Intuity Medical has raised $40 million to commercialize its diabetes blood glucose monitoring system. The round marks the long-delayed start of the next phase of Intuity’s evolution, which spent years trying to secure FDA clearance for its device before belatedly getting the green light in April.
New investor PTV Healthcare Capital led the round with support of existing backers including Venrock and Versant Ventures. Intuity will use the money set up infrastructure and make other preparations for the introduction of its oft-delayed glucose system. The round brings the total raised by Intuity in the 14 years since it spun out of the Sarnoff Corporation as Rosedale Medical toward $200 million, a sum that reflects the long slog toward approval.
Intuity had hoped to secure FDA approval using the $64 million it raised in 2009, but that proved to be wildly optimistic.
The delays stem, in part, from changes in the outlook of FDA that happened around the time Intuity was seeking approval. In recent years. FDA has started paying more and more attention to the finger-poking lancets diabetics use to draw blood and the accuracy of devices that calculate glucose levels. Both these shifts affected Intuity and its Pogo device.
Pogo is a is pitched as an automatic, all-in-one glucose monitoring device. Intuity has combined the lancets and test strips diabetics normally use into a self-contained 10-test cartridge. Pogo lances the finger, collects blood and displays the result. The user only has to insert a cartridge every 10 tests, press the test port and put a finger on the device. This approach has proven attractive to investors but problematic with regulators.
Some of the problems stemmed from concerns about the safety of the lancets in terms of the spread of bloodborne diseases. Intuity has spent years generating data to allay these concerns while also working to improve the accuracy of the device. This led to the FDA clearing the device for sale earlier this year. Now, with another $40 million in the bank, Intuity is finally positioned to find out whether patients and health plans take to the device.