OptiBiotix Health Regulatory News (OPTI)

OptiBiotix Health plc

("OptiBiotix" or the "Company" or the "Group")

SlimBiome® Approved by Health Canada

OptiBiotix Health plc (AIM: OPTI), a life sciences business developing compounds that modulate the microbiome to tackle metabolic syndrome, systemic low grade inflammation, obesity and diabetes, cardiovascular disease and high cholesterol, announces that SlimBiome® has received approval for use as a licensed product for weight management by Health Canada, a Canadian federal institution responsible for helping Canadians maintain and improve their health.

In Canada, every supplement must be approved and authorised by Health Canada, as a licensed Natural Health Product (NHP) and receive a National Product Number (NPN). The NPN is displayed on the product label and is confirmation that a product has been assessed and found to be safe and effective with approved health claims. As part of the approval process Health Canada have validated the scientific and clinical data on SlimBiome® and determined the following health and nutrition claims can be made: -

· Helps to lower cholesterol levels by reducing cholesterol absorption from the gastrointestinal tract

· Helps to maintain normal blood glucose levels and supports a healthy glucose metabolism

· Helps to prevent chromium deficiency and maintains the body's ability to metabolize nutrients

· Complementary to a healthy lifestyle with a calorie-reduced diet and regular physical activity for individuals involved in weight management

· Helps to support a feeling of fullness

· Is a source of fiber and prebiotics

Health Canada is seen as one of the world's leading authorities on regulating functional ingredients and supplements ensuring products are safe and marketed with approved health and nutrition claims. Health Canada approval is internationally recognised as a mark of a product quality, safety, and effectiveness and can lead to shortened product registration procedures in other international markets.

SlimBiome® is a patented weight management ingredient supported by independent human clinical studies (Keleszade et al, 2020) which show it reduces hunger, cravings for sweet and savoury foods, and fat intake. In addition to clinical studies, independent consumer surveys have shown that customers who used SlimBiome® in combination with a calorie restricted diet lose on average 2-3lbs (1-1.5kg) per week, experience a relief from feeling hungry and have fewer cravings for food, leading to easier and more sustainable dieting.

SlimBiome® has achieved three major industry awards: European Weight Management Ingredient of the Year (NutraIngredients 2018), Asia Weight Management Ingredient of the Year (NutraIngredients 2019), and most recently, best weight management product in the USA (Nutrition Industry Executive Award 2021).

René Kamminga, CEO of OptiBiotix Limited, commented: "We are pleased to achieve product approval for SlimBiome® by one of the toughest regulatory bodies in the world. This is a significant achievement and brings further international recognition to SlimBiome® as a scientifically backed and proven weight management ingredient. It underlines the value of the investment we made in a number of human clinical studies showing SlimBiome's® effectiveness and the creation of a large IP portfolio. SlimBiome® has won three major industry awards across all regions, obtained CE marked medical device registration in Europe, and now is a weight management product with approved health and nutrition claims by Health Canada. This opens up the Canadian and North American market for new sales opportunities and provides further validation of our product in international markets."

Carla Fabian, Sales Director of Agropur (Optibiotix's partner in North America) commented: "Health Canada approval and recognition with an NPN number is exciting news as this allows Agropur to safely manufacture, distribute, and sell SlimBiome in the Canadian marketplace. The registration is recognised by consumers, brand owners, retailers, and professional health care workers like pharmacists and dietitians. Everyone can be assured that SlimBiome® is safe, of high quality, and can amongst others help deliver benefits with respect to cholesterol reduction, maintaining blood glucose levels and compliment a healthy lifestyle. We, along with Optibiotix, look forward to partnering with brand owners who are looking to add proven science-based weight management functionality to existing products or to assist with new product development utilising our extensive innovation resources."

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of the UK Market Abuse Regulation and the Directors of the Company are responsible for the release of this announcement.

For further information, please contact: