Insulet Corp. said Horizon, its artificial pancreas, could be on the U.S. market in late 2019. Horizon is the Billerica, Mass.-based firm's first foray into continuous glucose monitoring-automated insulin delivery. If Insulet's Horizon gains FDA approval, it would go up against Dublin-based, Medtronic plc's Minimed 670G artificial pancreas, which received FDA approval in September and is set to launch in April of next year. (See Medical Device Daily, Sept. 29, 2016.)

Even though Horizon will be two years behind the Minimed 670G's launch, analysts said this could be to the Insulet's benefit.

"While Insulet is behind its competitors on CGM-automated insulin delivery, we believe the company could ultimately end up with the most compelling long term solution," said Doug Schenkel, an analyst with Cowen and Co.

The Horizon platform will have some similarities to the Minimed 670G, such as continuous basal dosing. Raj Denhoy, an analyst with Jefferies said that Insulet should not take Minimed 670G's pending arrival in the U.S. market lightly.

"[The] 670G marks a seminal event in the evolution of diabetes technology and the possibility that Insulet is underestimating the impact remains perhaps the biggest risk to the story over the coming months," Denhoy said.

Insulet is still in the early phase of trying to get Horizon onto the market. During an earnings call last month, the company revealed that it completed its first IDE trial for the device. Insulet said it just received FDA approval for a second phase of the IDE, which will evaluate its algorithm performance in adolescents and pediatric patients.

The prospect of an artificial pancreas could help remove some of the constraints diabetes patients have with monitoring and management. Insulet's vice president and medical director Trang Ly, said that traditional tools to help manage diabetes can be quite cumbersome for the patient.

"[Diabetes management] is an enormous amount of work, time and dedication," Ly, told Medical Device Daily. "What other condition is there out there, where if you overdose [on treatment therapy], you die?"

She noted that the artificial pancreas could help eliminate some of the burden of diabetes management.

OTHER PRODUCTS IN THE PIPELINE

During Insulet's investor's day, the company outlined a plan to reach $1 billion in 2021 revenue. This is expected to be achieved by increasing U.S. and Europe penetration, geographic expansion, and the launch of products to more aggressively address the type 2 opportunity.

Insulet is most known for its Omnipod insulin management system, an all-in-one insulin pump consisting of a completely tubeless "pod" that is wirelessly controlled by a personal diabetes manager.

The company is also developing a mobile insulin management system called Dash that was unveiled at its investor's day last month. The device will be operated from a locked-down touch-screen smartphone. It will collect insulin usage and battery data via Bluetooth connectivity from a chip directly in the Omnipod; feature a redesigned food library; enable patients to control basal and bolus dosing; read data from a CGM; and provide other useful and simplifying applications. Insulet is targeting mid-2017 for 510(k) submission, with a full launch to follow.

"While questions remain in the early stages of the Dash's development, such as if and when it can be integrated as an application on a functioning smartphone, it is a meaningful development that could especially appeal to the pediatric population," Denhoy said.

It will need these tools as the pool of competition continues to grow for the diabetes market, which is set to reach $35.5 billion by the year 2024, according to a report published by Grand View Research Inc.

Besides Medtronic, Insulet also faces off against San Diego-based Dexcom Inc. and San Diego-based Tandem Diabetes Care Inc.

The growing market opportunity in diabetes is also opening the door for non-traditional health care players to come into the space.

Mountain View, Calif.-based Verily Life Sciences LLC – formerly Google Life Sciences – teamed with Paris-based, Sanofi SA, to launch the diabetes-focused firm Onduo. (See Medical Device Daily, Sept. 13, 2016.) That venture blossomed about a year after Google and Sanofi reported a diabetes partnership, which followed Google's agreement with Dexcom covering continuous glucose monitoring products. Verily also partnered with Brentford, U.K.-based Glaxosmithkline plc to form Galvani Bioelectronics, a company slated to evaluate bioelectronic medicine to combat chronic conditions, starting with diabetes.