket
notification process. As part of the 510(k) or 510(k) de-novo notification process, the FDA may have required the following:
●
Development
of comprehensive product description and indications for use.
●
Completion
of extensive preclinical tests and preclinical animal studies, performed in accordance with the FDA’s Good Laboratory Practice
(GLP) regulations.
●
Comprehensive
review of predicate devices and development of data supporting the new product’s substantial equivalence to one or more predicate
devices.
●
If
appropriate and required, certain types of clinical trials (IDE submission and approval may be required for conducting a clinical
trial in the US).
If
required, clinical trials involve use of the medical device on human subjects under the supervision of qualified investigators in accordance
with current Good Clinical Practices (GCPs), including the requirement that all research subjects provide informed consent for their
participation in the clinical study. A written protocol with predefined end points, an appropriate sample size and pre-determined patient
inclusion and exclusion criteria, is required before initiating and conducting a clinical trial. All clinical investigations of devices
to determine safety and effectiveness must be conducted in accordance with the FDA’s Investigational Device Exemption, or IDE,
regulations that among other things, govern investigational device labeling, prohibit promotion of the investigational device, and specify
recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant
risk,” as defined by the FDA, the agency requires the device sponsor to submit an IDE application, which must become effective
prior to commencing human clinical trials. The IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA
denies the application or notifies the company that the investigation is on hold and may not begin. If the FDA determines that there
are deficiencies or other concerns with an IDE that requires modification, the FDA may permit a clinical trial to proceed under a conditional
approval. In addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board (IRB) for each
clinical site. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval
for the trial by one or more IRBs without separate approval from the FDA, but it must still follow abbreviated IDE requirements, such
as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.
14
Given
successful completion of all required testing, a detailed 510(k) premarket notification or 510(k) de-novo was submitted to the FDA requesting
clearance to market the product. The notification included all relevant data from pertinent preclinical and clinical trials, together
with detailed information relating to the product’s manufacturing controls and proposed labeling, and other relevant documentation.
A
510(k) clearance letter from the FDA then authorized commercial marketing of the device for one or more specific indications of use.
After
510(k) clearance, Biotricity is required to comply with a number of post-clearance requirements, including, but not limited to, Medical
Device Reporting and complaint handling, and, if applicable, reporting of corrective actions. Also, quality control and manufacturing
procedures must continue to conform to QSRs. The FDA periodically inspects manufacturing facilities to assess compliance with QSRs, which
impose extensive procedural, substantive, and record keeping requirements on medical device manufacturers. In addition, changes to the
manufacturing process are strictly regulated, and, depending on the change, validation activities may need to be performed. Accordingly,
manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with
QSRs and other types of regulatory controls.
After
a device receives 510(k) clearance from FDA, any modification that could significantly affect its safety or effectiveness, or that would
constitute a major change in its intended use or technological characteristics, requires a new 510(k) clearance or could require a PMA.
The FDA requires each manufacturer to make the determination of whether a modification requires a new 510(k) notification or PMA in the
first instance, but the FDA can review any such decision. If the FDA disagrees with a manufacturer’s decision not to seek a new
510(k) clearance or PMA for a particular change, the FDA may retroactively require the manufacturer to seek 510(k) clearance or PMA.
The FDA can also require the manufacturer to cease U.S. marketing and/or recall the modified device until additional 510(k) clearance
or PMA approval is obtained.
The
FDA and the Federal Trade Commission, or FTC, will also regulate the advertising claims of Biotricity’s products to ensure that
the claims it makes are consistent with its regulatory clearances, that there is scientific data to substantiate the claims and that
product advertising is neither false nor misleading.
We
received 510(k) clearance for both the software and hardware components of our Bioflux and Biocore products. To obtain 510(k) clearance,
a company must submit a notification to the FDA demonstrating that its proposed device is substantially equivalent to a predicate device
(i.e., a device that was in commercial distribution before May 28, 1976, a device that has been reclassified from Class III to Class
I or Class II, or a 510(k)-cleared device). The FDA’s 510(k) clearance process generally takes from three to 12 months from the
date the application is submitted but also can take significantly longer. If the FDA determines that the device or its intended use is
not substantially equivalent to a predicate device, the device is automatically placed into Class III, requiring the submission of a
PMA. Once the information is submitted, there is no guarantee that the FDA will grant a company 510(k) clearance for its pipeline products,
and failure to obtain the necessary clearances for its products would adversely affect its ability to grow its business. Delays in receipt
or failure to receive the necessary clearances, or the failure to comply with existing or future regulatory requirements, could reduce
its business prospects.
