Artivion wins FDA nod for Baxter-partnered clotting product
hapabapa
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.