The FDA approval follows the company's recent announcement of $4.5m seed financing round to fund the commercialisation of its first ventilator
CorVent Medical has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the use of its RESPOND-19 Ventilator for primary critical care.
RESPOND-19 is optimised for multiple patient use, and is said to enable sophisticated ventilation with enhanced infection control. The surge support system enables long-term storage and cost-efficient healthcare preparedness, said the company.
With the FDA authorisation, RESPOND-19 Ventilator is now allowed for commercial use in the US and CorVent is expecting to obtain CE Mark in early 2021.
CorVent Medical chief medical officer Patrick Troy said: “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. 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.”
RESPOND-19 rapidly expands critical care ventilation capacity for hospitals
RESPOND-19 is designed for quick expansion of critical care ventilation capacity to help hospitals treat greater number of acute respiratory distress syndrome (ARDS) patients during the times of need.
The ventilator is designed to complement the existing ventilator capacity by offering primary critical care support for multiple patient use in a cost-efficient device.
CorVent said that the intuitive system combines advanced ventilation features with a turnkey setup to simplify the patient care management.
Also, the multi-stage antiviral filters of the system offer infection control for the protection of both patients and healthcare providers.
CorVent Medical CEO Richard S Walsh said: “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.
“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.”
CorVent Medical is a privately held portfolio company of medtech incubator Coridea, focused on developing versatile, reusable, lifesaving ventilators for critical care.
RESPOND-19 Ventilator is the company’s first product, designed to provide lifesaving respiratory support during surges in demand.
The FDA approval follows the company’s recent announcement of $4.5m seed financing round to fund the commercialisation of its first ventilator.
The round was led by the European life sciences venture capital firm Sofinnova Partners, and participated by The Deerfield Foundation, Exor Seeds, Genesis Medtech Group, Redmile Group, The Pagliuca Family Office, and Accel.