Press Release

ORLANDO, Florida, November 15 /PRNewswire/ -- The first randomized intra-arrest cooling study performed using a novelintra-nasal cooling method showed much faster and earlier cooling in treatedpatients and significantly higher neurologically intact survival - to -discharge rate in many patients. The Pre-Resuscitation Intra-Nasal CoolingEffectiveness (PRINCE) study involved 200 patients and was conducted by 15Emergency Medical Systems (EMS) in Belgium, Germany, Italy, Czech Republicand Sweden. The aim was to determine safety and efficacy of intra-nasalcooling during ongoing resuscitation of cardiac arrest patients even beforethe return of circulation (ROSC).

The study was conducted using RhinoChill(TM), a non-invasive nasalcatheter that sprays a rapidly evaporating coolant liquid into the nasalcavity. This large cavity is a heat exchanger and lies right under the brain.

The trial was designed to determine the safety and effectiveness of earlycooling initiated at the site of the arrest. The RhinoChill(TM) technologyenabled cooling to start much earlier than is possible with conventionalmethods used in a hospital setting and focuses on the brain. "The brain isthe organ that dies first so the closer to the time of arrest the brain iscooled, the more of it is rescued," said Denise Barbut, M.D, founder and CEOof BeneChill(R), the company that makes RhinoChill. "The brain is the organthat controls the heart, much like a puppet on a string," she added.

Additional endpoints included cooling rates, time to achieve targettemperature, ease of use in the field, ROSC rates, survival andneurologically intact survival. EMS personnel recruited adults over 18 yearsold who were in cardiac arrest and not hospitalized during resuscitation. Allpatients who were deemed eligible for advance cardiac life support (ACLS)were included as long as the arrest was witnessed and cardiopulmonaryresuscitation (CPR) was initiated within 20 minutes of collapse.

  The results of the study included: - Cooling was initiated 23 minutes following arrest and lowered braintemperature (tympanic) (34.2 degrees C vs. 35.5 degrees C) and body (core) temperature (35.1 degrees C vs. 35.8 degrees C) significantly by ER arrival. - Time to target tympanic temperature of 34 degrees was three hoursfaster and time to target core temperature was two hours faster in patients cooled intra-nasally in the field compared to those receiving hospital cooling alone. - Survival to discharge was higher in treated patients admitted tohospital (46.7% vs 31%) and significantly higher in those in whom CPR was initiated within 10 minutes of collapse, irrespective of rhythm (59.1% vs 29.4%). - Neurologically intact survival to discharge was higher in treatedpatients admitted to the hospital (36.7% vs 21.4%) and significantly higher in those in whom CPR was initiated within 10 minutes of collapse, irrespective of rhythm (45.5% vs 17.6%). - Intra-nasal cooling with RhinoChill was feasible and safe during anarrest. Nasal discoloration was the most commonly reported adverse event occurring in 13 patients. This resolved spontaneously in all patients who were successfully resuscitated.

Maaret Castren, M.D, Ph.D of the Department of Clinical Science andEducation, Karolinska Institute, Stockholm, Sweden and the Department ofEmergency Medicine, Sodersjukhuset and PRINCE lead investigator noted, "Inthis study, early cooling of the brain combined with early CPR favorablyaffected outcomes, irrespective of rhythm. We believe that this studydemonstrates that making every attempt to initiate both CPR and intra-arrestcooling as early as possible in the resuscitation process should be adopted."

The EMS teams also noted that the portability of the device and ease ofuse meant that cooling could be administered in the field by non-specializedmedical personnel. This also is useful in the hospital setting where thepatient can be transported around with on-going cooling.

Dr. Castren presented the findings in Orlando, FL on Sunday, November 15during the American Heart Association's Resuscitation Science Symposium "Bestof the Best" presentations.

The sponsor of the study is BeneChill(R), a privately held medical devicecompany which develops novel, rapid cooling systems to improve survival andbrain function after cardiac arrest and other forms of brain ischemia. Itslead product, RhinoChill(TM), which was used in the PRINCE study, can beadministered quickly and close to the brain using a nasal catheter thatdelivers a rapidly evaporating coolant. RhinoChill(TM) will be marketed inEurope in early 2010 and currently is not available in the US.