ALung Technologies said yesterday that it won approval from an independent Data and Safety Monitoring board to continue the U.S.-based VENT-AVOID clinical trial of its low-flow extracorporeal carbon dioxide removal technology intended to treat COPD patients with acute respiratory failure.
The Pittsburgh-based company said that the VENT-AVOID trial looks to validate the safety and efficacy of its Hemolung Respiratory Assist System for COPD patients experiencing acute exacerbations requiring ventilatory support.
ALung said that the DSMB approved the continuation of the trial without modification following its first scheduled review of safety data from an initial 31 subjects.
“The attainment of this significant VENT-AVOID milestone is gratifying, and we look forward to the continuation of these pivotal trials, both of which hold the promise that the Hemolung RAS and ECCO2R therapy will provide a new tool in the treatment of acute respiratory failure,” chair & CEO Peter DeComo said in a press release.
The company also said that the pivotal UK-based REST trial of its Hemolung RAS system in patients with acute respiratory syndrome continues to enroll subjects, touting it as the largest prospective clinical study of extracorporeal lung support ever conducted.
The Hemolung RAS system already has CE Mark approval in the European Union.
In January, ALung Technologies reported raising $5 million in a round of debt and options financing, according to an SEC filing.