Swiss devicemaker CeQur secured $27 million in a second round of financing, which the company says will help bring its CE marked PaQ insulin pump into higher-volume manufacturing. The company also aims to begin navigating the U.S. regulatory process early next year.
The PaQ delivery device is designed for patients with Type 2 diabetes, CeQur CEO Jim Peterson told FierceDrugDelivery, for which a daily regimen of 4 to 5 insulin shots a day can be a struggle, leading to compliance issues and a demand for a simpler, more elegant approach. The PaQ is a small pump about the size of a patch that administers insulin through a small Teflon catheter. Insulin is delivered at a slow rate, but a button on the device also gives the option for extra bolus doses at mealtimes, Peterson said.
CeQur will file with the FDA for 510(k) approval in early 2014, hoping for a response later that year, Peterson said. Meanwhile, the PaQ device underwent a clinical trial in Austria that Peterson said "clearly pointed to better outcomes" both in patients' quality of life and in their well-being, as more consistent doses of insulin have shown to be better than injections during the day.
Like its latest round, CeQur's first round of financing--which amounted to $52 million--came from private investors, and the company declined to release any more information regarding the cash's source. The cash from the second round will be used to help scale up manufacturing, Peterson said, to supply the device "in the millions."
"There are more than 11 million patients with Type 2 in the U.S. and EU, and it is clear in the literature that 60% regularly omit injections," Peterson said. "This will be very important to these patients in large numbers, and consequently this is a very large opportunity beyond what a normal infusion device would be."
The diabetes market is seeing a surge in the development of devices designed to make patients' regimen simpler, notably with the artificial pancreas, still unapproved, which combines an insulin pump with a continuous glucose monitor to mimic a healthy pancreas. Currently a horse race is under way to bring it to market, with companies like Medtronic ($MDT) and Tandem Diabetes Care leading the way.
- here's the release
- and here's FierceMedicalDevices' take