Apreo Health ® Announces Presentation of Clinical Data from the BREATHE 1&2 Trials at ATS 2025 and Publication of Six-Month Data in American Journal of Respiratory and Critical Care Medicine
MENLO PARK, Calif.--(BUSINESS WIRE)--Apreo Health, a clinical-stage medical device company developing a novel, tissue-sparing treatment for severe emphysema, today announced the presentation of first-in-human six-month clinical data from the BREATHE 1&2 trials in a late-breaking abstract session at the American Thoracic Society (ATS) 2025 International Conference in San Francisco. The study was simultaneously published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).
The BREATHE trials represent the first clinical evaluation of Apreo's BREATHE Airway Scaffold, a bronchoscopically delivered, self-expanding implant designed to relieve emphysema-related hyperinflation by releasing trapped air in the lungs. The studies enrolled 60 patients across five centers in Australia and Europe and evaluated safety, technical feasibility, and initial clinical outcomes over a six-month period.
"These first-in-human data demonstrate early feasibility, safety, and efficacy of the Apreo BREATHE Airway Scaffold,' said Professor Dirk-Jan Slebos, Head of Pulmonary Medicine & Tuberculosis at University Medical Center, Groningen, Netherlands, and presenter of the BREATHE first-in-human study data. 'We observed meaningful improvements in lung function, symptoms, and quality of life — all without the risk of pneumothorax. For patients who have historically had few or no interventional options, this represents a promising new path forward.'
'We are impressed by the initial outcomes of this first-in-human study and are looking forward to partnering with our global clinical colleagues as we work toward developing a meaningful, safe solution for these patients with advanced disease,' said Dr. Anand Tana, Clinical Researcher at the Royal Brompton Hospital, London, lead author of the AJRCCM article.
Key Six-Month Findings from the BREATHE 1&2 Studies
92.4% technical success rate in device placement
No post-procedural pneumothoraxes were observed
Mean reduction in residual volume (RV) of 753 mL from baseline at six months (p<0.0001)
Clinically meaningful improvements observed in lung function, quality of life, and exercise capacity irrespective of disease heterogeneity and collateral ventilation status
The most frequently reported serious adverse events were pneumonia (10%) and COPD exacerbation (5%). Importantly, no pneumothoraxes were observed during follow-up — a common complication with current endobronchial therapies. The safety profile was consistent with other interventional approaches for severe emphysema
'The data from this study reinforces our belief that the BREATHE Airway Scaffold has the potential to become a new standard of care for patients with emphysema-related hyperinflation,' said Karun Naga, CEO of Apreo Health. 'We're developing a minimally invasive, tissue-sparing solution designed to eliminate uncertainty in patient qualification due to disease pattern and collateral ventilation and to relieve the burden of this disease on our healthcare system by enabling a more efficient treatment pathway. We are very grateful to these leading research institutions and investigators for their partnership and look forward to advancing this therapy to the next phase of clinical development.'
The AJRCCM publication, titled 'Airway Scaffolds for Emphysema-Related Hyperinflation - Six-Month Results from the BREATHE trial," is available online here.
About Apreo Health
Apreo Health is a clinical-stage medical device company redefining the role of intervention in severe emphysema. Built at The Foundry, an acclaimed medtech venture incubator, funded by a prestigious syndicate of venture capital investors and led by a team with deep medtech and pulmonary expertise, Apreo is developing the BREATHE Airway Scaffold — a tissue-sparing therapy designed to expand access to meaningful treatment.
About Chronic Obstructive Pulmonary Disease & Emphysema
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death and the eighth leading cause of poor health worldwide, according to the World Health Organization (WHO). The U.S. Centers for Disease Control and Prevention (CDC) estimates that nearly 16 million Americans have been diagnosed with COPD, with millions more undiagnosed. Emphysema, a severe form of COPD characterized by the destruction of lung air sacs, affects approximately three million people in the U.S. and is a leading contributor to COPD-related disability and mortality.
About BREATHE 1&2 Trials
The BREATHE (Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung) studies were commenced in 2023 in Australia (BREATHE-1) and Europe (BREATHE-2). Apreo partnered with world-renowned COPD research institutions to evaluate safety and feasibility of the BREATHE Airway Scaffold. Efficacy across pulmonary function, quality of life, and exercise capacity outcomes was also evaluated.
About BREATHE Airway Scaffold
The BREATHE (Bronchoscopic RElease of Air THErapy) Airway Scaffold is a lung implant designed to release air from a hyperinflated lung associated with severe emphysema. The proprietary scaffold is uniquely designed to resist foreign body reaction and promote durability of effect. The device was granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in May 2024.
