Introducing PregnanTech's LIONESS™: A
groundbreaking device to revolutionize preterm birth
TEL
AVIV, Israel, July 22,
2024 /PRNewswire/ -- Preterm birth (PTB) is a
poorly-noticed crisis impacting millions of families worldwide.
Defined as delivery before 37 weeks of gestation, PTB is the most
prevalent, devastating, and expensive pregnancy complication.
- 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.
About PregnanTech
PregnanTech, a pioneering medical technology company, is
dedicated to developing innovative solutions for maternal-fetal
health. Backed by a team of leading experts in obstetrics,
biomedical engineering, manufacturing and business, PregnanTech
focuses on combating preterm birth through their revolutionary
LIONESS™ device. Please visit our website at
www.PregnanTech.com.
Point of Contact
Dor Nadler
Outreach Coordinator
info@pregnantech.com
+972 52-823-6669
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SOURCE PregnanTech