Recently, a research team from the Institute for Precision Medicine at Tsinghua University, in collaboration with the First Medical Center of the Chinese PLA General Hospital (301 Hospital), the Department of Respiratory Medicine of the First Affiliated Hospital of Hainan Medical University, and Capital Medical University, published a landmark study in the international authoritative journal Signal Transduction and Targeted Therapy (a Nature sub-journal). The study, entitled “Clinical investigation on nebulized human umbilical cord MSC-derived extracellular vesicles for pulmonary fibrosis treatment,” systematically evaluated the safety and efficacy of nebulized human umbilical cord mesenchymal stem cell–derived extracellular vesicles (hUCMSC-EVs) in the treatment of pulmonary fibrosis.

Pulmonary Fibrosis

Pulmonary fibrosis is a chronic, progressive interstitial lung disease characterized by abnormal scar deposition in lung tissue, leading to thickening and stiffening of the lungs and impaired gas exchange. As the disease progresses, patients typically experience shortness of breath, persistent cough, and fatigue. The pathological process is believed to involve a cascade of inflammatory responses triggered by the activation of immune cells such as macrophages and T cells.

Pulmonary fibrosis is considered to result from multiple factors, including environmental exposure, autoimmune diseases, genetic predisposition, medications, and viral infections. Among these, viral infections such as influenza and coronaviruses are regarded as important triggers, as they can directly damage lung tissue or induce immune and fibrotic responses, exacerbating chronic inflammation and ultimately leading to progressive and difficult-to-treat disease.

Research Findings

The study established a rigorous manufacturing system to produce high-quality hUCMSC-EVs and performed comprehensive characterization at the levels of miRNA, proteins, and metabolites. Following nebulized inhalation, hUCMSC-EVs were found to predominantly accumulate in the lungs of mice and significantly alleviated bleomycin-induced pulmonary fibrosis. Notable outcomes included an increase in survival rate from 20% to 80%, restoration of lung volume, reduced lung injury, improved oxygen saturation, and enhanced pulmonary function parameters.

Clinically, the researchers conducted a randomized, single-blind, placebo-controlled Phase I trial (MR-46-22-004531, ChiCTR2300075466) involving 24 patients with pulmonary fibrosis. All participants tolerated nebulized hUCMSC-EV therapy well, with no serious adverse events reported. Patients receiving nebulized hUCMSC-EVs in combination with standard treatment showed significant improvements in pulmonary function indicators—such as forced vital capacity and maximal voluntary ventilation—as well as in respiratory health status, assessed by the St. George’s Respiratory Questionnaire and the Leicester Cough Questionnaire. Overall, patients receiving the combined therapy demonstrated markedly greater benefits than those receiving standard treatment alone.

Notably, two patients with advanced post-inflammatory pulmonary fibrosis showed clinically significant lesion regression on consecutive CT imaging after treatment. These findings suggest that nebulized hUCMSC-EVs represent a safe and promising novel therapeutic approach for pulmonary fibrosis and potentially other pulmonary diseases.

Feellife Supports Exosome Nebulization Research

This study demonstrates that nebulized hUCMSC-EV therapy can improve patient outcomes and can be used in combination with existing treatment regimens. It opens new avenues for the treatment of pulmonary fibrosis and offers renewed hope for improved recovery and quality of life for patients.

However, the biological properties of exosomes are highly complex, and their cargo varies significantly depending on their source and production conditions. Ensuring the stability, bioactivity, and reproducibility of exosomes, and successfully translating them from laboratory research into clinical applications, remain key challenges in this field.

Feellife has long been dedicated to the development and clinical application of vibrating mesh nebulization technology, continuously exploring more precise and safer pulmonary drug delivery solutions. Looking ahead, Feellife will work closely with research institutions and clinical teams to further advance the application of exosome nebulization in pulmonary diseases and provide technical support for clinical translation. We believe that, through innovative nebulization technologies and open scientific collaboration, exosome-based therapies will soon become a powerful force in improving pulmonary health, bringing new hope and possibilities to patients with respiratory diseases worldwide.

