Pluristem Therapeutics Inc. (NASDAQ:PSTI) announced that FDA had offered Orphan Drug Designation to its PLX-PAD cells that are used in the treatment of severe preeclampsia. Reports claim that preeclampsia is one of the most common medical complications that women during their pregnancy suffer. It also causes stillbirths, premature births and maternal deaths many times.
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When it comes to the cure of Preeclampsia, nothing except delivery comes to aid. Due to its complicated nature, if women suffer from preeclampsia during pregnancy, doctors tend to execute the delivery as soon as possible without caring if the baby will be premature or diseased. In Western countries, around 1% pregnant women suffer from preeclampsia.
There are many advantages of Pluristem receiving Orphan Drug Designation for PLX-PAD cells, but the biggest of them is the proper guidance that might enhance the orphan drug grants, marketing approvals, 7-year market and tax credits. The actual cost burden that preeclampsia puts on the global healthcare system is estimated to be around $3 billion every year.
The senior management team of the company is pleased to make this announcement and hopes that this approval will help it come up with a cure to fight preeclampsia in the future. According to Zami Aberman, CEO, Pluristem Therapeutics Inc. (NASDAQ:PSTI), getting Orphan Drug Designation from FDA is a clear evidence of how well the company is progressing towards increasing its approval pathways.
Severe preeclampsia is one of the most dangerous issues that pregnant women around the world deal with, and it requires inmate medical attention. Pluristem is on its way to come up with sustainable solution that can address this medical issue and save millions of women who suffer various complications due to it.
It has planned many more initiatives to forge ahead and come out with a cure to address this problem in the near future, details of which will be announced from time to time in the future.
