Sensifree Reports Statistically Significant Concordance of Arterial Pressure Signal Waveform

Sensifree, a medical device company developing advanced RF-based hemodynamic monitoring solutions, announced results of a clinical study showing excellent concordance between the signal morphology of its RF based sensor and invasive arterial line, the standard of care for continuous blood pressure monitoring. Clinical data from the study further validate blood pressure extraction and tracking algorithms. Preliminary results demonstrate accurate tracking of systolic and diastolic pressure values.
 
These study results represent a major milestone in the development of Sensifree’s continuous, non-invasive blood pressure monitoring solution for patients undergoing procedures involving general anesthesia or conscious sedation.
 
This single-center, non-randomized study compared the signal morphology using the Sensifree device on 14 healthy volunteers with signals from invasive arterial line and from pulse oximeter (PPG sensor). An independent clinical statistician concluded that the signal from Sensifree’s NEST technology was significantly more similar to arterial line than a PPG sensor (p<0.0001).
 
“About 85 percent of patients undergoing surgical procedures in the U.S. are monitored with a blood pressure cuff,” said Eran Agmon, Sensifree CEO and co-founder. “However, cuffs provide readings only once every five minutes. Sudden changes in blood pressure between these readings go unknown to anesthesiologists. These changes can be harmful or even fatal if not managed instantly. Our study results validate the quality and accuracy of our patented RF-based sensor technology by showing it generates signals that are essentially as accurate as those from arterial line monitoring. This is an important achievement in our quest to commercialize our first product based on the NEST technology.”
 
“The clinical data gathered in this study help us to refine our algorithms that feature novel cardiovascular modelling methods, to estimate and track systolic and diastolic pressure values from the mean arterial pressure and pulse morphology,” added Ilan Barak, Sensifree chief technology officer and co-founder.
 
Sensifree is a clinical-stage medical device company developing products based on its proprietary NEST (Noninvasive Electromagnetic Sensing Technology) platform for continuous and noninvasive hemodynamic monitoring. The company’s first product, a blood pressure monitor, will be a valuable tool at the hands of anesthesiologists, enabling them to increase patient safety by better monitoring. The firm is based in Cupertino, Calif., and operates an R&D office in Petah Tikva, Israel.