May. 14 at 10:03 AM
$NYXH Nyxoah reports Q1 EPS (EUR 0.60) vs. (EUR 0.42) last year
Reports Q1 revenue EUR 1.06M vs. EUR 1.22M last year. "We are excited that we are in the final stage of the FDA review process of our Genio system in the United States," commented Olivier Taelman, Nyxoah's CEO. "The FDA Approvable Letter we received previously confirms that our application substantially meets the requirements of the Federal Food, Drug and Cosmetic Act, including biocompatibility and acceptance of our clinical data demonstrating the safety and effectiveness of the Genio(R) system.
We have successfully completed the final process validation requested by the FDA. We understand that the last step toward FDA approval is an on-site inspection at the U.S. manufacturing site which we expect to be completed shortly. As part of the PMA process, this site has already successfully passed an on-site inspection with no deficiencies, which gives us confidence in completing this regulatory step. We continue to anticipate that our application could potentially be approved in the second quarter of 2025."
