PregnanTech
PregnanTech develops LIONESS™, a first-in-class device to prevent spontaneous preterm birth, reducing neonatal mortality and lifelong disability while addressing a multibillion-dollar market.
Problem & solution
PregnanTech is addressing preterm birth, which affects 1 in 10 babies globally and is a leading cause of newborn mortality and lifelong childhood disability. Current preventive options are inconsistently effective. LIONESS™ is a first-in-class, non-surgical silicone cervical-support device designed to support and elongate the cervix, reduce cervical load, and interrupt the biomechanical cascade leading to preterm birth.
Primary customers & users
LIONESS™ will be purchased by hospitals, health systems, and obstetric/Maternal-Fetal Medicine clinics. Given the absence of consistently effective preventive options and the enormous cost of preterm birth, demonstrated efficacy will support payer coverage and adoption as a standard of care.
Differentiation
LIONESS™ is a first-in-class, non-surgical device that directly addresses the biomechanical drivers of preterm birth by supporting and elongating the cervix and reducing cervical load. Unlike surgery, progesterone, or pessaries, it offers targeted, minimally invasive support for a broader at-risk population.
Current traction
LIONESS™ has completed two successful clinical studies. Among women with a 30–70% baseline risk of preterm birth, more than 90% delivered at term or within days of term, with no device-related serious adverse events. FDA IDE approval has been secured for our U.S. pivotal study, now initiating at UTHealth Houston. The substantial unmet need and promising early results have generated ongoing interest from leading women’s-health strategic partners.
How Summit participants can help
We seek introductions to investors with expertise in medtech and maternal-fetal medicine; leading clinical sites and investigators to collaborate on our pivotal study; and strategic commercialization partners with capabilities in women’s health, reimbursement, distribution, and global market access.