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Investing in This Breakthrough Medical Device Maker is Like Investing in Apple Before the iPhone

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Heart disease, the leading cause of death in the U.S., claims one life about every 42 seconds.  Demand for cardiology services is expected to rise 20% by 2025 as the U.S. population is expanding and aging and living longer than ever. At the same time, we face a severe shortage of doctors especially cardiologists owing to an aging workforce and poor distribution of providers. Besides training more doctors, the healthcare industry must innovate technology so that doctors could treat more patients while providing the best care possible.

Biotricity, a young-and-hungry startup in Redwood City, Calif., has developed a breakthrough medical device that will help do exactly that. Its state-of-the-art heart monitor and star product, the Bioflux, will reinvent how cardiologists work all the while lowering costs for insurers. Investing in Biotricity now would be like buying Apple before the iPhone. Bioflux could not only save lives but also hand investors a windfall.

The FDA approved Bioflux is a small, Internet-enabled mobile cardiac telemetry, MCT, system that sends real-time data to doctors so they can remotely monitor and diagnose patients. What’s more, Biotricity provides a 24/7 patient monitoring center staffed by certified heart specialists. If an emergency arises, doctors could be notified immediately. The Bioflux is quintessential to heart patients like burglar alarms for homeowners in crime-infested neighborhoods.

A Disheartening, Ever Growing Disease

About 47% of cardiac deaths happen outside of the hospital, suggesting people with heart disease fail to act on the early warning signs. More often than not, patients have no idea they’re having a heart attack when one strikes. They most frequently think they have indigestion or acid reflux, according to a February 2018 study published in Circulation, a journal of the American Heart Association.

Such was the case with Melissa Murphy of Des Moines, Iowa. She was only 40 years old when she suffered a heart attack. She suddenly felt excruciating pain stretching from the left side of her neck down to her arm. Doctors initially misdiagnosed her condition.

“I was sent home from the ER and told that everything looks good and it must be a musculoskeletal pain,” Murphy wrote in her blog Heartmom210, dedicated to helping heart attack patients. “You have to be kidding me!”

Melissa Murphy and daughter (Photo provided with permission from Melissa Murphy)

Health experts anticipate more than 40% of people in the U.S. will have CVD by 2030.

And the direct medical costs will triple to almost $1 trillion, says the Journal of the American College of Cardiology. CVD is the single most substantial burden on the U.S. healthcare system, eating up one in every six healthcare dollars spent.

Heart disease is responsible for a quarter of all U.S. fatalities, totaling 630,000 annually — more than all forms of cancer combined. Cardiovascular diseases, CVDs, are also the No. 1 killers globally. The World Health Organization estimates 17.7 million people worldwide died from CVDs in 2015, accounting for 31% of all deaths.  Among those deaths, 7.4 million was because of coronary heart disease and 6.7 million was because of stroke.

Observed and predicted number of cancer and heart disease deaths from 1969 through 2020 for men and women combined and age-standardized death rates (ASDR). Source: Centers for Disease Control and Prevention

Given an aging population and a rise in chronic diseases resulting from poor lifestyle habits, roughly 85.6 million Americans, 35% of the country’s population, are afflicted with some form of CVD or the aftermath of a stroke. Contrary to popular belief, only about half are older than 60 years old.

Nearly half of Americans, 49%, have at least one of three risk factors for heart disease: smoking, high blood pressure and high cholesterol, not to mention diabetes, obesity, poor diet, lack of exercise and alcohol abuse. Every year 735,000 people in the U.S. have a heart attack. Among those, about 120,000 or 16% die.

Experts foresee the prevalence of heart failure overall will jump 46% from 2012 to 2030. Chronic heart failure among those age 45 and older is seen spiking 30% from around 808,000 in 2015 to more than 1 million by 2025.

Heart disease versus cancer: Number of deaths 1969 to 2014 and predicted number of deaths from 2015–2020 and death rates for heart disease and cancer by year for all races and both sexes combined. (Chart from Statista.com)

Poor lifestyle choices are preventable. But aging is not. The over-65 age group accounts for 15% of the population. It is expected to grow to 20% by 2030. The percentage of the world’s population over 65 is projected to jump from 8.5% to 17% by 2050. U.S. Census calculates the age 85 and older cohort will double by 2036 and triple by 2049. A similar trend is expected throughout the developed world as this table below shows.


