Senseonics Archives - Medical Design Sourcing

Ascensia, Senseonics announce new CGM cost savings

The Eversense E3 system. [Image from Ascensia/Senseonics]Ascensia Diabetes Care and Senseonics today announced an extension to their Eversense Payment Assistance and Simple Savings (PASS) program.

The program aims to help people in the U.S. access the Eversense E3 continuous glucose monitor (CGM) more affordably. It offers major savings for eligible individuals looking to experience the benefits of the long-term, implantable CGM.

Eversense E3, a 180-day CGM, requires two sensor insertion and removal procedures per year. It offers a mean absolute relative difference (MARD — an accuracy metric for CGMs) of 8.5%. The system features predictive on-body alerts to never miss a critical event. Senseonics develops the sensor and Ascensia serves as the global exclusive distributor for Eversense E3.

Senseonics also has the regulatory wheels in motion for Eversense E3 with a 365-day wear time. The company expects an “imminent” submission to the FDA.

FDA submission for 365-day CGM from Senseonics is ‘imminent’

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast.

The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology.

Shares of SENS fell 3.5% to 69¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down 0.6%.

Get the full story at our sister site, Drug Delivery Business News.

Senseonics earns expanded Medicare coverage for long-term implantable CGM

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) and Ascensia Diabetes Care today announced expanded Medicare coverage for the Eversense E3 CGM system.

Medicare implemented Local Coverage Determinations (LCDs) providing access to implantable CGM for basal-only patients. It significantly expands access to Senseonics’ long-term (six months) implantable glucose monitor. The expansion for implantable CGMs includes all people with diabetes using insulin. It removes the previous requirement for multiple insulin administrations per day.

Additionally, the new policy covers non-insulin users with a history of problematic hypoglycemia. Noridian, Palmetto and National Government Services published the final LCDs. The earliest expansion becomes effective on Feb. 25, 2024, with the remainder expected to be finalized in the near future.

Get the full story at our sister site, Drug Delivery Business News.

Former Tandem CCO joins Ascensia as president of CGM

Ascensia Diabetes Care parent company PHC Holdings and Senseonics announced today that Ascensia named Brian Hansen its president of CGM.

Hansen’s appointment to the newly created role at the global distributor of Senseonics’ Eversense CGM went into effect today, Feb. 6.

Responsibilities for Hansen include the global commercialization and growth of the Eversense system. The fully implantable CGM allows for the continuous measurement of glucose levels for up to six months. With longevity, it also offers features like a removable transmitter, discreet on-body vibe alerts, accuracy and a smartphone app.

Hansen previously served as chief commercial officer at insulin pump maker Tandem Diabetes Care.

Get the full story at our sister site, Drug Delivery Business News.

Here’s what diabetes tech companies are doing on World Diabetes Day

Every November, the diabetes community comes together to recognize both National Diabetes Month in the U.S. and World Diabetes Day.

World Diabetes Day falls on today, Nov. 14, to mark the birthday of Sir Frederick Banting. Banting discovered the insulin hormone along with Charles Herbert Best in 1922.

In an effort to drive awareness and understanding of the chronic condition, a number of medtech companies in the diabetes space undertake efforts each year to celebrate and draw attention to the day and month recognizing the community. We compiled lists in 2021 and 2022 to share some of the initiatives brought forward by these companies.

On World Diabetes Day in 2023, here is what medtech’s diabetes community is doing:

Abbott

Abbott (NYSE:ABT) launched its new “Countdown at a Crossroads” initiative to mark National Diabetes Awareness Month.

The initiative features an animated installation promoting diabetes awareness at the Oculus Center…

Senseonics posts mixed Q3, iCGM designation expected next year

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) shares remained mostly unchanged today on third-quarter results that came in mixed compared to the consensus forecast.

Shares of SENS dipped 0.3% at 51¢ apiece before the market opened today.

The Germantown, Maryland-based implantable continuous glucose monitor (CGM) maker posted losses of $24.1 million. That equals 4¢ per share on sales of $6.1 million for the three months ended Sept. 30, 2023. The company posted a 60% bottom-line gain while remaining in the red on sales growth of 31.9%.

Senseonics’ losses per share of 4¢ fell 1¢ behind expectations on Wall Street. Sales, however, beat projections of $5.61 million.

