This screen shot of a marketing animation from Baxter shows PerClot sprayed on a bleeding site during surgery. Artivion developed the product.
PerClot requires no premixing, which means it can be applied to a bleeding source during surgery within second. [Image courtesy of Baxter]

Artivion today announced FDA premarket application (PMA) approval of its PerClot absorbable hemostatic system designed to control bleeding in specific surgical procedures.

The Atlanta-based company will transfer full ownership to Baxter


, following a sale agreement that occurred in July 2021.

Artivion anticipates receiving an $18.75 million milestone payment under the terms of the agreement. Of this, $4.5 million will go to Artivion’s former partner, Starch Medical.

As part of the terms of the agreement, Artivion will supply Baxter with PerClot for a minimum of 21 months. This term will last until all manufacturing operations are successfully transferred to Baxter or its selected designee.

It’s an important milestone for Artivion

In a news release, Artivion CEO Pat Mackin expressed his excitement at the FDA approval of PerClot. PerClot’s absorbable, plant-based, modified polymer particles rapidly absorb water from the blood, accelerating the normal physiological clotting cascade, according to a Baxter webpage.

“We are excited to receive FDA approval of PerClot, which represents a significant step forward in optimizing patient care by addressing intraoperative bleeding” Mackin said. “We continue to see Baxter as the perfect partner to commercialize PerClot due to its expertise in blood management and its strong hemostat portfolio, with corresponding customer relationships.”

Steve Wallace, President of Baxter’s Advanced Surgery business, also lauded the partnership with Artivion throughout the FDA review and approval process. He further underscored that the addition of PerClot to Baxter’s portfolio enhances their capability to address a wide array of intraoperative bleeding with both active and passive hemostatic technologies.

Following this latest milestone, Baxter will have paid approximately $44 million in cash to Artivion, $10.5 million of which was disbursed to Starch Medical.

As outlined in the agreements, Artivion may receive future Baxter payments, including up to $10 million based on Baxter’s cumulative worldwide net sales of PerClot before the end of 2026 and 2027 ($3 million is payable to Starch Medical). There’s also an estimated $800,000 payment upon the transfer of Artivion’s PerClot manufacturing equipment after concluding Artivion’s manufacturing and supply services for Baxter.

Artivion intends to use the net proceeds from this transaction for general corporate purposes, including potential debt repayment and fulfilling contingent consideration obligations.