Breakthrough Clinical Results
Aktiia announced FDA 510(k) clearance for its cuffless blood pressure monitoring technology, marketed as the Hilo Band. This marks the first FDA clearance for an over-the-counter (OTC) cuffless blood pressure monitor in the U.S. The Hilo Band, already available in Europe, uses optical technology and will be launched in the US in 2026. The device requires initial calibration with a provided cuff and data should be used in consultation with a healthcare provider. The FDA approval follows a successful Series B funding round of over $42 million.
Key Highlights
- FDA 510(k) clearance for over-the-counter (OTC) use of Aktiia's cuffless blood pressure monitoring technology.
- First FDA-cleared cuffless blood pressure monitor for OTC use in the United States.
- Hilo Band, already commercially available in Europe, will launch in the US in 2026.
- Successful Series B funding round exceeding $42 million.
Incidence and Prevalence
Global Epidemiology of Hypertension: Incidence, Prevalence, and Trends
Global Prevalence and Burden
Hypertension affects approximately one billion people worldwide and is an independent risk factor for death after acute coronary syndrome. Estimates suggest that 31.1% of adults (1.39 billion) worldwide had hypertension in 2010. More than 25% of adults in the world have hypertension, and this percentage is expected to increase in the coming years in all areas including sub-Saharan Africa.
The prevalence of hypertension among adults was higher in low- and middle-income countries (31.5%, 1.04 billion people) than in high-income countries (28.5%, 349 million people). Out of the estimated 1.13 billion people who have hypertension, less than 1 in 5 people have it under control.
Incidence Rates
The overall incidence of hypertension was 1.73 (95%CI 1.36-2.20) per 100 person-years according to the PERU MIGRANT study. In the United States, the crude incidence rate of hypertension per 1000 person-years varied by ethnicity: - 56.8 for whites - 84.9 for blacks - 65.7 for Hispanics - 52.2 for Chinese
Geographic and Demographic Variations
Regional Prevalence
- In South Asia, the prevalence of hypertension among adults (18-49 years) is 14.9% in India, 19.8% in Bangladesh, and 13.8% in Nepal
- In Pakistan, the overall pooled prevalence of hypertension was 26.34% (25.93%, 26.75%)
- In Ghana, the pooled prevalence across 24 studies was 30.3% (95% CI 26.1-34.8%)
- In China, age-standardized prevalence of hypertension increased from 12.5% to 16.0% between 2004 and 2009 and declined from 16.0% to 14.0% between 2009 and 2013
- According to the Korean Hypertension Fact Sheet, the prevalence of hypertension in the total population of Korea in 2018 was 28.3%
- In the Philippines, hypertension prevalence has steadily increased from 22% in 1993 to 25.15% in 2013
- In the Asia-Pacific region, the prevalence of hypertension ranged from 5-47% in men and from 7-38% in women across 15 countries
- In Mexico, the global hypertension prevalence was 26.9% (CI 95% 24.0-29.0)
- In Australia, population prevalence of hypertension was estimated at 12.4%
Urban vs. Rural Differences
Compared to rural settings, the burden of hypertension in urban populations was significantly higher in multiple studies. Urbanization, aging, dietary and lifestyle changes, high illiteracy rates, poor access to health facilities, poverty, high costs of drugs, and social stress have contributed to an increase in the prevalence of hypertension in developing countries.
Socioeconomic Factors
Better educated, wealthy individuals living in urban areas of developing economies in the South Asian region are more likely to have hypertension. The prevalence of hypertension positively correlated with per capita GDP at province level in China.
Temporal Trends and Projections
Despite the widespread use of antihypertensive medications, global mean blood pressure has remained constant or has decreased slightly over the past four decades. By contrast, the prevalence of hypertension has increased, especially in low- and middle-income countries.
Globally, the prevalence of hypertension is projected to decrease from 22.1% in 2015 to 20.3% by 2040. However, one-quarter of the world's adult population has hypertension, and this is likely to increase to 29% by 2025. Modeled projections indicate an increase to 1.15 billion hypertensive patients by 2025 in developing countries.
By 2040: - The prevalence of hypertension worldwide is expected to be higher in males than females - South-East Asia is projected to experience the largest hypertension prevalence in males - Africa is estimated to have the highest prevalence in females - Low-income countries are projected to have the highest prevalence of hypertension in both sexes - Among the world's most populated countries, Pakistan and India are likely to increase hypertension prevalence by 7.7% and 4.0% respectively
There were approximately 80 million patients with hypertension in sub-Saharan Africa in 2000 and projections suggest this figure will rise to 150 million by 2025.
Risk Factors and Etiology
Variations in risk factors for hypertension, such as high sodium intake, low potassium intake, obesity, alcohol consumption, physical inactivity and unhealthy diet, may explain some of the regional heterogeneity in hypertension prevalence. The increase in the incidence of hypertension appears to be closely correlated with aging of the population as well as with the growing number of overweight and obese persons.
In Black Africa, hypertension presents several etiopathogenic particularities mainly with regard to dependence on sodium sensitivity and lower plasma renin activity. Due to delayed and/or inadequate therapeutic management and likely genetic predisposition, organ-related complications are more common and occur earlier in Black Africa.
Economic Burden
Economic Burden of Treating Hypertension in USA and Europe
United States
Hypertension represents a significant health and economic challenge in the United States, affecting nearly 1 in 3 adults and causing thousands of deaths annually. The financial impact is substantial, costing the nation billions of dollars annually for medical management including hospitalizations, lost wages, and pharmacotherapy.
According to the most recent data (2019, analyzed in 2023), hypertension was associated with $2,759 (95% CI: $2,039, $3,479) in health care expenditures per person. Additionally, hypertension was linked to 10.3 (95% CI: 9.3, 11.3) health care events per person, including prescriptions filled.
Notable racial disparities exist in hypertension-related expenditures in the US: - Hispanic adults had $1,877 lower expenditures compared to non-Hispanic White adults - Asian adults had $2,452 lower expenditures compared to non-Hispanic White adults - Differences between non-Hispanic White and Black adults were not statistically significant
Europe
The economic burden of hypertension varies across European countries:
- In the Eastern Europe and Central Asia region, high blood pressure consumed 25% of all health expenditures
- France faces relatively high costs for treating heart failure compared to other countries
- Germany and the UK experience relatively high costs for renal failure without transplantation
Cross-country comparisons indicate that costs are generally higher in the US than in European countries, though with some exceptions.
Global Context
The global economic impact of hypertension is described as "staggering":
- Suboptimal blood pressure cost US$370 billion globally in 2001
- This represents about 10% of the world's overall healthcare expenditures
- Over a 10-year period, elevated blood pressure may cost nearly $1 trillion globally in health spending
- Indirect costs could be as high as $3.6 trillion annually
If current trends continue, the economic burden of hypertension-related conditions has the potential to cause healthcare delivery systems to fail.
Drug used in other indications
Hilo Band G0 Blood Pressure Monitoring System: Clinical Trials Information
Based on the provided context, there is no available information about the Hilo Band (G0 Blood Pressure Monitoring System) being trialed for hypertension or any other indications. The context explicitly states that no information about "Hilo Band" or "G0 Blood Pressure Monitoring System" could be found in any of the provided texts, and no trials related to these devices were mentioned.
Since no information is available in the provided context, I cannot provide details about: - Clinical indications beyond essential hypertension - Therapeutic intervention protocols or treatment models - Efficacy data for non-hypertensive conditions
The context indicates that this information was not present in the source materials reviewed.