Charles Sternberg, Associate Editor04.20.22
EvoEndo Inc., a medical device company which developed a single use system that allows for unsedated Transnasal Endoscopy (TNE), has completed 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.
Heather Underwood, CEO at EvoEndo, commented, “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.”
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, CEO 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.
“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.
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.
Reducing the Use of General Anesthesia and Sedation
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, which 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.Heather Underwood, CEO at EvoEndo, commented, “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.”
About the EvoEndo Single-Use Endoscopy System
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, CEO 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.
“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.