Diabetes: Insulet seeks FDA nod for next-generation OmniPod insulin pump

May 10, 2011 by MassDevice staff

Insulet Corp. says it is seeking 510(k) clearance from the FDA for a smaller, lighter Omnipod insulin management system and reports a 36 percent first-quarter sales jump.

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Insulet Corp. (NSDQ:PODD) is hoping to win 510(k) clearance* for a new Omnipod officials said will help the company reduce its production costs by more than a third.

The latest version of the Omnipod insulin management system is one-third smaller, 25 percent lighter and "expected to reduce our cost of production by about a third, driving significant gross margin improvement," CEO Duane DeSisto said in a prepared release. "We are confident that the easy-to-use design of our tubeless insulin pump will raise the bar for the industry again and improve our competitive position in the marketplace."

The Bedford, Mass.-based insulin management company did plenty to cut costs in the first three months of 2011, trimming net losses by 32 percent, to $9.8 million, on $28.2 million in sales for three months ended March 31. That compares with a $14.5 million net loss on $20.8 million in sales during the same period last year.

The company credited strong international sales with helping to boost revenues by 36 percent.

Insulet reiterated its full-year 2011 sales guidance for $123 million to $133 million and operating losses of $20 million to $28 million. For the second quarter of 2011, the company forecast revenues of $28 million to $32 million.

*Correction: Due to a reporter's error this article incorrectly stated that Insulet had received 510(k) clearance from the FDA.