FDA has granted breakthrough designation to Advanced Prenatal Therapeutics’ device for treating preeclampsia, a sometimes life-threatening complication that can occur during pregnancy.
The Targeted Apheresis Column for Preeclampsia is designed to remove pathogenic factors from a mother’s blood, thereby preventing a condition that can be fatal to both the baby and pregnant woman.
The company said it is preparing for initial clinical studies and hopes the special FDA designation will expedite its path to market.
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Around 10,500 babies die from preeclampsia in the U.S. every year and others suffer complications associated with premature delivery. Yet, the causes of the condition remain unclear and the toolkit of techniques to treat and manage it is limited.