XENiOS® Will Seek Regulatory Approval for i-lung®

XENiOS®, a commercial-stage medical device company, announced today it expects to receive CE-marking for its i-lung® device within 18 months. XENIOS expects to launch i-lung® in 2017. Currently available devices lack durability and wearability. Additionally, the size of current systems restricts patient mobility and limits quality of life. i-lung represents an innovative and first-of-its-kind fully wearable artificial lung for long-term use in a hospital environment.

"The availability of i-lung will open the door to significant medical progress for respiratory support. For many patients in lung failure currently undergoing invasive mechanical ventilation, the use of i-lung is designed to avoid sedation and immobility, thus creating active, self-managed patients," said Georg Matheis, MD, Managing Director & Founder of XENIOS. "In addition, i-lung is designed to be used to bridge the waiting time for a donor organ (bridge-to-lung-transplant)."

"Of special note," added Juergen Boehm, MD, Managing Director of Xenios, "i-lung paves the way for XENiOS to continue development of a bioartificial lung for use by patients outside of a hospital environment analogous to current artificial heart protocols, which will represent a paradigm shift in the approach to long-term respiratory support."

i-lung is the result of the successful completion of the AmbuLung project, a three-year R&D consortium project funded by the European Union’s FP7 Program that developed the basis for i-lung, the world’s first-of-its-kind wearable artificial lung. In addition to XENiOS, the consortium included Fraunhofer IGB (Stuttgart, Germany); Imperial College of Science, Technology and Medicine (London, UK); and, the University of Florence (Italy).

"We are forever indebted to the vision and the work of Professor Dame Julia Polak, who passed away last year," said Dr. Matheis. "Julia and I co-founded the i-lung project, and because of her enormous contribution i-lung is now a reality, and a bioartificial next-gen of i-lung on the horizon." The author of some 1,000 original papers, 115 review articles and editor or author of 25 books, Julia Polak, MD, PhD, was one of the most widely cited researchers in her field, and had undergone a heart lung transplant. She served on several national and international tissue engineering and stem cell advisory panels, and was the European editor of the journal Tissue Engineering.

Funding for the commercialization of i-LUNG® has already been procured. XENIOS announced in September 2015 that it received an eight-figures cash infusion from existing investors, in part to fund CE-marking and launch of i-LUNG, led by ZFHN, one of the largest Single Family Offices in Germany investing in start-up companies.

About XENiOS®
XENiOS AG is a privately held medical technology company that is comprised of two product brands, novalung® and i–cor®, that run on a single XENiOS® console. The XENIOS platform is designed to provide at least four essential advantages with its minimally invasive lung and heart therapies: (1) patients are awake and mobile;(2) self-actuated patients facilitate improved outcomes; (3) there is no ventilator-associated lung injury or pneumonia; (4) additionally, the XENIOS platform maintains a physiologic natural pulse designed to protect the heart.

Most Popular Now

European Artificial Intelligence Act Com…

The European Artificial Intelligence Act (AI Act), the world's first comprehensive regulation on artificial intelligence, enters into force. The AI Act is designed to ensure that AI developed and used...

Patient Safety must be Central to the De…

An EPR system brings together different patient information in one place, making it easier to access for healthcare professionals. This information can include patients' own notes, test results, observations by...

ChatGPT Shows Promise in Answering Patie…

The groundbreaking ChatGPT chatbot shows potential as a time-saving tool for responding to patient questions sent to the urologist's office, suggests a study in the September issue of Urology Practice®...

Survey: Most Americans Comfortable with …

Artificial intelligence (AI) is all around us - from smart home devices to entertainment and social media algorithms. But is AI okay in healthcare? A new national survey commissioned by...

AI Spots Cancer and Viral Infections at …

Researchers at the Centre for Genomic Regulation (CRG), the University of the Basque Country (UPV/EHU), Donostia International Physics Center (DIPC) and the Fundación Biofisica Bizkaia (FBB, located in Biofisika Institute)...

Video Gaming Improves Mental Well-Being

A pioneering study titled "Causal effect of video gaming on mental well-being in Japan 2020-2022," published in Nature Human Behaviour, has conducted the most comprehensive investigation to date on the...

New Diabetes Research Links Blood Glucos…

As part of its ongoing exploration of vocal biomarkers and the role they can play in enhancing health outcomes, Klick Labs published a new study in Scientific Reports - confirming...

Machine learning helps identify rheumato…

A machine-learning tool created by Weill Cornell Medicine and Hospital for Special Surgery (HSS) investigators can help distinguish subtypes of rheumatoid arthritis (RA), which may help scientists find ways to...

New AI Software could Make Diagnosing De…

Although Alzheimer's is the most common cause of dementia - a catchall term for cognitive deficits that impact daily living, like the loss of memory or language - it's not...

A New AI Tool for Cancer

Scientists at Harvard Medical School have designed a versatile, ChatGPT-like AI model capable of performing an array of diagnostic tasks across multiple forms of cancers. The new AI system, described Sept...

Vision-Based ChatGPT Shows Deficits Inte…

Researchers evaluating the performance of ChatGPT-4 Vision found that the model performed well on text-based radiology exam questions but struggled to answer image-related questions accurately. The study's results were published...

Bayer Launches New Healthy-Aging Ecosyst…

Combining a scientifically formulated dietary supplement, a leading-edge wellness companion app, and a saliva-based a biological age test by Chronomics, Bayer is taking a big step in the emerging healthy-aging...