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Sathya Elumalai is the CEO of Aidar Health, a digital healthcare company that provides monitoring of health data, cloud-based machine learning and other proprietary technology applications.

Improving patient care globally has been the focus of my entire career.

After training as a biomedical engineer and graduating from business school, I spent over 12 years working with the leadership team at Johns Hopkins Medical Institute (JHMI) to enhance patient safety, satisfaction, and care. From there, I moved to a multinational company to focus on bettering healthcare all over the world.

But the greatest challenge I’ve faced in patient care was much closer to home.

Over the years, my mother has been diagnosed with multiple chronic conditions. Despite all my training and experience, it was a struggle to help care for her. I made sure she had access to every relevant tool on the market, so she wound up using five different devices to monitor her vitals. Still, she was hospitalized more frequently, and I was getting frustrated with the lack of insight her doctors and I had into her health. I couldn’t find a way to understand what was happening day-to-day.

My experience was not unique. More than 130 million Americans live with chronic diseases today. That number is projected to rise, with roughly 80 million people in this country expected to have multiple chronic conditions by 2020, according to National Health Council. Comorbidity is becoming the new normal.

For someone like my mother, managing these conditions requires several doctors. She has a primary care physician, of course, who is focused on her overall health. But she also sees a cardiologist, a pulmonologist and takes multiple medications. The problem is, her doctors aren’t connected to each other. There’s no communication about how a drug she’s taking for her heart condition will affect a drug she’s taking for her lung condition.

All of her health metrics are not stored in one place, and doctors don’t have a holistic overview to rely upon when making decisions about her health.

So, in 2015, I co-founded Aidar Health (previously known as Alavita Health) to begin coming up with a solution to this problem. Four years later, our team developed a device that could measure overall health quickly and easily—every single day.

MouthLab and its services give a comprehensive health overview, making life easier for people managing chronic conditions.

This device isn’t just another healthcare tool to add to an already formidable at-home collection. It’s a replacement. That’s because it’s a simple, non-invasive device that measures more than 10 different health parameters in under one minute.

MouthLab is currently using the mouth and hand to capture health metrics, measuring respiratory rate, pulse, electrocardiogram, blood oxygen saturation, temperature, blood pressure, and several lung functions—with more parameters in development.

The device uses Bluetooth and LTE technology to connect to the cloud, so after each use, the patient’s data is automatically sent to the cloud in real time. Once there, it’s accessible to physicians and caregivers through accompanying mobile apps and dashboards.

By making a patient’s health data easily available, we’re aiming to reduce hospitalizations, patient costs and risks. Unnecessary trips to the hospital are expensive and more difficult for older or weaker patients. By establishing a baseline for each patient’s health through daily testing, we can give their providers the information they need to determine if a visit is really necessary.

The value of the device lies in its simplicity.

If something doesn’t seamlessly integrate into your daily routine, you don’t do it. That’s why using the MouthLab is easier than brushing your teeth.

You’ll find there’s no sequence of buttons to operate it. You don’t need a smartphone or a MacBook to collect the data. All you have to do is place the device in your mouth for 30 seconds and breathe normally. It’s that simple.

The easy-to-use nature of the device is perfect for someone like my mother. She’s not tech-savvy and only uses her smartphone for calls. For those of us who are constantly on our phones, it may not seem like a big deal to add another app to our home screens. But keep in mind that, according to Pew Research Center, fewer than half of Americans over the age of 65 have a smartphone.

MouthLab is a hardware device connected to a smartphone app, with a communications platform attached to it.

The simplicity of the MouthLab also extends to its pricing. We originally thought that a device with so many capabilities would cost thousands of dollars, but our current estimate shows it cost would around $200 to manufacture in the United States.

The data collected allows providers to offer better care and gives pharma companies more accurate data to work with.

The MouthLab and its services may sound simple, but it’s taken nearly a decade to reach this point. Finally, we’re on the cusp of improving health monitoring for millions of people around the world.

We’ve already had several pre-submission meetings with the FDA in 2018 and received positive feedback. Currently, we’re gathering the necessary documentation and awaiting validation data from our tests. We’re approximately four months away from submitting our application. We expect to have our FDA clearance before the end of the year.

While we move through this clearance process, we’re exploring another avenue to get MouthLab into patients’ hands. The pharmaceutical industry holds what are known as observational studies, which allow devices that have proven to be safe.

Currently, we’re working with pharma companies and clinical research organizations (CROs) who are using our device as a part of exploratory studies and observational trials. Clinical trials and post-marketing studies will use our device after FDA approval. We’re also offering data-as-a-service or trial-management-as-a-service offerings.

Ultimately, we’re targeting providers and payers who will be using our device to monitor patients with complex, chronic conditions.

A 2016 report by the National Conference of State Legislatures on improving existing U.S. healthcare system found that “preventative medicine is an important part of efforts to stabilize and meet the needs of patients with complex conditions and to prevent additional costly complications.”

There are other monitoring devices available, but they all fall into two categories: some are too invasive, while others are non-specific wearables with far fewer capabilities than the MouthLab.

Given the myriad health parameters our device measures and its affordability, we feel well-positioned to serve the at-home monitoring market.

Our revenue will be generated from the device, the enterprise data capture platform, telehealth services, consumables (such as the mouthpiece), and additional home-care services. We’re aiming to generate revenue this year through pharma observational studies, but are expecting that number to jump after receiving clearance from the Food and Drug Administration. Additionally, we already raised $2 million during our seed round and expect to raise $7.5 million during our Series A round, which we plan to start at the end of the third quarter of 2019.

It has been a long road to get to this moment, but we hope to achieve our goal of improving patient care by eliminating the traditional barriers for at-home health monitoring within a matter of months.

Soon, all over the world, hundreds of millions of people living with chronic diseases and undergoing innovative clinical treatments will have a simple, affordable, and efficient way to monitor their health every day.