ALung Technologies wins FDA de novo nod for Hemolung respiratory assist system

[Image from ALung]ALung Technologies announced today that it received FDA de novo clearance for its Hemolung respiratory support platform.

Pittsburgh-based ALung designed its Hemolung system to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) for patients with acute respiratory failure.

According to a news release, the de novo nod makes Hemolung the first and only ECCO2R device cleared by the FDA. Its indication covers respiratory support that provides ECCO2R from the patient’s blood for up to five days in adults with acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately or safely achieved using other available treatment options and continued clinical deterioration is expected.

The company touts Hemolung as a first-of-its-kind, comprehensive system for providing minimally invasive, low-flow ventilatory support through a single 15.5 French, central venous catheter at blood flows of 350 – 550 mL/min, offer…

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ALung Technologies raises $2m

ALung Technologies filed an SEC Form D to confirm the sale of $2 million in debt, options, warrants and other rights to purchase securities.

The Pittsburgh-based company made its first sale in the new notice on May 20 and reached its offering total of $2 million by June 1. Just one investor participated in the offering.

According to the filing, the offering is not being made in connection with a business combination transaction, such as a merger, acquisition or exchange offer. The company did not offer an intended use of proceeds.

ALung develops the Hemolung respiratory assist system, which uses ECCO₂R therapy to allow carbon dioxide to be removed from the blood independently of the lungs in an effort to facilitate the avoidance or reduction of intubation and invasive mechanical ventilation.

In April, Hemolung received FDA emergency use authorization (EUA) for use in treating patients suffering from COVID-19.

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