The BREATHE Airway Scaffold is an Investigational Device - Limited by Federal (or United States) law to investigational use. Exclusively for Clinical Investigations.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
2 days ago
- Yahoo
Stanford Health join forces with Kivo Health for AI-driven pulmonary rehab
Academic medical centre Stanford Health Care has announced a collaboration with Kivo Health to enhance AI-driven virtual pulmonary rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) patients. Pulmonary rehabilitation, a critical component of COPD management, leads to reduced hospitalisations by up to 56%. However, access remains limited, with less than 3% of eligible patients receiving this vital treatment. The partnership with Kivo Health aims to enable several patients to complete pulmonary rehabilitation from home, thus enhancing COPD outcomes. Kivo Health CEO Victor Sadauskas said: 'This collaboration reflects a bold commitment to evidence-based innovation, health equity, and value-based care. 'Together, we are transforming how COPD is managed—expanding access, improving outcomes, and dramatically reducing avoidable hospitalisations for one of the most underserved, highest-cost chronic conditions in the US.' Stanford Health Care is a component of Stanford Medicine, which encompasses the Stanford University School of Medicine, Stanford Health Care, and Stanford Children's Health, including Lucile Packard Children's Hospital. Stanford Health Care Digital Health senior director Leah Rosengaus said: "We are thrilled to collaborate with Kivo Health to bring virtual pulmonary rehabilitation to our COPD patients. "We are dedicated to enhancing access to care, and believe innovative solutions like virtual pulmonary rehabilitation provide patients with new channels to connect to services, and support healing in the comfort of home.' Stanford Health Care delivers clinical innovation across its speciality health centres, inpatient services, physician offices, virtual care offerings as well as health plan programmes. In April 2021, Stanford Health Care selected Experience Management (XM) provider Qualtrics to overhaul its patient experience programme. "Stanford Health join forces with Kivo Health for AI-driven pulmonary rehab" was originally created and published by Hospital Management, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Time Magazine
2 days ago
- Time Magazine
Can Air Conditioning Make You Sick?
At the height of the tuberculosis epidemic in the 19th century, doctors began advising people to venture outside to escape the ' bad air ' in their homes. In the 1960s, by contrast, AC became widespread in the U.S., increasing the appeal of staying inside. These days, many of us—the so-called ' indoor generation '—spend summer mostly inside, relying on AC to beat the heat. This technology saves lives; our sealed, climate-controlled spaces keep us healthy during dangerous heat waves. AC also helps many people avoid pollution outside. But did the 19th century physicians have a point about the downsides of stale indoor air? It depends. 'Multiple studies show that spending too much time in air-conditioned rooms can lead to more respiratory symptoms,' says Dr. William Checkley, a pulmonary and critical care physician and professor of medicine at Johns Hopkins School of Medicine. Here are the benefits, risks, and simple ways to make AC healthier this summer. The many benefits of AC AC is key to getting through summertime without a heat-related illness—or worse. 'The statistics on deaths from extreme heat are shocking, especially for the elderly and immunocompromised,' says Jeffrey Siegel, professor of civil engineering at the University of Toronto. From 1999 to 2023, heat-related deaths in the U.S. doubled. AC's benefits go beyond its cooling effect. A well-working AC system filters the air to reduce intake of dust, pollen, and airborne pathogens, Checkley says. AC is also critical in areas with pollution. Its filters can cleanse the air of particulate matter 2.5, a toxin shed in vehicle exhaust, industrial activity, and wildfires. Research shows that PM2.5 enters homes and contributes to heart and lung disease—but these effects aren't as severe in places with more AC use. 'Every time the AC system operates, it's pulling some particles out of the air,' says Brent Stephens, professor of civil, architectural, and environmental engineering at Illinois Institute of Technology. Cranking up the AC also makes the air less humid, reducing the dampness that contributes to bacterial growth, mold, and dust mites, which can contribute to—or, in rare cases, even cause—conditions like pneumonia, asthma, and COPD. Too much of a good thing Now, some big caveats. If you overdo it with AC, the air becomes too dry. If you're inhaling a lot of dry air, the human body adds water vapor to the inhaled air to maintain your internal humidity level, Checkley says. When you exhale, that moist air leaves your body with every breath. Ultimately, this dries out your respiratory tract, Checkley explains. The airways become irritated and inflamed, causing coughs, sore throat, and nasal congestion—a condition known as ' sick building syndrome.' Another consequence of air that's too dry: the lungs' natural defenses to microbes weaken, increasing susceptibility to disease, especially among kids and the immunocompromised. Viruses may be more likely to circulate in drier conditions. Think of how often people get sick right after long trips inside a dry airplane. It's the same effect in people's homes or offices. This may seem like a no-win situation: dampness leads to mold and dustmites, and dryness leads to cold-like symptoms and disease. However, there's a sweet spot. 