ZEVASKYN Treatment Delay Resolved

The FDA required that Abeona add a test that would be done during the last 72 hours of manufacturing to detect any bacteria. They had to rush to implement this for the first commercial patient. As the lab was in the last stage of manufacturing that rapid test showed positive for bacteria. A more precise test that takes longer showed no bacteria.

Upon more investigation, they found that some human cells can result in a false positive on the rapid test. After this happened in late August, they quickly designed a new test that would not trigger a false positive from human derived cells. They did a bunch of testing to confirm this works. The innovation here is having a test that is highly accurate and provides a rapid readout.

The product has a shelf life of 84 hours after harvest and assembly. So the demand for accuracy and speed here are critical. The lab is now fully operational.