Feellife acquires an exciting development in our ongoing journey toward excellence in medical device manufacturing. A total of 78 more products in our portfolio have recently received certification under the European Union Medical Device Regulation (EU MDR), one of the world’s most demanding regulatory systems. This accomplishment underscores our unwavering dedication to delivering high-quality, compliant, and trustworthy medical solutions to healthcare professionals and patients around the world.

Introduced to enhance patient safety and improve the performance of medical devices across Europe, the EU MDR (Regulation (EU) 2017/745) represents a significant shift from the previous MDD (Medical Device Directive). It places a strong emphasis on clinical evaluation, traceability, post-market monitoring, and a comprehensive approach to risk management.

To meet the MDR’s strict requirements, each of the 78 newly certified Feellife products underwent extensive evaluation, including:

In-depth Clinical Validation: Demonstrating that each device performs safely and effectively in real-world settings.

Robust Risk Analysis: Identifying and mitigating all potential hazards throughout the product lifecycle in line with international standards.

Certified Quality Management Systems: Ensuring that Feellife’s manufacturing and operational processes adhere to ISO 13485 and are consistently reviewed by notified bodies.

Comprehensive Technical Documentation: Compiling evidence that the products conform to all applicable safety and performance requirements.

Achieving this level of compliance is not only a technical success but also a strategic one. It enables Feellife to enhance its presence in the European market and strengthens our partnerships with distributors, clinics, hospitals, and patients who demand the highest standards of quality and safety.

It reinforces our promise to provide safe, effective, and innovative products that meet the evolving needs of global healthcare systems.

As the global healthcare landscape continues to evolve, regulatory expectations are becoming more rigorous. Feellife not only embraces these higher standards—we are actively advancing them through continual investment in compliance, innovation, and user-centered design.

When Breath Becomes a Galaxy: A New Era of Smart Respiratory Care Begins

A revolution in medical experience has begun—where breath transforms into stardust trails, and cutting-edge innovation meets aesthetic elegance. Yesterday, the AeroIns+ StarSmart Nebulizer by Feellife was honored with the 2025 Red Dot Award: Product Design, thanks to its groundbreaking AiMesh® technology and Air 360® respiratory sensing system.

This marks Feellife’s third major international design recognition, following the French Design Awards and the International Design Awards (IDA), solidifying China’s presence in the global innovation arena and redefining the future of respiratory health management.

Red Dot Award: The Ultimate Trial by Design

The Red Dot Award, often dubbed the "Oscars of industrial design," is known for its rigorous evaluation based on innovation, functionality, aesthetic quality, and human-centered design. In 2025, AeroIns+ stood out among over 10,000 entries from more than 60 countries—becoming the first medical nebulizer to receive this prestigious accolade this year.

Core Technologies: Redefining Efficiency and Empathy in Nebulization

1. AiMesh® – Intelligent Mesh Nebulization Technology
Feellife’s proprietary bio-elastic mesh features a bionic honeycomb structure that’s highly durable and rupture-resistant under vibration. It ensures smooth atomization, reduces liquid waste, prevents clogging, and guards against dry burning—delivering every drop with precision and safety.

2. Air 360® Respiratory Sensing – Teaching Machines to Breathe
Equipped with advanced breathing sensors, AeroIns+ detects real-time breathing patterns and automatically adjusts nebulization output, creating a truly personalized treatment experience.

3. StarSmart Interface – Turning Data Into Art
The world's first interactive nebulizer screen inspired by dynamic starlight. As you inhale and exhale, your respiratory data transforms into mesmerizing particle trails—turning treatment into an interstellar journey.

4. Bluetooth 5.0 + iBreathe® App Integration
Instant connection to the iBreathe® app allows users to generate detailed 3D respiratory health maps. Dr. Laura from Bologna Hospital, Italy, calls it "a flawless fusion of medical precision and digital artistry."

