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Thursday, October 21, 2021

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HomeHemovent GmbHCompletion of GLP Standardized in vivo Trial for Long-Term Use of Its...

Completion of GLP Standardized in vivo Trial for Long-Term Use of Its Next-Gen ExtraCorporeal Membrane Oxygenation (ECMO) System Mobybox™ Produces “Stunning Results” Reports Hemovent

Key endpoints in all-six subjects — no hemolysis, no thrombosis at low anticoagulation and no functional device wear — will be used for CE mark registration and FDA submission of Mobybox™, the initial application of Hemovent’s Bionique™ platform. “The oxygenators and pumps looked as if they had just left cleanroom manufacturing, while post-study blood lab gas exchange rates were identical to those of a new oxygenator: stunning results,” said Dr. Oliver Marseille, a cofounder and CTO of Hemovent and a cofounder of CircuLite® (HeartWare®).

Today Hemovent GmbH announced t has successfully completed a GLP standardized in vivo study for long-term (7 days) use of its novel and portable Bionique artificial lung technology platform, designed for a wide range of indications: from ExtraCorporeal Life Support (ECLS) to ExtraCorporeal CO2 Removal (ECCO2R).

“We are extremely pleased by our study results, which we will use for the basis of a CE mark registration submission this year as well as our subsequent FDA submission,” said Christof Lenz, a co-founder and CEO of Hemovent. “Completing this study, especially with these dramatic results, constitutes an important benchmark for Hemovent toward commercializing our Bionique technology, which is positioned to disrupt a billion-dollar market, whose standard therapy is complex to use, costly to purchase, and not portable.

“We expect that when our initial technology application, Mobybox, is commercially available, it will dramatically simplify ECMO usage, not only for life support applications (ECLS) but also as an effective therapy for respiratory failure indications including ECCO2R protocols,” added Lenz.

These types of applications are also known as ExtraCorporeal Membrane Oxygenation (ECMO): the establishment of an artificial external blood circuit with a portable pump and gas exchanger system in order to support the lung function only or even establish a full cardiopulmonary bypass.

Hemovent is an emerging medical device company that has developed the world’s smallest and first self-contained, fully portable device for ExtraCorporeal Membrane Oxygenation (ECMO) /ExtraCorporeal Life Support (ECLS) applications designed to support or replace heart and lung function in the event of cardiac and/or respiratory failure.

CAUTION: The Hemovent ECMO/ ECLS System is not approved for human use.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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