Highlights in the quarter included entering into a $50 million loan facility and completing a 365-day cohort in a study of its Eversense implantable CGM.

Get the full story at our sister site, Drug Delivery Business News.

Senseonics completes 365-day CGM study cohort

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) announced today that it completed its ENHANCE pivotal clinical study adult cohort for its 365-day Eversense CGM.

Germantown, Maryland-based Senseonics’ ENHANCE study recorded the completed 365-day visit for the final study patient. The study evaluates the year-long implantable continuous glucose monitor in adults. It also has a pediatric cohort (ages 14 to 18), which saw its first patient insertion in April.

ENHANCE evaluates the safety and accuracy of Eversense over one year. More than 165 adult subjects received Eversense insertions across four U.S. centers. The company completed enrollment in September 2022. Senseonics also used data from the study to support its FDA submission for integrated continuous glucose monitoring (iCGM) designation this year.

Get the full story at our sister site, Drug Delivery Business News.

Senseonics enters into $50M loan facility

Senseonics (NYSE:SENS) announced today that it entered into a $50 million loan facility with Hercules Capital.

The Germantown, Maryland-based long-term, implantable continuous glucose monitor (CGM) maker drew $25 million upon closing.

Senseonics CFO Rick Sullivan said the facility provides increased financial flexibility for the company. It looks to continue collaborating with Ascensia Diabetes Car to build its Eversense CGM brand and drive global adoption. Recent highlights for the company include the submission of the Eversense CGM system to the FDA for an iCGM designation. Analysts expect this approval to integrate the system with insulin delivery systems to come in 2024.

Get the full story at our sister site, Drug Delivery Business News.

Analysts: GLP-1 drugs should have minor impact on insulin pump market — but will boost CGMs

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies could be among those affected by the rise of the GLP-1 drug class. [Images courtesy of Insulet, Medtronic and Senseonics]Based on conversations with diabetes experts, analysts are playing down the potentially negative impact of GLP-1 receptor agonists on the diabetes technology industry.

The GLP-1 drug class, which includes Ozempic and Wegovy, has cast a shadow of doubt over diabetes technology of late. This therapeutic class, a glucagon-like peptide 1, has proven to lead to improved blood sugar control and weight loss.

In addition to the popular therapeutics, some companies — like i20 Therapeutics and Vivani Medical — are developing long-term implants that elute GLP-1s.

Positive clinical results from these drugs led to some negative market movement for a few of the biggest names in diabetes technology. Analysts even recently trimmed some forecasts o…

Senseonics posts mixed Q2 results, submits to FDA for iCGM designation

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) shares took a hit today on second-quarter results that missed the consensus sales forecast.

Shares of SENS fell nearly 12% at 65¢ apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed relatively even.

The Germantown, Maryland-based implantable continuous glucose monitor (CGM) maker posted losses of $20.4 million in the quarter. That amounts to 4¢ per share on sales of $4.1 million for the three months ended June 30, 2023.

Losses per share came in equal with Wall Street estimates, while sales came up short of the analysts’ forecast of $4.5 million. However, BTIG analysts Marie Thibault and Sam Eiber noted an outlier in the average forecast. Without this, Senseonics would still be short of a projection of $4.2 million, but only just.

G…

The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies were part of some of the biggest stories from the American Diabetes Associations’ 2023 Scientific Sessions. [Images courtesy of Insulet, Medtronic and Senseonics]

As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space.

At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for a number of technologies and innovations. From continuous glucose monitors (CGMs) to insulin pumps to digital platforms and diabetes reversal procedures, ADA 2023 saw it all.

Usual suspects, like Dexcom, Abbott, Medtronic and Insulet shared their updates. Meanwhile, promising data came …

The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies were part of some of the biggest stories from the American Diabetes Associations’ 2023 Scientific Sessions. [Images courtesy of Insulet, Medtronic and Senseonics]As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space.

At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for a range of technologies and innovations. From continuous glucose monitors (CGMs) to insulin pumps to digital platforms and diabetes reversal procedures, ADA 2023 saw it all.

Usual suspects, like Dexcom, Abbott, Medtronic and Insulet shared their updates. Meanwhile, promising data came out of Senseonics, Sernova, Bigfoot Biomedical and more.<…