Source: U.S. Census

Potentially Life-Saving Breakthrough

Powerful yet easy to use, Bioflux is a hospital-grade heart monitor for at-home use. Here’s how it works:

Say you’ve suffered a cardiac event (heart failure, heart attack) or are at risk of having one. Your cardiologist gives you the Bioflux to monitor your heart for 10 to 30 days as you go about your daily life. The device takes the real-time electrocardiogram, ECG, data and instantly transmits them to your doctor via 3G and 4G cellular networks.

Your doctor already has your ECG report before you return to bring back the monitor. Your doctor can more efficiently diagnose, prescribe meds and manage therapy thanks to having keen insights and trends beforehand.

Without Bioflux, you would have to see your doctor in three visits instead of two to achieve the same result. You would have to initially meet with the doctor and get a heart monitor. After a week to 30 days of monitoring, you return to the doctor and turn in the monitor. The doctor has to download the information and analyze it. You return a third time to get the diagnosis and therapy.

Heaven forbid you have a heart attack while using the Bioflux. But it could potentially save your life. Biotricity’s 24/7 patient monitoring center is staffed by certified cardiac technicians, registered nurses, and arrhythmia professionals. Bioflux can be programmed to alert when patients have a cardiac event.

You and your family can take comfort in knowing that Biotricity professionals are always looking out for you. Hospital-level monitoring is the best level of care next to having an attendant in your own home.

One of biggest fears for elderly patients is having a heart attack or failure when no one is around to call 911. Time is of the essence. Patients could die if they’re unable to call for help themselves.

AT&T believes in Biotricity so much that it signed a deal in 2016 to be Biotricity’s preferred network for real-time connectivity to power the heart monitors.

Heart rate monitoring is to CVD patients what blood glucose monitoring is to diabetics. Cardiac events can happen anywhere at anytime. They come and go.

Bioflux detects fast, slow or abnormal heart rhythms, arrhythmias, and other problems that patients don’t even realize they have. It helps doctors see heart activity while they go about day-to-day activities and then use the vital data to help diagnose potential abnormalities.

ECG tests done in a doctor’s office can only measure heart rates at one moment in time in a situation that’s very different from the patient’s daily life. The tests have a 35% chance of being wrong for women. Menstrual cycles and birth control pills could affect results. Women are likely to get false positives or told they have heart disease when they don’t.

Handheld ECG monitoring could potentially detect false heart attacks, which have been known to ironically cause so much stress and anxiety that they trigger real heart attacks.

Clinically Proven

Bioflux is a next-generation MCT that combines the immediacy of the internet with all of the features of the two existing industry-standards, Holter and Event monitors. Bioflux is a huge improvement considering Holters record for 24 to 48 hours. As their name implies, Event monitors only records events. Thus you only get pieces of ECG readings. Neither transmit data to a monitoring center like Bioflux.

Patient monitoring with MCT has been clinically proven to be far superior compared with the Holter or Event monitors. A 2013 scientific study published in Medical Devices: Evidence and Research concluded: “Given the superior outcome of MCT regarding both patient care and hospital savings, hospitals only stand to gain by enforcing protocols that favor the MCT system over the Event or the Holter monitor.”

Patients monitored with MCT showed a diagnostic yield, the likelihood a test will provide the data needed to make a diagnosis, of 61%. “That is significantly higher than that of patients that use the Event monitor (23%) or the Holter monitor (24%),” the study stated. Also, patients using MCT instead of Event and Holter monitors saved hospitals tens of thousands of dollars depending on the procedure they had.

Data from the Milken Institute shows nearly two in five heart disease patients have adopted the use of medical technology.

Financial Incentives for Doctors

The U.S. Food and Drug Administration (FDA) issued a 510(k) clearance for Bioflux in October 2016. Biotricity is currently running a pilot program at five large healthcare facilities in four states: California, Florida, New York and Texas. They will likely become the company’s first set of customers. The pilot is set to end in June. Biotricity plans to kick off Bioflux sales at the beginning of the third quarter.

Upon launch, Biotricity plans to hire a sales force of 25 to 30 staffers on top of leveraging healthcare distributors and reseller partners.

Biotricity gives doctors every financial incentive to use its devices. Biotricity charges no upfront costs. Thus doctors should have no resistance to adopting the use of Bioflux in their practice. Biotricity will use a billing model similar to Comcast in which the company initially provides users the equipment at no cost and recoups the cost through monthly fees.

