EvoEndo^®, Inc. (“EvoEndo”), a medical device company which developed a single use system that allows for unsedated Transnasal Endoscopy (TNE), has announced the completion of an $8.4 million Series A financing round led by founding investor TLP Investment Partners LLC (TLP) and including the Sunshine Charitable Foundation and the Jill and Paul Meister family. Proceeds from the financing will be used to support the initial commercial launch of the EvoEndo^® Single-Use Endoscopy System by hiring additional personnel and growing inventory capacity. The company will also deploy the funding to conduct clinical and post-market surveillance studies.

EvoEndo^® was founded by clinicians to address the significant need to reduce the use of general anesthesia and sedation during endoscopic procedures in pediatric and adult patients. The use of sedation in endoscopy increases the risk of adverse events, imposes significant pre- and post-procedure burdens on patients and clinic personnel, and results in high resource utilization that increases costs and reduces the number of procedures that can be performed each day. Additionally, the COVID-19 pandemic has highlighted the limitations of re-usable devices that carry a risk of infection transmission and require additional cost and personnel time for cleaning and maintenance.

“The recent FDA clearance of the EvoEndo^® Single-Use Endoscopy System marks a significant milestone for our company and is a major step forward in making unsedated endoscopy a reality for pediatric and adult patients,” said Heather Underwood, Chief Executive Officer at EvoEndo. “Our Single-Use Endoscopy system is the first sterile single-use system to enable unsedated TNE of the complete upper GI tract and is the only gastroscope indicated for both pediatric and adult patients. With the tailored combination of features and our comprehensive suite of education and training materials, our system is clearly differentiated from competitors, and we believe that the benefits it provides to patients and physicians will support rapid adoption and transform the TNE landscape.”

The EvoEndo^® Single-Use Endoscopy System received FDA 510(k) clearance in February 2022 and the company is executing a rollout of this novel TNE device to both pediatric and adult patients this year. While traditional endoscopy requires patients to undergo general anesthesia or sedation, the EvoEndo System combines sterile, single-use, flexible endoscopes, a portable video controller, and a take-home “comfort kit” containing virtual reality (VR) goggles for patient distraction during the procedure to allow for unsedated TNE. Unsedated TNE can be used to evaluate and diagnose a wide range of upper GI conditions that may require frequent monitoring including eosinophilic esophagitis (EoE), dysphagia, celiac disease, gastroesophageal reflux disease, Barrett’s esophagus, malabsorption, and abdominal pain.

Find out more in the press release.