Bedford, Mass.-based insulin management devices maker Insulet (NSDQ:PODD) landed an FDA nod for its next-generation OmniPod insulin pump.
The hand-held OmniPod insulin pump, the world’s 1st tubing-free insulin pump, features a waterproof pod and the new OmniPod updated personal diabetes manager, which wirelessly programs insulin delivery to help patients with insulin-dependent diabetes more easily take control of their diabetes, according to the press release.
"The OmniPod revolutionized insulin delivery with its tubeless and wireless design when it was introduced in 2005, and today the next-generation OmniPod raises the bar for insulin pump therapy again," president & CEO Duane DeSisto said in prepared remarks. "We are thrilled to have received FDA approval and it is my hope that our new OmniPod insulin pump will continue to make living with diabetes easier for our customers across the U.S."
The latest version of the OmniPod insulin management system is about 38% smaller and 25% lighter while maintaining the same features as existing devices, CFO Brian Roberts told MassDevice.com.
"This is a giant step forward for our product," he said.
Roberts said about a third of their patients are children under the age of 18.
"The smaller the product and the more discreet it can be on clothing, the more normal the kids will feel," Roberts said.
Medtronic‘s (NYSE:MDT) Minimized subsidiary in October sued Insulet for allegedly infringing a pair of its patents with Insulet’s OmniPod insulin management system for diabetes.
”It is in initial stages," Roberts said of the lawsuit. "We don’t believe we infringe them."
Insulet last month reported 3rd quarter losses of $12.4 million, or 26¢ per share, on sales of $54.8 million during the 3 months ended Sept. 30, reducing losses by some 8.4% and experiencing 23% growth in sales.
The new OmniPod brings solid financial benefits for the company. The device costs less to produce, which will drive higher margins, Roberts said.
Insulin expects to launch the initial shipments in the U.S. for the new OmniPod in 1st quarter next year.