Hemolung RAS Nearer FDA Approval Through Preclinical Research at T3 Labs

Share

ALung Technologies continues to rely on T3 Labs for preclinical research for the Hemolung RAS (Respiratory Assist System) as GLP study for FDA IDE application draws near.

ALung’s relationship with T3 began in 2013 for preclinical studies supporting U.S. regulatory approval for the first fully-integrated respiratory dialysis system, Hemolung RAS. Early in the engagement, T3 advised ALung shift its preclinical research model to calves, which are more docile, compliant and physiologically appropriate than the sheep used for previous studies conducted in ALung’s original university setting.

“I am convinced this recommendation has accelerated our product refinement testing and preclinical trials, saving ALung time and money at every step along the way,” said Jeremy Kimmel, PhD, ALung’s director of new technology. “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.”

With these kinds of achievements, Kimmel said he’d be hard pressed to consider another CRO for preclinical research. “We would decline due to the value of having developed effective protocols together and the consistency we have generated that sets us up for long-term success.”

Jeremy Kimmel alung headshot

After four preclinical studies with ALung, T3 Labs is looking forward to executing the GLP study for the Hemolung RAS, expected to begin in March. IDE application to the FDA is anticipated in Q2 2016.

The full case study of T3 Labs partnership for preclinical research with ALung Technologies can be found here.

To find out how T3 Labs can maximize your investment in preclinical research, contact info@t3labs.org or call (404)252-0600.