The Artificial Pancreas Created in Israel May One Day Cure Diabetes

On the eve of World Diabetes Day, traditionally celebrated on November 14, the Israeli biotechnology company Betalin Therapeutics announced the start of the process to review its application for clinical trials of its revolutionary invention – an artificial pancreas.

The microscopic pancreas developed by Israeli specialists is intended for patients suffering from the most severe forms of diabetes and is designed to free them from the need for constant monitoring of blood sugar levels and daily insulin injections. According to statistics, about 160 million people worldwide are dependent on insulin.

Type 1 diabetes develops due to the irreversible destruction of the pancreas's beta cells by the person's own immune system, which are responsible for producing insulin, an important hormone that regulates blood glucose levels. Disruption of its synthesis leads to increased sugar levels in the blood serum.

Previously, doctors attempted to implant beta cell clusters extracted from donor pancreases into patients. Unfortunately, the transplanted cells died fairly quickly, and immunosuppressive drugs did not help. As a result, the treatment lost effectiveness, and most patients were forced to return to insulin injections within a year. After five years, 90% of diabetics with donor cells became insulin-dependent again.

The main reason for the failure lies in the fact that beta cells are not naturally adapted to survive independently in the body. "They need to be surrounded by a kind of supportive tissue – a scaffold, as we call it," says Nikolai Kunisher, CEO of Betalin Therapeutics. "This scaffold, or – in other words – framework, mimics the natural environment of the cells. This helps them live longer and function better."

The Israeli artificial pancreas is that very scaffold. Measuring only seven millimeters in diameter and 300 microns in thickness, it consists of pig lung tissue and insulin-secreting cells taken from a donor or created in a laboratory. This micro-organ essentially replaces the poorly functioning pancreas.

"It determines the glucose level, and the beta cells release the necessary amount of insulin when needed," says Nikolai Kunisher, who holds a degree in microbiology. The artificial gland is implanted under the skin – usually on the leg – using local anesthesia and quickly integrates into the vascular system. The entire process should take no more than an hour.

The expected cost of one implant will be around $50,000, with most of it expected to be covered by insurance. "The cost of treating diabetes complications and the price of insulin are so high that it will be more beneficial for the government and insurance companies to agree," says Kunisher. How high? According to forecasts, by 2024, the global market for type 1 diabetes will be valued at $25 million. According to the World Health Organization, nearly half a billion people worldwide suffer from type 1 or type 2 diabetes, which is about 8.8% of the adult population. Diabetes is a serious disease; it doubles the risk of premature death.

Creating Beta Cells

The most challenging task for Betalin Therapeutics is obtaining the necessary number of beta cells to fill the artificial gland. Currently, the only way to obtain them is from deceased donors. One patient requires up to three donors to provide the optimal number of beta cell clusters – between 400,000 and 500,000.

This has led to the creation of a new sought-after niche for companies engaged in producing beta cells in the laboratory. For example, in September, Vertex Pharmaceuticals paid $950 million to acquire Boston's Semma Therapeutics, which produces beta cell clusters from human stem cells.

According to Kunisher, Betalin Therapeutics can use beta cells from third-party manufacturers, such as Semma, but the company is also working on creating its own. Recently, it received a binational grant from the Israeli Innovation Authority and the Italian government to work with beta cell expert and renowned transplant researcher Professor Lorenzo Piemonti.

Years of Clinical Trials Ahead

Diabetic patients will have to wait several years before the technology passes all necessary testing stages. To date, the company has only conducted animal trials. In preclinical studies on mouse models of diabetes, about 70% of the rodents implanted with the artificial pancreas no longer needed insulin injections, even after a long period (three months) post-implantation.

At Betalin Therapeutics, they say it will take another year – and an additional five million dollars, which the company has already begun to raise – to complete all the regulatory work necessary to start clinical trials on humans. The startup has already established testing collaborations with clinics in Germany, England, the USA, Italy, and China. If all goes well, the artificial pancreas will hit the market within the next five years.