An Israeli company claiming to have created a tiny micro-pancreas that can “cure” diabetes for millions of people has said it will submit a request next month for human clinical trials in the UK.
Betalin Therapeutics said its “bio-artificial” pancreas aims to free patients of the need for insulin injections and blood sugar monitoring. It is designed for people with type 1 diabetes, and those with type 2 diabetes who require insulin.
The Jerusalem-based firm told the Guardian it would provide a plan for clinical trials to Britain’s regulatory agency in August. Betalin aims to begin human testing early next year, with the hope of delivering to the market by 2024.
Central to the innovation is a biological scaffold, adapted from pig lung tissue, that holds beta cells. Those cells release insulin based on the patient’s blood sugar levels. The miniature artificial pancreas, just visible to the naked eye, is implanted under the skin on the thigh using local anaesthesia.
“Our unique technology allows the body to heal itself,” said Nikolai Kunicher, the chief executive of Betalin. “For now, the focus is on diabetes, but there are many more diseases that we intend to cure with the aid of this technology.”
More than 460 million people live with diabetes, according to the International Diabetes Federation, although not all have been diagnosed. A 2016 study by the World Health Organization found the metabolic disorder was the seventh most common cause of death, above road injury.
Betalin’s technology was developed by Prof Eduardo Mitrani of the Hebrew University of Jerusalem’s Institute of Life Sciences.
The company said it chose to conduct tests in Britain because the country had already approved another diabetes treatment, called the Edmonton Protocol, in which beta cells are implanted on the liver. But Betalin said its micro-pancreas would be more robust, longer-lasting, and cheaper, although its still likely to coast more than $40,000 (£31,000).
Trials are planned in several hospitals affiliated with the Leeds and Newcastle universities, with Omar Masood, a UK transplant surgeon with experience in combatting diabetes, directing the project.
“This has the potential to affect up to 400,000 people in the UK,” he said.
It has received grants amounting to about £4.5m from the EU and raised more than £6m from Chinese, US and Israeli investors.