CHICAGO--(BUSINESS WIRE)--Advanced Cooling Therapy (ACT), an emerging medical device manufacturer, has announced that it is changing its corporate name to Attune Medical. The name change reflects the company’s commitment to temperature management therapy in all clinical contexts and better represents the corporate culture of remaining attuned to clinical needs, patient safety and the state of science.
Over 20 million patients in the United States experience a clinical event that warrants active temperature management each year, but researchers estimate that less than 10 percent receive the appropriate therapy, and that part of this discrepancy is attributed to workflow challenges.1,2 “We believe simple solutions can solve complex problems. Our outsized growth in the temperature management marketplace has been driven by the need for a simple solution in the face of a continuous stream of new clinical evidence and practice guidelines that define the importance of core temperature across the clinical spectrum. Having taken this into account, our transition to Attune Medical aligns our strategic focus with what the marketplace needs and expects,” said Clinical Marketing Director, Melissa Naiman.
Attune Medical’s proprietary technology simplifies access to the patient’s core and allows providers to control patient temperature, whether warming or cooling, through the esophagus when clinically indicated. This prompted the renaming of Attune Medical’s primary device, the Esophageal Cooling Device (ECD) to EnsoETM, reflecting the product’s simplicity and the broader focus on Esophageal Temperature Management. The EnsoETM is designed to modulate and control patient temperature through a single use, fully-enclosed triple lumen system that is inserted into the esophagus. Two lumens attach to an external heat exchange unit while a third, independent, lumen simultaneously allows gastric decompression and drainage. The EnsoETM can be rapidly placed by most trained healthcare professionals, in similar fashion to a standard gastric tube, and can be used to control patient temperature in the operating room, recovery room, emergency room, or intensive care unit. No other products on the market are approved to use the esophageal environment for whole-body temperature modulation.
"This transition to Attune Medical reflects the ability of our technologies to apply high fidelity body temperature ‘tuning’ which can be customized to specific warming or cooling needs. Our technology platform’s ability to ’tune’ patient temperature – regardless of the direction or the goal – goes well beyond the concept of cooling,” commented Robin Drassler, VP North American Sales.
Founder and CEO, Erik Kulstad said, “Our EnsoETM has proven useful and effective in addressing a significant demand in emergency departments, intensive care units and operating rooms for a variety of temperature management needs. Given the company’s advancing commercial success and increasing demand in the market, Attune Medical is continuing to build its team of innovators, disruptors and evangelizers across the organization, with a particular focus on expansion of its commercial teams. With an extremely seasoned group of investors and Board Members, the company is also finalizing plans for a third fundraising round for Attune Medical which will be instrumental in product line expansion and continued worldwide sales growth.”
Attune Medical (as Advanced Cooling Therapy) received US FDA de novo clearance for the EnsoETM (Esophageal Cooling Device or ECD) in 2015 for use with the Medi-Therm III by Stryker®. It received FDA 510(k) clearance in 2016 for use with the Blanketrol® II and III Hyper-Hypothermia systems made by Cincinnati Sub-Zero, a Gentherm Company, and FDA 510(k) clearance for use with the Altrix System by Stryker® in 2017. It received its CE Mark in Europe in 2014, with an expanded indication for use up to 120 hours in 2016 and a CE Mark for use with the Altrix System by Stryker® in 2017. It is also licensed for sale in Canada and Australia.
2. Majersik, J. J. et al. Public health impact of full implementation of therapeutic hypothermia after cardiac arrest. Resuscitation. 77 (2), 189-194 (2008).
