ARDS Oxygenation Device (AOD)

A lack of definitive treatment for Acute Respiratory Distress Syndrome (ARDS) threatens the health of military service members and civilians alike. Pharmacotherapeutics aimed at treating ARDS have shown promise in preclinical studies but failed to demonstrate success in clinical trials, likely owing to the inability of drugs to reach the damaged alveolar surface either directly or systemically. Boundless Science will demonstrate that a relatively small volume (~200ml) of oxygenated liquid perfluorocarbons (PFCs) uniformly distributed in ARDS lungs will dramatically improve morbidity and mortality among these patients. Liquid perfluorocarbons carry 50% of their volume in oxygen(unlike blood plasma), have extremely low surface tension (similar to pulmonary surfactant), and are ~2X the density of plasma(allowing them to sink through pulmonary edema to epithelial walls). Boundless has confirmed previous toxicology testing demonstrating that the liquid PFCs we are considering are non-inflammatory and nontoxic. Our specific combination will be completely bio-eliminated from the body within a few hours of administration through exhalation. Liquid PFCs, both through administration via inhaled aerosolization and liquid pour, have proven effective as a therapy for ARDS in numerous animal studies and one human study. Aerosolized PFCs offer the promise of better effect using significantly less volume than a pour. Proposed mechanisms of action from aerosolized PFCs into ARDS lungs include alveolar recruitment, supplemental pulmonary surfactant (PFC is hydrophobic and may act as surfactant), and local pulmonary therapeutic cooling (3°C). PFCs carry 50% of their volume in oxygen, so dispersing them through the lung offers the opportunity to deliver a bolus of oxygen through the therapy. Packaged in a small form-factor, such a device could provide unprecedented pulmonary support for injured warriors both at advanced and remote care stations, as no good solution currently exists for ARDS at any level. Our initial prototype device delivered 10ml/min of aerosolized PFCs into cadaver pig lungs covering ~50% of their alveolar surface while cooling the lungs ~3°C. We have created a team of Key Opinion Leaders to include senior military and non-military pulmonologists, intensivists, anesthesiologists, nurses, medics, cellular biologists, toxicologists along with our experienced biomedical engineering team to guide us from the laboratory to the hospital. While broad industrial use of PFAS is coming under restriction, no government body has recommended limiting medical uses, where their unique profile of safety and efficacy is well documented. This project creates a simple-to-use device compatible with any ventilator circuit which can deliver aerosolized liquid perfluorocarbons throughout a majority of ARDS lungs with no external power source.