RespirAq, an AUT tech spinout, has recently been granted breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its Active Humidifier product*.
AUT Ventures launched RespirAq in late 2021, along with its founder and CEO, Dr Sandra Grau-Bartual, who was an AUT PhD student in the Faculty of Design and Creative Technologies, based in AUT’s Institute of Biomedical Technologies (IBTec).
Steve Corbett, CEO of AUT Ventures says, “This type of recognition by the FDA is very rare and a testament to Sandra and her team at RespirAq who have made incredible progress since they spun out in late 2021.
“They’re a great example of how a ground-breaking business can be created around AUT research, creating impact far beyond what we could achieve as an academic institution alone. It’s disruptive innovation by AUT on a global scale and I congratulate the RespirAq team for this fantastic achievement,” says Steve.
Commenting on the development, Sandra says, “This is a major achievement for a small start-up company like ours. We had a really successful first year, focusing on product development, manufacturing, regulatory clearance, IP portfolio development and establishing initial discussions with potential international partners.
“We’re thrilled to have received this news from the FDA and I’d like to take this opportunity to thank AUT Ventures for backing us from the start. We cannot wait to see where this goes next,” says Sandra.
Sandra’s team includes AUT alumna Dr Helen Cunningham who did her PhD in health and industrial design, and Matt Wilson, who was part of Professor Andrew Lowe’s MBIE Endeavour-funded research programme at IBTec before joining RespirAq.
Sandra’s supervisor was Professor Ahmed Al-Jumaily from IBTec.
The U.S. FDA only designates a breakthrough device if it meets certain criteria, including:
* The designation as a breakthrough device does not change the requirements for FDA clearance and it is subject to the final regulatory approval.