EvoEndo is a medical device company developing sterile single-use, flexible endoscopes that enable unsedated transnasal upper endoscopy in adults and pediatric patients. Its cleared EvoEndo Single-Use Endoscopy System (FDA 510(k) clearance, February 2022) includes a sterile single-use gastroscope and a small portable video controller; the EvoEndo Comfort Kit (VR goggles) is not part of the cleared system. The Model LE gastroscope is intended for visualization, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb in patients over age five and can be inserted orally or transnasally. EvoEndo positions its technology to move routine endoscopy from ambulatory procedural suites into office-based settings, allowing traditional sedation procedure rooms to focus on more complex therapeutic cases. The company says its platform can improve care, save time and resources for hospitals, and expand unsedated options for both pediatric and adult patients. EvoEndo announced an investment from the American Gastroenterological Association's GI Opportunity Fund 1 and says it will continue expanding adoption among the GI community, physicians, and patients. EvoEndo developed the Single‑Use Endoscopy System to enable unsedated Transnasal Endoscopy (TNE) across the complete upper GI tract for pediatric and adult patients. The system combines sterile single‑use flexible endoscopes, a portable video controller, and a take‑home comfort kit with VR goggles to facilitate unsedated procedures. The device received FDA 510(k) clearance in February 2022 and the company is executing a commercial rollout this year. EvoEndo says the single‑use design reduces preparation and recovery time, eliminates sedation risks, and removes costs and cross‑contamination risks associated with reusable scopes. Proceeds from the recent financing will fund the initial commercial launch, hiring, increased inventory capacity, and clinical and post‑market surveillance studies. The company plans to leverage its scope design and imaging expertise to develop additional systems for pulmonology and otolaryngology (ENT). EvoEndo is developing a system that enables unsedated transnasal endoscopy (TNE) by combining sterile, single-use flexible endoscopes with VR-based patient distraction. The technology is intended to allow routine endoscopies in the clinic for pediatric patients and adults without general anesthesia or sedation, with the goal of reducing procedure complexity, cost, infection risk, and hospital time. The company positions the system to help physicians diagnose, treat, and monitor gastrointestinal disorders including GERD/reflux, ulcers, celiac disease, and eosinophilic esophagitis. EvoEndo is a preclinical company co-founded in 2017 by Dr. Joel Friedlander and the interdisciplinary aerodigestive medicine team at Children’s Hospital of Colorado and is led by CEO Heather Underwood. Its system is pending U.S. FDA 510(k) clearance and is not yet available for sale in the United States. The company announced a $10.1M equity financing to advance the technology and support broader adoption of unsedated TNE programs in hospitals.

Total raised

$19M

Funding rounds

3

Latest round

Series A

Latest activity

Apr 2022