MDT - Aziyo sheds 56% as FDA cites issues in marketing submission for antibacterial product
2023-03-20 09:09:13 ET
- Aziyo Biologics ( NASDAQ: AZYO ), a biotech focused on regenerative medical products, lost ~56% premarket Monday after announcing that the FDA noted deficiencies in its marketing application for CanGaroo RM Antibacterial Envelope.
- The issue relates to the 510(k) premarket notification the company sought from the FDA in April 2022 for CanGaroo RM, which is designed to cut infection risk following the surgical implantation of an electronic device.
- Regarding the filing, the FDA has sent a “Not Substantially Equivalent determination,” highlighting the issues the company has to address to obtain market clearance for the product.
- The items in question relate to drug testing, Aziyo ( AZYO ) said, adding the company doesn’t plan to appeal the decision “as it believes the most expeditious path forward is to work with FDA to provide the additional data requested.”
- According to Seeking Alpha contributor Bret Jensen, Aziyo ( AZYO ) with CanGaroo RM aims to rival Medtronic’s ( MDT ) synthetic envelope TYRX in a market estimated at $600M.
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Aziyo sheds 56% as FDA cites issues in marketing submission for antibacterial product