Novel device that prevents preterm birth developed in Israel

One in ten babies are at risk of being born prematurely, amounting to 15 million worldwide.

PregnanTech's Lioness device, a silicon ring developed to prevent preterm birth.  (photo credit: PREGNANTECH)
PregnanTech's Lioness device, a silicon ring developed to prevent preterm birth.
(photo credit: PREGNANTECH)
A team of Israeli doctors and engineers have developed a simple yet intelligently structured medical device designed to prevent premature birth, the most common, catastrophic and costly problem in obstetrics.
One in 10 babies is at risk of being born prematurely, or 15 million worldwide, according to the World Health Organization. Babies who are born prematurely are at risk of death and long-term disability due to complications from their birth. Moreover, the burden on healthcare facilities and families is enormous, and medicine currently has no effective working solution.
In light of this situation, PregnanTech, an Israeli company founded in 2018, set out to develop a solution.
“We want to revolutionize the current form of treatment to prevent preterm birth,” said Dr. David Shashar, a gynecologist and PregnanTech’s CEO.
PregnanTech’s device, named Lioness, was developed by gynecologists and obstetricians at Sheba Medical Center in Tel Hashomer and engineers from Trendlines Labs and Eliachar Technologies.
“Preterm labor is a common and catastrophic occurrence,” Shashar told The Jerusalem Post.
Of the 15 million babies delivered preterm each year, one million will not survive, and another one million will suffer from disabilities for the rest of their lives. The number of annual preterm deliveries represents about 5%-12% of all births in developed countries and up to 18% of births in underdeveloped countries.

 
“The rates haven’t changed in decades,” Shashar said, adding: “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.”
“Between 9% and 17% of all pregnancies are at risk of premature birth,” he said. “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.”
PregnanTech was formed with the goal of finding a solution to a “catastrophic” situation that affects so many, Shashar said, and led to the subsequent development of its innovative product, Lioness.
Lioness is a silicon ring placed high around the uterine cervix during a simple, nonsurgical procedure that takes just minutes in a physician’s office or clinic, he said.
The ring’s special structure enables it to remain in place and keeps the cervix elongated and closed, even in the presence of contractions. It reduces the load on the cervix, thereby inhibiting the biomechanical cascade that leads to preterm birth, intended to delay them for weeks.
“From my experience as a gynecologist, I know very well the extent of the phenomenon and the suffering it entails for newborns and families,” Shashar said. “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.”
Following a complicated hospital delivery in preterm labor, a baby will be taken to a hospital’s intensive-care unit, where he or she can stay for weeks and even months, while worried parents must wait without knowing if their baby will survive or come home healthy.

 
Moreover, preterm delivery not only affects the physical health of mothers and their babies, it also has detrimental financial effects both on families and health institutions worldwide. The cost of preterm newborn care is on average 10 times the cost of caring for a full-term newborn. About half of all hospitalization costs among newborns are intended to cover the hospitalization costs of infants born prematurely.
In the United States, expenses associated with preterm births surpass $25 billion. PregnanTech estimates the market potential for Lioness to be more than $2b. annually in developed countries alone.
PregnanTech is conducting a clinical trial to evaluate the safety of using Lioness in women about to undergo hysterectomies. Results have proven to be successful, Shashar said.
Following the current clinical trial, a second one is planned with pregnant women at risk for preterm birth to be conducted at King’s College Hospital in London, with the endorsement of leading obstetricians from the UK.
“We are very open to investment from Israelis or others who wish to support healthy babies coming into this world,” Shashar said. “We also expect Lioness to have a snowball market effect once it is approved.”