Tandem Diabetes care expects double-digit revenue growth in 2023

Tandem Diabetes Care (Nasdaq:TNDM) announced preliminary fourth-quarter results and offered expectations for the coming year.

San Diego-based Tandem expects sales to total $221 million, coming in $11 million higher than the same quarter last year. Wall Street analysts expect $221.6 million in revenues. The automated insulin delivery technology developer noted that its adjusted sales rise to $224 million for the quarter. That total includes the impact of its Tandem Choice Program which allows users to switch to a new pump model when available.

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The 10 biggest diabetes tech stories from 2022

Some of the biggest diabetes technology developments in 2022. These include the Dexcom G7 (top left), Insulet Omnipod 5 (bottom left), Senseonics Eversense E3 (top right) and Abbott FreeStyle Libre 3 (bottom right. 2022 represented a landmark year for next-generation diabetes technologies. Here are the biggest stories from the past year.

Some companies picked up major regulatory nods. Others experienced major regulatory setbacks.

Partnerships were formed and ended, while mergers and acquisitions came and went. There were many stories to choose from, but here are 10 big ones that stood out:

Dexcom G7 receives FDA clearance

The long-awaited regulatory nod for Dexcom’s next-generation continuous glucose monitor (CGM) finally came in December.

Some suggested that San Diego-based Dexcom may pick up clearance as soon as summer 2022. However, a software change recommended by the FDA, plus COVID-19-related backlog, delayed proceedings.

Dexcom COO Ja…

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Tandem Diabetes Care to acquire patch pump maker AMF Medical

The Sigi insulin patch pump. [Image courtesy of Tandem Diabetes Care/AMF Medical]Tandem Diabetes Care (Nasdaq:TNDM) announced today that it acquired AMF Medical, maker of the Sigi patch pump for insulin delivery.

Switzerland-based AMF Medical currently develops the Sigi patch pump and does not offer it commercially. The system received FDA breakthrough device designation just over one year ago.

AMF Medical designed Sigi as an ergonomic, rechargeable patch pump for reducing the burden of diabetes management. It uses pre-filled insulin cartridges and offers compatibility with automated insulin delivery technology.

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Axonics, Outset lead medtech space on Deloitte’s list of fastest growing companies

Deloitte today released its “North America Technology Fast 500” list of growing companies, including a handful of medtech firms.

The list, which ranking of the fastest-growing North American companies across a range of sectors, included several “Life Sciences” outfits. Immunology company Vir Biotechnology led the way in first place on the list.

Axonics (Nasdaq:AXNX) represented the highest-ranked medical device company at No. 4. According to Deloitte, the company registered 25,401% growth over a three-year period. Axonics reported $180.3 million in revenue in fiscal 2021, compared to $707,000 in fiscal 2018.

The company topped last year’s version of the list. Axonics develops novel products for adults with bladder and bowel dysfunction. Its sacral neuromodulation (SNM) systems provide adults suffering from overactive bladder and/or fecal incontinence with long-lived, easy-to-use, safe, clinically effective therapy. The compa…

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Tandem stock ticks up after Wells Fargo upgrade

Tandem Diabetes Care (Nasdaq:TNDM) shares ticked up today after Wells Fargo declared it “Equal Weight,” an improvement from “Underweight.”

Shares of TNDM rose 8.3% at $42.81 apiece in midday trading today. MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 6.8%.

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Study supports Tandem t:slim X2 insulin pump for type 2 diabetes

Image from Tandem Diabetes

Tandem Diabetes Care (Nasdaq:TNDM) announced that a study of adults with type 2 diabetes supported its automated insulin delivery system.

The study evaluated adults with type 2 diabetes using the t:slim X2 insulin pump with Control-IQ technology. Patients achieved improvement in all clinical endpoints with the technology, which currently does not hold approval for type 2 diabetes.

Data demonstrated safety during six weeks of use. It also presented substantial improvements in time in range and mean glucose related to a reduction in hyperglycemia. Tandem reported no increase in continuous glucose monitor (CGM)-measured hypoglycemia.

