New Hope for Chronic Nausea: Enterra Medical Begins NAVIGATE Study After Gaining FDA IDE Approval and Breakthrough Device Designation

Enterra Medical, Inc., a leader in innovative treatments for gastrointestinal disorders, has initiated the NAVIGATE study to evaluate the safety and effectiveness of Gastric Electrical Stimulation (GES) as a treatment for patients with chronic nausea that have normal gastric emptying. This study was approved as an IDE study by the U.S. Food and Drug Administration (FDA) and was subsequently granted Breakthrough Device designation. NAVIGATE and its potential therapy indication represent a promising advancement for a patient population with extremely limited treatment options.

The NAVIGATE study will assess whether the Enterra^® Therapy System provides safe and effective improvement for nausea severity, vomiting frequency, and quality of life measures for individuals who have not found relief through available diet and drug therapies. Unlike previous GES studies that focused on patients with refractory gastroparesis, this study is evaluating patients who experience chronic nausea with severe symptoms, despite normal gastric emptying. Importantly, NAVIGATE also allows enrollment of patients who have previously undergone pyloric interventions.

“Patients with normal gastric emptying can experience symptoms equally severe as those with delayed emptying, making us question if gastric emptying status is as central to patients’ symptoms as previously believed,” said Prof. Jan Tack, Global Principal Investigator for the NAVIGATE study. While patients with refractory gastroparesis have been treated with GES for over two decades, the NAVIGATE study aims to expand the patient population that may benefit from GES therapy.

NAVIGATE is a multi-center, randomized, double-blind, placebo-controlled study that will enroll at least 148 subjects across leading medical institutions throughout the U.S., Europe, and the United Kingdom. The first patient was enrolled at the University of Louisville by the team of Gastroenterologist Dr. Abigail Stocker and Surgeon Dr. John Olsofka. Find all currently enrolling centers for the NAVIGATE study on ClinicalTrials.gov.

About Enterra Therapy

Enterra Therapy was approved by FDA in 2000 under a Humanitarian Device Exemption (HDE). A unique therapy called Gastric Electrical Stimulation (GES), Enterra Therapy delivers mild electrical pulses to the nerves and smooth muscles of the stomach to control the chronic nausea and vomiting symptoms associated with gastroparesis. To learn more about Enterra Therapy visit the company’s website and follow us on LinkedIn.

About Enterra Medical

Enterra Medical was founded in 2022 to help people living with chronic nausea and vomiting find the relief to take back their seat at the table. Learn more and view important safety information at www.enterramedical.com.

Enterra^® is a registered trademark of Enterra Medical, Inc. in the US, EU, and other regions.

This press release contains “forward-looking statements” concerning the development of Enterra Medical’s products, the benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Enterra Medical undertakes no obligation to update any forward-looking statements for any reason.

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Unlike previous GES studies that focused on patients with refractory gastroparesis, this study is evaluating patients who experience chronic nausea with severe symptoms, despite normal gastric emptying.