We wish to extend a huge congratulations to our sponsor ALung Technologies!
Just last week, it was announced that ALung has received IDE approval to conduct a VENT-AVOID trial of the Hemolung RAS for the US Market. The device, which achieved its CE mark in 2013, permitting sales throughout the EU, is the world’s first fully integrated respiratory dialysis system. ALung worked collaboratively with the FDA under its Expedited Access Pathway (EAP) program to obtain IDE approval.
From the release: “The achievement of FDA approval for initiation of the VENT-AVOID Trial is an important milestone towards making the Hemolung RAS and ECCO2R therapy available to US patients and their physicians,” said Peter DeComo, Chairman and CEO of ALung. “We believe that there is great potential for the Hemolung technology to facilitate ventilator avoidance, resulting in improved clinical outcomes and a lower cost of care through a reduction in length of stay in the intensive care unit.”
Forty hospitals will enroll up to 800 patients in the trial.
ALung selected T3 Labs as the GLP preclinical CRO partner in support of their IDE application for the Hemolung RAS. ALung completed four preclinical studies with T3 Labs leading up to the GLP study.
Jeremy Kimmel, PhD, ALung’s VP of new technology shared, “I am convinced T3’s recommendations have accelerated our product refinement testing and preclinical trials, saving ALung time and money at every step along the way. Through smart trial and error, we have gone from inconsistent initial outcomes to a position of confidence that we have determined the best protocol to use.”
Click here to read the full release.
You can read the entire ALung preclinical case study with T3 Labs here.
If your medical device company is seeking a flexible, reliable, innovative partner committed to learning and maximizing your investment in preclinical trials, contact us!