Medtronic (NYSE:MDT) has won the race to get an artificial pancreas to the U.S. market. At least, this is what the Minneapolis firm is claiming after the approval of its MiniMed 530G system, a continuous blood glucose sensor hooked up to an insulin pump.
But if the point of an artificial pancreas is that it works exactly like a healthy person’s native organ, the technology is still some way away. The 530G has only one advance over earlier pump-and-sensor combos: it stops delivering insulin if the patient ignores an alarm triggered by low blood sugar. Nevertheless Medtronic is further advanced than anyone else, and hopes are high that the device could turn its U.S. diabetes sales back to growth after a disappointing period.
The MiniMed 530G is the first product approved through a new FDA designation intended to smooth the regulatory path for these devices. It has the classification “OZO: Artificial Pancreas Device System, Threshold Suspend”.
U.S. approval has come early – it had been expected in the first quarter of next year – and the timing is propitious: analysts at Deutsche Bank say that the end of the calendar year tends to see strong pump sales owing to patients’ insurance dynamics.
This is just as well, as Medtronic’s U.S. diabetes revenues were down 3% in the first quarter of fiscal 2014, though this dip had been expected. The company had deferred $33m in revenue as it knew some type 1 diabetes patients – the population for whom these devices are intended – were waiting for approval of the 530G before upgrading. The approval could boost the company’s US diabetes sales back to low to mid single-digit growth.
A post-approval study in children above the age of two will cut into profits, as will the direct patient follow-up and manufacturing changes Medtronic will have to make after its receipt of an FDA warning letter on September 19. The company says it has already made most of the changes and plans to launch the system in the US in “the next several weeks.”
Sales will be helped by data from its pivotal U.S. trial, Aspire, showing that the MiniMed 530G significantly decreased cases of overnight hypoglycaemia (ADA – Medtronic brings constant blood sugar control closer to reality, June 24, 2013).
The 530G is merely the first step towards a true artificial pancreas. The type 1 diabetes charity Juvenile Diabetes Research Foundation (JDRF) has laid out six steps to the creation of such a device, each representing a technological advance. The MiniMed 530G is only step one.
Medtronic is, however, close to cracking step two. Its MiniMed 640G system, slated for European launch in the first quarter of 2014, not only suspends insulin delivery during low glucose, but predicts when hypoglycaemia will occur and pre-emptively suspends insulin. The pump and sensor used in the MiniMed 530G were CE marked in Europe in 2009 and 2011 respectively, and the combined system is sold in Europe as the MiniMed Veo.
Step three could see a change in market leader. The JDRF is working with Johnson & Johnson’s Animas division on a system that can predict and thus head off both high and low blood sugar. The JDRF believes that this device will be the first of its kind to market “in the next few years”, thereby wresting the crown from Medtronic.
For now though, even with the MiniMed 530G, type 1 diabetics must continue to calibrate their system with finger stick blood tests and administer bolus insulin injections at mealtimes to guard against hyperglycaemia. But so far Medtronic is beating Johnson & Johnson as well as others including DexCom, Abbott and Insulet.
The artificial pancreas is still years away. But this is a start.