Statistically Significant Results With RhinoChill™ In A Pooled Analysis Of 858 Patient Data Of Intra-Arrest Cooling In Out-Of-Hospital Cardiac Arrest
Two coming publications, with statistically significant results with the product RhinoChill™ was presented at American Heart Association meeting November 16, 2019.
During the Resuscitation Science symposium (ReSS) meeting in Philadelphia, Dr. Per Nordberg, Karolinska Institute, made a presentation of the importance of time to cooling in out-of-hospital cardiac arrest patients to influence neurologically intact survival. Moreover, he also made a short pitch of another forthcoming scientific publication of pooling of data of the Prince and Princess studies conducted with the BrainCool’s product, RhinoChill™ System. Dr. Nordberg was selected as one of four recipients of the prestigious award for the top-scoring abstracts submitted to the ReSS for the best of the best submitted abstract.
A pooled analysis of 858 patients from two randomized trials (PRINCE and PRINCESS) assessing the effect of prehospital trans nasal evaporative intra-arrest cooling in OHCAs. In the analysis, a total of 843 patients were included of which 325 patients had initial shockable rhythms (158 intervention vs. 167 control) and 518 had initial non-shockable rhythms, asystole or pulseless electric activity (250 intervention vs. 267 control). Among patients with initial shockable rhythm, the results showed a statistically significant result ( p-value = 0,027 ) in the patients with shockable rhythm, with a survival with CPC 1 -2 at 90 days of 36,4 % in the active group (cooling with RhinoChill™ from the ambulance) compared to the 25,6 % in the control group (cooling only at the ICU).
CEO Martin Waleij comments;
- We await eagerly the coming publication of this study of 858 patients, and expect these significant results will effect international guidelines. The chairman of GRC and board member of ERC was leading the question session, and was quoted from the session, ”the clinical findings strongly support, what we all know, that the key to an effective route of hypothermia is reaching target temperature as quickly as possible. We all know, that hypothermia works if implemented as quickly as possible.”
This gives an indication of the interest from this new method, which is the only safe and feasible method to implement cooling treatment within minutes from the onset of a cardiac arrest. New guidelines in Europe, Germany and the US is expected to be published in 2020.
In Germany, healthcare systems have already decided to implement RhinoChill™ in the early phase, and recently, BrainCool applied for reimbursement grant (NUB- New innovations and treatment methods) for RhinoChill™ in collaboration with a number of leading university hospital in Germany. The NUB procedure is intended to accelerate the establishment of new and effective therapies for the German patient population. Duration of the program is a minimum of 3 years and individually for the hospitals
A Swedish version of this press release will be published November 19, 2019.
For more information
Martin Waleij - CEO
+46 - 733 -93 70 76
About BrainCool AB (publ)
BrainCool AB (publ) is an innovative medical device company that develops, markets, and sells leading medical cooling systems for indications and areas with significant medical benefits within the healthcare sector. The company focuses on two business segments, Brain Cooling and Pain Management. BrainCool AB (publ) is based in Lund, Sweden, and its share is listed on Spotlight Stock Market.