EvoEndo secures AGA investment to scale unsedated transnasal endoscopy technology

In a move that signals growing institutional interest in non-sedated gastrointestinal (GI) procedures, U.S.-based medical device developer EvoEndo announced on April 14, 2023, that it has received investment from the American Gastroenterological Association’s GI Opportunity Fund 1. The amount of the investment remains undisclosed, but the partnership underscores EvoEndo’s emergence as a leading innovator in the endoscopy market with its sterile, single-use, flexible transnasal endoscopy systems that do not require sedation.

The financial backing from the GI Opportunity Fund 1, a newly launched venture capital initiative by the American Gastroenterological Association, highlights the increasing demand for scalable GI diagnostic tools that reduce patient burden, minimize risks associated with sedation, and improve procedural efficiency in outpatient settings.

What is EvoEndo’s unsedated transnasal endoscopy system and how does it work?

EvoEndo, short for “Evolution in Endoscopy,” has designed its flagship product—the EvoEndo Single-Use Endoscopy System—for non-sedated, transnasal upper GI procedures. The system is composed of a sterile, disposable, flexible endoscope; a portable video controller; and a take-home Comfort Kit intended to ease patient anxiety and improve procedural compliance, particularly among pediatric patients.

The Comfort Kit includes virtual reality goggles that serve as a distraction tool during procedures, helping reduce the need for sedation in children and adults. Notably, the Comfort Kit is a supplementary product and is not part of the FDA-cleared core system. The core EvoEndo System focuses on clinical functionality, allowing gastroenterologists to perform diagnostic evaluations of the upper GI tract—esophagus, stomach, and duodenum—without requiring the patient to undergo sedation.

This approach not only lowers risk but also significantly reduces procedural costs, post-procedure recovery time, and hospital resource allocation. By eliminating the need for anesthesiology support and recovery beds, clinics can process more patients in shorter timeframes, offering clear economic and operational benefits.

Why does the AGA’s investment in EvoEndo signal a turning point in GI diagnostics?

The American Gastroenterological Association’s decision to fund EvoEndo through its GI Opportunity Fund 1 marks a pivotal moment in the evolution of gastroenterological care. The fund is structured to identify and support disruptive innovations that align with the AGA’s mission of improving digestive health and clinical outcomes through science, education, and innovation.

Michael L. Kochman, Fund Manager and Advisor to the GI Opportunity Fund 1, emphasized that the AGA’s support for EvoEndo stems from the technology’s potential to improve care delivery, conserve clinical resources, and drive down healthcare costs. Kochman stated that EvoEndo’s approach has implications not just for high-throughput hospitals but also for ambulatory surgical centers, pediatric care units, and global health systems facing resource constraints.

The AGA’s venture backing lends credibility to EvoEndo’s platform and signals institutional validation of non-sedated GI endoscopy as a scalable, efficient care model. For EvoEndo, this opens the door to increased physician engagement, potential hospital adoption, and wider integration into clinical pathways.

How has EvoEndo’s regulatory progress shaped its commercial outlook since FDA clearance?

In February 2022, EvoEndo received 510(k) clearance from the U.S. Food and Drug Administration for its Single-Use Endoscopy System, including the EvoEndo Model LE Gastroscope. The device is approved for use in adults and children over the age of five and is indicated for visual examination of the upper digestive tract. The clearance came after years of engineering and validation, with a focus on reducing the logistical and safety barriers associated with traditional sedated endoscopy.

FDA clearance served as a critical inflection point for the Denver-based medical device developer. It not only validated the system’s technical performance and safety profile but also enabled EvoEndo to begin direct-to-provider engagement across GI practices, hospitals, and children’s hospitals. Since clearance, EvoEndo has positioned itself as a viable alternative for clinicians seeking to expand throughput without compromising diagnostic accuracy.

