Durham, NC, Jan. 18, 2024 (GLOBE NEWSWIRE) — The publication of a landmark research paper demonstrates the exceptional efficacy of the ForePass® endoscopic device in treating prevalent metabolic conditions like severe obesity, type-2 diabetes, and metabolic dysfunction-associated steatohepatitis (MASH). The study, authored by an international team of prominent researchers, appeared in Gut, which is the leading international journal in the field of gastroenterology.
The study’s goals were to evaluate the ForePass device’s impact on weight, insulin sensitivity, and fecal microbiota in pigs, compared to a control group that did not undergo the procedure. Key results of the study include:
- 79% reduction in weight gain compared to the control group, suggesting it may be substantially more effective than common metabolic surgeries like gastric bypass.
- Substantial improvements in how the body handles insulin and reduces glucose in the liver compared to controls.
- Markedly improved response to insulin, enhanced overall body’s use of glucose, and beneficial changes in metabolic health-related gut bacteria.
ForePass is an innovative device that combines a funnel-shaped gastric balloon linked to an intestinal sleeve, effectively replicating 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, which surgically reduces the stomach and connects it to the small intestine. 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.
Dr Manoel Galvao Neto, a globally recognized endoscopic surgeon and lead author of the study, commented: “The ForePass device is a game-changer and the first device of its kind for treating severe metabolic conditions. 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.”
Professor Geltrude Mingrone of King’s College London, and co-author of the study, said: “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.”
Dr Giorgio Castagneto Gissey, Keyron’s CEO, stated, “ForePass is a real breakthrough for high BMI individuals, for whom available treatment options are often ineffective or inappropriate. 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.
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- Dr Manoel Galvao Neto
- ForePass