DENVER--(BUSINESS WIRE)--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.
“My family has extensive experience with sedated endoscopies, and from my perspective, the thought of getting a scope at noon and being back at work or school by 1 o’clock is transformational. EvoEndo's platform allows a gastroenterologist and one assistant to immediately perform an endoscopy upon a patient presenting with symptoms versus waiting months to find an available sedated procedure with a team of physicians,” said David Bunning, Chief Executive Officer of TLP.
The EvoEndo® Single-Use Endoscopy System radically reduces preparation and recovery time for upper endoscopy procedures and eliminates risks associated with sedation. As a single-use device, it also eliminates capital costs for cleaning and repair as well as the risk of cross-contamination that can occur with reusable devices.
|
Sedated Endoscopy |
Unsedated TNE |
Pre-procedure fasting |
6-8 hours |
2-4 hours |
Check-in prior to procedure |
15-30 minutes |
15 minutes |
Procedure prep |
40-45 minutes |
20 minutes |
Endoscopy performed |
5-10 minutes |
5-10 minutes |
Post procedure |
1+ hours |
5-10 minutes |
Recovery |
Go home and recover from sedation |
Return to school, work, daily activities |
“In addition to enabling safer and faster upper endoscopy procedures, the EvoEndo® Single-Use Endoscopy System also provides significant health economic value by improving utilization of operating room capacity, clinic space, and personnel resources,” said Joel Friedlander, D.O., M.A-Bioethics, Chief Medical Officer at EvoEndo. “We believe that unsedated TNE technology will help transform the clinical practice of gastroenterology and endoscopy. We are also committed to leveraging our expertise in enhanced scope design, imaging, and clinical practice to develop additional systems for use in the specialties of pulmonology and otolaryngology (ENT).”
The EvoEndo® System is only intended for use by medical professionals. Physicians and other medical providers interested in learning more about EvoEndo’s TNE system or to schedule demonstrations and training can contact the company here.
About EvoEndo®
EvoEndo®, Inc. is a medical device company developing systems that enable unsedated endoscopic procedures through a combination of sterile single-use, flexible endoscopes with enhanced patient comfort features and enhanced physician use features together with VR-based patient distraction. EvoEndo’s technology allows pediatric patients and adults alike to receive routine endoscopies in a clinic setting without the use of general anesthesia or sedation, while reducing complexity, cost, and patient/provider apprehension. To learn more, please visit: https://evoendo.com/.
