Insulet Corporation PODD recently received CE mark approval under the European Medical Device Regulation for the added compatibility of the Abbott Laboratories’ ABT FreeStyle Libre 2 Plus sensor with its Omnipod 5 Automated Insulin Delivery System. It is applicable for individuals aged two years and above with type 1 diabetes.
The Omnipod 5 System consists of the tubeless Pod enhanced with SmartAdjust Technology and the Omnipod 5 Controller with its integrated Smartbolus Calculator.
Insulet expects Omnipod 5 integration with the Abbott FreeStyle Libre 2 Plus sensor to be available first in the U.K. and Netherlands in a phased launch in the first half of 2024. Additional markets are expected to follow.
With the latest regulatory approval, Insulet is expected to solidify its foothold in the global continuous glucose monitoring (CGM) business.
Significance of the Approval
Per Insulet, Omnipod 5 is currently the first and only tubeless hybrid closed loop system (also known as automated insulin delivery) that is approved for CE marking and integrated with two CGM sensor brands, Abbott’s FreeStyle Libre and Dexcom.
Insulet’s management believes that the addition of the Abbott FreeStyle Libre 2 Plus sensor to its CGM compatibility will likely expand the accessibility of Omnipod 5 and serve more people who have diabetes.
Industry Prospects
Per a report by Grand View Research, the global CGM device market size was valued at $4.60 billion in 2023 and is expected to reach $7.51 billion by 2030 at a CAGR of approximately 7.2%. Factors like the rising cases of diabetes and the increasing adoption of CGM devices are likely to drive the market.
Given the market potential, the latest regulatory approval is expected to provide a significant boost to Insulet’s business globally.
Notable Developments
In November 2023, Insulet reported its third-quarter 2023 results, wherein it registered a robust uptick in its top and bottom lines. The company’s performance benefited as a result of the continued high demand for Omnipod 5 both in the United States and globally. The company commercially launched Omnipod 5 in Germany — the second European Omnipod 5 launch — with the intent to launch Omnipod 5 more broadly across Europe starting in 2024.
In October, Insulet received the FDA’s 510(k) clearance for the Omnipod 5 App for iPhone.
Price Performance
Shares of Insulet have lost 30.6% in the past year against the industry’s 6.2% rise and the S&P 500's 22.9% growth.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Insulet carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the broader medical space are DaVita Inc. DVA and Merit Medical Systems, Inc. MMSI.
DaVita, carrying a Zacks Rank #2 (Buy), has an estimated long-term growth rate of 17.3%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 36.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 34.9% compared with the industry’s 7.4% rise in the past year.
Merit Medical, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 11.5%. MMSI’s earnings surpassed estimates in each of the trailing four quarters, with the average being 14.4%.
Merit Medical has gained 10.6% compared with the industry’s 12.4% rise in the past year.
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