Insulin pumps have greatly improved the quality of life of those living with Type 1 diabetes. However, they are far from perfect due to the short lifespan and high failure rate of the pump’s most critical component: the ISC or infusion set cannula.
“The ISC is a small tube which is inserted into the subcutaneous tissue and it’s the only way to get the insulin from the pump into the body. The problem is that an ISC only lasts two to three days before it has to be changed. This constantly interrupts the delivery of insulin and can have a negative impact on blood-glucose control,” explains Rob Wylie, co-founder of Fada Medical which has developed a novel infusion technology that extends the cannula’s lifespan to 30 days.
When a foreign object is implanted or semi-implanted into the body, a very complex series of events takes place
Wylie’s co-founders at Fada Medical are Prof Garry Duffy and Dr Eimear Dolan from University College Galway and Prof Ellen Roche from Massachusetts Institute of Technology. All three share an interest in investigating systems within the body that cause drug delivery devices, such as ISCs, to fail.
“Devices fail because our bodies have a very clever defence mechanism that protects us from foreign objects,” Wylie says. “When a foreign object is implanted or semi-implanted into the body, a very complex series of events takes place to create a barrier around the foreign object to protect us. This is known as the foreign body response.
“Of course what this mechanism doesn’t realise is that it is potentially blocking something that’s really needed from getting in. In the case of the ISC, the foreign body response means the cannula gets blocked and needs to be changed every few days.”
Wylie adds that current drug delivery devices use passive diffusion to push medication from the reservoir into the body at a set rate. If a cannula becomes blocked, however, it’s not possible to solve the problem by simply increasing the flow as this could cause potentially fatal complications.
“What’s needed is a new type of diffusion technique to negate the effects of this foreign body response. That’s exactly what our tech does — it gets the therapies past the barrier,” says Wylie who declines to be drawn on how the new system actually works as it is patent pending and potential competitors are watching.
“Nobody has been able to extend the lifespan of infusion set cannulas as long as we have,” he says. “Our closest competitor has developed a seven-day infusion while a 10-day one is reportedly in development, but we’re still three times ahead of this.”
Fada is yet another high-potential start-up to emerge from the well-developed, multidisciplinary innovation ecosystem fostered by the University of Galway and the newly formed company is now in the process of commercialising its technology with the support of a commercialisation grant of just over €500,000 from Enterprise Ireland. It expects to spin out from the university in roughly 12 months.
Fada will sell its solution to insulin pump manufacturers and this market is set to grow in the years ahead
In the meantime, preparations for regulatory approval and preclinical and clinical trials are under way while the company is also starting down the funding route to raise a seed round in the region of €5 million. Because the approval process for medical devices is typically slow, it will be roughly 2027 before Fada’s product is patient-ready.
Fada will sell its solution to insulin pump manufacturers and this market is set to grow in the years ahead. Only about 10 per cent of those with Type 1 diabetes use pumps at present. In addition, the number of patients with Type 2 being put on pumps is rising.
The insulin-specific version of its new technology is Fada’s market launch product but the company’s solution has wider applications. “Our tech is a platform technology which is highly scalable and easily translatable to other therapeutic options such as therapies for Parkinson’s disease and for palliative care,” Wylie says.
