OxiWear officially has a Buffalo space and is raising funds in preparation for going to market.
The Arlington, Virginia-based startup, founded in 2019, has created a wireless, ear-worn pulse oximeter for continuous oxygen monitoring. CTO George Beckstein, who has been involved in the local startup community since 2017, joined the OxiWear team in late 2019 and has worked for the business from Buffalo since then.
Earlier this summer, the startup opened an engineering office in the Queen City at the HANSA coworking space on Ellicott Street downtown. The company, which employs 7 full-time workers, expects to add a few more local employees this year as it grows its compliance and engineering teams and begins making its medical devices.
But before it can start selling its product as a medical device, it needs to get U.S. Food and Drug Administration clearance. The business is working on that process now and expects to hear back late this year or Q1 of next year. Its device is non-invasive.
“So far we’ve passed all the testing needed, and … we’re compiling all the documentation we need,” Beckstein said. “We expect to submit in September at this point.”
The team has worked with an FDA consultant for guidance through the process.
OxiWear is raising a $3.5 million seed round and so far has closed about $2.55 million of it. The business doesn’t currently have any Buffalo investors but is interested in tapping into that network, according to Shavini Fernando, founder and CEO.
The funding will help the business finish its clinical and regulatory testing requirements for FDA clearance.
In 2021, OxiWear closed a $1.25 million pre-seed round with notable investors such as Ted Leonsis, the business mogul who owns the Washington Wizards and Washington Capitals professional sports teams. Future Communities Capital – which has invested in Buffalo-based startups HELIXintel and Ognomy – participated as well.
Currently, the startup’s product is on the market as a consumer and fitness device, though long-term the target market is the medical side, once it gets FDA clearance. The company has had about 200 devices sales, Beckstein said.
The startup has done testing with high-performance athletes and is working with through research partnerships with hospitals around the country, including the Johns Hopkins Hospital in Baltimore. The hospitals want to use OxiWear’s devices for research, rehabilitation and monitoring patients with diseases that affect lungs and cause a shortage of oxygen.
With a long sales cycle, Beckstein encouraged entrepreneurs to iterate as quickly as possible and then get feedback so they can keep making the products better.
“Break it down into chunks and work on it piece by piece,” he added. “Don’t always look at the big picture. Keep it in mind, but it can be overwhelming if you’re focused too much on the big picture.”
