The Future of Wearable Health Technology with OxiWear

In 2015, Shavini Fernando was given just two years to live as a result of a late-diagnosed hole in her heart, which caused her to develop a life-threatening condition called Eisenmenger syndrome and severe pulmonary hypertension. The Sri Lankan native came to the US to seek treatment at Johns Hopkins but was told by doctors that she couldn’t fly, meaning she was unable to return home. The diagnosis forced her to restart her life in the U.S., where she went on to develop OxiWear, an ear-wearable pulse oximeter that continuously monitors for low oxygen levels.

In 2021, OxiWear was selected to join the second cohort of the leAD Lake Nona Accelerator, and last fall, the company brought its first product to market. In honor of last week’s World Pulmonary Hypertension Day, Shavini shares lessons learned as a startup founder and her outlook on the future of wearable health technology.

How does OxiWear envision its role in the future of wearable technology?

OxiWear is the first wireless ear-wearable pulse oximeter for continuous oxygen monitoring and low oxygen alerting. More than 10% of the global population is at risk of hypoxia, or low oxygen levels in the body, caused by environmental factors, chronic medical conditions, or high-altitude exertion and recreation.

OxiWear offers an unobtrusive means to track saturated oxygen levels and heart rate, while also providing an alert if oxygen levels drop below set thresholds. Paired with a proprietary mobile application, OxiWear connects its user with designated contacts in times of an emergency and can also provide downloadable reports to be sent to medical providers.

Athletes can benefit from wearing OxiWear to optimize performance and to ensure acclimation is achieved before competing or training in high altitude environments. Not only does pulse oximetry help optimize performance during training, but it also indicates whether an athlete is recovering properly, especially whether he/she is recovering effectively when sleeping. A customized dashboard can monitor multiple players or athletes in real-time.

What role do you see OxiWear playing in the larger conversation around pulmonary hypertension, and how do you hope to contribute to ongoing efforts to improve diagnosis, treatment, and care for those affected by this condition?

OxiWear was founded by Shavini Fernando after she was diagnosed with pulmonary hypertension in 2015. She did not want to lose her independence as a young professional and graduate student studying at Georgetown University, but she was at high risk of silent hypoxia and needed a way to monitor her oxygen levels continuously throughout the day.

It took a patient to identify a problem – continuous oxygen monitoring and low oxygen alerting for active individuals. Since wearing a finger cuff pulse oximeter was not a practical option for her, especially for a full-time student and a web designer who uses her computer throughout the day, she learned that the ear is one of the most accurate places to track oxygen saturation levels. She set out to create a device that would help herself as well as anyone experiencing similar challenges.

The goal of OxiWear is to provide the freedom for anyone with risks of hypoxia, caused by chronic medical conditions such as pulmonary hypertension, COPD, asthma, long Covid, and sleep apnea, to be able to confidently know what their oxygen levels are at any given point throughout the day. With reliable tracking and continuous monitoring, OxiWear can help to lower healthcare costs by informing patients of hypoxia before they are subject to costly medical tests and emergency room visits, and it can ultimately help to save lives.

What collaborations or partnerships does OxiWear have with advocacy organizations or medical professionals in the field of pulmonary hypertension, and how have those relationships impacted your work?

OxiWear is currently approved for general wellness and fitness applications and the company is in the process of submitting its FDA application for medical use. While OxiWear continues to navigate through the FDA process, the consumer fitness device was launched in December 2022.

To date, OxiWear works with the Pulmonary Hypertension Association, other chronic disease organizations as well as pulmonary, cardiovascular, and respiratory specialists and anesthesiologists to test and improve its algorithms to cater to the patient markets and to address their needs.

OxiWear has signed a memorandum of understanding with Mount Sinai Abilities Research Center in New York and works closely with pulmonary specialists at Johns Hopkins Hospital.

What challenges have you faced while building OxiWear, and how have you overcome them?

OxiWear was founded in 2019 after its CEO won the Leonsis Family Entrepreneurship Pitch Competition at Georgetown University called Bark Tank. While the first iteration of the product was created that year, the founder initially faced funding questions from potential investors about the need for a new device for oxygen monitoring. Awareness of the need for and importance of pulse oximetry was nearly impossible until the Covid pandemic. Investors and the general population were under the impression that only those with oxygen concentrators needed pulse oximetry devices, which slowed development due to the lack of funding and resources.

While clinical testing and product development was on hold during the pandemic, the business model became clear – oxygen tracking is relevant to everyone and has medical as well as fitness applications.

In 2021, OxiWear closed a pre-seed funding round at $1.25M and will be closing its seed round soon to support the company’s efforts to submit its FDA clinical application and for product manufacturing.

What do you see as the most important factor that leads to innovation within the sports/health tech industry?

As the world becomes more data driven, people are aware of and interested in monitoring their health, wellness, and fitness through new technologies. In the sports and health tech industry, data provides insights to allow the user to make informed decisions. OxiWear offers reliable, medical grade data to track oxygen and heart rate levels and other respiratory and metabolic data for fitness purposes and provides an accurate resource for those at risk of hypoxia to live a full and independent life. Not only can pulse oximetry help with training performance, but it also reveals whether an athlete is recovering appropriately, particularly whether he or she recovers effectively when sleeping and during injuries.

To learn more about OxiWear, check out the company’s feature in the Washingtonian and Shavini’s founder story in Washington Business Journal.