A new medical device preventing preterm birth, which exacts the heaviest toll on the field of obstetrics, has been developed by a team of Israeli doctors and engineers.

According to the World Health Organization, one in ten babies are at risk of being born prematurely, between 24 and 37 weeks into gestation. That amounts  to 15 million newborns a year, of which 1 million will die. One million will suffer from disabilities due to preterm complications, putting a heavy burden on healthcare systems.

“We want to revolutionize the current form of treatment to prevent preterm birth,” CEO of PregnanTech, and senior obstetrician from Sheba Medical Center in Tel Hashomer Dr. David Shashar told the Jerusalem Post.

The device, called Lioness, is a disposable, patented silicone ring that is inserted vaginally, surrounding the uterine cervix and prevents early shortening or dilatation of the cervix even through uterine contractions. It does this by reducing the load on the cervix and intercepting the biomechanical cascade that leads to preterm birth. The device is removed once the pregnancy is close to term.

The procedure is simple and takes place in a matter of minutes at the gynecologist’s office.

“Between 9% and 17% of all pregnancies are at risk of premature birth. This is a large target market. There are no successful solutions today and the health systems are desperate for it. Leading doctors in Israel and around the world see our product as a breakthrough,” Shashar said.

“The rates haven’t changed in decades,” he added, stating currently there is no solution. “In some cases physicians will try to prevent early delivery using methods such as hormones, medications, suturing the cervix (cerclage), and pessaries, but they are mostly unsuccessful.”

“From my experience as a gynecologist, I know very well the extent of the phenomenon and the suffering it entails for newborns and families. Each extra week in the womb is critical for fetal development, and just one additional week can make the difference between a baby growing up healthy and a baby suffering from a variety of problems during its life,” Shashar said.

The financial burden of preterm births surpasses $25 billion annually.

PregnanTech is currently conducting a clinical safety trial with women who have opted for hysterectomies. The results have been successful.