PregnanTech develops the LIONESS device, a smartly-structured silicone ring designed for vaginal placement to prevent preterm birth. This outpatient procedure keeps the uterine cervix elongated, addressing a major complication in obstetrics. The technology aims to significantly reduce the global incidence and associated burdens of spontaneous preterm birth.
Funding
Funding not disclosed
Founders
Product
Problem
Preterm birth, occurring in 9-17% of pregnancies globally, is the leading cause of infant mortality and morbidity. Existing interventions, including pharmacological, surgical, and pessary-based methods, have proven unsatisfactory in reducing these rates, which have remained stagnant for decades. This condition imposes significant emotional and financial burdens on families and healthcare systems.
Solution
PregnanTech offers the LIONESS™ device, a silicone ring designed to prevent preterm birth by maintaining cervical elongation. This non-surgical, outpatient procedure involves placing the device high around the uterine cervix, similar to a Shirodkar cerclage, to reduce the biomechanical load and delay the cascade leading to preterm labor. The device is easily removed at term or features a self-release mechanism in case of active labor. A pilot clinical trial demonstrated promising results with a high rate of term births and no significant adverse events, validating the technology for further clinical studies.
Target Audience
The primary target audience includes obstetricians, maternal-fetal medicine specialists, and healthcare providers managing high-risk pregnancies.
Features
- LIONESS™ is a silicone ring designed for cervical elongation to prevent preterm birth.
- The device is placed in an outpatient setting with intuitive application tools.
- It is engineered to maintain cervical length under pressure and contractions, preventing dilation.
- Features a self-release mechanism for active labor scenarios.
- Successfully tested in a safety and feasibility pilot clinical trial, with results published in the American Journal of Obstetrics and Gynecology.
- Intended for investigational use.