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Tandem Diabetes' (TNDM) Insulin Pump Approved by Health Canada

Zacks Equity Research
·4 min read

Tandem Diabetes Care, Inc. TNDM recently announced the receipt of Health Canada’s approval for its t:slim X2 insulin pump with Control-IQ technology. Control-IQ technology is an advanced hybrid closed-loop feature which has been designed to help increase time-in-range and deliver automatic correction boluses along with adjusting insulin to help prevent blood sugar level fluctuations.

Notably, the system is integrated with Dexcom’s G6 continuous glucose monitoring (“CGM”), which requires no fingersticks for adjustment or diabetes treatment decisions.

Tandem Diabetes plans to begin the shipping of t:slim X2 insulin pumps with Control-IQ technology in Canada in the first quarter of next year. Further, the company will continue offering the t:slim X2 insulin pump with Basal-IQ predictive low glucose suspend technology for users who are seeking a system especially designed to help prevent low blood sugar levels.

With the latest regulatory approval, Tandem Diabetes aims to strengthen its diabetes care business on a global scale.

Significance of the Approval

The approval of the t:slim X2 insulin pump with Control-IQ Advanced Hybrid Closed-Loop Technology by Health Canada will provide all in-warranty t:slim X2 pump users in Canada the option to add Control-IQ technology to their existing pumps from March 2021 via remote software update. Notably, the free update will be available till Dec 31, 2021.

Per management, the t:slim X2 insulin pump with Control-IQ technology is the most advanced automated insulin dosing system currently available. Further, the company is upbeat about the opportunity to contribute to the Canadian diabetes community by providing the advanced hybrid closed-loop system.

For investors’ note, the Control-IQ technology uses Dexcom G6 CGM sensor values to predict glucose levels 30 minutes ahead and adjust insulin delivery to help prevent fluctuations. The system also delivers automatic correction boluses up to once per hour, which is a first for any commercial automated insulin delivery system. Control-IQ technology also offers optional settings for sleep and exercise that will change the treatment values to better match the different physiological needs during these activities.

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 incidences of diabetes and greater adoption of insulin pumps over traditional methods are expected to drive the market.

Given the market potential, the positive study results are expected to boost the company’s business.

Notable Developments

Of late, Tandem Diabetes has been witnessing a slew of developments.

The company, in August, announced the publication of favorable study outcomes from the Protocol 5 study (DCLP5) of the International Diabetes Closed Loop (iDCL) trial in the New England Journal of Medicine.

The company, in July, entered into a non-exclusive patent cross-license agreement with Medtronic plc MDT for certain technologies in the field of diabetes. The same month, Tandem Diabetes announced a new national partnership with JDRF (a global organization funding type 1 diabetes research) to help drive awareness and education on topics related to technology innovation, diabetes management and healthcare for diabetics.

Price Performance

Shares of the company have rallied 30.4% in the past year compared with the industry’s 12.9% growth and the S&P 500’s 13.9% rise.

Zacks Rank & Key Picks

Currently, Tandem Diabetes carries a Zacks Rank #3 (Hold).

Some other better-ranked stocks from the broader medical space are ResMed Inc. RMD and Thermo Fisher Scientific Inc. TMO.

ResMed’s long-term earnings growth rate is estimated at 14.5%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Thermo Fisher’s long-term earnings growth rate is estimated at 18%. It currently carries a Zacks Rank #2.

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Medtronic PLC (MDT) : Free Stock Analysis Report
 
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