ForePass - Keyron

ForePass ^TM simulates the mechanisms of metabolic surgery via

A fully incisionless procedure

The first cut-free endoscopic treatment for diabesity, ForePass^TM is able to replicate the most common types of metabolic surgery (Roux-en-Y Gastric Bypass, RYGB, BilioPancreatic Diversion, and Sleeve Gastrectomy). The first version of our product is aimed at RYGB.

The Device

Keyron’s ForePass ^TM is the first device truly designed to reverse insulin resistance and obesity

A Unique Next-Generation Technology Platform

ForePass ^TM replicates the three most common metabolic surgeries without making a single cut

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

A study of 30 small animals

Superior Efficacy in Rodents

Conclusion: ForePass^TM reduces body weight, glycemia and insulin resistance, and liver fat deposition to the same level of gastric bypass surgery

We demonstrated a full reversal of diabetes and NASH, and weight loss, to levels not statistically different from gastric bypass surgery

Note: ForePass ^TM was previously named Sleeveballoon.

Long-Term Safety & Efficacy in Swines

Pre-clinical studies in the USA and Italy have shown that the efficacy of ForePass^TM may be unprecedented, and even better than RYGB. Data from our one-month study includes:

Safe Deployment and Retrieval

Correct and Stable Long-Term Positioning Achieved

ForePass ^TM caters to patients with obesity (BMI over 38) and diabetes, or NASH, who do not respond to or tolerate drugs and refuse metabolic surgery

This represents a widely underserved patient population of at least 22 million people just in the USA and EU

Therapies for Severe Diabesity

Only highly effective treatment for diabetes and obesity, leads to full diabetes remission and the highest weight loss. However, it also leads to 15% complications, including death

Widely considered safe, but ineffective on diabetes.

The fact that balloons move throughout the stomach fails to maximize weight loss

Current drugs are not very helpful for weight loss when it comes to people with BMIs over 38

Designed to replicate metabolic surgery without any cuts to internal organs. As effective on diabetes and obesity as metabolic surgery in both small and large animals

Next steps

We are due to complete preclinical work by Q4-2023.
Our first-in-human study is expected to begin in Q1-2025 and end by Q1-2026.

2023

Final Swine Study

2025

First in Human Study

2028

Pivotal Study

2029

Expected Approvals

ForePass^TM is an extremely promising technology which may allow us to deliver the same benefits of metabolic surgery but without the complications from a surgical procedure

Prof. Carel Le Roux

Professor of Obesity
UCD & Imperial College

The rodent data obtained with ForePass shows that the device is expected to reach the same unmatched efficacy of metabolic surgery, primarily a remission of insulin resistance and substantial weight loss.

Prof. Geltrude Mingrone

Professor of Diabetes
King’s College London

ForePass could allow many more people to access the efficacy that metabolic surgery is known for. Its elegant anchoring system could ensure the required safety that so many other devices in the space have not been able to achieve