'The ideal humidity in a home is between 40% and 60%,' Checkley says. Bacteria and viruses thrive both below and above these thresholds. 'There are indoor air conditions we can't perceive, which can be good or bad for us—it's not all about comfort,' says Dr. Stephanie Taylor, a clinician and consultant on healthy indoor environments. So how do you keep your home in the optimal humidity zone? Checkley advises buying a thermostat with a humidity sensor, called a hygrometer, to track the level. Many are inexpensive yet accurate. If humidity drops below 40%, give the AC a rest. If humidity tops 60%, crank it back up. Maintain your unit The AC may also pose health risks if it's working sub-optimally, even if it's not outright broken. 'What really matters is the condition of your air conditioning,' Siegel says. Much of this comes down to homeowner fundamentals like remembering to change your AC filter. With an old dirty filter, the AC coil and ducts could become 'cesspools of mold, bacteria, and allergens,' Taylor explains—which tag along with the AC's airflow. Slide in new filters every 1-2 months during peak AC use. The cost of additional filters is worth keeping up your home's air quality, Checkley says. Look for filters with minimum efficiency reporting value (MERV) ratings of 11 or 13. They're effective at trapping dust, mold, and other particles. In addition, calendar a yearly visit from an HVAC specialist. 'People think of AC as this magic black box that makes cold,' Siegel says. 'We only think about servicing it when it's not making cold anymore.' Even if the cold magic still works, a specialist should occasionally inspect the coil and ducts to ensure they're clean. In addition to regular assessments, get one after any major leak or other moisture problem, which can result in a dirty coil, Siegel adds. You can also install a UV light in your AC system. This device emits radiation that damages the cells of microorganisms like bacteria and mold—keeping the coil and interior components clean. Quality varies; make sure to work with a reputable manufacturer and contractor, and choose a light with a safety certification from UL or ETL, two independent organizations that test and certify products like lights for safety. Lights without these certifications may generate harmful byproducts, Taylor notes. Proper AC maintenance will also amplify AC's benefits, like thinning out PM2.5 from the air. 'With a decent filter, you reduce exposure to a ton of things we know have very serious health effects,' Siegel says. For a window AC, don't move it straight from the closet to the window when summer starts. 'Open it up and clean it first,' Taylor says. Use air purifiers Although your AC can—if it's working on all cylinders—clean PM2.5 pollution from outdoor sources, it does not clean another type of toxin that originates inside the home: volatile organic compounds, or VOCs. If the AC is on constantly, and you rarely open windows, your air may be rife with these chemicals. Potentially harmful VOCs are emitted by many home products such as furniture, cleaning supplies, and air fresheners. They've been linked to headaches, throat irritation, hormone disruption and, with long-term exposure, chronic diseases. VOCs play a role in what experts increasingly view as a building's microbiome, Taylor says. Indoor spaces, just like the human body, harbor communities of bacteria, fungi, and other microbes. With optimal humidity and AC maintenance, your indoor microbiome supports healthier, more diverse microbes. But VOCs can suppress or kill these microbes and promote the growth of pathogenic strains and imbalanced communities. Counter toxic VOCs by occasionally turning off the AC and opening windows. Indoor air has 2 to 5 times more VOCs than outdoor air, Stephens says. Another strategy: buy a portable HEPA air purifier. The best versions have carbon filters with porous surfaces that trap the gas molecules of VOCs, taking them out of the air. Purifiers also help remove about 50% of PM2.5. Stephens has one purifier on each level of his townhome. He keeps the purifiers' fan speeds on low or medium constantly to filter the air without having to think about it—but changes the speed to high when there's pollution, such as during rush hour when PM2.5 comes from outside, or when he's cleaning with chemicals that produce VOCs inside. VOC levels may be higher if your home is tightly sealed, trapping the chemicals inside. 'Every home is an absolute unicorn,' Stephens says. A professional air sampling measures VOCs. A number of VOC monitors are also available for people to buy, but Stephens says these consumer-grade devices can't detect levels of specific VOCs, so they won't tell you the potential toxicity or health risk. However, he adds that low-cost monitors for particles like PM2.5 have become much more accurate in recent years. An even less expensive, relatively simple humidity monitor combined with good AC maintenance will help ensure that you stay both cool and healthy this summer.
