FDA grants breakthrough status to preeclampsia device


Dive Brief:

  • 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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Dive Insight:

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.

APT thinks its product can provide physicians with a better treatment option. The device separates the mother’s blood into plasma and blood cells. The plasma then passes through an apheresis column designed to filter out molecules linked to the emergence of life-threatening preeclampsia symptoms, such as a soluble antiangiogenic protein sFlt-1.

Studies suggest that protein binds to growth factors, including VEGF, that help to maintain healthy blood vessels in organs affected by preeclampsia, such as the kidney and liver. Researchers have detected increases in sFlt-1 prior to the development of preeclampsia and correlated levels of the protein to disease severity. As such, the company is betting that removing sFlt-1 and other biomarkers could improve outcomes.

That hypothesis remains unproven but, after many years working on the idea, APT is now nearly in a position to put it to the test.

“We were navigating virtually uncharted waters in 2005 when we first proposed that preeclampsia could be treated using an apheresis column to remove pathogenic factors such as sFlt-1,” CEO James Smith said in a statement. “Now that we are preparing for initial clinical studies, we are very pleased that the breakthrough designation will help provide a clear and efficient pathway to market.”

FDA’s breakthrough designation is designed to provide additional support and accelerated regulatory reviews to novel devices with the potential to improve treatment of life-threatening or irreversibly debilitating diseases. Companies that receive the designation gain closer contact with FDA, prioritized review of regulatory submissions and other perks intended to accelerate development.