May 22, 2024

Revolutionary Incisionless Device Offers Hope for Diabetes, Liver Disease, and Severe Obesity Treatment

A groundbreaking incisionless device has the potential to revolutionize the treatment of metabolic conditions such as severe obesity, type 2 diabetes, and metabolic dysfunction-associated steatohepatitis (MASH). The device, known as the ForePass, replicates the effects of metabolic surgery without the need for invasive procedures or incisions.

The ForePass device was studied by an international team of scientists, including researchers from King’s, who published their findings in the journal Gut. The study aimed to evaluate the impact of the ForePass device on weight, insulin sensitivity, and fecal microbiota in pigs compared to a control group that did not undergo the procedure.

Remarkably, the results showed a 79% reduction in weight gain in the group that received the ForePass device, suggesting that it may be significantly more effective than traditional metabolic surgeries like gastric bypass. The device also demonstrated improvements in insulin handling and glucose reduction in the liver compared to the control group.

Furthermore, the study found that the ForePass device led to enhanced response to insulin, improved glucose utilization, and beneficial changes in gut bacteria related to metabolic health.

According to Dr. Manoel Galvao Neto, the lead author of the study and an endoscopic surgeon and researcher, the ForePass device will be a game-changer for the treatment of severe metabolic conditions. It is the first device of its kind and offers the benefits of metabolic surgery without invasive procedures or incisions. Dr. Neto emphasized that the medical community eagerly awaits the upcoming clinical trials involving the ForePass device.

The innovative ForePass device, developed by Keyron, consists of a gastric balloon connected to a flexible intestinal sleeve through a central channel. This configuration effectively replicates the mechanisms of invasive metabolic surgery without the need for surgery or incisions.

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 surgery. Unlike surgical interventions, the ForePass device is fully reversible, making it an appealing option for patients.

During the study, the pigs were implanted with the ForePass device for one month, and the device demonstrated a significant 79% decrease in weight gain. It also showed marked improvements in glucose balance compared to the control group.

Additionally, the device positively altered the composition of fecal microbiota, promoting the growth of bacteria associated with metabolic well-being. These findings suggest that the ForePass device could potentially reverse severe obesity, diabetes, and MASH, leading to overall improvements in metabolic health.

Co-author Geltrude Mingrone, a Professor of Diabetes and Nutrition at King’s, described the study’s findings as extraordinary and unprecedented. The ForePass device has the potential to be even more effective than traditional metabolic surgery, offering a solution for individuals with higher body mass indexes (BMIs) who do not respond well to drugs or other treatments. It could revolutionize the treatment of severe obesity, insulin resistance-related pathologies like diabetes, and various liver diseases.

The device is designed to decrease food consumption, resulting in significant weight loss, and redirect food deeper into the gut. This process improves insulin resistance, effectively treating or potentially reversing diabetes and serious liver conditions such as MASH.

Considering that current medications often fail to achieve the necessary weight loss for individuals with very high BMIs, the ForePass device offers a transformative solution. Co-author Professor Stefan R Bornstein, a Chair in Diabetes and endocrinology consultant at King’s, believes that the device has the potential to significantly impact the lives of tens of millions of people in the U.S. and EU alone.

Keyron plans to initiate clinical trials for the ForePass device in early 2025. If the trials confirm the safety and efficacy observed in animal studies, the device could revolutionize the treatment of severe obesity in the coming years.

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it