A team of an international team of researchers, led by those from India’s Madhya Pradesh, has developed a completely incisionless device that replicates metabolic surgery without making any cuts and could surpass current technologies for managing conditions such as severe obesity, Type 2 diabetes, and metabolic dysfunction-associated steatohepatitis (MASH).
The researchers found that the ForePass endoscopic showed extraordinary efficacy in treating these metabolic conditions, providing unmatched treatment for millions of people who reject invasive surgery or do not respond to drugs.
“The ForePass device will be a game-changer for treating severe metabolic conditions. It replicates the effects of metabolic surgery without invasive procedures and without making any cuts to internal organs. It’s the first device of its kind and will pave the way for a new era in managing severe metabolic conditions,” said lead author Dr. Manoel Galvao Neto, endoscopic surgeon and researcher based at Sri Aurobindo Medical College, in Madhya Pradesh.
“It is a crucial development, as only 1 per cent 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,” Dr. Neto added.
ForePass is an innovative device, developed by Keyron, that combines a gastric balloon crossed by a central channel that connects to a flexible intestinal sleeve, thereby effectively replicating the mechanism of invasive metabolic surgery without the need for surgery or making any incisions.
The device is inserted into the stomach and initial tract of the small intestine using endoscopy, a much less invasive and cheaper procedure compared to metabolic surgery. Unlike metabolic surgery, ForePass is fully reversible, making it an appealing option for patients.
The team evaluated the ForePass device’s impact on weight, insulin sensitivity, and faecal microbiota (a range of microorganisms) in pigs.
The results, published in the journal Gut, revealed a 79 per cent reduction in weight gain compared to the control group, suggesting it may be substantially more effective than common metabolic surgeries like gastric bypass. It also showed substantial improvements in how the body handles insulin and reduces glucose in the liver compared to controls.
The study found markedly improved response to insulin, enhanced use of glucose, and beneficial changes in metabolic health-related gut bacteria.
The device also favourably altered faecal microbiota, boosting bacteria linked to metabolic well-being. These outcomes align with a reversal of severe obesity, diabetes, and MASH, indicating an overall improvement in metabolic health.
Keyron plans to initiate human clinical trials for ForePass, which is anticipated to start in early 2025.
