PerClot helps control bleeding in certain open and laparoscopic surgical procedures. Credit: Roman Zaiets / Shutterstock.com.

Artivion has received approval from the US Food and Drug Administration (FDA) for its premarket application (PMA) for the PERCLOT absorbable haemostatic system (PerClot).

PerClot is intended to control bleeding in certain open and laparoscopic surgeries.

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In July 2021, Baxter International (Baxter) acquired the PerClot product line from Artivion.

According to the previously announced agreements between the companies, Artivion will transfer ownership of the PMA to Baxter.

Artivion chairman, president and CEO Pat Mackin said: “We continue to see Baxter as the perfect partner to commercialise PerClot due to its expertise in blood management and its strong haemostat portfolio, with corresponding customer relationships.

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“The sale of PerClot to Baxter and the recent FDA approval marks the culmination of years of hard work and collaboration across many dedicated teams and we are proud to have played a part in bringing this product to market.”

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Upon receiving a milestone cash payment of $18.75m, the company will start shipment of the PerClot product to Baxter. Out of this amount, $4.5m will be directed to Artivion’s former partner, Starch Medical.

The latest payment will bring the total made by Baxter to Artivion to approximately $44m in cash.

Artivion agreed to supply PerClot to Baxter for at least 21 months until the manufacturing operations are fully transferred to Baxter or its designee.

Proceeds from the transaction will be used for potential debt repayment, general corporate purposes and contingent consideration obligations.

Baxter’s advanced surgery business president Steve Wallace said: “The addition of PerClot to Baxter’s portfolio further enhances our ability to optimise patient care by addressing a broad range of intraoperative bleeding with both active and passive haemostatic solutions.”