From Europe's Hospitals to Global Homes

With a mission to pioneer the “third pathway for drug delivery,” Feellife has already secured over 250 global patents and certifications. Its AiMesh®-powered devices, including the clinical-grade AirICU, are now used in ICUs across more than 40 countries, marking a significant milestone in respiratory therapeutics.

Behind the Breakthrough: 2000 Hours Under the Stars

To perfect the cosmic interface, Feellife’s R&D team camped in high-altitude regions to capture authentic star trail data. Every detail—from the tactile feel of silicone buttons to the visual dynamics of the interface—was fine-tuned through over 1,000 blind user tests, all in pursuit of harmony between design and empathy.

AeroIns+ is not just a medical device—it's a vision of the future, where breath, technology, and beauty converge.

Intravenous milrinone, a phosphodiesterase inhibitor and inodilator, has long been used in cardiac surgery to manage pulmonary hypertension (PH), especially during challenging separations from cardiopulmonary bypass (CPB). A notable disadvantage of intravenous milrinone is its potential to cause systemic hypotension. To mitigate this risk, inhalation has been proposed as an alternative method of administration. Pulmonary drug delivery offers benefits such as rapid absorption, high bioavailability, and increased local concentrations. Over the past decade, it has been hypothesized that inhaling milrinone before CPB could protect against the worsening of PH in cardiac surgery patients by reducing CPB-induced inflammation, preventing pulmonary endothelial dysfunction, and easing CPB separation. A multicenter randomized controlled trial confirmed the clinical efficacy of inhaled milrinone in lowering PH levels, though it did not show a reduction in the difficulty of CPB separation. Several factors, including suboptimal drug delivery, may account for these findings.

Nebulizers are commonly used for aerosol therapy in patients with pulmonary conditions. These devices work by converting liquid medications into fine, breathable droplets. There are three main types of nebulizers: jet, ultrasonic, and mesh. While ultrasonic and mesh nebulizers have been used in four clinical studies involving inhaled milrinone, jet nebulizers have typically been the standard for drug delivery in adult cardiac patients. Jet nebulizers operate by using a high-velocity jet of compressed gas (air or oxygen) to draw and shear the solution into aerosol droplets of various sizes. Ultrasonic nebulizers, on the other hand, use a high-frequency vibrating piezoelectric element to generate ultrasonic waves, breaking the solution into small aerosol droplets at the surface. Recent advancements in nebulization technology have led to the development of mesh nebulizers, which use a multi-aperture vibrating mesh (up to 10,000 apertures) to force the solution through holes, creating a high proportion of fine aerosol droplets. Over the past decade, mesh nebulizers have become increasingly popular, particularly for aerosol therapy in mechanically ventilated patients. These devices offer numerous advantages, including portability due to their compact design, no need for secondary airflow or liquid heating, and high efficiency in delivering drugs to the lungs with minimal waste.

This study on inhaled milrinone presents results from a randomized controlled pilot trial involving cardiac surgical patients undergoing CPB. The study had two main objectives: first, to assess the early plasma concentrations of milrinone in patients after both types of nebulization; and second, to determine whether systemic exposure in vivo was consistent with the inhaled dosing observed in vitro. It was hypothesized that milrinone delivered via mesh nebulization, with its smaller particle size, would result in higher early plasma levels compared to jet nebulization.

References

1Doolan, L. A., Jones, E. F., Kalman, J., Buxton, B. F. & Tonkin, A. M. A placebo-controlled trial verifying the efcacy of milrinone in weaning high-risk patients from cardiopulmonary bypass. J. Cardiothorac. Vasc. Anesth. 11, 37–41 (1997).

2. Solina, A. et al. A comparison of inhaled nitric oxide and milrinone for the treatment of pulmonary hypertension in adult cardiac surgery patients. J. Cardiothorac. Vasc. Anesth. 14, 12–17 (2000). 

