Keyron announced publication of landmark preclinical data showing its ForePass device achieved unprecedented efficacy against severe obesity and diabetes in head-to-head comparison with semaglutide, the active ingredient in Ozempic and Wegovy that generated $28 billion in 2024. The results, published in the peer-reviewed journal Diabetes, Obesity and Metabolism, demonstrate the potential for a paradigm shift in treating patients with severe obesity and type 2 diabetes.
Dramatic Efficacy Advantage Over Leading GLP-1 Drug
In a four-week study using growing pigs, ForePass limited weight gain to just 2.0 kg (4%) compared with 16.3 kg (36%) with semaglutide and 21.1 kg (47%) with controls (p<0.0001). Semaglutide reduced weight gain by only 11% versus controls (p<0.05), mirroring outcomes observed in human studies. Beyond weight control, ForePass demonstrated more than twice the improvement in insulin sensitivity compared to semaglutide, a critical factor in diabetes management.
The device addresses a significant treatment gap for patients with severe obesity (BMI ≥35) and type 2 diabetes, who require approximately 30% weight loss to reverse disease. Current GLP-1 drugs fall short of this target, with 92% of patients on semaglutide failing to achieve even 15% weight loss according to data published in the New England Journal of Medicine. Additionally, 85% of patients discontinue GLP-1 treatment within 24 months, as reported by Reuters.
Bridging the Gap Between Drugs and Surgery
ForePass represents a novel approach to severe obesity treatment, positioned between ineffective drug therapy and invasive bariatric surgery. With fewer than 1% of eligible patients undergoing bariatric surgery due to invasiveness and risk, more than 50 million patients in the US and EU5 remain inadequately treated.
Unlike current endoscopic devices that perforate, ablate, puncture, or suture tissue, ForePass is placed and removed endoscopically in under 30 minutes, leaving the stomach and intestines completely intact. The device has demonstrated safety and tolerability across multiple studies while achieving efficacy levels that approach surgical outcomes without incisions.
Expert Perspectives on Clinical Impact
Prof. Geltrude Mingrone, Principal Investigator and Professor of Medicine at King's College London, emphasized the breakthrough nature of the technology. "This is a defining moment for the field. ForePass achieves the metabolic benefits of surgery without the risks, invasiveness, or anatomical alteration. For the more than 50 million patients in the US and EU5 with severe obesity and diabetes, this is a unique and urgently needed solution that medicine has never been able to offer — until now."
David Feigal, former Director of the FDA's Center for Devices and Radiological Health and Keyron's Head of Regulatory Affairs, highlighted the regulatory implications. "These are exactly the kind of results that get regulators' attention. ForePass delivers truly transformative efficacy with an incision-free safety profile that supports rapid clinical translation. This is the breakthrough the field has been waiting for — in my opinion, the single most important innovation in the treatment of severe obesity and diabetes."
Addressing an Underserved Patient Population
Dr. Giorgio Castagneto Gissey, CEO of Keyron, emphasized the clinical need addressed by ForePass. "This data is unambiguous. GLP-1 drugs fail 92% of the time to deliver meaningful weight loss. For the first time, more than 50 million patients have a powerful option to reverse disease without surgical removal of the stomach or small intestine. ForePass is the unique solution positioned to redefine the field and set a new standard of care."
The device specifically targets patients with severe obesity and type 2 diabetes who have been inadequately served by existing treatment options. This population faces significant health risks and limited therapeutic alternatives, making the potential impact of ForePass particularly significant for clinical practice.
Keyron, headquartered in London with operations on the U.S. East Coast, is pioneering non-surgical biometabolic therapies that replicate the effects of bariatric and metabolic surgery without incisions. The company positions ForePass as a scalable alternative to surgery for severe obesity and diabetes, potentially transforming treatment options for millions of underserved patients worldwide.
