OxiWear lands FDA clearance for oxygen monitor - Washington Business Journal

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The green light creates a massive market opportunity for the local company.

OxiWear Inc. has earned Food and Drug Administration clearance to sell its wearable oxygen monitor as a medical device, potentially creating a massive market opportunity.

Shavini Fernando, founder and CEO of the 5-year-old Arlington startup, has been fighting to get the device to chronic disease patients for years. She developed it to monitor her own severe pulmonary hypertension.

The earpiece monitors blood-oxygen levels and pulse rates in patients with medical conditions including seizure disorders and cardiovascular disease. OxiWear’s technology continuously collects the wearer’s oxygen saturation data and alerts the wearer when levels drop below a safe threshold.

The company can now target health care organizations as customers — “and they are interested,” Fernando told me in an email. They may use OxiWear’s device for routine patient observation, to assess oxygen levels during exercise or in remote patient monitoring programs tracking a patient’s blood-oxygen levels at home, she said.

“The immediate focus will be to create partnerships with health care institutions and providers who can use, prescribe and recommend OxiWear to patients with chronic cardiovascular and pulmonary diseases that require measurement of blood oxygen levels,” Fernando said. “In 2025, we will continue to strengthen our health care market position, while building our relationships in the military and sports verticals to help continue our positive growth.”

Up to this point, OxiWear has been selling the product directly to consumers and businesses, such as fitness chains and software companies. The company has generated some revenue from those sales, as well as a subscription edition of its app, whose dashboard monitors and displays health data that’s not available in the free version.

The startup had $95,000 in revenue in 2023 entirely from organic sales “as we couldn’t do any kind of marketing,” Fernando said. But armed with the FDA’s nod, it’s shooting for roughly $300,000 in revenue for 2024 and $3.5 million for 2025, she said.

To prepare for those sales, OxiWear will need to ramp up manufacturing — but not yet. The company has enough inventory to meet initial demand this year, Fernando said, and will start to increase production in 2025. That will involve expanding the 13-person company’s engineering, sales and marketing staffs, in addition to hiring two executives to manage sales and operations, she said. It’ll also require raising a Series A financing round, she said, declining to share specifics for now. Her startup has raised $6 million in funding to date.

Fernando pushed her company forward in the face of regulatory delays, pandemic pivots and fundraising obstacles, while securing capital from local investors including D.C.’s Halcyon and its angel group. And she’s done it through her own health challenges: Fernando, one of the Washington Business Journal’s Women Who Mean Business of 2023, suffers from Eisenmenger’s syndrome, which has caused severe pulmonary hypertension, a form of high blood pressure that affects arteries in the heart and lungs. She discovered a market of more than 150 million people with cardiovascular and pulmonary diseases who could also benefit from her device.