Before joining Attune Medical in 2017, Warner was a consultant to life science investment firms, 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 CMO, Dr. Erik Kulstad commented, “Since Keith has joined us, Attune’s commercial adoption has accelerated, and we have attracted attention from new investors due to the company’s potential for high growth and growing opportunities in adjacent markets where temperature management is a key to clinical success.” Kulstad added, “I am looking forward to working with Keith to help Attune reach its full market potential.”
Says Mr. Warner, “Attune’s EnsoETM represents a paradigm shift in how we can safely and effectively manage patient temperature in the surgical suite, ICU, emergency department and many other clinical areas where application of temperature is critical to patient success. It is a privilege to join forces with a successful entrepreneur like Erik to lead our team across all areas of our business, from sales and marketing to product development, as we reach our growth objectives in the US and worldwide healthcare markets.”
Formerly known as Advanced Cooling Therapy, Attune Medical has developed proprietary medical device technology that simplifies access to the patient’s core to efficiently control core temperature. Whether warming or cooling, the company’s technology platform optimizes, or “tunes”, patient temperature safely and effectively. Attune’s initial product, 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, drainage, or the administration of enteral fluids such as tube feeds and medications. 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, and/or intensive care unit. No other products on the market are cleared for use in 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®. The company 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.