First medical device developed to filter blood to treat preeclampsia

courtesy: APT

The U.S. Food and Drug Administration (FDA) granted a Breakthrough Device Designation for the Advanced Prenatal Therapeutics, Inc. (APT) Targeted Apheresis Column for Preeclampsia (TAC-PE) in the treatment of preeclampsia.

Currently, the therapeutic options for preeclampsia are limited and include bed rest, anti-hypertensive medications and induction of preterm labor if needed.

The TAC-PE column is an apheresis device that works like kidney dialysis in selectively removing the harmful substances from the blood. While the exact cause of preeclampsia is not known, several biomarkers have been identified that are responsible for life-threatening preeclampsia symptoms like kidney and liver dysfunction and high blood pressure.

The apheresis procedure resembles voluntary blood donation. The woman’s blood is pumped through the apheresis machine to separate it into plasma and blood cells. The plasma then passes through the TAC-PE device, where the toxic substances are captured. The toxin-free plasma is mixed with the cells and returned to the patient.

APT first therapeutic target is soluble fms-like tyrosine kinase-1 (sFlt-1). The circulating sFlt-1is made by the placenta and antagonizes the action of Vascular endothelial growth factor (VEGF), that triggers new vessel formation and vasodilatation in normal pregnancies. Pre-eclampsia occurs when the relative functional activity sFlt-1 exceeds that of VEGF resulting in vasoconstriction in important organs like kidney, liver, and brain (the organs most affected by preeclampsia).

Removal of sFlt-1 from blood helps to restore the vascular homeostasis by alleviating the endothelial dysfunction. This eliminates the need for premature termination of pregnancy, helps stabilize the mother and baby to let the pregnancy proceed naturally to term.

“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,” said Dr. James Smith, President/CEO of APT. “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.”

APT is a Laguna Hills, California based company involved in developing an effective treatment that will safely prolong pregnancy, allowing babies more time to develop in the womb in patients with preeclampsia.

TAC-PE: TARGETED APHERESIS COLUMN FORPREECLAMPSIA

Advanced Prenatal Therapeutics PressRelease…

Here is a video from APT