According to EvoEndo Chief Executive Officer Jonathan T. Hartmann, the AGA’s backing is a recognition of the startup’s dedication to improving GI outcomes through technology-driven innovation. He stated that EvoEndo is committed to broadening its technology’s reach across the gastroenterological community—including both clinicians and patients.

What market trends are driving demand for sedation-free GI procedures in the U.S.?

Across the U.S. healthcare system, there is a growing emphasis on cost-effective, patient-friendly diagnostic solutions. Traditional endoscopy, while widely practiced, often requires IV sedation, which comes with risks including respiratory complications, longer recovery times, and higher procedural costs. For pediatric patients and high-risk individuals, sedation can be particularly challenging.

This has created a demand for alternatives that prioritize comfort without compromising diagnostic utility. EvoEndo’s approach enables unsedated examination of the upper GI tract using a smaller-diameter, transnasal scope, which many patients find more tolerable than traditional oral endoscopy.

In addition to patient-centric benefits, outpatient care providers and hospital systems are increasingly drawn to technologies that reduce resource intensity. The disposable nature of the EvoEndo scope also eliminates the need for scope reprocessing and sterilization—a major operational cost center in endoscopy units.

With nearly 20 million upper endoscopies performed annually in the United States alone, even a modest shift toward unsedated procedures could reshape reimbursement models, staffing requirements, and procedural workflows.

How does EvoEndo compare with competitors in the flexible endoscopy market?

The flexible endoscopy market has seen a rise in single-use device manufacturers, driven by infection control concerns, increasing throughput demands, and interest in eliminating capital-intensive reprocessing. Companies such as Ambu A/S, Pentax Medical, and Boston Scientific have launched or are developing disposable scopes in bronchoscopy, urology, and GI.

However, EvoEndo stands out by focusing specifically on unsedated transnasal endoscopy—a relatively under-penetrated segment. Unlike traditional upper GI scope manufacturers that prioritize full-featured reusable systems requiring sedation, EvoEndo’s clinical thesis centers on minimalism, portability, and patient tolerance.

By reducing the diameter of its gastroscope and optimizing the angle of entry via the nasal cavity, EvoEndo reduces the gag reflex and procedural discomfort. This positions the American medical device innovator as a niche leader in pediatric and minimally invasive diagnostics, a strategic differentiation from general-purpose endoscope makers.

What is the long-term outlook for EvoEndo’s technology adoption across U.S. hospitals and GI clinics?

With the support of the AGA’s venture arm and prior regulatory clearance in hand, EvoEndo is now focused on commercial scaling and physician education. Training programs for unsedated transnasal endoscopy are expected to gain traction, especially in pediatric and academic centers already familiar with minimally invasive techniques.

Clinicians adopting EvoEndo’s system are likely to benefit from lower sedation-related complications, reduced facility turnaround times, and improved patient satisfaction scores. Furthermore, payers and accountable care organizations may eventually view EvoEndo procedures as more aligned with value-based care models, particularly if supported by real-world outcome data.

Over the coming quarters, EvoEndo’s priorities will likely include expanding distribution partnerships, publishing real-world clinical performance metrics, and integrating its systems into electronic health records (EHRs) and endoscopy workflow tools.

Could unsedated transnasal endoscopy redefine GI diagnostics in the U.S.?

EvoEndo’s progress suggests that unsedated endoscopy is no longer just a niche technique—it could be the foundation for a new standard of care in GI diagnostics. With the endorsement of the American Gastroenterological Association and the regulatory greenlight from the U.S. Food and Drug Administration, EvoEndo is well-positioned to accelerate its commercial footprint in the months ahead.

As healthcare systems look to optimize cost, safety, and efficiency, EvoEndo’s portable, single-use endoscopy system offers a compelling alternative to conventional procedures. Whether this model can reach critical mass across hospital networks and outpatient clinics remains to be seen—but with institutional capital and physician momentum behind it, EvoEndo is quickly becoming a startup to watch in the gastrointestinal device sector.