Breakthrough in COPD Treatment: Pulmonary Shield Medical's Cute X® ECCO₂R System Successfully Completes First Human Rescue of AECOPD Patient in China
Recently, Yixing People's Hospital adopted the Cute X, independently developed by Suzhou LungShield Medical Technology Co., Ltd. (hereinafter referred to as "LungShield Medical")®Extracorporeal Carbon Dioxide Removal System (ECCO₂R)2R), successfully treated a patient with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Supported by this therapy, the patient was successfully weaned off the invasive ventilator after 12 hours. The patient is recovering well and has already begun rehabilitation exercises.
This patient has long suffered from chronic obstructive pulmonary disease (COPD). Since June 2023, due to a COVID-19 infection, the patient has been bedridden and dependent on non-invasive ventilation for respiratory support. Due to prolonged immobility, generalized muscle atrophy developed, with body weight dropping below 40 kg, leading to difficulties in both eating and breathing. On March 19, 2024, the patient was urgently admitted to the Department of Respiratory and Critical Care Medicine due to an acute exacerbation. Despite various conventional treatments employed by physicians, including endotracheal intubation and invasive mechanical ventilation, the patient’s condition did not improve. After seven days of invasive mechanical ventilation, attempts at weaning failed, significantly increasing the risks of ventilator-induced lung injury and related complications. Furthermore, the inability to communicate with family members led to a temporary loss of confidence in continuing the fight against the illness.
Experts from the Department of Critical Care Medicine and the Department of Respiratory Medicine at Yixing People's Hospital conducted a consultation and, after analyzing the patient's condition, decided to adopt LungShield Medical's Cute X.®Extracorporeal Carbon Dioxide Removal System (ECCO2R) Emergency treatment was administered to the patient. After initiation of extracorporeal life support, the patient’s condition was rapidly and effectively controlled. The retained carbon dioxide levels in the blood gradually decreased to normal ranges, alleviating symptoms such as respiratory distress. By the next day, the endotracheal tube was successfully removed, allowing the patient to breathe spontaneously without invasive mechanical ventilation and resume normal oral intake. After more than two weeks of rehabilitation training, the patient is now able to engage in ambulation with assistance from medical staff. This further demonstrates the efficacy of LungShield Medical’s Cute X.®Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Systems in Clinical Applications.
Feidun Medical Cute X® Extracorporeal CO2 Removal System (ECCO2R) is a product pioneered in China for the treatment of patients with severe chronic obstructive pulmonary disease (COPD).
The successful development of this technology not only significantly reduces the clinical treatment difficulty for respiratory failure indications such as AECOPD and acute respiratory distress syndrome (ARDS), as well as patient treatment costs and trauma, but also fills the gap in the interface between traditional ventilators and ECMO (extracorporeal membrane oxygenation) technology, marking ECCO2Breakthrough Advances in R Technology in China: Profound Significance for Enhancing China’s Medical Technical Capabilities and Sustaining the Development of Its Healthcare Sector.
China has approximately 100 million patients with chronic obstructive pulmonary disease (COPD), with nearly 1 million deaths annually, ranking first globally in COPD-related mortality and significantly reducing the labor supply.
According to the “Study on Pulmonary Health in Chinese Adults” published by Academician Wang Chen, President of the Chinese Academy of Medical Sciences, in The Lancet in 2018, the prevalence of chronic obstructive pulmonary disease (COPD) in China was clarified for the first time. Study data show that# China's COPD Patient Population Reaches 100 Million, China currently ranks first globally in the number of deaths from chronic obstructive pulmonary disease (COPD),Nearly 1 million deaths annually, is the third leading cause of death after stroke and ischemic heart disease, imposing a heavy burden on society. In 2005, more than 3 million people worldwide died from chronic obstructive pulmonary disease (COPD), and this problem appears to be worsening. The World Health Organization (WHO) estimates that by 2030, it will rank as the third leading cause of death globally.
Although China is already the world’s largest market for severe chronic obstructive pulmonary disease (COPD),Currently, there is no effective treatment available.。
Furthermore, although non-invasive positive pressure ventilation (NPPV) has made progress in managing patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD), up to 50% of patients requiring NPPV still need invasive mechanical ventilation. However, the use of invasive ventilators carries certain risks. These multiple risks are reflected in an in-hospital mortality rate of up to 25%, and a 5-year mortality rate of 76% among COPD patients with acute exacerbations who require mechanical ventilation due to respiratory failure. Therefore, extracorporeal carbon dioxide removal (ECCO2R) technology has emerged as a therapeutic approach to reduce or avoid the need for invasive mechanical ventilation.
Extracorporeal Carbon Dioxide Removal (ECCO₂R)2R) is an extracorporeal life support technology that diverts blood to an artificial membrane lung oxygenator for gas exchange and CO₂ removal.2, and then reinfused into the human body, thereby achieving gas exchange to substitute for pulmonary ventilation. In the human body, most of the CO2Dissolved in the blood as bicarbonate, it exhibits good solubility and is more readily diffused out of the membrane lung; theoretically, ECCO₂R at 1–1.5 L/min2R-flow can effectively eliminate CO₂ produced by the human body.2。
Application of ECCO2R can significantly enhance CO2clearance, thereby reducing respiratory rate, pulmonary hyperventilation, and the development of intrinsic positive end-expiratory pressure (PEEPi). In addition, ECCO2R can effectively reduce oxygen consumption, decrease the work of breathing of respiratory muscles, and lower CO2 production by reducing the patient's respiratory rate, thereby further reducing CO2. Current observational clinical studies abroad have shown that implementing ECCO in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD)2R can effectively avoid endotracheal intubation and mechanical ventilation, or assist in extubation to wean from invasive mechanical ventilation, therebyReducing Complications Associated with Mechanical Ventilation, reduce the adverse reactions of sedative drugs,thereby reducing patient mortality, and at the same time be able toAddressing oxygen and carbon dioxide exchange impairments that cannot be resolved by current ventilator therapy. Furthermore, patients can be encouraged to engage in self-directed activities to facilitate more active physical rehabilitation therapy, thereby improving their quality of life.
