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GENinCode Plc

("GENinCode" or the "Company")

De Novo Update - FDA Supervisory Review

Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the prevention of cardiovascular disease, announces an update on its Food and Drug Administration (FDA) De Novo submission. In response to a request by the Company for a Supervisory Review, the FDA recently provided a review of its April 2025 assessment. While the number of the outstanding deficiencies has been reduced, the review upheld the FDA's prior view that there remains certain outstanding elements, including further information in relation to clinical validation.

With the feedback from the Supervisory Review, the Board remains of the view that there is a path forward to provide the further information to resolve these deficiencies to obtain De Novo classification. Discussions with the FDA have been productive with the outstanding deficiencies reducing. The Board does not believe that there are any elements that it cannot address, however there can be no certainty that the information provided will be sufficient.

The Company has arranged further ongoing clarifictory discussions with the FDA and will provide a further update if this provides additional information.

For more information visit www.genincode.com

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About GENinCode:

GENinCode Plc is a UK based company specialising in genetic risk assessment of cardiovascular disease. Cardiovascular disease is the leading cause of death and disability worldwide.

GENinCode operates business units in the UK, Europe through GENinCode S.L.U, and in the United States through GENinCode U.S. Inc.

GENinCode predictive technology provides patients and physicians with globally leading preventative care and treatment strategies. GENinCode CE marked invitro-diagnostic molecular tests combine clinical algorithms and bioinformatics to provide advanced patient risk assessment to predict cardiovascular disease.

About Cardiovascular Disease (CVD):

Heart and circulatory disease known collectively as Cardiovascular disease (CVD) are the leading cause of death globally, taking an estimated 17.9 million lives each year. CVD is a group of disorders of the heart and blood vessels that include coronary heart disease, cerebrovascular disease, rheumatic heart disease and other conditions. More than four out of five CVD deaths are due to heart attacks and strokes, and one third of these deaths occur prematurely in people under 70 years of age.

Coronary heart disease is the most common type of heart disease. In 2021 in the US, coronary heart disease accounted for 375,476 deaths. About 1 in 20 adults age 20 and older have CHD (about 5%). In 2021, about 2 in 10 deaths from CHD happened in adults less than 65 years old. Globally it is estimated around 200 million people are living with coronary heart disease. Around 110 million men and 80 million women have coronary heart disease. Coronary heart disease kills an estimated nine million people each year - in 2019 it was the world's single biggest killer.

In the UK, cardiovascular disease causes a quarter of all deaths and is the largest cause of premature mortality in deprived areas and the single biggest area where the NHS can save lives over the next 10 years. CVD is largely preventable, through lifestyle changes and a combination of public health and NHS action on smoking and tobacco addiction, obesity, tackling alcohol misuse and food reformulation.

Aside from the genetic risk of cardiovascular disease, the most important behavioural risk factors of heart disease and stroke are unhealthy diet, physical inactivity, tobacco use and harmful use of alcohol. The effects of behavioural risk factors may show up in individuals as raised blood pressure, raised blood glucose, raised blood lipids,  excess weight and obesity. These "clinical risks factors" can be measured in primary care facilities and indicate an increased risk of heart attack, stroke, heart failure and other complications.

Identifying those at highest risk of coronary heart disease and ensuring they receive appropriate treatment can prevent premature deaths. Access to medicines and basic health technology in all primary health care facilities is essential to ensure that those in need receive treatment and counselling.

Early detection and treatment of CVD can help patients live longer, healthier lives is set out in the NHS 10 Year Plan. Too many people are still living with undetected, high-risk conditions such as raised cholesterol, high blood pressure and atrial fibrillation (AF). Globally, healthcare systems are making progress on identification and diagnosis of high genetic risk individuals and working towards people routinely knowing and understanding their 'ABC' (AF, Blood pressure and Cholesterol risk). Replicating this approach is now increasingly possible with advanced molecular testing and digital technology.