OxiWear Inc., an Arlington med-tech startup developing a wearable device to monitor oxygen levels, has raised $1.25 million in new funding to get its product to market in 2022 — after a long road only lengthened by Covid-induced delays.
The biotech’s oversubscribed pre-seed round included a $100,000 lead investment in June from the Virginia Innovation Partnership Corp. — formerly the Center for Innovative Technology — GAP Funds program. Existing investors Ted Leonsis and The Paul and Rose Carter Foundation participated, as did new investors Paul Caicedo, Future Communities Capital, Gaingels, Hourglass Venture Partners, TiE’s D.C. and Boston chapters, and Tysons Angel Group.
Also among the company’s new investors: Halcyon Fund, which put in $100,000, according to OxiWear founder and CEO Shavini Fernando.
OxiWear, which makes a blood-oxygen-level monitor, is an alum of the Halcyon incubator, the nonprofit’s flagship residency fellowship in Georgetown. Halcyon does not take equity in the companies that participate in its programs, but has been building up an investment strategy over the past couple of years, now with an angel investment network and a microloan fund. The goal: improve access to capital for founders of color and female entrepreneurs.
Dahna Goldstein, chief investment officer for Halcyon, declined at this time to comment on the fund that invested in OxiWear. But we know the organization plans to announce a third funding vehicle at some point. We also know Halcyon started raising its first fund in 2019, but has not publicly discussed it since then.
“Shavini is an incredibly talented and dedicated entrepreneur, whose determination and vision have led her to a point where increasing numbers of parties — from investors to strategic partners — are jumping on board,” Goldstein said in an email Monday.
OxiWear closed its oversubscribed round Oct. 30, after setting out this summer to secure a total of $750,000. The raise brings the company’s lifetime funding since its 2019 founding to $1.53 million.
OxiWear’s earpiece monitors blood-oxygen levels and alerts the wearer when it drops and requires attention. The startup plans to use the latest capital for beta testing to further validate its device design; clinical testing to assess the product’s accuracy in a study at the University of California, San Francisco Hypoxia Lab; and product manufacturing for a nonmedical wearable for the fitness market.
That version of the product, which is slated to come out in July, will target professional athletes and extreme sports and high-altitude athletes, Fernando said. She intends to initially sell the device through the company’s own website and other online platforms for individuals to purchase. And, she said, “by having elite and extreme athletes use OxiWear, we hope to destigmatize the use of an ear-wearable oxygen monitoring device, before it becomes available to the patient population,” Fernando said.
The business, still pre-revenue, had taken $10,000 in pre-orders for the device in 2020 with the intention of launching OxiWear in 2021. But the Covid-19 pandemic slowed clinical testing, manufacturing and fundraising, including an initial $500,000 raise Fernando prematurely closed at $175,000 in summer 2020 because the global health crisis led investors to pull out.
The eight-person company is seeking regulatory clearance for the device, after submitting Nov. 12 a pre-submission package to the Food and Drug Administration with. A pre-submission meeting is scheduled for January and OxiWear is shooting to file for a medical device designation by the third quarter of 2022 and receive approval in 2023.
“I’ve been a proud, early supporter of Shavini and her lifesaving work and I congratulate her on not only meeting her pre-seed funding round target — but decisively beating it,” Monumental Sports & Entertainment CEO Ted Leonsis said in a statement. “It’s a testament to how in-demand her product is and how smartly she has built her company around it. I expect she will only continue to grow, and I happily stand by her to offer advice whenever she needs it.”
Leonsis, a Georgetown University alum, previously supported OxiWear through the school’s annual Bark Tank pitch competition, and is part of OxiWear’s advisory board, alongside a handful of other big names in the Greater Washington business community.
Fernando, who suffers from severe pulmonary hypertension, started OxiWear to help people like her who experience hypoxia, or a lack of oxygen, from various diseases. She soon found that the market comprised more than 100 million people suffering from medical conditions as well as overexertion at high altitudes. She’s seen rising demand for her product — and, with it, increasing attention.
That most recently manifested with OxiWear landing a slot in the leAD Lake Nona Sports & Health Tech Accelerator, which chose five out of nearly 500 applicant companies to participate in this cohort, Fernando said. The program, which runs through December, came with a $75,000 equity stake in exchange for 8% of the business, she said. “The program helped us to accelerate our work by introducing us to product development firms and medical research and performance trainers, which will lead to future partnerships.”