Update on the Hemolung FDA Expedited Access Pathway process
In 2015, we announced that the Hemolung RAS had been selected by the FDA for its new Expedited Access Pathway (EAP) program. This new program aims to reduce the time and cost of market approval for breakthrough medical technologies aimed at addressing significant unmet clinical needs. The program promises to help accomplish this through things like a more interactive review, senior management involvement, and assignment of a case manager. Additionally, the program facilitates development of a potentially less burdensome premarket clinical trial, shifting a portion of data collection to the post-market phase, while still meeting the statutory standard of reasonable assurance of safety and effectiveness.
FDA has set very specific criteria for accepting devices into the EAP program. Specifically, EAP devices should treat or diagnose a life threatening or irreversibly debilitating disease or condition, or address a significant unmet need for which the standard of care is poor. FDA recently announced on its blog that only 17 devices received EAP designation in the first full year of the program. We are very proud to count the Hemolung RAS as part of this group!
Our experience working with the FDA so far has been overwhelmingly positive. The FDA has indeed devoted resources, including senior leadership attention, to our project. The process has been collaborative, which has helped reduce uncertainty and accelerate activities leading to our IDE submission.
At ALung, we are committed to providing better treatment options to patients suffering from acute respiratory failure. We envision a day when patients will no longer require intubation and mechanical ventilation during COPD exacerbations, but instead will remain awake, communicate, and rehabilitate. We look forward to continued collaboration with the FDA and the medical community as we work to bring our innovative technology to patients in the United States.