Program Director/Principal Investigator (Last, First, Middle): Ornato, Joseph, Pasquale Summary One hundred thirty Americans die from an opioid overdose (OD) daily. The key to improving this survival is the timely delivery of the antidote naloxone. Current US Emergency Medical Services (EMS) systems are often unable to deliver the life-saving drug fast enough manner to save the victim’s life. Our uniquely-qualified team (Virginia UAS, LLC commercial drone pilot training instructors; a Virginia Commonwealth University (VCU) faculty physician EMS medical director/jet and commercial drone pilot with extensive experience leading high-impact, multicenter, prehospital NIH clinical trials; and VCU engineers with experience in development and commercialization of drone hardware and software) has developed a novel prototype drone system that is interfaced to Richmond’s 9-1-1 dispatch computer. The system automatically loads a 9-1-1 bystander caller’s GPS phone location into a drone and launches it to the scene of an opioid OD carrying a lightweight, removable, patent-pending, real-time audio/video package (COMMRx) containing naloxone nasal spray. Just five drones in the City of Richmond could ensure delivery of the naloxone package to bystanders in ≤2 min as EMS first responders begin racing to the scene. Trained 9-1-1 pilot dispatchers would direct the bystander to remove COMMRx from the drone, take it to the victim, and administer the naloxone spray long before first responders can physically reach the victim. This Phase I project proposes to: 1) finalize the system customization; 2) train/FAA-certify seven 9-1-1 dispatchers drone pilots; and 3) perform realistic simulation testing of the system to guide design of a Phase II clinical trial to take place in Richmond, Henrico/Chesterfield counties, and Roanoke, VA. This novel system developed and executed by a uniquely qualified team shifts the paradigm of prehospital emergency care delivery by empowering and directing laypersons to initiate time-dependent, life-saving treatment to opioid OD victims long before EMS personnel can physically treat the patient. Our commercial goal is to expand our flight school business to provide similar capability throughout the 5,783 9-1-1 centers nationally. OMB No. 0925-0001/0002 (Rev. 01/18 Approved Through 03/31/2020) Page Continuation Format Page

Program Director/Principal Investigator (Last, First, Middle): Ornato, Joseph, Pasquale Emergency Medical Services (EMS) systems can’t reliably deliver life-saving naloxone antidote treatment needed to save opioid overdose (OD) victims because first responders can’t physically get there in time. We propose to finalize development of our novel, rapid, drone delivery system that can deliver naloxone spray antidote and direct lay bystanders to administer the life-saving treatment. Our proposal can be implemented cost-effectively at 9-1-1 centers nationwide to mitigate the mortality burden from the ongoing opioid crisis. OMB No. 0925-0001/0002 (Rev. 01/18 Approved Through 03/31/2020) Page Continuation Format Page