Devices
that cannot be cleared through the 510(k) process due to lack of a predicate device but would be considered low or moderate risk may
be eligible for the 510(k) de-novo process. In 1997, the Food and Drug Administration Modernization Act, or FDAMA added the de novo classification
pathway now codified in section 513(f)(2) of the 29&C Act. This law established an alternate pathway to classify new devices into
Class I or II that had automatically been placed in Class III after receiving a Not Substantially Equivalent, or NSE, determination in
response to a 510(k) submission. Through this regulatory process, a sponsor who receives an NSE determination may, within 30 days of
receipt, request FDA to make a risk-based classification of the device through what is called a “de novo request.” In 2012,
section 513(f)(2) of the 29&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA),
in order to provide a second option for de novo classification. Under this second pathway, a sponsor who determines that there is no
legally marketed device upon which to base a determination of substantial equivalence can submit a de novo request to FDA without first
submitting a 510(k).
In
the event that a company receives a Not Substantially Equivalent determination for its candidates in response to a 510(k) submission,
the device may still be eligible for the 510(k) de-novo classification process.
Devices
that cannot be cleared through the 510(k) or 510(k) de-novo classification process require the submission of a PMA. The PMA process is
much more time consuming and demanding than the 510(k) notification process. A PMA must be supported by extensive data, including but
not limited to data obtained from preclinical and/or clinical studies and data relating to manufacturing and labeling, to demonstrate
to the FDA’s satisfaction the safety and effectiveness of the device. After a PMA application is submitted, the FDA’s in-depth
review of the information generally takes between one and three years and may take significantly longer. If the FDA does not grant 510(k)
clearance to its future products, there is no guarantee that Biotricity will submit a PMA or that if it does, that the FDA would grant
a PMA approval of Biotricity’s future products, either of which would adversely affect Biotricity’s business.
15
We
have installed a suitable and effective quality management system, which establishes controlled processes for our product design, manufacturing,
and distribution. We plan to do this in compliance with the internationally recognized standard ISO 13485:2013 Medical Devices –
Quality Management Systems – Requirements for Regulatory Purposes. Following the introduction of a product, the FDA and foreign
agencies engage in periodic reviews of our quality systems, as well as product performance and advertising and promotional materials.
These regulatory controls, as well as any changes in FDA policies, can affect the time and cost associated with the development, introduction
and continued availability of new products. Where possible, we anticipate these factors in our product development processes. These agencies
possess the authority to take various administrative and legal actions against us, such as product recalls, product seizures and other
civil and criminal sanctions.
Foreign
Regulation
In
addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial
sales and distribution of our products in foreign countries. Whether or not we obtain FDA approval for a product, we must obtain approval
of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the
product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required
for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly
from country to country.
The
policies of the FDA and foreign regulatory authorities may change and additional government regulations may be enacted which could prevent
or delay regulatory approval of our products and could also increase the cost of regulatory compliance. We cannot predict the likelihood,
nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the
United States or abroad.
Manufacturing
and Suppliers
Earlier
in the life-cycle of the Company, we focused primarily on research and development of the first generation version of the Bioflux. We
have since completed the development of Biocore and of Bioheart and their proposed marketing and distribution. We currently assemble
our devices at our Redwood City, California facility. In order to maintain compliance with FDA and other regulatory requirements, our
manufacturing facilities must be periodically re-evaluated and qualified under a quality system to ensure they meet production and quality
standards. Suppliers of components and products used to manufacture our devices must also comply with FDA regulatory requirements, which
often require significant resources and subject us and our suppliers to potential regulatory inspections and stoppages.
We
have a scalable manufacturing strategy and goals and use Providence Enterprises (herein “Providence”), which
is an FDA qualified manufacturer for contract manufacturing. We do not have a contract with Providence or any obligation to use them
(nor do they have any obligations with respect to us other than with respect to any specific orders we may make) and we enter into purchase
orders for each manufacturing request we have with Providence, as we would with other vendors. Despite our working relationship with
Providence, we intend to continue to identify and develop other efficient, automated, low-cost manufacturing capabilities and options
to meet the quality, price, engineering, design and production standards or production volumes required to successfully mass market our
products, especially at the low-cost levels we require to facilitate our business plan.
We
currently rely on a number of principal suppliers for the components that make up our products and proposed products; these 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. We believe that the raw materials used or expected to be used in our planned products can be acquired from multiple sources
and are readily available on the market.
Employees
We
currently have 46 full-time employees and approximately 20 consultants who are based in our offices located in Silicon Valley, California
and Toronto, Canada. These employees oversee day-to-day operations of the Company and, together with the consultants, support management,
engineering, manufacturing, and administration. We have no unionized employees.
We
plan to hire 10 to 15 additional full-time employees within the next 12 months, as needed to support continued growth in our business.
Their principal responsibilities will be the support of our sales, marketing, research and development, and clinical development activities.
We
consider relations with our employees to be satisfactory.
16