Alito Scientific's Phase I technology is a highly sophisticated implantable medical device which can augment the O2/CO2 transfer in the patient's bloodstream. Currently, the challenge with treating lung disease is not only oxygenating the blood but, more importantly, removing the excess CO2 that builds up in the system. Our Phase I medical device performs both functions in a manner which will not only improve the patient's condition, but is ambulatory and will improve the patient's quality of life. This product will be used as a bridge therapy. This device utilizes a micro-machined, vascular network, which can be introduced into the patient's bloodstream. This machined vascular bed is separated from an air exchange chamber by a gas-permeable membrane. Oxygen is pumped from an external source, through a catheter, and into the air chamber where it diffuses across the membrane into the blood which flows through our vascular bed and CO2 diffuses from the blood in our vascular bed and into the air chamber, and is then expelled from the body. Each layer of the Phase I device is made up of these three components: vascular bed, membrane, and gas exchange chamber. By increasing the number of layers, Alito Scientific can increase the total amount of O2/CO2 transfer in the recipient's bloodstream. The device is designed to be implanted in various sites depending on the overall condition of the recipient. Our current model is a 40-layer device that can provide 40% of the required lung function.

Download an in-depth scientific analysis and data of our technology's history, novel approaches, in vitro data and analysis, large animal studies, design history, anti-clotting regimens, and FDA plan for Alito Scientific's implantable lung assist device. (PDF)

Alito Scientific's Phase II product is a biohybrid system which introduces stem cells/cells into our vascular bed, which will endothelialize this network. This will allow the vascular bed in our device to mirror the vascular network in the body. This product is designated for candidates who need a longer duration of care. This will expand the patient population who are candidates for our device.

Alito Scientific's Phase III product is a biohybrid implantable system which is seeded with stem cells/cells which will proliferate, generating a new lung. As the cells proliferate the biomaterials of the device degrade out, leaving the generated fully functioning lung inside the recipient. This product will be a destination therapy for those suffering from a wide variety of lung diseases.