Israeli startup PregnanTech said it has developed a silicone ring that, when placed in the vagina and secured high around the uterine cervix, can help prevent preterm births.
The silicone ring, called the Lioness, which looks like a bottle cap with a hole in the middle, clasps onto the cervix with the same level of effectiveness as the existing surgical solutions to the problem, and maintains its position there in spite of pressure and contractions, keeping the cervix elongated and closed, thus helping halt cervical dilation and preventing premature birth. The nonsurgical procedure to insert the ring takes just minutes in a physician’s office or clinic, the company said in a statement.
Premature birth is the most common and costly problem in obstetrics, and the prevalence of preterm birth has not changed in decades. It is caused by cervical softening, pressure and a biomechanical cascade of the fetus. Every year, about 15 million preterm infants are born worldwide, which represents about 5% to 12% of all births in developed countries, and up to 18% of births in other countries. About 1 million of these newborns do not survive. Those that do survive often suffer from disabilities that have a significant effect not only on their quality of life but on their families.
To date, there is no effective medical solution to prevent the phenomenon, and the cost of preterm newborn care is about 10 times the cost of caring for a full-term newborn, $49,000 vs $4,500 for a newborn at term, PregnanTech said.
A cervical stitch is a treatment commonly used to deal with cervical weakness, which is when the cervix starts to shorten and open too early during a pregnancy, which causes either a late miscarriage or preterm birth. In the procedure, a strong suture is sewn into and around the cervix, usually between weeks 12 to 14 of the pregnancy, and then it is removed towards the end of the term. The procedure is done with local anaesthesia, usually with spinal block. It is generally done as an outpatient procedure, by an obstetrician or gynecologist.
The startup is currently conducting a clinical safety trial in women about to undergo hysterectomies. Next year, a clinical trial in pregnant women at risk for preterm birth is planned at King’s College Hospital London, the statement said.
PregnanTech was founded in 2018 by Dr. David Shashar, in collaboration with a team of gynecologists and obstetricians from Israel’s Sheba Medical Center and engineers from Trendlines Labs. The initial investment in the company was made by The Trendlines Group, a firm that invests in, and incubates startups in the medical and agri-food sectors.
“Each extra week in the womb is critical for fetal development, and just one additional week can be the difference between a baby growing up healthy and a baby suffering from a variety of problems during its life,” said the startup’s CEO Shashar. “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 got his medical degree from the Hebrew University in Jerusalem and is board certified in obstetrics and gynecology. He holds an executive MBA from the Kellogg-Recanati Business School and an MSc in biomedical engineering from the Technion-Israel Institute of Technology.
Before leading PregnanTech, Shashar was the medical director of multidisciplinary collaboration platforms at Sheba Medical Center, assigned to align physicians and engineers from the Israeli medical industry and academia to develop cost-effective, innovative medical technological solutions to meet pressing clinical problems.