Artio Medical Inc. checked off one of its biggest goals for 2022, founder and CEO Dr. Nick Franano said.
The Prairie Village-based innovative medical device company secured U.S. Food and Drug Administration approval for its Solus Gold Embolization Device, a next-generation product that can block or reduce blood flow in blood vessels. The FDA approval paves the way to start marketing and selling its device this year to physicians and hospitals in the U.S.
"It's our first regulatory clearance. Solus will be our first commercial product in the U.S., so it's a huge milestone for the company," he said.
As part of the milestone, Artio will build out a sales team, including regional sales managers, and fill other key roles such as head of HR, a CFO, engineers and clinical support specialists.
It employs 52 people and plans to reach about 100 by year's end. In 2023, the company could balloon to 200 people, and Franano is hopeful it will secure regulatory clearances for four additional products. Fourteen products sit in its portfolio for peripheral vascular, neurovascular and cardiology uses.
"I'm so proud of our team," Franano said. "Getting a product approved is just a huge amount of work. ... It's a team effort to develop a device like this. Nearly everyone in the company had a role."
Artio started working toward regulatory approval about 18 months ago and participated in the voluntary Q-Submission process, which added about three months to the timeline. But it was worth it, to glean valuable feedback from the FDA early in the submission process, he said.
Solus Gold combines a flexible catheter assembly and a gold non-porous, balloon-like implant for easy delivery, precise placement and immediate vessel occlusion.
“Current occlusion devices can be difficult to position in challenging anatomy, often require multiple implants, and usually take time to completely occlude the target vessel. This can be a problem when physicians need to control or prevent bleeding and reduce the risk of further complications. The Solus Gold device aims to overcome these limitations,” Dr. Blaise Baxter, vice president of neurovascular and peripheral vascular interventions for Artio, said in a release.
Baxter provided physician input throughout the development process, Franano said.
"You don't want to make something and then doctors say, 'I don't need this, or I really needed it to do this and it doesn't,'" Franano said.
He also credited Vera Shinsky, lead engineer on Solus Gold, who's worked on the device for two and a half years and helped it secure FDA clearance.
"She was the first person I called when I got the news," he said. "It's a big deal when it gets approved, because the FDA doesn't easily grant approval for new medical devices."
Solus Gold can be used in a variety of cases, such as high-speed vehicle accidents that rupture a patient's spleen. Instead of removing the spleen, which can make a patient more susceptible to infections, doctors can insert Solus Gold into the artery that feeds the spleen to stop excessive bleeding and save the spleen. The device also can be used as a preventative measure in diseased blood vessels at high risk of bleeding or rupturing.