3. Feneck, R. O., Sherry, K. M., Withington, P. S., Oduro-Dominah, A. & European Milrinone Multicenter Trial Group. Comparison of the hemodynamic efects of milrinone with dobutamine in patients afer cardiac surgery. J. Cardiothorac. Vasc. Anesth. 15, 306–315 (2001). 

4. Solina, A. R. et al. Dose response to nitric oxide in adult cardiac surgery patients. J. Clin. Anesth. 13, 281–286 (2001). 

5. Jaski, B. E., Fifer, M. A., Wright, R. F., Braunwald, E. & Colucci, W. S. Positive inotropic and vasodilator actions of milrinone in patients with severe congestive heart failure. Dose-response relationships and comparison to nitroprusside. J. Clin. Invest. 75, 643–649 (1985). 

6. Cufe, M. S. et al. Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial. JAMA 287, 1541–1547 (2002). 

7. Couture, P., Denault, A. Y., Pellerin, M. & Tardif, J. C. Milrinone enhances systolic, but not diastolic function during coronary artery bypass grafing surgery. Can. J. Anesth. 54, 509–522 (2007).

Results showed that after mesh nebulization, the mean in vitro inhaled dose was nearly three times higher than after jet nebulization (46.4% vs. 16.6% for mesh and jet, respectively; mean difference, 29.8%; 95% CI, 14.1 to 45.5; P= 0.006). Consistent with this, early plasma concentrations in vivo were also 2–3 times higher after mesh nebulization (P= 0.002–0.005). Following both types of inhalation (jet or mesh nebulization), milrinone's early plasma concentrations remained within the therapeutic range, and no instances of systemic hypotension were reported in the patients.

Introduction

In China, the prevalence of paediatric asthma has increased over the past 20 years and is now approximately 3%. The long-term goals of asthma management according to the Global Initiative for Asthma (GINA) 2020 update are to improve and individualize the care of patients with asthma so that patients are able to achieve good control of symptoms and maintain normal activity levels, and have minimized risk of: asthma-related death, exacerbations, persistent airflow limitation and side effects.3The 2020 GINA guidelines suggest that poor adherence can be identified in clinical practice by empathic questioning that encourages open discussion, and acknowledges the probability of incomplete adherence. For optimal control of chronic diseases such as asthma, long-term adherence to treatment is required. If symptom control is poor and/or exacerbations persist despite 3 months of controller therapy, before considering a step-up of controller treatment, the relationship of symptoms to asthma should be confirmed, inhaler technique checked, good adherence confirmed or for children under 5-years old, an alternative treatment considered.

Methods

The CARE study was a 12-week, multicentre, prospective, observational study across 12 tertiary hospitals in China. Patients were aged 0–14 years, clinically diagnosed with asthma and prescribed home nebulizer inhaled corticosteroid (ICS) therapy for ⩾3 months. The primary endpoint was electronically monitored treatment adherence. Patients attended onsite visits at 0, 4, 8 and 12 weeks to assess asthma control, severity and treatment adherence (recorded by electronic monitoring devices and caregivers).

Results

The full analysis set included 510 patients. Median treatment adherence reported by electronic monitoring devices was 69.9%, and median caregiver-reported adherence was 77.9%. The proportion of patients with well-controlled asthma increased from 12.0% at baseline to 77.5% at visit 4. Increased time between asthma diagnosis and study enrolment was a significant predictor for better adherence [coefficient: 0.01, p = 0.0138; 95% confidence interval (CI): 0.00, 0.01] and asthma control (odds ratio = 1.001, p = 0.0498; 95% CI: 1.000, 1.002). Negative attitude to treatment by the caregiver was associated with poorer asthma control.

Discussion

To the best of our knowledge, this study is the first multicentre real-world study in China to record adherence to home nebulization of ICS treatment in asthmatic children using electronic monitoring devices.

