Market Overview

Attune Medical Completes Final Close of Series C Raise of over $15 Million to Support Continued Global Adoption of Esophageal Temperature Management Device


Chicago-based medical device firm Attune Medical has completed the final
close of its Series C raise, now oversubscribed to total more than $15.5
million. This financing will be used to ensure Attune's continued
revenue growth in the worldwide temperature management market, along
with expansion of Attune's technology into emerging clinical
applications such as hypothermia prevention during OR procedures, and to
pursue further clinical studies and ultimately regulatory clearance for
new clinical applications focused on reduction of esophageal thermal
injury which can result from cryo- or radiofrequency-based cardiac
ablation, a commonly used treatment for atrial fibrillation. The EnsoETM
is the only patient temperature management system cleared for use in the
esophageal environment for delivery of whole body temperature management.

Attune Medical's Chief Executive Officer, Keith Warner, commented, "As
the clinical use of temperature management gains a broader worldwide
footprint in healthcare overall, Attune will continue to expand the
application base for the EnsoETM toward novel, clinically impactful uses
across a diverse array of clinical settings. We are well-positioned for
continued growth in the critical care space, while also pursuing
clinical evidence in support of new applications positioned to bring
increased safety and efficacy to operating rooms and electrophysiology
labs. This oversubscribed fundraising is a concrete signal of investor
and market confidence in our mission to make temperature management as
accessible and useful as possible for all clinical applications and
patients who can benefit from this therapy."

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, as well
as the administration of enteral fluids such as tube feeds and
medications in some models. 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.

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 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. The EnsoETM model for use with enteral
feeding was cleared by the FDA in January 2018, with an additional
clearance for use with Cincinnati Sub-Zero's Norm-O-Temp Hypothermia
System in May 2018. 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.

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