- 1 in 10 babies are born preterm – 15 million a year worldwide
- 1 million will not survive
- PTB is the leading cause of morbidity in children till the age of 5, enduring lifelong disabilities
- The earlier a baby is born, the higher the risk of severe health complications. Every additional day in the womb is critical.
The Hidden Toll of Preterm Birth
As their newborn fights for life in the Neonatal Intensive Care Unit (NICU), parents face immense emotional and psychological stress creating trauma for years to come.
The financial burden is equally overwhelming. The cost of treating a preterm newborn in the United States is 10X that of a full-term baby, while not accounting for long-term care required for children with disabilities. This burden debilitates the average family and exhausts limited hospital resources.
Preterm birth is lose-lose situation for all stakeholders: Payers, hospitals, physicians and families.
A Revolutionary Approach to Delaying Preterm Birth
Despite decades of research, traditional methods such as bed rest, tocolytic drugs, progesterone and cervical cerclage have not significantly reduced PTB rates.
Introducing the LIONESS™, a groundbreaking, non-surgical device developed by PregnanTech that offers a new hope for families at risk of PTB birth.
LIONESS™ is a smartly designed silicone ring that is placed high around the uterine cervix by a physician in a quick, non-surgical procedure. Unlike other methods, LIONESS™ maintains its position despite contractions, preventing dilation and reducing the cervical load. LIONESS™ is easily removed at term and includes a self-release mechanism to prevent tissue damage during active labor.
Promising Clinical Results
Clinical trials of LIONESS™ have shown promising outcomes. Recently, the company concluded a pilot safety and feasibility study among pregnant women at high risk of PTB, published in the highly prestigious American Journal of Obstetrics and Gynecology (article). Results reported a high rate of term births and no significant device-related side effects. These findings highlight LIONESS™’s potential to safely and effectively reduce PTB rates.
“Every 30 seconds, a baby dies of spontaneous PTB around the world. That is over a million babies every year. The Lioness is a non-surgical intervention, shown already to be safe, that could save tens of thousands of these babies.” Dr. Vincenzo Berghella, Director of the Maternal-fetal medicine (MFM) division at Thomas Jefferson University in Philadelphia
In 2025, PregnanTech plans to conduct a pivotal study in the United States to prove the efficacy of LIONESS™ in delaying PTB and to support the FDA approval process.
Looking Ahead
LIONESS™ offers a beacon of hope in the fight against preterm birth. Its innovative design, ease of use, and lack of significant side effects make it a promising solution for reducing PTB rates and improving outcomes for millions of infants and their families worldwide.
