An Israeli startup has developed a non-surgical device to help prevent preterm births (PTB) – babies born before completing 37 weeks of gestation.
PregnanTech says that 1 in 10 babies are born preterm, which translates to 15 million global births each year. And according to the World Health Organization, complications from preterm birth are the leading cause of death among children under the age of 5 years.
The Lioness device developed by PregnanTech is a silicon ring that is placed around the cervix by a physician in what the company says is a quick, non-surgical procedure.
According to PregnanTech, the Lioness remains in place even when a pregnant woman experiences contractions, preventing dilation of the cervix and reducing the cervical load.
The device can be removed easily when a woman reaches full term and even has a self-release mechanism to prevent tissue damage during active labor.
A recent safety and feasibility pilot study of pregnant women at high risk of PTB who used the Lioness showed a high rate of full-term births with no significant device-related side effects.
The results were published in the prestigious American Journal of Obstetrics and Gynecology.
The company is now planning a study in the US next year, in order to prove the Lioness’ efficacy in delaying PTB, and in order to facilitate its request for FDA approval.
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