In some cases a new and surprising regulation can ruin a company. In more rare cases, new regulation may provide a company with a boost. The latter seems to be the case for the veteran diabetes company Beta-O2.Technologies. The company has developed a device that contains living pancreas cells that automatically secrete insulin into the blood stream, based on signals received from the body - basically an artificial pancreas. Then, the US Food and Drug Administration (FDA) has decided that any company that implants insulin-secreting stem cells must place them in such a device. Suddenly, these companies have begun taking interest in Beta-O2, which has been working on such a product for over a decade.
Beta-O2 has been founded around a more interesting, but less practical, product. Beta-O2 CEO Dr. Yuval Avni explains, "One of the challenges in implanting cells in the body is providing them with oxygen. Beta-O2's original product included implanted cells together with a source of oxygen, an alga, similar to those living in the sea, and a small LED lamp providing light for the alga to photosynthesize. This idea, like many Israeli ideas, was genius but less practical. We have replaced the alga and the lamp with an internal oxygen reservoir, which can be filled by an injection to a subcutaneous port. At present, a daily injection is required; in the future, we intend to enable a weekly injection - not nearly as frequent as the many injections diabetes patients are required to make, and more pleasant than insulin injections," says Dr. Avni.
Beta-O2 injects live pancreas cells from various sources, but the regulation regards stem cells specifically. At present, implanted stem cells must be encapsulated in order to enable removal if their functioning becomes problematic, for example if they turn into cancer cells.
"The world has invested in stem cells in the field of diabetes, but it has invested less in instrumentation so far, which puts us in an interesting position. There are a few other companies capable of wrapping membrane around the cell, but they rely on blood vessels growing around the cells and providing them with oxygen, and this assumption is problematic. It is unclear whether the cells will receive enough oxygen, and when they receive less oxygen the cells either die or secrete less insulin. We also have the oxygen source." Avni adds that the membrane is required not only in order to remove the cells when necessary but also to prevent them from being attacked by the immune system - the reason Beta-O2 developed it in the first place, even before the current regulation and before it has decided to use stem cells.
So far, this technology has undergone successful trials involving live cells, but not stem cells.
The stem cell company Kadimastem Ltd. (TASE: KDST) is one of the companies Beta-O2 is currently examining its technology with. Avni says, "We are examining the cells of nine companies, four of them big pharma companies, and we are testing them all in the same way. Our objective is to eventually choose a partner we could decide on an exclusive cooperation with. We are now testing cell biology and will later also examine the partner itself - its experience and financial resources. Bringing such a product to the market is an enormous mission and we must have someone with the capabilities."
Published by Globes [online], Israel business news - www.globes-online.com - on August 22, 2016
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