PROVIDENCE, R.I.--(BUSINESS WIRE)--Maternova Inc., empowering global health through innovative solutions, today announced that they have signed an agreement with BirthTech Lda, Portugal, to distribute its Preemie-Test in multiple geographies around the world. The Preemie-Test is the first medical device clinically proven to accurately assess the gestational age of a newborn, which is the major marker of neonatal survival. Maternova has an exclusive distribution agreement across Africa, Asia (except India) and Latin America (except Brazil) and non-exclusive rights in Brazil, India, the United States and Europe. Initial areas of regulatory approval and marketing focus for the Preemie-Test are Peru, Colombia, Philippines, Bangladesh and specific states in India.
Immediately after childbirth, a newborn with unknown or unreliable gestational age often requires resuscitation and hospitalization. Without this critical care, preterm newborns are at risk of mortality or serious, life-long health problems. According to the WHO, every year around 15 million babies are born too early and one million die due to prematurity complications. While most of these lives could be saved with prompt prematurity identification, in the absence of a prenatal ultrasound (often too expensive and not accessible), there has been no reliable method for pregnancy dating.
“The commercial launch of the Preemie-Test is a significant milestone in providing a new way of measuring gestational age and addressing a crucial need in low-resource settings,” said Rodney Guimarães, PhD, BirthTech CEO and the inventor of the device. “With a shared commitment to maternal and infant healthcare, we are proud to work with Maternova and believe its unique distribution network will help us quickly place this cost-effective solution into the hands of healthcare professionals from midwives to obstetricians.”
“I am delighted we were selected to commercialize and distribute the Preemie-Test,” said Meg Wirth, founder and president of Maternova. “Demand for effective and affordable maternal, newborn and child health innovations continues to grow across the globe. The Preemie-Test answers the call for a highly accurate solution that can be used in time-sensitive situations where self-sufficiency and portability are essential to newborn lives.”
Maternova is an exhibitor at the Florida International Medical Expo (FIME 2022) being held at the Miami Beach Convention Center from July 27-29. Representatives, including the inventor of the device, will be at booth V64 to demonstrate the Preemie-Test.
About the Preemie-Test
- Portable, hand-held device
- Rapid, accurate results
- Easy to use
The Preemie-Test is the first medical device capable of accurately assessing gestational age within +/- 4 days immediately after an infant is born. The hand-held device features a probe containing light emitters and receivers that is applied against the newborn’s foot and, using mathematical algorithms, can estimate dating in a matter of seconds. This noninvasive optoelectronic device measures the thickness of the skin through backscattering of light using a light-emitting diode, and the battery lasts up to three years allowing hundreds to thousands of measurements. Support is available through a mobile app.
Multiple clinical trials to date have validated the effectiveness and 96% accuracy of the Preemie-Test in Brazil, Portugal, Mozambique, India and Malawi. According to ANVISA, the Brazilian regulatory health agency, this medical device is categorized as Class II Safety: Noninvasive and Medium Risk.
Maternova is taking pre-orders in all countries, pending registration and regulatory approval. To learn more about the Preemie-Test, please visit https://maternova.net/collections/newborn/products/preemie-test.
About Maternova, Inc.
Maternova is a global health solutions company that develops, curates, licenses and distributes innovations that save maternal and infant lives. Founded in 2009, it has built and grown a one-of-kind digital marketplace for distributors, governments and humanitarian organizations to research, source and fulfill orders of trusted and rigorously tested medical devices, diagnostics and nutritional products that improve care. Since 2015, Maternova has impacted the lives of more than 1.2 million mothers and babies around the world. Learn more about Maternova and its mission at www.maternova.net.