Both users of multiple daily injections (MDI) and basal insulin-only showed similar levels of improvement. According to a news release, participants indicated a high level of satisfaction with the Tandem system.

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Tandem stock dives on Q3 misses, reduced guidance

Image from Tandem Diabetes

Tandem Diabetes Care (Nasdaq:TNDM) shares took a big hit after hours on third-quarter results that missed the consensus forecast.

Shares of TNDM. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down 0.3%.

The San Diego-based company posted losses of nearly $49 million for the quarter. That amounts to 76¢ per share on sales of $204.5 million for the three months ended Sept. 30, 2022.

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Tandem Diabetes Care delivers 1 million insulin boluses using t:connect mobile app

Tandem Diabetes Care mobile bolus user and professional skier Lauren Salko with her Tandem mobile bolus app. [Image from Tandem Diabetes Care]Tandem Diabetes Care (Nasdaq:TNDM) announced today that its users have delivered more than 1 million insulin boluses using its app.

Users of the t:connect app feature on their personal mobile device have reached the 1 million insulin bolus milestone with the t:slim X2 insulin pump within the first month following its commercial release.

San Diego-based Tandem designed the t:connect mobile app to offer users of the t:slim X2 insulin pump the ability to program and cancel bolus insulin requests through the convenience of their compatible smartphone. The company said in a news release that it is the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems. The company added that it is now available on approximately 30 different devices.

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Wells Fargo downgrades Tandem amid rise of automated insulin delivery competition

Image from Tandem Diabetes

Wells Fargo downgraded Tandem Diabetes Care (Nasdaq:TNDM) as competitors apply pressure to the automated insulin delivery technology developer.

According to SeekingAlpha, analysts led by Larry Biegelsen moved Tandem from “Overweight” to “Underweight” due to bullish expectations on Wall Street as the company’s competition, including Insulet and Medtronic, come to the fore. The street responded in kind, with shares of TNDM down 6.8% at $56 per share in early-morning trading today.

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Tandem sinks on Q2 misses, slashed sales guidance

Tandem Diabetes Care (Nasdaq:TNDM) shares took a bit hit after hours on second-quarter results that missed the consensus forecast.

Shares of TNDM were down 7.2% at $64 per share after the market closed, which was when it released its quarterly results.

The San Diego-based automated insulin delivery technology developer posted losses of $15.1 million, or 24¢ per share, on sales of $200.3 million for the three months ended June 30, 2022, for a roughly $20 million bottom-line slide into the red on sales growth of 16.3%.

On Wall Street, analysts had been looking for sales of $205.3 million and adjusted earnings per share of 2¢.

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Tandem Diabetes Care adds two new members to its board

Image from Tandem Diabetes

Tandem Diabetes Care (Nasdaq:TNDM) announced today that it appointed two new independent members to its board of directors.

Myoung Cha and Joao Malagueira have been named to the San Diego-based automated insulin delivery technology developer’s board, effective yesterday, June 15, 2022.

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The biggest stories from the American Diabetes Association (ADA) 2022 Scientific Sessions

For the 82nd time, the American Diabetes Association (ADA) Scientific Sessions convened to highlight all the innovations within the diabetes technology space.

Major players like Dexcom, Medtronic, Abbott and more continue to plug along, while companies like Bigfoot Biomedical, One Drop and others shared data backing the technology that they bring to the table.

The data showcased at ADA supported the usual continuous glucose monitoring (CGM) and automated insulin delivery (AID) technology, plus different digital health platforms and diabetes reversal procedures.

BTIG analyst Marie Thibault wrote in a report that there was plenty of buzz on the ground at the event, particularly around Insulet’s Omnipod 5 AID system, Abbott’s recently FDA-cleared FreeStyle Libre 3 CGM and Bigfoot Biomedical’s Bigfoot Unity platform.

“In general, we believe that accuracy and clinical benefit is proven for all commercial CGM and AID offerings an…

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