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Tandem Diabetes Gets Expanded Indication for Insulin Pump
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Tandem Diabetes Care, Inc. (TNDM - Free Report) announced the receipt of the FDA’s approval of an expanded pediatric indication for its t:slim X2 insulin pump with Control-IQ technology for children aged six and above. Notably, the pump was earlier approved for use in children aged 14 years and above.
A high point of the t:slim X2 pump with Control-IQ technology is a recent six-month study of children aged from six years to 13 years using the said technology. The study showed favorable outcomes with respect to sensor time in range (TIR) unlike the control group, which was using sensor-augmented pump alone. Further, the children using Control-IQ stayed within the range majority of the time unlike the control group.
With this latest regulatory clearance, Tandem Diabetes aims to strengthen foothold in the global insulin pump business.
Significance of the Receipt
Control-IQ technology, an advanced hybrid closed-loop feature designed to increase TIR, helps simplify diabetes management in young patients by adjusting insulin delivery to aid in preventing glucose level fluctuations. This automatically delivers correction boluses up to a maximum of one per hour and offers exercise and sleep-specific features.
Further, the technology does not require fingersticks for calibration or diabetes treatment decisions when integrated with Dexcom’s G6 continuous glucose monitoring system.
Per management, the expanded indication for use in younger patients is an important feat for the company as it is difficult for this patient population to accurately control their glucose level.
Industry Prospects
Per a report by Grand View Research, the global insulin pump market was valued at $3.30 billion in 2018 and is projected to see a CAGR of 9.6% between 2019 and 2026. Factors like rising technological advancement, increasing incidence of diabetes and greater adoption of insulin pumps over traditional methods are expected to drive the market.
Given the market potential, the well-timed FDA clearance for an expanded indication is expected to boost the company’s business.
Recent Developments
Of late, Tandem Diabetes has been witnessing a slew of developments.
The company in June presented favorable real-world data from the early use of the t:slim X2 insulin pump with Control-IQ technology. The outcome demonstrated statistically significant improvements in sensor TIR in patients having both type 1 and type 2 diabetes with no increase in hypoglycemia (or glucose deficiency in the bloodstream).
During first-quarter 2020 earnings call in May, Tandem Diabetes confirmed registering buoyant momentum in the reported quarter, which soared above 80% year over year to approximately 2,200 renewal pump shipments. Further, the company’s mobile application with Remote Bolus capability for the t:slim X2 is one of the most highly requested features by customers. The first generation of the app had a beta launch in the first quarter and will be rolled out more broadly in the coming weeks.
In March, the company received the FDA’s nod for its Basal-IQ technology as an interoperable automated glycemic controller (iAGC). This is the second system to receive an iAGC designation from the regulatory agency, following the t:slim X2 insulin pump with Control-IQ technology in December 2019.
Price Performance
Shares of the company have rallied 29.5% in the past year compared with the industry’s 2.4% growth and the S&P 500’s 6.8% rise.
Zacks Rank & Key Picks
Currently, Tandem Diabetes carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Quest Diagnostics Incorporated (DGX - Free Report) , Hologic, Inc. (HOLX - Free Report) and QIAGEN N.V. (QGEN - Free Report) .
Hologic’s long-term earnings growth rate is estimated at 7%. The company presently has a Zacks Rank #2.
QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.
Zacks’ Single Best Pick to Double
From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
This young company’s gigantic growth was hidden by low-volume trading, then cut short by the coronavirus. But its digital products stand out in a region where the internet economy has tripled since 2015 and looks to triple again by 2025.
Its stock price is already starting to resume its upward arc. The sky’s the limit! And the earlier you get in, the greater your potential gain.
Image: Bigstock
Tandem Diabetes Gets Expanded Indication for Insulin Pump
Tandem Diabetes Care, Inc. (TNDM - Free Report) announced the receipt of the FDA’s approval of an expanded pediatric indication for its t:slim X2 insulin pump with Control-IQ technology for children aged six and above. Notably, the pump was earlier approved for use in children aged 14 years and above.
A high point of the t:slim X2 pump with Control-IQ technology is a recent six-month study of children aged from six years to 13 years using the said technology. The study showed favorable outcomes with respect to sensor time in range (TIR) unlike the control group, which was using sensor-augmented pump alone. Further, the children using Control-IQ stayed within the range majority of the time unlike the control group.
With this latest regulatory clearance, Tandem Diabetes aims to strengthen foothold in the global insulin pump business.
Significance of the Receipt
Control-IQ technology, an advanced hybrid closed-loop feature designed to increase TIR, helps simplify diabetes management in young patients by adjusting insulin delivery to aid in preventing glucose level fluctuations. This automatically delivers correction boluses up to a maximum of one per hour and offers exercise and sleep-specific features.
Further, the technology does not require fingersticks for calibration or diabetes treatment decisions when integrated with Dexcom’s G6 continuous glucose monitoring system.
Per management, the expanded indication for use in younger patients is an important feat for the company as it is difficult for this patient population to accurately control their glucose level.
Industry Prospects
Per a report by Grand View Research, the global insulin pump market was valued at $3.30 billion in 2018 and is projected to see a CAGR of 9.6% between 2019 and 2026. Factors like rising technological advancement, increasing incidence of diabetes and greater adoption of insulin pumps over traditional methods are expected to drive the market.
Given the market potential, the well-timed FDA clearance for an expanded indication is expected to boost the company’s business.
Recent Developments
Of late, Tandem Diabetes has been witnessing a slew of developments.
The company in June presented favorable real-world data from the early use of the t:slim X2 insulin pump with Control-IQ technology. The outcome demonstrated statistically significant improvements in sensor TIR in patients having both type 1 and type 2 diabetes with no increase in hypoglycemia (or glucose deficiency in the bloodstream).
During first-quarter 2020 earnings call in May, Tandem Diabetes confirmed registering buoyant momentum in the reported quarter, which soared above 80% year over year to approximately 2,200 renewal pump shipments. Further, the company’s mobile application with Remote Bolus capability for the t:slim X2 is one of the most highly requested features by customers. The first generation of the app had a beta launch in the first quarter and will be rolled out more broadly in the coming weeks.
In March, the company received the FDA’s nod for its Basal-IQ technology as an interoperable automated glycemic controller (iAGC). This is the second system to receive an iAGC designation from the regulatory agency, following the t:slim X2 insulin pump with Control-IQ technology in December 2019.
Price Performance
Shares of the company have rallied 29.5% in the past year compared with the industry’s 2.4% growth and the S&P 500’s 6.8% rise.
Zacks Rank & Key Picks
Currently, Tandem Diabetes carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Quest Diagnostics Incorporated (DGX - Free Report) , Hologic, Inc. (HOLX - Free Report) and QIAGEN N.V. (QGEN - Free Report) .
Quest Diagnostics’ long-term earnings growth rate is projected at 7.6%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Hologic’s long-term earnings growth rate is estimated at 7%. The company presently has a Zacks Rank #2.
QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.
Zacks’ Single Best Pick to Double
From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
This young company’s gigantic growth was hidden by low-volume trading, then cut short by the coronavirus. But its digital products stand out in a region where the internet economy has tripled since 2015 and looks to triple again by 2025.
Its stock price is already starting to resume its upward arc. The sky’s the limit! And the earlier you get in, the greater your potential gain.
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