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January 19, 2024
In a groundbreaking development, an entirely incisionless device could revolutionize the treatment landscape for metabolic conditions such as severe obesity, type-2 diabetes, and metabolic dysfunction-associated steatohepatitis (MASH). The ForePass® endoscopic device, as detailed in a study published in the peer-reviewed journal Gut by an international team of researchers, has demonstrated unprecedented efficacy in treating these challenging conditions.
The study, led by Dr. Manoel Galvao Neto, an endoscopic surgeon and researcher based at Sri Aurobindo Medical College, India, revealed remarkable results in pigs subjected to the ForePass device. Compared to a control group that did not undergo the procedure, the ForePass group exhibited a staggering 79% reduction in weight gain, surpassing the effectiveness of common metabolic surgeries like gastric bypass.
Notably, the ForePass device showed significant improvements in insulin sensitivity and glucose reduction in the liver, indicating its potential to outperform traditional metabolic surgeries. Furthermore, the study highlighted enhanced responses to insulin, improved glucose utilization, and positive changes in metabolic health-related gut bacteria.
Dr. Neto emphasized the significance of this development, stating, “It is a crucial development, as only 1% of patients opt for bariatric surgery due to its invasive nature. The medical community is eagerly anticipating the upcoming clinical trials involving the ForePass device.”
Developed by Keyron, the ForePass device combines a gastric balloon with a central channel connected to a flexible intestinal sleeve, effectively replicating the mechanisms of invasive metabolic surgery without the need for any incisions or surgery. The device is inserted into the stomach and initial tract of the small intestine using endoscopy, a less invasive and more cost-effective procedure compared to traditional metabolic surgeries.
Unlike current surgical interventions, the ForePass device is fully reversible, making it an attractive option for patients wary of invasive procedures. Co-author Geltrude Mingrone, Professor of Diabetes and Nutrition at King’s, commented on the device’s potential impact, saying, “ForePass stands out as it offers the benefits of metabolic surgery without the need for actual surgery, making it a game-changer for millions who are reluctant to undergo surgery.”
ForePass is designed to decrease food consumption, leading to significant weight loss, and directs food deeper into the gut. This process improves insulin resistance, offering an effective treatment or potential reversal of conditions like diabetes and serious liver diseases such as MASH.
Co-author Professor Stefan R Bornstein, Chair in Diabetes and endocrinology consultant based at King’s, highlighted the transformative potential of ForePass, especially for individuals with very high BMIs. He stated, “Considering that existing medications fall short in achieving the necessary weight loss for individuals with very high BMIs, ForePass will be a transformative solution for these patients.”
Keyron plans to initiate clinical trials for ForePass in early 2025. If the safety and efficacy observed in animal studies are confirmed in human trials, ForePass could revolutionize the treatment of severe obesity, offering hope to millions of individuals worldwide.
