Recent clinical trials of the intravenacaval oxygenator (IVOX) indicated that this unique, innovative device transfers oxygen into and carbon dioxide out of circulating venous blood at clinically significant rates with a favorable risk/benefit ratio for patients in advanced but potentially reversible acute respiratory failure. Data from the clinical trials and recommendations of the clinicians utilizing the IVOX device have identified which, if overcome or ameliorated, could significantly enhance the benefits and minimize difficulties associated with its use, thereby expanding its clinical applicability and commercialization. The major shortcoming defined by the clinicians was low gas transport and the desire to increase gas transport by 50-100%. In Phase I of this program we demonstrated IVOX gas transport of 45% (compared to our goal of 30%) and gas into water increases of 275%. Based on these positive results we project Phase II increases of 172%. In Phase II we will optimize full scale systems, perform key in-vitro and in-vivo tests plus biocompatibility tests to demonstrate the system viability.
Successful completion of this project would make the IVOX applicable for support of up to 150,000 USA patients annually who die of acute respiratory failure when managed by other support methods. At $2,500 per device, the potential market for an improved second generation IVOX device could be in excess of $375 million annually in the USA, and a similar additional amount worldwide.