Medscape
2 days ago
- Medscape
Women With ILD Fare Better After ICU Care
Women admitted to ICU for interstitial lung disease (ILD) had shorter hospital stays and a lower risk for death than men, based on a new analysis of more than 800,000 individuals. Although previous studies have shown gender-based disparities in disease progression and severity for ILD based on subtype, data on the effect of gender on ICU outcomes in these patients are limited, according to Matthew Viggiano, MD, an internal medicine resident at Temple University Hospital, Philadelphia, and colleagues. In a study presented at the American Thoracic Society (ATS) 2025 International Conference, the researchers analyzed data from the National Inpatient Sample (NIS), part of the Healthcare Cost and Utilization Project for the period from 2016 to 2018. They identified 810,295 adults aged 18 years or older hospitalized with ILD, of whom 42,080 received ICU care. Of these, 46.7% were women. Female patients were significantly younger than male patients (mean age, 66.9 vs 69.1 years), more likely to be African American (17.0% vs 10.9%), and less likely to be Caucasian (63.7% vs 69.2%; P < .001 for all). Mortality was significantly lower in women than in men (40.5% vs 48.1%) even after adjusting for confounders including age, race, and comorbidities, and this difference was the most striking finding, Viggiano said in an interview. 'It also surprised us that these women tended to have a shorter length of hospital stay, given many came from lower-income areas,' he said. ICU stays were defined using International Classification of Diseases (ICD) codes for central line placement and mechanical ventilation. Overall, hospital stays for female patients lasted 1.15 days less than hospital stays for male patients. Female patients also were significantly more likely than male patients to come from lower-income ZIP codes (38.3% vs 33.2%) and less likely to have a history of tobacco use disorder (35.0% vs 43.9%; P < .001 for both). The reasons for the disparities remain unclear, but new studies suggest that hormones may play a role in disease progression and severity, Viggiano told Medscape Medical News . 'For example, estrogen has been implicated in modulating immune responses and fibrotic processes in the lungs via downregulating profibrotic pathways,' he said. 'Additionally, women may have lower threshold to seek medical attention or follow-up, leading to earlier intervention and management of ILD,' he noted. Other comorbidities unrelated to ILD also may contribute to morbidity and hospital length of stay, he added. 'Overall, recognizing these disparities is a key step toward more personalized treatment strategies, and our hope is that this research will prompt further studies to fully understand and address the underlying causes,' said Viggiano. Not Time for Gender Neutral Treatments Although the results suggest that clinicians should be aware that gender could influence ILD prognosis, the data do not suggest a need to advocate for entirely separate protocols as yet, Viggiano said. 'Instead, we encourage clinicians to recognize that men may have unique risk factors and might require more aggressive monitoring or early interventions; further studies will help refine specific management strategies,' he said. 'We believe evaluating for mortality and hospital stay in different subtypes of ILD would be an immediate future direction for the project,' said Viggiano. The investigation of specific biological, immunologic, and social factors also must be an area of focus, he said. 'Understanding why women fare better could lead to targeted therapies, especially for men who are at higher risk of poor outcomes, and ultimately to more personalized approaches to ILD care,' he added. To that end, Viggiano and colleagues intend to conduct prospective studies to explore specific biological markers and social determinants in men and women with ILD. 'We'll also look at the influence of treatment interventions, medication use, and rehabilitation services on outcomes. Ultimately, we'd like to identify targeted strategies to reduce the mortality gap and enhance care for both genders,' he told Medscape Medical News . Data Reinforce Differences 'As more treatments for interstitial lung diseases emerge, it is important that we now start focusing on which populations get the greatest benefit for specific treatments,' said Anthony Faugno, MD, a pulmonologist at Tufts Medicine, Boston, in an interview. To that end, the authors of the current study used data from the NIS to ask important questions about how sex, demographics, and socioeconomic factors affect patient outcomes, said Faugno, who was not involved in the study. Were You Surprised by Any of the Findings? Why or Why Not? Biologically important differences in hormones between men and women are known to affect the way a given disease behaves; therefore, it is important to have representative samples of diverse sex and race in clinical trials to ensure the generalizability of therapy, Faugno told Medscape Medical News . The current study findings were not surprisingbut reinforce the value of a diverse population using a large, nationally representative sample, he said. The current study findings may not directly affect clinical practice, as the results were based on ICD codes that cover many different diagnoses, Faugno noted. However, as the authors suggest, 'I do think it informs additional research directions, such as doing a similar analysis in specific interstitial diseases,' he said. The current study addresses a global catch-all term of ILD, which may include many different pathologies that respond to different treatments, said Faugno. 'A future analysis that addressed the gender disparities in more specific diagnoses would add to our understanding and help patients better understand how they may respond to a specific therapy,' he said.
