Oxford Medical Products is delighted to report positive topline results from the first randomised controlled trial (RCT) of Sirona, its innovative, non-invasive, and non-pharmaceutical weight-loss technology.
In a 12-week RCT, Sirona showed an excellent safety profile and was well-tolerated among participants. A clear treatment effect was observed, with participants on Sirona achieving more weight loss than those in the placebo group. The highest percentage of total body weight loss (TBWL) in the treatment group was 10%, with 25% of treated individuals losing more than 5% of their total body weight (TBW).
Sirona is a dual-polymer hydrogel pill designed to rapidly expand in the stomach, occupying space to suppress appetite mechanically. Once deployed, its size allows it to remain in the stomach for several days, providing sustained appetite control—a crucial aspect in achieving effective weight loss. Sirona’s mechanical action is non-invasive, safe, and well-tolerated, offered at a fraction of the cost of current treatments.
Overweight and obesity affect over 2 billion people globally, costing the NHS £18 billion annually. JP Morgan analysts project the obesity treatment market could reach $100 billion by 2030, primarily driven by GLP-1 pharmacotherapies. OMP sees Sirona as a differentiated technology that not only complements GLP-1 therapies but can also reach market segments these therapies may not. Sirona’s strong safety and tolerability make it well-suited for both the overweight and weight maintenance markets, helping those transitioning off GLP-1s to avoid weight regain and maintain a healthy weight long-term.
The double-blind RCT (ISRCTN14083641) assessed Sirona’s safety, feasibility, and tolerability, with approximately forty adults with a BMI of 30-41 participating. Subjects were split into two groups, receiving either Sirona or a placebo in a 3:1 ratio. Weight loss was an exploratory endpoint over the 12 weeks. No serious adverse events (SAEs) were reported, with most side effects graded as mild. No participants left the study due to adverse events related to Sirona, underscoring its favourable safety and tolerability. Those in the treatment group lost up to 10% of their total body weight.
Interestingly, the trial found that participants with class I obesity (BMI 30-34.9) had a greater percentage of TBW loss than those with class II obesity (BMI ≥35). This observation diverges from findings on GLP-1 receptor agonists, which typically show higher efficacy in individuals with higher BMIs, suggesting that further research is warranted.
Oxford Medical Products’ CEO, Dr Camilla Easter, remarked on the trial results, saying: “Data like these prove our initial belief – that Sirona represents a safe approach to weight loss. We are extremely pleased that the participants in our study responded well to Sirona, and we have now delivered over 8,000 doses, with our fantastic safety profile and non-pharmacological approach we are uniquely positioned to disrupt the overweight and obesity treatment market.”
She added, “Sirona’s effect in the BMI category 30-34.9 may also indicate its potential as an effective treatment option for people with an overweight BMI (25-30) who currently have very few treatment options available. Due to the scale and complexity of the obesity crisis, there is an urgent need for a broader range of treatment options to address the needs of individuals living with excess weight and obesity. Sirona offers a totally novel solution, which can be used stand alone or in conjunction with other medical weight loss treatments. Oxford Medical Products are both proud and excited to offer an alternative and complimentary solution for people living with overweight and obesity.”
Following these promising results, Oxford Medical Products intends to commence the pivotal trial of Sirona in Q2 2025. The company is also developing Sirona as a gastroretentive drug delivery system to improve the pharmacokinetic profiles of oral anti-obesity and metabolic drugs, enhancing their oral bioavailability.
Oxford Medical Products partnered with the NIHR Southampton Biomedical Research Centre (Southampton BRC) and the NIHR Bristol Biomedical Research Centre (Bristol BRC) for the trial. These BRCs specialise in early phase translational research, bridging the gap between early discovery science and larger clinical studies.
The study also received support from the NIHR Southampton Clinical Research Facility.
Professor James Byrne, Chief Investigator from the NIHR Southampton BRC, commented: “This first-in-human study of Sirona is a really exciting collaboration between the team at the NIHR Southampton BRC and Oxford Medical Products. Working with clinical research colleagues at the Bristol BRC and Milton Keynes, we have delivered a randomised study confirming safety, feasibility and tolerability of this completely new and first in class product as a tool to support those living with overweight and obesity. I am delighted that our results clearly also demonstrate the potential of Sirona as an entirely new approach to weight loss and weight management. Our team is looking forward now to the pivotal study planned for 2025 as the next step that will further assess the effectiveness of Sirona in a larger multinational randomised trial.”
For further information or to speak directly with Oxford Medical Products’ CEO, Camilla Easter.
