Attune Medical, a breakthrough medical device company with a technology platform based on targeted temperature management using the esophageal space, has achieved significant corporate milestones as part of the company’s aggressive growth plan.
The company’s ongoing support of clinical research for emerging temperature management applications and the ensoETM has resulted in the first major peer-reviewed clinical publication using the device. Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation. The IMPACT Study summarizing his findings was published on November 17, 2020 (online in advance of print) in the journal Europace. Also of note, another study was published recently in Europace by different authors (OPERA) that showed intraesophageal temperature monitoring during cardiac ablation procedures using a traditional temperature sensor probe did not affect the incidence of endoscopically detected esophageal lesions, highlighting the need for continued research regarding alternative methods to protect the esophagus from thermal injury during cardiac ablations.
The company also completed the final closing of a $4M convertible note offering. The funds will be used to increase the company’s commercial and clinical presence while supporting further studies in key device application areas.
Konstantin Kostov and the investment group Cantina Angels that he co-manages participated in the Attune note offering. "It is our privilege to invest in Attune’s technology platform and we are pleased to see the expansion and continued growth across both existing and new clinical applications. It is incredibly satisfying to invest in a company that both helps patients and continues to achieve important milestones for investors," commented Kostov.
"As uses of esophageal-based temperature management continue to expand, we are committed to supporting clinical studies such as the IMPACT trial to advance clinical practice in growing fields such as cardiac ablation," commented Keith Warner, CEO. "Our mission is to apply temperature management solutions using our proprietary esophageal-based device to maximize clinical benefit across a range of applications and patient groups."
Attune Medical’s ensoETM is a single use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for heat transfer to increase or decrease patient temperature. Its placement in the esophagus, with proximity to blood flow from the heart and great vessels, allows highly efficient heat transfer. Unlike surface warming devices, ensoETM‘s internal placement doesn‘t impede patient access during surgery and allows gastric decompression and administration of fluids and medications.
Attune Medical has developed a novel medical device technology that simplifies access to the patient’s core to efficiently control temperature and is the only device FDA-cleared for use in the esophagus for whole-body temperature management. The ensoETM device is used in critical care units, operating rooms, and emergency departments for the intentional modulation of patient core temperature and can be rapidly placed by most trained healthcare professionals.
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