We’ve received FDA approval!
I have some very exciting news today. The Ujenzi uterine balloon just got FDA approval!
After years of rigorous laboratory and field tests, the ESM-UBT device has now been approved by the FDA. ESM-UBT stands for Every Second Matters – Uterine Balloon Tamponade. Put simply, this balloon is used to stop bleeding during childbirth. It has been proven to save nearly every new mother in danger of dying from postpartum hemorrhage if used in a timely manner.
This video shows how ESM-UBT works.
The functionality of this life-saving device is equivalent to a Bakri Balloon (retail $400). But at 1% the price point (about $5), it will be accessible within lower and middle-income countries that cannot afford the more expensive alternative.
FDA approval paves the way for us to ramp up distribution to a global scale and make this life-saving device available to mothers in need worldwide!