ForePass® simulates the mechanisms of metabolic surgery

A fully incision-free procedure

The first incision-free endoscopic treatment for severe obesity and metabolic disease, ForePass ® aims to replicate Roux-en-Y Gastric Bypass, RYGB.

Treatment Options for Severe Diabesity Requiring ≥30% Weight Loss

Metabolic Surgery

Metabolic surgery can achieve substantial and durable weight loss and improvements in type 2 diabetes and other obesity-related conditions. However, it is invasive and carries perioperative and longer-term risks, limiting its suitability and acceptance for many patients.

Medical Devices

 

Existing endoscopic and device-based therapies can offer less-invasive treatment options, but generally produce more modest weight loss than metabolic surgery. This leaves a significant treatment gap for patients requiring substantial weight loss and metabolic improvement.

Drugs

GLP-1–based therapies have transformed obesity treatment and can produce substantial weight loss and metabolic benefits. However, response varies between patients, treatment is generally chronic, and rapid weight regain can occur following discontinuation. A significant need therefore remains for patients who do not achieve or maintain sufficient benefit with pharmacotherapy.

ForePass ®

ForePass® is fully endoscopic device designed to reproduce key mechanisms of metabolic surgery without surgical resection or anastomosis. Preclinical studies have demonstrated encouraging effects on weight and metabolic parameters, supporting its continued development toward clinical evaluation.

 

The Device

 

Keyron’s patented ForePass® device is designed to target key mechanisms underlying insulin resistance and obesity.

A Unique Next-Generation Technology Platform

ForePass® is a technology platform designed to replicate key mechanisms of Roux-en-Y gastric bypass and other metabolic surgery procedures, without requiring incisions in the abdomen or digestive tract.

The final device may differ in size and characteristics to that shown in this video.

Long-Term Safety & Efficacy in Swine

Our large-animal data were published in Gut, the official journal of the British Society of Gastroenterology and one of the leading journals in gastroenterology and hepatology.

Preclinical studies have demonstrated substantial effects on weight and metabolic outcomes. In animal studies, ForePass® showed the following changes from baseline compared with endoscopic controls:

Designed for Reversibility

Purpose-Built For 100% Reversibility

Strong Preclinical Data

A controlled 30-animal study demonstrated metabolic effects comparable to Roux-en-Y Gastric Bypass

Published Evidence of Gastric Bypass-Like Metabolic Effects

ForePass ® reduced body weight, glycemia, insulin resistance and liver fat deposition to levels comparable to Roux-en-Y gastric bypass in this animal study.

It produced metabolic reversal with weight and metabolic outcomes not statistically different from Roux-en-Y gastric bypass.

Note: ForePass ® was previously named Sleeveballoon.

Roux-en-Y Gastric Bypass (RYGB)

  • Roux-en-Y Gastric Bypass (RYGB) is an effective operation that determines type 2 diabetes remission and reversion of insulin resistance.
  • A large portion of the stomach, the entire duodenum and the initial part of the jejunum are bypassed from food transit after RYGB. The bypass of the duodenum and the jejunum covers a central role in the improvement of glycemic control.