2023-05-23 08:38:46 ET
Artivion, Inc. ( NYSE: AORT ) announced Tuesday that the FDA cleared its premarket application (PMA) for PERCLOT Absorbable Hemostatic System, a clotting product the medical device maker has sold to Baxter International ( NYSE: BAX ).
With the clearance of PMA, PerClot will be indicated in the U.S. to control bleeding in certain open and laparoscopic surgical procedures.
Artivion ( AORT ) sold its PerClot line of products to Baxter ( BAX ) in July 2021. In line with prior agreements, the company will transfer the PMA to the MedTech giant following the approval.
Per the terms, Artivion ( AORT ) of Atlanta, Georgia, is expected to supply PerClot to BAX for at least 21 months until manufacturing operations are transferred completely.
The supplies are expected to begin after Baxter ( BAX ) pays a cash-based milestone payment of $18.75M, out of which Artivion's former partner Starch Medical, will receive $4.5M.
The company expects to spend the net proceeds from the transactions on a range of functions including debt repayment and general corporate purposes.
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For further details see:
Artivion wins FDA nod for Baxter-partnered clotting product