In the present study, the median treatment adherence rate reported by portable home nebulizer devices was 69.9%, which compares favourably with many previous reports among children in other regions worldwide: the median electronically monitored adherence was 58.4% and 46%, respectively, in two studies in the USA, changing from 54% and 41% at month 4 to 47% and 31.5% at month 12 in patients with controlled and uncontrolled asthma, respectively, in a study from Brazil,16 and 49.5% in a study from The Netherlands. Results of the present study also compared favourably with other studies in China investigating treatment adherence in patients with asthma (adults or children). Furthermore, the World Health Organization reported that mean adherence was approximately 50% based on key studies in adults and children. Most of these studies reported adherence to metered-dose inhaler (MDI); comparatively, this results suggest that a home nebulizer device may facilitate better treatment adherence in paediatric patients.

Conclusion

Results of this study show that the rate of adherence to home nebulizer treatment in Chinese paediatric patients is good relative to prior reports in other countries and compared with other methods of ICS delivery. Furthermore, GINA-defined asthma control improved as the duration of treatment increased. We conclude that home nebulization of ICS is an effective long-term treatment method for paediatric patients with asthma.

Reference

1. Guo X, Li Z, Ling W, et al. Epidemiology of childhood asthma in mainland China (1988–2014): a meta-analysis. Allergy Asthma Proc 2018; 39: 15–29.

2. Hong J, Bao Y, Chen A, et al. Chinese guidelines for childhood asthma 2016: major updates, recommendations and key regional data. J Asthma 2018; 55: 1138–1146.

3. Global Initiative for Asthma. Global strategy for asthma management and prevention

4. Coutts JA, Gibson NA, Paton JY. Measuring compliance with inhaled medication in asthma. Arch Dis Child 1992; 67: 332–333.

5. Jentzsch NS, Camargos PA, Colosimo EA, et al. Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods.

6. Milgrom H, Bender B, Ackerson L, et al. Noncompliance and treatment failure in children with asthma. J Allergy Clin Immunol

7. Boulet LP, Vervloet D, Magar Y, et al. Adherence: the goal to control asthma. 

November 20, 2024, marks the 23rd World COPD Day, with this year's theme, Know Your Lung Function. Lung function testing is a key method for diagnosing chronic obstructive pulmonary disease (COPD) and plays a crucial role in its early detection and prevention.

Chronic obstructive pulmonary disease (COPD) is a persistent lung condition resulting from lung damage. This damage leads to inflammation, or swelling and irritation, within the airways, restricting airflow in and out of the lungs—referred to as obstruction. Common symptoms include difficulty breathing, a daily mucus-producing cough, and a tight, whistling sound known as wheezing.

COPD is primarily caused by prolonged exposure to irritants such as smoke, fumes, dust, or chemicals, with cigarette smoke being the leading cause.

The two main forms of COPD are emphysema and chronic bronchitis, which often occur together but can vary in severity among individuals. Chronic bronchitis involves inflammation of the bronchi, the tubes that carry air into the lungs. This inflammation hinders airflow and results in excessive mucus production. In emphysema, the tiny air sacs in the lungs, called alveoli, are damaged, reducing their ability to transfer oxygen to the bloodstream.

Although COPD tends to worsen over time, it is manageable. With effective treatment, many people with COPD can control their symptoms, enhance their quality of life, and reduce the risk of complications like heart disease and lung cancer.

Feellife offers a comprehensive solution for respiratory health management through its innovative medical equipment. Its diverse range of core products—including pulmonary function meters, spirometry trainers, respiratory meters, and portable oxygen concentrators, each with unique functions and features—collectively supports the scientific prevention and treatment of COPD.

Management of acute exacerbations in emergency care primarily depends on nebulizers. Although jet nebulizers (JN) have been traditionally used, vibrating mesh nebulizers (VMN) are now being implemented.

A study compares aerosols generated by VMN with NIV and pulmonary deposition and distribution across regions of interest with administration of radiolabeled aerosol with jet nebulizer (JN) during NIV.

