New Intra-Arrest Cooling Method May Save More Brains During Cardiac Arrest

Study Unveiled at AHA Late Breaking 'Best of Best' Presentation Shows Survival Benefit -

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

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

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

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

    The results of the study included:
    - Cooling was initiated 23 minutes following arrest and lowered brain
      temperature (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 hours
      faster 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 to
      hospital (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 treated
      patients 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 an
      arrest. 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 and
Education, Karolinska Institute, Stockholm, Sweden and the Department of
Emergency Medicine, Sodersjukhuset and PRINCE lead investigator noted, "In
this study, early cooling of the brain combined with early CPR favorably
affected outcomes, irrespective of rhythm. We believe that this study
demonstrates that making every attempt to initiate both CPR and intra-arrest
cooling as early as possible in the resuscitation process should be adopted."

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

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

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

Lynn Rubenson, +1-858-922-9201 (mobile), lrubensol at sbcglobal.com