Oxygen Therapy Inc.’s drug OTI-1011 is designed to treat chronic wounds resulting from ischemia caused by occlusion of capillaries. OTI-1011 has the same modality and physical properties as OTI-629; however, its unique carbohydrate structure can improve the healing of pressure and arterial ulcers. OTI-1011 is also a modified hemoglobin structure, bound to a proprietary co-polymer structure. Its size, roughly 1/5,000th that of a red blood cell, enables it to perfuse constricted, ischemic capillaries, which are inaccessible to red blood cells due to ischemia conditions or other obstructions of the blood flow.
The starting material for making the product is bovine blood, collected from cows. It undergoes a process of multiple separation techniques, including filtration, diafiltration, centrifugation, chromatography, and ultrafiltration, followed by polymerization and fractionation for sizing, including unique co-polymer reaction steps, ending with a sterile fill and finish step. To monitor the reproducibility and stability of the process, several analytical methods are used to measure the impurities profile, endotoxins, and bio burden, as well as a product quality assay.