HeRO Receives CE Marking for Sale into EU
CHARLOTTESVILLE, Va., November 8, 2012 Medical Predictive Science Corporation (MPSC) announces that it has received the CE mark for the Heart Rate Observation System, or HeRO® System. The CE mark allows the device to be marketed and sold in the European Union indicated for the prediction of sepsis and improvement in mortality.
MPSC CEO Will King commented, “This is an important milestone in the adoption of the HeRO technology. Through this one action, we have effectively doubled the market for HeRO monitors.”
“The evidence from the 3000-infant randomized controlled trial was clear and convincing: the HeRO System predicts sepsis and saves lives,” noted Ray Schumin, Director of Regulatory Affairs. “We couldn’t be more pleased with this outcome,” he added.
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MPSC is immediately looking to engage distributors in the European market at the MEDICA conference, in Dusseldorf, Germany later this month. “This is a great opportunity for us to build immediate momentum. Our distributor in the UK has already identified our first potential customer. I’m hopeful we can identify equally motivated sales partners throughout continental Europe,” remarked Geoff Alms, PhD, Exec. VP of Sales and Marketing.
HeRO is a pioneering monitoring system for premature infants that detects early signs of distress, commonly caused by infection and other potentially life-threatening illnesses. HeRO generates an hourly numeric score that quantifies the prevalence of abnormal patterns in each patient’s heart rate and provides a new tool for clinical assessment so that standard diagnostic and therapeutic decisions are better founded. :
About MPSC
MPSC is an entrepreneurial medical device company that translates ICU research discoveries to the patient’s bedside. The company develops predictive technology that detects imminent, catastrophic illness. MPSC’s HeRO monitor is the first of a line of products to monitor in-hospital patients.
Press Release: New Clinical Study Reveals Statistically Significant Reduction in NICU Infant Mortality
CHARLOTTESVILLE, Va., Aug. 25, 2011 In a long-running randomized study of over 3,000 preterm infants, those whose care included the Heart Rate Observation System, or HeRO® monitor, experienced greater than 20 percent reduced mortality, effectively saving one infant’s life for every 48 who were monitored. The results of this multicenter study of the HeRO monitor, co-sponsored by the National Institutes of Health and Medical Predictive Science Corporation (MPSC), appear in The Journal of Pediatrics.
HeRO is a pioneering monitoring system for premature infants that detects early signs of distress, commonly caused by infection and other potentially life-threatening illnesses. HeRO generates an hourly numeric score that quantifies the prevalence of abnormal patterns in each patient’s heart rate and provides a new tool for clinical assessment so that standard diagnostic and therapeutic decisions are better founded.
The study, “Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial,” was conducted from April 2004 to September 2010 at leading neonatal intensive care units (NICU) at the University of Virginia, Wake Forest University, University of Alabama at Birmingham, Vanderbilt University, University of Miami/Jackson Memorial Hospital, Greenville SC Hospital System, Winnie Palmer Children’s Hospital and Pennsylvania State University.
There were 152 deaths (10.2 percent) in the group that received standard NICU care and 122 deaths (8.1 percent) in the group that received standard NICU care plus HeRO monitoring, an absolute risk reduction of 2.1 percent. There were no significant differences in demographics between the two groups, nor any of the other outcomes measured by the study.
The study’s lead investigator and co-inventor J. Randall Moorman, M.D., a University of Virginia cardiologist said, “The HeRO monitor is the voice for infants who can’t speak for themselves. It’s an early warning system for NICU doctors and nurses to get to the right bedside at the right time.”
According to the March of Dimes, about 12.8 percent of babies (more than half a million a year) in the U.S. are born prematurely and the rate of premature birth has increased by 36 percent since the early 1980s. Among the 60,000 premature babies born less than 3.3 pounds each year, the mortality rate is approximately 10 percent. The results of the study point to the possibility of saving the lives of an additional 1,200 premature babies each year.
The patented monitoring technology was developed at the University of Virginia and licensed to Medical Predictive Science Corporation in Charlottesville, Virginia. The monitor, which is made by MPSC, has been cleared by the FDA to monitor neonatal distress and is being used by hospitals across the country.
About MPSC
MPSC is an entrepreneurial medical device company that translates ICU research discoveries to the patient’s bedside. The company develops predictive technology that detects imminent, catastrophic illness. MPSC’s HeRO monitor is the first of a line of products to monitor in-hospital patients.