An extended wear infusion set cannula to improve the delivery of insulin for people with type 1 diabetes.
Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease that prevents the body from producing insulin naturally. Therefore, the 18 million people around the world living with T1D continuously and carefully balance insulin intake with eating, exercising, and other activities to keep their blood glucose within a target range. Getting insulin into their body is a lot of work, with most people needing 3-4 insulin doses every single day. The development of insulin pump technologies has significantly improved treatment benefits over more manual approaches, however, only 10% of people with T1D use these insulin pumps despite the known clinical benefits. The reason for such low adoption is the failure of the most critical component of the system; the infusion set cannula, which is a small tube inserted into the patient's skin and is the only way to get insulin from the pump into the user's body. Infusion set cannulas are left inserted for 2-3 days and frequently fail within hours of insertion. The short lifespan and high failure rates cause recurring interruptions to insulin therapy, which negatively impact blood-glucose control. To meet this need, Fada Medical have developed a 30-day infusion set cannula which uses our proprietary diffusion technology to extend the cannula lifespan. This will minimise the interruption of insulin delivery from insulin pumps, reducing the overall changing of infusion sets from 136 to just 12 per year. The technology can be integrated into existing insulin pump systems, enhancing their efficacy to positively impact blood-glucose control and potentially increase the uptake over more manual approaches to the wider T1D population.
The total addressable insulin pump & consumables market is valued at €2B with 1.8 million people using insulin pumps every day to deliver their insulin. The average cost of an infusion set is €20 per unit, which means the economic burden of a one-year supply is between €2720 - €4000. A reduction to this burden by introducing an extended wear infusion set would have a major impact to patients and payors. Insulin pump manufacturers have in recent years developed more compact devices called “patch pumps”, which are the integration of infusion set cannulas and insulin pumps in one device. The remaining limitation to these new devices is the wear time, as they still only last 3 days, which means the complete system must be thrown out at the end of use. In addition to this, there is a recent trend of people living with Type 2 diabetes mellitus who are insulin dependent using insulin pump systems. These indicators are strong demonstrators of the extent of the demand in this space, suggesting a highly attractive commercial opportunity for Fada Medical’s patient focused, extendable wear solution. In the long term, Fada Medical’s proprietary platform diffusion technology has the scope to be expanded into other drug delivery areas, due to its ability to overcome the route source of short cannula lifespan: the foreign body response (FBR). This is complex issue with drug delivery devices that interact with the body, as it slowly affects their ability to deliver much needed medication. Our team have developed this technology in the University of Galway and MIT with the aim to spin out to continue our commercial and technical pathways in 2023.
Fada Medical are extremely grateful to Enterprise Ireland for the opportunity to participate in this year’s Big Ideas, where we hope to share our goal of revolutionising insulin delivery for people living with Type 1 diabetes mellitus. We are at the beginning of our commercial journey, and this is the ideal platform to showcase our ambition and our technology with the innovation and investor communities here in Ireland.