Vapotherm up on accelerated review status for Oxygen Assist Module

The FDA has granted Breakthrough Device Designation for Vapotherm’s (NYSE:VAPO) Oxygen Assist Module (OAM).

The designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application.

Vapotherm OAM is a module for use with most versions of Vapotherm’s Precision Flow systems.

Shares are up 10% premarket.

https://seekingalpha.com/news/3559591-vapotherm-up-10-premarket-on-accelerated-review-status-for-oxygen-assist-module