Nightingale Health Plc

Press release

20 August 2024 at 9:15 a.m. (EEST)

Nightingale Health Plc ("Nightingale Health"), a pioneer in disease risk detection and preventative health has received additional regulatory approval from Singapore's Health Sciences Authority (HSA), the national body that regulates medical devices, therapeutics, and other healthcare products.

Nightingale Health announced earlier this year the first approval that covered the analysis of eight common clinically used biomarkers: total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, glucose, and creatinine. The second regulatory approval covers the analysis of fatty acids: total fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, saturated fatty acids, omega-3 fatty acids and omega-6 fatty acids.

Since late 2023 Nightingale Health has worked together with Innoquest Diagnostics, a leading clinical diagnostics service provider in Singapore, to enable access to Nightingale Health's blood analysis technology in Southeast Asia. This regulatory approval is an important step towards launching Nightingale Health's comprehensive and high-quality blood testing services in the region.

The approval is based on the review of conformity with the safety and performance requirements set for medical devices. The HSA approval means that Nightingale Health's product satisfies the strict requirements for quality, safety, and efficacy.

Being able to comply with some of the world's strictest regulatory requirements in healthcare demonstrates the applicability of Nightingale Health's technology in routine blood testing, as it matches the quality of gold standard tests.

Moreover, in contrast to the current solutions, Nightingale Health's technology enhances standard blood testing by offering a comprehensive panel of familiar gold standard biomarkers and, importantly, market-leading risk assessments for multiple chronic diseases from every measured sample. This capability empowers the building of more preventative and sustainable health systems worldwide.

"Nightingale Health's blood analysis technology demonstrates again its capabilities to become the new improved standard in routine blood testing for chronic diseases. By replacing the current methods of clinical chemistry, Nightingale Health's blood test can offer groundbreaking value in building more preventative and sustainable healthcare," says Teemu Suna, Nightingale Health's CEO and Founder.

"Our technology not only replaces directly many of the common blood values, but importantly offers additionally, for the first time in the diagnostic industry, a possibility to detect comprehensively the risk for developing chronic diseases. These capabilities are enabled by the unique combination of Nightingale Health's proprietary blood analysis technology and pioneering population data driven approach," Suna continues.

"Nightingale Health's technology is already used in nationwide primary healthcare in Finland covering approximately 30% of Finland's working population. In addition to Singapore, we are also making rapid progress in the United States and in the United Kingdom in adopting our technology in healthcare. We are truly excited to bring the advantages of modern blood testing technology available around the world, and the additional regulatory approval in Singapore continues to demonstrate the high quality and performance of our unique technology" Suna concludes.

For further information, please contact:

Teemu Suna, CEO
ir@nightingalehealth.com

About Nightingale Health

Nightingale Health's mission is to build sustainable healthcare and reduce health inequalities. Nightingale Health has developed the world's most advanced health check that provides risk detection for multiple chronic diseases from a single blood sample. Nightingale's Health Check can be scaled to entire populations at a low cost, and it can replace many of the current clinical risk assessments. Detecting disease risks on a population level allows for the effective targeting and tracking of health interventions, and better prevention of the onset of chronic diseases. With every sample we help to create a healthier world.

Nightingale Health operates globally with a parent company in Finland and seven subsidiaries in countries such as Japan, the United States, Singapore, and the United Kingdom. Nightingale Health has customers in more than 34 countries in the healthcare and medical research sectors. The company's technology is being used in many of the world's leading health initiatives, such as the UK Biobank, and over 600 peer-reviewed publications validate the technology. The company's Series B shares are listed on the First North Growth Market Finland marketplace. Read more: https://nightingalehealth.com