Mr. Warner is a seasoned executive in the life science and diagnostic industry with over three decades of experience building high value companies. Most recently as a consultant to life science investment firms, Mr. Warner has been instrumental in assessing new technologies and building early stage companies toward successful M&A transactions. Mr. Warner served in leadership roles at organizations including Wafergen BioSystems, Novartis/Chiron and Biodesix. Mr. Warner also held numerous positions of increasing responsibility in manufacturing, sales and marketing and management at Abbott Diagnostics. Mr. Warner received his undergraduate degree in microbiology from Kansas State University and his M.B.A. from Pepperdine University.
Founder and CEO, Erik Kulstad said, “The addition of Keith to the team will support our aggressive growth trajectory as the EnsoETM continues to gain global adoption. His significant commercial and operational experience, reputation of excellence, and industry insight will help Attune continue to innovate in patient temperature management.”
Says Mr. Warner, “I look forward to accelerating the progress made by Dr. Kulstad and his team toward maximizing the clinical impact of esophageal-based temperature management. Recent progress toward closing additional financing and attracting key contributors to the Attune team will position the company as a leader in patient temperature management.”
Attune Medical’s proprietary technology allows providers to safely and efficiently control core patient temperature, whether warming or cooling, through the esophagus when clinically indicated. Attune Medical’s primary device, the EnsoETM (formerly Esophageal Cooling Device or ECD), is designed to modulate and control patient temperature through a single use, fully-enclosed 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.
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.