Neola Medical’s CEO Hanna Sjöström has been interviewed by Redeye Equity Research Analyst Oscar Bergman following the FDA’s decision to grant Neola® Breakthrough Device Designation.
In the interview, Hanna Sjöström discusses the process leading to the designation, what it means for Neola Medical’s US regulatory pathway, and the key milestones ahead.
The designation provides for more frequent and interactive communication with the FDA, as well as prioritized review of future regulatory submissions. It represents an important external validation of the clinical need and the potential of Neola® to support earlier detection of potentially life-threatening lung collapse in preterm infants.
Watch the interview here:
https://player.vimeo.com/video/1224613918
