Phoenix-based Aesthetics Biomedical Inc. has received clearance from the U.S. Food and Drug Administration for its Vivace RF micro-needling device.
Designed locally, the product will be manufactured in the Valley as well, said MaryAnn Guerra, CEO of Aesthetics Biomedical.
When she launched the company in 2016, Guerra gained exclusive rights to market South Korea-based Shenb Co. Ltd.'s own micro-needling machine to stimulate collagen skin growth.
But over time, her team began working on its own machine and now has gained FDA 510K clearance to sell the device in the United States. Medical device companies are required to gain approval from the FDA to ensure their devices are safe and effective.
"We moved from being a distributor to being a developer and manufacturer," Guerra said. "Shenb knew we were doing it. They were totally aware of all that."
She credits Shaun Wooten for getting patents on the Vivace devices.
"I hired him as an intern for the summer," Guerra said. "This guy is brilliant. Now he's director of our innovations center."
The Vivace devices will be manufactured at Arizona Prototyping in Mesa, she said.
She also teamed up with Eric Miller at Tempe-based PADT Inc. to design the product.
"They've been a really good partner," Guerra said. "If it wasn't for them, we would not have been able to keep things moving along the way we kept moving along. I'm so glad we picked Eric. We had a couple of other vendors outside of Arizona, but we decided to go local with people we know."
Miller said his team has enjoyed working with the ABM team.
"The 510K clearance from the FDA is a major milestone we are proud to have played a small part in reaching," Miller said. "This effort is a great example of the breadth and depth of the medical device ecosystem in Arizona — design, manufacturing, quality, and marketing input were managed by a strong team at ABM to drive toward this strong product."
With 45 employees, the company has generated $70 million in cumulative revenue since its founding in 2016.
Revenue is expected to reach $15 million in 2022, down from $21 million in 2019 before the coronavirus pandemic took its toll on the health care company.
"It's been slow," she said. "We're now just starting to see an uptick."
With $1.4 million in seed capital, Aesthetics Biomedical was poised to receive $10 million from a venture capital firm in February 2020.
But the coronavirus pandemic killed that deal, she said.
"We were right at the brink of having that kind of capital and it got pulled away," Guerra said. "We took some big blows during Covid, that's for sure."
Joan Koerber-Walker, president and CEO of the Arizona Bioindustry Association, congratulates Guerra and her team for gaining FDA 510K clearance.
"The team is committed to continuous innovation and worked diligently to gather feedback from both patients and health professionals to determine how current products can be improved and to develop new products to meet their needs," she said. "With this new 510K clearance, they can now build and deliver."