The difference is that Biotricity will bill doctors a flat fee for each patient’s use of the device. Doctors forward the bill to insurers for reimbursement. Bioflux is also eligible for coverage from Medicare and Medicaid.

Valuable Intellectual Property 

The raw power of Biotricity’s proprietary software provides highly-customizable reports and integrates seamlessly with existing medical systems used in doctors’ offices. The software programs are a trade secret and are even more valuable than Biotricity’s design patent, says CEO Waqaas Al-Siddiq. Reports can be faxed or emailed through a secure online portal. The data is stored in a protected, HIPAA-compliant, cloud-based system.

Biotricity records data for up to 30 days. Some kinds of heart disease, like cardiac arrhythmia, require analyzing several days or weeks of data. Cardiac arrhythmia is when the heart beats too fast, slowly, or irregularly. It varies from normal, not requiring medical attention, to a life-threatening emergency. The symptoms of cardiac arrhythmia may show up randomly, making it nearly impossible to accurately diagnose the type of arrhythmia a patient has and determine which treatments are necessary without a robust set of data.

Best of all, Bioflux costs much less use than competing products and is covered by insurance. Patients would not have to see a bill. Doctors simply enroll patients online and activate the device. Biotricity’s monitoring center takes care of the rest.

Bioflux MCT Device Features and Benefits

  • Incredibly powerful yet user-friendly
  • Monitors and transmits ECG data via 3G and 4G cellular networks
  • Provides three channels of remote ECG data offering increased diagnostic yield
  • Data gets recorded for up to 30 days
  • Proprietary, FDA-cleared software automatically detects advanced beat and arrhythmia
  • Remotely programmable auto-triggers on bradycardia, tachycardia, atrial fibrillation, and pauses are customizable for each patient’s individual needs
  • A sampling rate of up to 1,000 readings per second offers unrivaled clinical precision
  • A compact, comfortable and single-piece design that encourages patient use
  • High-security measures for maximum patient confidentiality
  • 24/7 patient monitoring by certified healthcare professionals

Artificial Intelligence 

Biotricity is working on adding artificial-intelligence capabilities to Bioflux and plans to apply for an FDA 510(k) hardware clearance in the third quarter of 2018. The AI system could sift through massive amounts of data to reveal commonalities among people who have had a heart attack or failure. Algorithms potentially could predict who is likely to experience a cardiac event and when so that they get treatment as early as possible.

AI is still in its infancy. But it could eventually help doctors screen patients more accurately and quickly. Biotricity’s data would make valuable contributions to the development of medical AI systems, which needs access to tomes of data from a variety of patients to work well.

New Product Pipeline

Biotricity’s product pipeline overflows with potential. Its monitoring hardware and software can be used for an array of diseases and health purposes: sleep apnea, prenatal care, stroke recovery, chronic obstructive pulmonary disease, COPD, and other chronic conditions.

Biotricity is on the brink of the fitness data and technology revolution. It’s developing a personal heart monitor, called Biolife, for people at risk of CVD. The wearable device will give users information about their ECG, respiration, physical activity, calorie burn, core body temperature, and much more in a user-friendly way.

Biolife will provide an analysis of the state of users’ health and useful feedback on their workouts. The data combined with an AI program could tell users when they should push harder or ease up to optimize their fitness routines. Programs could give personalized fitness advice based on all of their vital statistics.

They could eventually calculate how much sleep and exercise someone needs. Down the road, AI could eventually collect enough data to predict people’s mental and physical states and tell them what exercises and intensity level they need under the given circumstances.

Inordinate Benefits of Heart Monitoring

Christine Mountz-Hartline checks her heart rate several times a day ever since she suffered a widowmaker heart attack in August 2016. She felt severe jaw pain and vomited. The paramedics took four EKG readings before discovering she had a heart attack. At age 45, she expects to use a handheld heart rate monitor for the rest of year life.

“Anyone who is a survivor would appreciate having all of that info and the facts,” said Hartline, who had a heart attack. She takes her heart rate before, during and after her daily walking and bicycling routine.

“Just knowing that it’s there and we can use it really helps with the anxiety,” said Hartline, who lives in Birdsboro, Pa.