Methods

A crossover single dose study involving 9 stable subjects with moderate to severe COPD randomly allocated to receive aerosol administration by the VMN and the jet nebulizer operating with oxygen at 8 lpm during NIV. Radiolabeled bronchodilators (fill volume of 3 mL: 0.5 mL salbutamol 2.5 mg + 0.125 mL ipratropium 0.25 mg and physiologic saline up to 3 mL) were delivered until sputtering during NIV (pressures of 12 cmH2O and 5 cmH2O - inspiratory and expiratory, respectively) using an oro-nasal facemask. Radioactivity counts were performed using a gamma camera and regions of interest (ROIs) were delimited. Aerosol mass balance based on counts from the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory filters, and mask were determined and expressed as a percentage of the total.

Results

Both inhaled and lung doses were greater with VMN (22.78 ± 3.38% and 12.05 ± 2.96%, respectively) than JN (12.51 ± 6.31% and 3.14 ± 1.71%; p = 0.008). Residual drug volume was lower in VMN than in JN (3.08 ± 1.3% versus 46.44 ± 5.83%, p = 0.001). Peripheral deposition of radioaerosol was significantly lower with JN than VMN.

Intragroup analysis of radioaerosol pulmonary index for ROI across vertical and horizontal gradients is shown in Table below

When analyzing intergroup deposition in different ROI across vertical and horizontal gradients, we found that NIV + VMN group had higher counts in comparison to NV + VMN group, as shown in Table below.

The percentage of inhaled mass was significantly higher in NIV + VMN group when compared to NIV + JN group (19.90 ± 3.18% versus 7.03 ± 2.97%, p = 0.008). VMN presented a lower residual volume (3.20 ± 1.33% versus 48.53 ± 6.40%, p = 0.008) and more radioaerosol deposited in the face mask and upper airways, in comparison to jet nebulizer during NIV. The JN demonstrated greater deposition in the expiratory filter than the VMN device. No differences were found regarding to mass balance found in the stomach, circuit and inspiratory filter for either group. Table represent the mass balance obtained in each compartment from both groups and mass balance of aerosol across pulmonary, extrathoracic and device compartments.

Conclusion

This study found more than 3-fold aerosolized particles from the total dose of 3 mL of solution charged into the VMN in comparison to JN. Further randomized controlled trials are necessary to evaluate clinical response to the increased level of aerosol deposition obtained from VMN and its impact to relieve respiratory discomfort and dynamic hyperinflation in COPD, as well as to develop recommendations for the use of this resource.

Reference

[1] Global Initiative for Chronic Obstructive Lung disease (GOLD), Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease, (2013) available from: http://www.goldcopd.org/ , Accessed date: 3 April 2013.

[2] P. Haidl, S. Heindl, K. Siemon, M. Bernacka, R.M. Cloes, Inhalation device requirements for patients' inhalation maneuvers, Respir. Med. 118 (2016) 65–75.

[3] D. Hochrainer, H. Hӧlz, C. Kreher, L. Scaffidi, M. Spallek, H. Wachtel, Comparison of the aerosol velocity and spray duration of Respimat Soft Mist inhaler and pressurized metered dose inhalers, J. Aerosol Med. 18 (3) (2005 Fall) 173–282.

[4] V.G. Press, V.M. Arora, L.M. Shah, S.I. Lewis, K. Ivy, J. Charbeneau, et al., Misuse of respiratory inhalers in hospitalized patients with asthma or COPD, J. Gen. Intern.Med. 26 (6) (2011 Jun) 635–642.

[5] W. Vincken, P.R. Dekhuijzen, P. Barners, The ADMIT series – Issues in inhalation therapy. 4) How to choose inhalers devices for the treatment of COPD, Prim. Care Respir. J. 19 (1) (2010 Mar) 10–20.

[6] C. Leach, G.L. Colice, A. Luskin, Particle size of inhaler corticosteroids: Does it matter? Allergy Clin. Immunol. 124 (6 Suppl) (2009 Dec) S88–S93.