The ForePass endoscopic device (Keyron Ltd.) results in a 79% reduction in weight gain compared to the control group in a swine model, suggesting it may be substantially more effective than common metabolic surgeries like gastric bypass.
ForePass is an innovative device that combines a funnel-shaped gastric balloon linked to an intestinal sleeve, which according to the device’s manufacturer Keyron effectively replicates the mechanism of metabolic surgery without the need for surgery or making any incisions. The device is inserted into the stomach and proximal intestine using endoscopy, a less invasive and cheaper procedure compared to metabolic surgery. Unlike metabolic surgery, ForePass is fully reversible, making it an appealing option, especially considering that the vast majority of patients with metabolic diseases reject invasive surgery.
The ForePass device links the stomach to the jejunum via a gastric funnel connected to an intestinal sleeve. The balloon, which reduces the gastric volume by approximately 2/3, is traversed by a central channel that connects to the sleeve, which extends through the duodenum and proximal jejunum. subsequently, ingested foods bypass the duodenum and proximal jejunum arriving directly into the mid-jejunum.
"The ForePass device is a game-changer and the first device of its kind for treating severe metabolic conditions,” commented Dr Manoel Galvao Neto, lead author of the study. “It replicates the effects of metabolic surgery without making any cuts to internal organs, which is a much-needed innovation. The medical community is eagerly anticipating the upcoming clinical trials involving the ForePass device."
The study’s goals were to evaluate the ForePass device's impact on weight, insulin sensitivity and faecal microbiota in four pigs, compared to a control group that did not undergo the procedure. The researchers hypothesised that the ForePass, which limits food intake and bypasses the upper gut, significantly improves glucose disposal and reduces weight gain in pigs relative to controls.
They assessed glucose disposal, weight gain, metabolomics and faecal microbiota in eight pigs that were assigned to either Sham-operation (controls) or Forepass. After fourweeks, they reported a large reduction (79%) in the overall weight gain in part due to reduced food intake (22%) and in part to incomplete food digestion with increased faecal nutrient loss in the group with ForePass as compared with sham operation. There were no reported instances of macroscopical or microscopical lesions of the stomach and duodenal mucosa and submucosa.
In addition, they observed a significant decrease in plasma glucose, insulin and C-peptide levels in response to an intragastric glucose load in ForePass group, with insulin sensitivity significantly higher in the ForePass than in the sham group.
"As a truly incisionless and highly effective solution, ForePass can be very useful for those who are ineligible for or reluctant to undergo metabolic surgery, and those seeking alternatives to medications, addressing a large unmet healthcare need, said Professor Geltrude Mingrone, King's College London and co-author of the study.
The study authors concluded that the ForePass device could be used for those hesitant in undergoing surgery, high-risk patients who are ineligible for surgery, as a bridge to surgery, as well as a complement or substitute to new anti-obesity and anti-diabetic medications for these lifelong diseases.
"ForePass is a real breakthrough for high BMI individuals, for whom available treatment options are often ineffective or inappropriate,” added Dr Giorgio Castagneto Gissey, Keyron’s CEO. “It marks a pivotal shift in managing severe metabolic conditions."
Keyron aims to begin clinical trials for ForePass in early 2025. Should the upcoming trials, as anticipated, confirm the safety and efficacy demonstrated in animal studies, this device is poised to transform the treatment of severe and morbid obesity in the years ahead.
The findings were reported in the paper, ‘ForePass endoscopic bypass device for obesity and insulin resistance - metabolic treatment in a swine model’, published in Gut. To access this paper, please click here