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Insulet Receives FDA Approval for ACE Pump Implementation

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Insulet Corporation PODD recently received FDA approval for the use of its Alternate Controller Enabled Infusion (ACE) Pump with Omnipod DASH Insulin Management System. Following this development, Insulet will be able to market its Omnipod DASH System as an integrated insulin pump (Omnipod DASH ACE Pump).

The clearance will enable the company to be a part of an interoperable automated insulin delivery (AID) system. Insulet aims to strengthen its foothold in the global continuous glucose monitoring (CGM) market on the back of the approval.

About ACE Pumps

ACE Pumps are devices for the infusion of drugs into a patient. These are designed to establish reliable and secure connections and be compatible with external devices (like automated drug dosing systems) for targeted drug delivery.

Why is the Approval Significant?

The Omnipod DASH System was developed by Insulet keeping in mind the end-user’s convenience and discretion. The clearance indicates that the system meets FDA-established special controls that chalk out the necessary standards for guaranteeing accuracy, reliability, cybersecurity and clinical relevance of ACE pumps.

The diabetes industry is dynamic and witnesses continuous developments. Naturally, Insulet believes that technological and regulatory progresses will facilitate interoperability and provide more options for treatments and disease management.

Industry Prospects

Per a report published by Polaris Market Research on MarketWatch, the global CGM market is expected to reach $1,325.9 million at a CAGR of 15.8% between 2019 and 2025. Increasing incidents of diabetes on a global scale and higher demands for instant glucose level testing are the primary factors driving the market.

The innovative technology enables immediate access to test blood glucose level, which will further drive the industry. Considering the potential for management of diabetes, this approval is well timed.

Recent Developments

Of late, Insulet has made certain developments with respect to its Omnipod DASH System.

The company has launched the Omnipod DISPLAY and Omnipod VIEW apps for the users of the new Omnipod DASH System in August. These apps make it easier for diabetic patients and their families to conveniently track their blood sugar levels as well as take necessary precautions and manage the disease.

The market seems to be upbeat about the positive outcome from the latest clinical trial of the Omnipod Horizon Automated Insulin Delivery System, conducted in June. The study proved the efficiency of the investigational Omnipod Horizon System and concluded that it can be safely used on children with type 1 diabetes.

Price Performance

The company’s shares have surged 50.5% in the past year against the industry’s decline of 2.4%. Moreover, the S&P 500 index inched up 1.5% during the same period.

Zacks Rank & Key Picks

Currently, Insulet carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the broader medical space are Capricor Therapeutics, Inc CAPR, GW Pharmaceuticals PLC GWPH and Neurotrope, Inc NTRP.

Capricor, sporting a Zacks Rank #1 (Strong Buy), has a projected third-quarter 2019 earnings growth rate of 28.2%. You can see the complete list of today’s Zacks #1 Rank stocks here.

GW Pharmaceuticals estimates third-quarter earnings growth rate to be 72.8%. It currently flaunts a Zacks Rank #1.

Neurotrope, with a Zacks Rank #2 (Buy), has a projected third-quarter earnings growth rate of 27.7%.

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