M-Health solution for managing premature births

As Neonatal Intensive Care Unit (NICU) staff members see day in and day out, the premature birth rate continues at a pace that organizations such as the World Health Organization and the March of Dimes deem too high.  NICUs are at a constant struggle with providing enough beds and enough staff to meet the numerous needs of these tiny infants.  With money pouring into research on the causes of preterm labor, there is a new company on the market locating itself in Switzerland that is focused on solutions that help to perinatal professionals curb to get an edge on preterm labor now. 

Lumeden was founded in 2009 in the United Kingdom to address the needs of expectant mothers at high risk for premature birth using mobile technology and now plans to locate its worldwide headquarters to Zug, Switzerland in Q1, 2014.  Investors have already seeded the company with 2,326 million CHF to date, and the company is currently looking to raise another 9,120 million CHF in Q1, 2014 from investors to complete development of its flagship FULLTERM wireless pregnancy management mHealth product, and enter the market. Lumeden has already achieved a major milestone with its CE marked Lumescope wireless cervical examination system which is on sale now in Europe, and manufacturing of the FULLTERM mHealth product is slated to start in Switzerland in Q1, 2015.

FULLTERM focuses on using an iPhone mobile app platform and diagnostic sensor to provide real time, critical, time sensitive information for high-risk pregnancy management anytime, anywhere; information that was not available at all due to the expectant mother’s location or historically obtained in clinic or hospital relating to the cervix. The two critical events that occur when a preemie is about to be born are that the cervical effaces and dilates, e.g. cervical effacement and dilation.  FULLTERM provides the high-risk patient’s doctor with early warning of these two critical events on the doctor’s iPhone or iPad so the doctor can intervene to provide the fetus additional in womb development time with a drug therapy or, if delivery is imminent, get the expectant mother and fetus to a center with a neonatal intensive care unit to improve the newborn’s chances of survival. FULLTERM has three main components: the FULLTERM intravaginal monitoring sensor (IMS), the patient’s mobile app subscription, and the doctor’s iPhone or iPad.

Multi-center European clinical trials are slated for Q1, 2015 and are designed for European CE mark and FDA approvals. FULLTERM is targeted for CE mark approval Q2-Q3, 2015, and will be available in Europe upon CE mark approval.  FDA approval is slated for Q1, 2016.