Pre-Clinical Development

Beta-O2 Technologies Ltd. has successfully proved a long-term functional performance of the βAir BAP device in various animal models. It was evidenced to be effective in diabetic isogeneic model (Lewis rats), allogeneic (rat Lewis donor islets to Sprague-Dawley recipients), and xenogeneic (Sprague-Dawley or bovine donor islets to Sinclair mini-swine and porcine islets to non-human primates) implantation systems. The results obtained demonstrated safety of the device and long term efficacy in immunocompetent animal models.
The results of the studies demonstrated:

• The ability of the βAir BAP device to support donor islets oxygen demands under various experimental setups.

• The ability of the βAir BAP device to protect allogeneic and xenogeneic islets from host’s immune systems.

• The ability of the βAir device to maintain near-normal glycemic control in diabetic animal models.
Beta O2 Technologies is developing a 2nd generation BAP device that would be specifically adapted for stem-cell derived beta cells clusters. This device is designed as to accommodate cell clusters at a very high volume density. We began to test several subtypes using in-vitro and in-vivo experiments. The outcome of these studies will lead to final design of the human BAP device.

• The ability of the βAir BAP device to protect allogeneic and xenogeneic islets from all tested host immune systems.

• The ability of the βAir device to approach a near-normal blood glucose concentration range in diabetic animal models.

• The ability of the βAir device to approach a near-normal blood glucose pharmacokinetics patterns in diabetic animals.

Implantation of bAir device restore glycemic ontrol in diabetic pigs (N=5)