Breakthrough Clinical Results
Breath Diagnostics announced results from a peer-reviewed clinical study published in The Journal of Thoracic and Cardiovascular Surgery, demonstrating its OneBreath™ technology's ability to diagnose and predict pneumonia in patients undergoing elective cardiac surgery. The study, involving 75 patients, showed the technology, using volatile organic compounds (VOCs) in exhaled breath and AI-powered machine learning, achieved an AUROC and PRAUC of 0.833. Importantly, the predictive model identified high-risk patients days before symptoms appeared, enabling potential early interventions. This non-invasive technology offers rapid, repeatable sampling and scalable integration with machine learning, potentially applicable to various diseases beyond pneumonia.
Key Highlights
- OneBreath™ technology accurately diagnoses and predicts pneumonia onset in patients undergoing elective cardiac surgery.
- The technology uses exhaled breath analysis and AI-powered machine learning to identify volatile organic compounds (VOCs) as biomarkers.
- The predictive model identified high-risk patients days before clinical symptoms, enabling potential early interventions.
- The non-invasive nature of the test allows for rapid, repeatable sampling and scalable integration with machine learning.
Incidence and Prevalence
Global Pneumonia Incidence and Prevalence: Latest Estimates
Based on the available research, there is limited comprehensive global data on pneumonia incidence and prevalence. However, several regional and pathogen-specific studies provide valuable insights into pneumonia epidemiology:
Regional Findings
In rural Thailand, a 2008 population-based surveillance study identified 3489 cases of clinically-defined pneumonia over one year. The study found:
- Legionella longbeachae pneumonia requiring hospitalization: 5-29 cases per 100,000 population
- Chlamydia pneumoniae pneumonia: 3-23 cases per 100,000 population
- Mycoplasma pneumoniae pneumonia: 6-44 cases per 100,000 population
- These pathogens collectively accounted for 15% of all pneumonia cases
- Highest rates were observed among patients aged <1 year (18-166 cases per 100,000) and ≥70 years (23-201 cases per 100,000)
A 2021 study at Korle Bu Teaching Hospital found pneumonia was the main indication for antimicrobial prescribing at 18.4% of cases, followed by skin and soft tissue infections (11.4%) and sepsis (11.1%).
In North Queensland, a retrospective study (2000-2019) on bacteraemic cases of community-acquired Acinetobacter pneumonia identified 28 cases with an overall mortality of 28.6%.
Healthcare-Associated Pneumonia
A 2010 Hospital Infection Society prevalence survey across England, Wales, Northern Ireland and the Republic of Ireland reported:
- Overall prevalence of healthcare-associated infections: 7.59% (5743 out of 75,694)
- 15.7% of these infections were pneumonia
- 7.0% were lower respiratory tract infection other than pneumonia
- Pneumonia prevalence was higher for males than females
- Prevalence increased threefold from those aged <35 to those aged >85 years
Recent Epidemic Patterns
A 2023 study from Beijing reported four distinct epidemic waves of respiratory pathogens, with Mycoplasma pneumoniae as the first wave, followed by influenza viruses and SARS-CoV-2.
Environmental Factors
A 2024 nationwide study in China (2013-2019) found that ambient temperature impacts pneumonia mortality, with both low and high temperatures increasing pneumonia risks. The mortality attributable fraction for influenza-related pneumonia (29.78%) was the highest among pneumonia types.
Regional Burden
A 2017 literature review identified pneumonia and acute respiratory infections as leading causes of disease and death in the Eastern Mediterranean Region, though noting a lack of necessary data on the burden of acute respiratory diseases in the region.
While these studies provide valuable insights into specific aspects of pneumonia epidemiology, comprehensive global estimates of pneumonia incidence and prevalence are not available from the current research.
Economic Burden
Economic Burden of Treating Pneumonia in USA and Europe
United States
According to a 2023 study, the fully adjusted population-averaged cost for community-acquired pneumonia inpatients in US hospitals was $14,486 (95% confidence interval 13,982-14,867). This study examined adult pneumonia patients discharged between July 2010 and June 2015 from 260 US hospitals in the Premier database.
The research found that certain hospital practices significantly affected costs, including intensity of diagnostic work-up (+$14) and de-escalation of antibiotic therapy (+$6,836). Importantly, the study concluded that greater spending at the hospital level was not associated with lower mortality. Lower diagnostic costs were associated with lower overall care costs, suggesting that judicious use of diagnostic testing might reduce expenses without compromising patient outcomes.
For ICU-acquired pneumonia (including ventilator-associated pneumonia), a 2019 study noted that the economic burden is substantial. The increased costs are primarily related to longer periods of ventilatory assistance and extended ICU and hospital stays.
Europe
In Belgium, based on 2015 data, the annual average costs were €20.2 million for pneumonia and influenza (PI) hospitalizations and €274.6 million for respiratory and circulatory (RC) hospitalizations.
The average cost per hospitalization for PI in Belgium was €5,779 (2007 data), while for RC it was €6,111. These costs increased with complications (PI: €7,159, RC: €7,549). The average length of hospital stay for PI was 11.6±12.3 days, whereas for RC it was 9.1±12.7 days.
A 2018 study in Belgium estimated potential annual pneumonia hospital cost savings of €15.5 million using a log-linear exposure-response function and €34 million using a log-log exposure-response function if PM2.5 exposure was reduced from the mean (21.4μg/m³) to the WHO guideline (10μg/m³).
For Interstitial Lung Diseases (ILDs) in Europe (2016 data), which included pneumonia among the conditions studied, total mean annual per capita costs were €11,131 in the pooled cohort. Comorbidities significantly increased care costs, with pulmonary hypertension having a strong cost-driving effect (factor of 2.606 in pooled data).
Cost Drivers
Across all studies, the main cost driver for pneumonia treatment was inpatient cost. Most studies examining pneumonia costs did not account for indirect costs, though these can be substantial. In Belgium, the highest numbers of hospital admissions with primary diagnosis as PI were reported for the elderly patient group (n=10,184) followed by children below five years of age (n=3,451).
The economic impact of pneumonia varies significantly between countries, largely dependent on the different costs associated with healthcare systems and practices.
OneBreath™ Technology Clinical Trials Beyond Pneumonia
Based on the available information, there is insufficient data regarding clinical trials of OneBreath™ technology for indications other than pneumonia. The context does not provide specific details about:
- Additional respiratory conditions being investigated
- Non-pneumonia indications where OneBreath™ is being tested
- Intervention protocols for trials beyond pneumonia applications
- Treatment regimens for other respiratory conditions
- Clinical implementation models for alternative uses
The OneBreath™ respiratory therapy technology appears to have established applications for community-acquired pneumonia and hospital-acquired pneumonia, but information about expanded clinical trials for other respiratory conditions is not documented in the provided materials.
Without specific trial information, it's not possible to detail the intervention models, dosing protocols, treatment durations, or clinical parameters being evaluated for non-pneumonia applications of this technology.
Healthcare professionals interested in the broader applications of OneBreath™ technology would need to consult the most recent clinical trial registries, published research literature, or contact the technology developers directly for information about ongoing or planned investigations into additional therapeutic indications.