On Aug. 11 Medtronic announced the launch of a new insulin pumps for people who are 16 and older.
The MiniMed 630G system boasts a HD-color screen, is waterproof and has an intuitive, user-friendly interface along with the SmartGuard technology by which insulin delivery automatically shuts off when a low blood glucose threshold is reached preventing a life threatening situation.
But that announcement of a new hardware platform raised questions in the minds of analysts who were on Medtronic’s fiscal first-quarter earnings call on Thursday. They were curious about the company’s breakthrough product now under regulatory review: the artificial pancreas or what Medtronic calls the Hybrid Closed Loop system — the 670G.
But precious little — other than broad assurances — came in the way of details regarding when the Food and Drug Administration is expected to approve that device widely expected to forever alter how Type 1 diabetes is managed. Simply put it, the Hybrid Closed Loop system automates insulin delivery based on blood glucose readings from a continuous glucose monitoring sensor, requiring minimum patient input. (Medtronic filed with the FDA in June and Bloomberg reported at the time that premarket approval is expected within a year.)
Now two months later, analysts wanted more information about the 670G.
Here’s how one exchange went between Michael Weinstein, an analyst with JP Morgan, and Hooman Hakami, president of Medtronic’s Diabetes group, according to a transcript of the call from Seeking Alpha (slightly edited):
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Weinstein: … I was wondering if Hooman could comment on 670G timing in light of the 630 approval.
Hakami: Yes, with respect to 670 Mike, the PMA is with the FDA. It’s really hard to predict when they’re going to approve it; obviously it’s in their hands now. We are working actively with them to answer the questions that they have regarding our submission but as you know and as Omar (Medtronic’s CEO) talked about in the commentary in the meantime we launched the 630G. We received approval and have launched the 630G and we’re excited about this.
Hakami went on to elaborate how the features of the new device is a boon for patients and what they have been asking for, citing the waterproof nature of the 630G among other things. The 530G, launched in 2013, needed a product refresh, and 630G provides that, he said.
Still, analysts were less interested in this iteration of Medtronic’s insulin pump and the questions continued. Bob Hopkins, an analyst with the Bank of America, pressed again to make sure that there was “no change in timelines on 670G.”
Hakami recognized the concern that lurked beneath — why launch a new pump when a potentially breakthrough device is already with the FDA unless of course the executives of the Irish company fear some regulatory snafu that will delay its launch. Here’s how Hakami responded:
There’s absolutely no change or any indication that things are going to push out on the 670G and may be Bob just an additional point of clarification we didn’t launch the 630 because we thought there was a risk to the 670 timeline. So the 670 is as I said we’re working very, very closely with the FDA, the relationship is outstanding and we’re actively engaged with — we launched the 630 not due to anything related to the 670 ….
Hakami’s assurances notwithstanding, this should be a question for patients too — if you had the iPhone 3 and you knew the iPhone 5 was in the works, would you go for the iPhone 4S even with Siri and additional bells and whistles?
Photo Credit: Getty Images, PeopleImages.com
