Novel device that prevents preterm birth developed in Israel
Novel device that prevents preterm birth developed in Israel

A team of Israeli doctors and engineers have developed a simple yet smartly structured medical device designed to prevent premature birth, the most common, catastrophic and costly problem in obstetrics.

One in ten babies are at risk of being born prematurely, amounting to 15 million world wide according to the World Health Organization. Babies that 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,  founded in 2018, set out to develop a solution."We want to revolutionize the current form of treatment to prevent preterm birth," said PregnanTech CEO Dr. David Shashar.

The device, named Lioness, was developed by PregnanTech, an Israeli company formed by gynecologists and obstetricians from Israel’s Sheba Medical Center and engineers from Trendlines Labs and Eliachar technologies.

"Preterm labor is a common and catastrophic occurrence," CEO of PregnanTech, and gynecologist Dr. David 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 other countries.

"The rates haven't changed in decades," he added, stating that 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."

"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," Dr. Shashar added.

Understanding the "catastrophic" situation that affects so many, PregnanTech was formed with the goal of finding a solution which led to the subsequent development of Lioness.

Lioness, the innovative product developed by PregnanTech, 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.

The ring’s special structure enables it to remain in place, and keeps the cervix elongated and closed, even in the presence of contractions. The device reduces the load on the cervix, thereby inhibiting the biomechanical cascade that leads to preterm birth, intended to delay premature births by a period of 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. 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," noted Dr. Shashar.

Following a complicated hospital delivery in preterm labor, a baby will be taken to a hospital's Intensive Care Unit, where they 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, but 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 $2 billion annually in developed countries alone.

Currently, PregnanTech is conducting a clinical safety trial in women about to undergo hysterectomies in order to evaluate safety of using Lioness. Results have proven to be successful.

Following the current clinical trial, a second one is set to be held with pregnant women at risk for preterm birth to be conducted at King's College Hospital 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. We also expect Lioness to have a snowball market effect once it is approved,” Dr. Shashar told the Post

Related: Nuvo Group Receives FDA Clearance for its Innovative INVU Remote Pregnancy Monitoring System