There are 6.1 million upper endoscopies, otherwise known as esophagogastro-duodenoscopy (EGD), performed in the U.S. each year. Esophageal dilation is a common non-surgical procedure which uses a balloon dilation catheter to stretch the lower esophageal sphincter (LES) so solids and liquids can pass. This procedure can be performed on a range of disease states, including achalasia, eosinophilic esophagitis (EoE), esophagogastric junction outflow obstruction (EGJOO), and radiation injury and often may require multiple dilations to relieve the patient. We have identified an area of potential expansion in the usage and indications for large balloon EGD dilations procedures, with a $1.4 billion market opportunity.

In a standard through-the-scope (TTS) procedure, the gastroenterologist will pass a balloon catheter, sized between 6 to 20 mm in diameter, through the endoscope working channel to stretch the LES. In cases of severe esophageal stricture, a pneumatic dilation balloon is required, sized between 30 to 40 mm in diameter. This advanced procedure requires fluoroscopy for visualization and involves the passage of the balloon over a guidewire without the endoscope. Pneumatic dilation involves several procedural risks, including esophageal perforation, fever, and pleural effusion. These risks with the pneumatic dilation procedure can be attributed to the guidewire and fluoroscopy, such as guidewire movement and limited fluoroscopic visibility. These challenges contribute to physician reluctance to use/train for pneumatic dilation. Peroral endoscopic myotomy (POEM) is the first-line of treatment because it is minimally invasive, has reduced perforation risks, and higher treatment success rate compared to pneumatic dilation. Pneumatic dilation, although a second-line treatment, offers advantages such as a cost-effective, non-surgical option that is more accessible than POEM.

Gastroenterologists are constrained by advanced training requirements due to the complex procedure and size limitations for large balloons that cannot be used in conjunction with the gastroscope working channel. Established products such as the RigiFlex™ Balloon Dilators do not address this area of limitation. Innovations driven by the need to enable real-time visualization of the esophagus during large balloon dilation are expected to enhance endoscopist precision in balloon positioning, inflation, sizing estimation, and mitigation of perforation risk, while also making the procedure more accessible for general endoscopists by eliminating the need for fluoroscopy training and equipment.