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| 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.
Here is a video from APT
