MOBYBOX®, the World's First Integrated Portable Pneumatic ECMO Product, Completes Its Initial Commercial Applications in Europe

Aachen, Germany, 24 May 2024 - Recently, Hemovent GmbH (Hemovent) announced that its pioneering integrated portable pneumatic extracorporeal membrane oxygenation (ECMO) system, the MOBYBOX®, has completed its first batch of commercial deployments in Europe, successfully showcasing its exceptional portability through multiple intra-hospital and inter-hospital transfers. To date, MOBYBOX® is the only ECMO system to have received Medical Device Regulation Certification. MOBYBOX® has been launched in global markets including Germany, The Netherlands, Italy, Greece, and Israel, and efforts are underway to advance market access in several Middle East Countries as well as in the United States and China.

ECMO, used for cardiac arrest, acute severe heart failure, and acute severe respiratory failure, provides continuous extracorporeal oxygenation and circulatory support, easing the burden on the heart and lungs. Originating over half a century ago, it gained widespread use in the 1990s. Initially transitional, ECMO aids patients' transition to further therapies like heart transplantation. Its applications have expanded with evolving clinical practice. During the Covid-19 pandemic, ECMO demonstrated higher survival rates compared to mechanical ventilation in supporting patients with severe cardiopulmonary failure. Additionally, it has shown significant efficacy in treating patients with cardiac arrest by improving survival rates through the integration of CPR techniques. These applications indicate that ECMO is no longer just a transitional treatment but is redefining our understanding of life support, becoming a key technology in emergency medical rescue.

While traditional ECMO's clinical value is continuously being explored, there are still several challenges that need addressing. Firstly, the high costs associated with the entire setup including equipment, consumables, training, and maintenance, create significant barriers for many hospitals considering its adoption. The complexity of the machinery and its large size limits its use in ICUs and beyond, making it difficult to provide prompt treatment for patients in need of pre-hospital emergency care or urgent interventions. Moreover, transferring patients between different hospital departments, such as emergency rooms, ICUs, operating rooms, and laboratories, presents significant logistical hurdles. Additionally, the intricate preoperative setup and configuration of various components entails complex operational procedures, resulting in a steep learning curve that requires considerable effort.

MOBYBOX® is the first ECLS device that uses only pneumatic power as its energy source, integrating both blood flow control and gas management into a single device. This design weighs just 2.5 kilograms, with consumables adding only 5.8 kilograms. The MOBYBOX® pump works pneumatically and is only driven by the pressure of the oxygen supply that is required anyway for the gasexchanger, so that it works independently of external energy sources without a battery or motor. Its unique mechanical pump drive control module and electrical module operate independently, ensuring continuous functioning even during a power outage. Its Bionique Flow Technology allows for a gentler blood handling, enhances gas exchange efficiency and significantly reduces the risk of clotting and thrombotic events with optimized flow channel design.

Healthcare professionals have praised the MOBYBOX® system for its significantly expanded application scope. Physically, it has moved beyond being confined to ICU beds and is now used in various mobile settings, including intra-hospital transfers, inter-hospital transport, and emergency care on ambulances, ships, planes, and even disaster relief efforts. Globally, its simplified control equipment reduces hospital procurement barriers and learning burdens, facilitating its adoption not only in traditional ECMO markets but also in remote areas and small hospitals.

A physician from a Hospital in Hesse, Germany stated that, “After switching from our standard transport system to the MOBYBOX® device, we observed no negative effects on the status of our patient.” The patient, who suffered from ARDS due to Covid-19, was transferred from a hospital in Romania for treatment. Having already undergone ECMO treatment in Romania, the patient used MOBYBOX® for medical support during the transfer, experiencing no complications. MOBYBOX® was utilized for a total of 12 days.

Another physician from a North Rhine-Westphalian Hospital in Germany praised the quick stabilization of MOBYBOX®. The patient, suffering from cardiogenic shock following acute myocardial infarction, was brought to the hospital and immediately received MOBYBOX® support upon arrival, restoring cardiac function promptly. “Thanks to the rapid deployment of MOBYBOX® and the resulting stabilization of the circulation, the patient's cerebral status could be verified at an early stage. The early diagnosis of brain death made it unfortunately impossible to save this patient, but he subsequently became a suitable candidate for organ donation with the maintained circulation, thereby saving and improving the lives of several other patients.”

The nursing staff from another Hospital in Rhineland-Palatinate, Germany reported that the mobility of MOBYBOX® is very convenient to handle. A patient was diagnosed with severe lung disease and utilized MOBYBOX® continuously for 44 days with no complication. “MOBYBOX® was easily carried with the patient during mobilization and aided in care from nurses and physiotherapists.”

Due to its high portability and integration, MOBYBOX® is poised to be revolutionary within this industry. In its initial commercial applications, it has led the way into expanding the application of ECMO technology beyond the ICU. Additionally, MOBYBOX® has begun the process of acquiring certification for transport scenarios, paving the way to become the world's first ECMO system approved for use in mobile settings such as ambulances, ships, and aircrafts, thus exploring cutting-edge solutions for patient care.

The current clinical applications of ECMO technology represent only a fraction of its potential. In a recent article titled, “How ECMO is Redefining Death”, published in The New Yorker, the author outlines potential future scenarios for ECMO application. This includes wearable ECMO devices for patients to resume normal life, ECMO membranes that secrete nitric oxide to discourage clots from forming, and ECMO used in organ transplantation to enhance transplant surgery outcomes. Undoubtedly, there is vast untapped potential in this field, with MOBYBOX® leading the way in exploring new avenues of application.

Dr. Jürgen O. Böhm, CEO & CMO of Hemovent, emphasized that, “Our completely new approach to pump drive, to handle blood flow as well as the safety, simplicity and compactness of the entire ECMO system will allow MOBYBOX® serving both traditional in-hospital settings and mobile medical scenarios, playing a crucial role in scenarios like intra-hospital and outdoor transport, as well as outdoor rescue. We are very proud of our achievements thus far and are actively expanding its market access in more countries, with the aim of extending the benefits of this technology to more patients.”

About Hemovent

Hemovent is an innovative medical device company located in Aachen, Germany, and has won multiple awards. Its product, MOBYBOX®, is small and portable, easily fitting into a backpack and simple to operate. Through this highly innovative ECLS system, Hemovent aims to take life-saving heart-lung support technology to a new level. Hemovent is always dedicated to research and development, striving to constantly lead and shape the future of portable ECLS systems in critical care medicine.