CorVent Medical, a Coridea portfolio company focused on developing versatile, reusable, lifesaving ventilators, announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for primary critical care use of the company’s RESPOND-19™ Ventilator
| NEW YORK, Dec. 8, 2020 /PRNewswire/ -- CorVent Medical, a Coridea portfolio company focused on developing versatile, reusable, lifesaving ventilators, announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for primary critical care use of the company’s RESPOND-19™ Ventilator. Establishing a new category of ventilators, RESPOND-19 is designed for rapid expansion of critical care ventilation capacity to allow hospitals to treat more patients suffering from acute respiratory distress syndrome (ARDS) during times of greatest need. The surge support system is optimized for long-term storage and ensures cost-efficient healthcare preparedness. With EUA granted, the RESPOND-19 Ventilator is now available for commercial use in the U.S. and the company is expecting CE Mark in early 2021.
“Like many fellow healthcare providers, I experienced the first wave of COVID-19 cases and the resulting surge in ventilator support required for patients. When demand exceeds ventilator supply, healthcare providers need the ability to quickly scale resources in a safe and financially responsible manner,” stated Dr. Patrick Troy, pulmonologist at Hartford Hospital in Hartford, CT and Chief Medical Officer of CorVent Medical. “Moving forward, successful healthcare disaster preparation will inevitably include reliable surge support ventilators that can be deployed on-demand to meet an increased patient demand.” The CorVent RESPOND-19 Ventilator complements existing ventilator capacity by providing primary critical care support for multiple patient use in a cost-efficient device. The intuitive system combines sophisticated ventilation features with a plug-and-play setup to streamline patient care management. In addition, the system’s multi-stage antiviral filters provide excellent infection control to protect both patients and healthcare providers. Optimized for long-term storage with no maintenance, the reliable system eliminates the need for costly service contracts required for ICU ventilator systems. COVID-19 transformed the market and RESPOND-19 aims to address the immediate and growing need for flexible, critical care ventilator capacity. “Current critical care ventilators are not designed for periodic use, such as during global pandemics or disaster recovery. They require costly maintenance and additional time to deploy from long-term storage and are not optimized to prevent the transmission of respiratory illnesses,” commented Richard S. Walsh, CEO of CorVent Medical. “Our team’s expertise in ventilator development and proven track record of bringing innovative products to market positions us to successfully address this pressing clinical need. We are proud that the RESPOND-19 ventilator expands access to lifesaving respiratory support, in a financially sustainable way, for hospitals and government agencies during this healthcare crisis and beyond.” This announcement builds on the company’s recent news of a $4.5M seed financing round to fund commercialization of the company’s first ventilator. The round was led by the prominent European life sciences venture capital firm Sofinnova Partners with participation from The Deerfield Foundation, Exor Seeds, Genesis Medtech Group, Redmile Group, The Pagliuca Family Office, and Accel Founder Jim Swartz. About CorVent Medical, Inc.
SOURCE CorVent Medical, Inc. |
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