It frightens Hartline to think what would have happened if no one was around when the heart attack came on. “I wouldn’t have been able to get my phone to call 911,” she said. “The legs go rubbery, and everything feels like Jello.”

Christine Mountz-Hartline and granddaughter (Photo provided by Christine Mountz-Hartline)

CVD patients have to keep track of numerous things — heart rate, prescription meds, weight. etc. — to manage their condition well. But all of this could be too overwhelming for some elderly patients. Biolife would eliminate the need for them to measure and record their heart rate manually. Remote monitoring is crucial in helping doctors diagnose and track response to prescriptions and other medical treatments. It could identify early warning signs and prevent patients from having to be re-hospitalized.

For patients with pacemakers, Biolife could show whether they are working correctly. Biolife could help doctors decide whether they need more testing, different medications or cardioversion procedure to restore regular heartbeats. The ability to record data in real time and continuously, without interruption, may help doctors spot potential health risks and causes of heart problems.

Biolife could help determine whether patients are engaging in enough exercise and alert them when they are over-exerting themselves.

“It would be good info for anyone to know what you’re heart is doing so you have solid numbers to show if you need to walk instead of run,” said Mark Otsuji, who lives in Surprise, Ariz. The 42-year-old physical education teacher and father of a 2-year-old girl and 6-year-old boy had heart failure five years ago and has been wearing a pacemaker ever since. He would be dead without it.

“Informationally, it’s a great tool no matter what to monitor what your body is doing,” Otsuji said. “I don’t see anything but positives to increase people’s knowledge base.”

Mark Otsuji and family (Photo provided by Mark Otsuji)

If patients are feeling ill, a reading could be taken immediately to diagnose the problem and take the appropriate measures. Otherwise, they may wait to see if the condition goes away or wait too long to get medical care. Biolife could help explain why they are experiencing dizziness, faintness or the sensation that the heart is racing or skipping a beat and whether it is getting enough oxygen.

On the Forefront of Healthcare Trends

Biotricity stands at the forefront of a radically changing healthcare system that’s becoming more digital and home-based or remote. Healthcare providers are increasingly using technology to treat and monitor patients remotely in hopes of providing better care while lowering costs as The Wall Street Journal reported Feb. 26. Traditional hospital care is too expensive and time-consuming.

Berg Insight predicts 36.1 million patients will be monitored from home annually by 2020. That’s a compounded annual growth rate (CAGR) of 49% over five years starting at 4.9 million patients in 2015. More than 50% of hospitals are already using RPM solutions to improve risk management and care quality. The shift toward self-management for chronic illnesses has sparked tremendous growth in the use of connected healthcare devices, which is predicted to reach $59 billion by 2020. They’re seen booking a CAGR of 33.4% between 2012 and 2020.

study in Home Health Care Management & Practice concluded that home-based care lowered costs 19% on top of delivering higher satisfaction and better outcomes compared to hospital care. Others studies cited by the WSJ article mentioned above claimed 30% to 50% cost reductions coupled with fewer complications and lower death rates. Being hospitalized carries the risk of bacterial infection. One in 25 patients gets infected during a hospital stay even though it is often preventable.

Massive Market Potential for Heart Monitors

Industry experts forecast the global ECG market will top $28 billion by 2021 from $22 billion in 2016, at a CAGR of 4.8% between those years. Markets Research Future projects it will grow at a much faster CAGR of 13.50% from 2017 to 2023. The U.S. made up 34% of sales worldwide as of 2016.

The global heart-rate monitoring devices market is divided into wristband, 49%, and chest strap, 51%, as of 2015. A total of 1.3 million heart rate monitors were sold in the U.S. in 2016. The number of heart rate monitors sold in the U.S. has been rising steadily since 2013 and is expected to hit a new high this year, as this table below shows.

An Explosion of Wearable Medical Devices

The use of fitness trackers and wearable medical devices is a fad that’s here to stay. People want to take control of their health while insurance companies and employers are bribing people to exercise and wear these devices. It’s a one-two punch that lowers healthcare costs, generates good PR and develops a sense of community for the participants.

Experts at a B2B research firm forecast the global wearable medical devices market will expand at a CAGR of 18.3% from  $6.2 billion in 2017 to $14.4 billion by 2022. North America will be the largest market thanks to its robust healthcare infrastructure coupled with the development of very advanced, interconnected healthcare apps and compatible devices.

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