For some patients with end-stage chronic obstructive pulmonary disease (COPD), lung transplantation is the ultimate surgical treatment option, but donor shortage remains a clinical reality. Patients who experience acute deterioration of lung function requiring invasive mechanical ventilation while awaiting lung transplantation have significantly increased mortality rates. For such patients, the application of ECCO2R can serve as a bridge-to-transplantation therapy during the waiting period for lung transplantation. Over the past decade, a series of observational studies have confirmed that the preoperative application of ECCO2R, which can better maintain patients' survival status and improve postoperative survival rates.
Targeting a Gap in the Domestic Market, China’s First Product for Treating Patients with Severe COPD
With ECCO2R-Value Takes Center Stage as More ECMO Giants Enter the ECCO Market2The R market is populated by manufacturers such as MAQUET, Fresenius Medical Care, and LivaNova. However, the high prices of imported products, coupled with product and functional designs that do not adequately meet domestic clinical needs, have prevented many patients in China from truly benefiting from this advanced medical technology, while also limiting operational convenience for clinicians. More critically, the domestic ECCO2R market remains virtually untapped, with no Chinese manufacturers having yet commercialized related products.
In response to this current landscape, Lung Shield Medical has targeted this vast unmet clinical market. Through medical-engineering collaboration, its Chinese-German team, in partnership with multiple clinical centers across China, has successfully developed Cute X, a first-of-its-kind innovation in China, after years of dedicated effort.®Extracorporeal Carbon Dioxide Removal System (ECCO₂R)2R), including a series of products such as portable blood pumps, long-acting oxygenators, and blood pump heads. This is also the world’s first innovative product specifically designed for the treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD).
Cute X®It is a life support treatment regimen based on the principle of medium-flow (0.5–2.5 L/min) extracorporeal circulation. Similar to VV-ECMO in its working mechanism, it withdraws blood from the veins and returns it to the venous system with the support of an extracorporeal blood pump. Unlike traditional VV-ECMO, which operates at high flow rates (up to 7 L/min), the medium-flow strategy prioritizes carbon dioxide removal efficiency, reduces the incidence of vascular complications, and allows for prolonged clinical application.
Cute X®The oxygenator kit consists of an extracorporeal blood pump head, a carbon dioxide removal oxygenator, and circulation tubing. The entire Cute X set®The oxygenator kit features a biocompatible coating (phosphorylcholine coating) that minimizes the adverse effects of blood contact with foreign surfaces. It effectively reduces platelet adhesion, inflammatory responses, and thrombus formation.
The successful completion of the first human clinical trial of Feidun Medical’s extracorporeal carbon dioxide removal system not only validates the product’s efficacy and safety but will also further accelerate its adoption and commercialization in the Chinese market.
“Full-Platform” Layout Accelerates Product R&D, Iteration, and Commercialization
In recent years, major international ECMO players have been actively positioning themselves in the ECCO market.2As domestic companies continue to enter the R-product space, the sector is gaining momentum. Facing this blue-ocean market, Feidun Medical has secured a first-mover advantage through its deep technological expertise and “all-platform” strategy, which have enabled it to stay ahead in product development.
The company’s ability to achieve breakthroughs in a “blank slate” field stems fundamentally from its established core technology platform and innovative medical device development pathway. Its “full-platform” layout enables the use of computer simulation technologies to model devices and treatment scenarios during development, allowing for rapid design adjustments based on feedback. This approach not only enhances product development efficiency but also reduces production costs.
It is precisely for this reason that, since its establishment in 2020, Feidun Medical has, in just over three years, aside from ECCO2In addition to the R system (extracorporeal CO2 removal system), the company has also completed the development of innovative products such as the pVAD (percutaneous ventricular assist device) and ECMO systems. Among these, the ECMO system has completed pivotal human clinical trials, entered the regulatory submission phase, and is poised to commence commercialization.
The future holds great promise. With breakthroughs in the company’s core technologies and the acceleration of clinical trials for its existing products, the company is poised to launch more innovative offerings. As a Sino-German multinational medical device enterprise, Feidun Medical will leverage its China headquarters in coordination with global regional centers to actively advance regulatory approvals, market deployment, and international expansion of its current product portfolio. Meanwhile, it remains committed to developing more innovative life-support medical devices dedicated to saving patients’ lives.
References:
3. “Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (2023 Revised Edition)”
4. "Progress in the Clinical Application of Extracorporeal Carbon Dioxide Removal Technology"
5. “High School Student Diagnosed with ‘Chronic Bronchitis’: China Tops Global COPD Mortality Rates, Alarming Trend of Younger Patients Cannot Be Ignored”