According to the International Diabetes Federation, 425 million adults worldwide have diabetes of whom 8-10% are diagnosed as T1D. These numbers are steadily increasing.

In the pancreas, Islets of Langerhans (IOL) are producing two essential hormones required for normal maintenance of carbohydrate metabolism – insulin and glucagon. The delicate balance between the two allows for directional flow of sugar molecules (glucose) from the intestine or the liver towards target organs (e.g., muscles). In diabetes, this fine balance is disrupted, leading to increase in blood glucose while, at same time, target cells are starving. Cure from the disease could be achieved following transplantation of endocrine cells, either from deceased donors, from animals (e.g. pigs) or from stem cells differentiation. All these clinical protocol are dependent on life-long use of immune-suppressive drugs.

The ßAir BAP provides a viable and safe environment for pancreatic IOL inside a subcutaneously implanted bioreactor. Consequently, they can thrive, function like native IOL thus providing the body with the two essential hormones at the correct ratio. The ßAir BAP is able to do so as Beta-O2 has solved the two major challenges of islet transplantation – adequate oxygen supply and full immune-protection. At the same time, the sick patient is freed from risky and morbidity-inducing immune-suppressive drugs therapy. Evidently, this platform technology can be adopted as to maintain any future source of hormones secreting cells.
The key differentiating factor of Beta-O2 from all of the other players in the BAP field is the ability to proactively supply oxygen to contained cells. Insulin secreting ß-cells are one of the most oxygen demanding types of cells in the human body. Therefore, the challenge of adequately supply requested amount of oxygen to these hyperactive cells in a poor-oxygen environment is challenging. The ßAir BAP successfully meet this criterion even under stringent requirements (e.g., insulin secretion in response to increased blood glucose). Though immune protection of isolated endocrine cells is prosecuted also by others, unlike Beta-O2, they all failed the challenge of creating a practical solution for supplying oxygen.

The company tested the safety and the efficacy of the ßAir BAP device in several small and large animal models and in two first-in-human clinical trials, both published in the PNAS. In parallel, mutual evaluation studies with key biomed and pharma companies are now examining combinations of ßAir second generation devices containing stem-cells derived beta cells.