Latest news with #CGMs
Yahoo
17-05-2025
- Business
- Yahoo
Dexcom CEO says CGMs fit MAHA agenda ‘very nicely'; Tandem preps for new products
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Dexcom CEO Kevin Sayer touted the company's recent efforts to expand coverage of CGMs for people with Type 2 diabetes. On a May 1 earnings call, the CEO told investors that all three major U.S. pharmacy benefit managers now cover the company's G7 glucose monitor for anyone with diabetes. Dexcom expects to have coverage for nearly 6 million people with Type 2 diabetes who don't take insulin by the end of the year. 'While this still represents only a portion of this 25 million-person population in the U.S., we often see smaller and customized plans quickly follow suit of the larger PBM formularies,' Sayer said. Dexcom will seek coverage from Medicare for people with diabetes who don't take insulin. The company is working to gather evidence from a randomized controlled trial to submit a request to the Centers for Medicare and Medicaid Services, Sayer said. Wolfe Research analyst Mike Polark on the earnings call noted comments by Health and Human Services Secretary Robert F. Kennedy Jr. supporting CGMs. Food and Drug Administration Commissioner Martin Makary has also suggested making the devices more widely available. 'We're very pleased with the comments of the administration,' Sayer said, adding that the company thinks its devices 'fit the Make America Healthy agenda very nicely.' Dexcom reported revenue of $1.04 billion in the first quarter, a 12% increase year over year. Tandem is seeking Europe's CE mark for its newer, smaller Mobi insulin pump, CEO John Sheridan said in an April 30 earnings call. Tandem received FDA clearance for the device in 2023. The company plans to launch Mobi outside of the U.S. with multiple sensor integrations by the year's end, Sheridan said. In February, Tandem received an expanded FDA indication for its Control-IQ+ algorithm for Type 2 diabetes. The algorithm pairs data from glucose monitors with the company's insulin pumps for automated dosing. Tandem hopes to launch the newer version of that algorithm internationally by the end of the year, pending regulatory approval, Sheridan said. The CEO also provided an update on Tandem's efforts to develop an insulin patch pump. The company is working on a tubeless feature for its Mobi pump that is now in verification testing and manufacturing buildout, Sheridan said. Meanwhile, the company has moved development of the Sigi patch pump that it acquired in 2022 to San Diego. Insulet, which received an expanded indication last year for its Omnipod 5 patch pump, said people with Type 2 diabetes represent a growing portion of new patients. Eric Benjamin, chief product and customer experience officer, told investors on May 8 that people with Type 2 diabetes made up more than 30% of new starts in the first quarter, an increase from 25% in the fourth quarter. The company grew revenue by nearly 29% to $569 million in the first quarter, compared to the year-ago period, and named longtime medtech executive Ashley McEvoy as CEO. Insulet estimated in February that the Type 2 indication expands the total addressable market for its patch pumps in the U.S. to more than 5.5 million people with Type 2 diabetes who take insulin. About 2.5 million of those people take multiple daily injections of insulin. Insulet estimated the market is less than 5% penetrated. Benjamin expects the company could double or triple that number, telling investors, 'Right now, we're making that market.' Recommended Reading New Insulet CEO Ashley McEvoy sets priorities Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Indianapolis Star
12-05-2025
- Business
- Indianapolis Star
Roche will put $550 million facility for glucose monitors in Indianapolis, adding 650 jobs
Roche Diagnostics will invest $550 million in its Indianapolis base to construct a new manufacturing facility for glucose monitoring devices, which will add several hundred jobs and further solidify the company's footprint and presence in Indiana. Swiss-based Roche will refurbish an existing building at its North American Headquarters located along I-69 on the border of Fishers and Marion County. The building will be completed in phases by 2030 and house technology to manufacture continuous glucose monitoring devices, the company announced May 12. If the company decides it needs more space for the operations, it could construct additional buildings. Some 650 high-skill jobs are expected to be added in Indianapolis because of the investment. Roche employs nearly 5,000 people in the Indianapolis area, where the company has had strong roots since the 1960s when Roche established its diagnostics arm. "Indianapolis was a natural choice when we sought a location for this newest investment," said Richeal Cline, Roche head of global operations. "This location has strong manufacturing capabilities and a longstanding history of producing diabetes care products for Roche." The investment is part of a larger $50 billion investment in U.S. manufacturing that Roche announced last month to strengthen the biotech behemoth's production capacity. Eventually Roche plans to export more medicines from the United States than it imports into the country. Roche is the latest pharmaceutical company to take steps to increase drug and medical device production in the United States amid President Donald Trump's ongoing tariff war. On May 12, Roche also announced a $700 million facility in North Carolina to build the next generation of weight-loss medications. Roche executives believe the company is better off than other drugmakers as it has been increasing production in the United States for years. Roche can significantly increase U.S. manufacturing output "overnight," CEO Thomas Schinecker said in an April earnings call. Roche's Indianapolis campus has established itself as a hub for glucose monitors and diabetes research. The site produces approximately 5.2 billion Accu-Chek diabetes test strips each year and serves as one of Roche's two global distribution hubs, helping make Indiana the largest state for advanced manufacturing in the country. Continuous glucose monitors, or CGMs, are wearable devices that record sugar levels just under the skin for 24 hours a day. More than 38 million Americans live with diabetes, a hard disease to manage given its unpredictability, Roche officials said. The investment will help with rising global demand for CGMs and improve diabetes management for millions, President and CEO of Roche Diagnostics Brad Moore said. In choosing to build the facility in Indianapolis, Roche will receive a 10-year tax abatement from the city worth $40 million in addition to a state tax incentive package worth $20 million. Roche will also spend $2 million on community investments. State Secretary of Commerce David Adams said the creation of several hundred in-demand jobs resulted in a generous tax credit package for Roche. When offering incentive packages, the state wants to help companies keep talented employees in Indiana while attracting others to the state who want to work in a strong biotech hub. "We also want to be able to track down talent from around the country as they see the life sciences ecosystem here as a destination location," Adams said. Roche responds to tariffs: As potential tariffs loom, Roche in 'much better' position than competitors, CEO says Since 2012, Roche has poured $450 million into the Indianapolis campus and increased operational space and warehouse capacity by 37%. Roche's $50 billion investment includes several other facilities across the country, including:
Reuters
02-05-2025
- Business
- Reuters
Dexcom beats quarterly sales estimates, reiterates annual forecast
Companies May 1 (Reuters) - Medical device maker Dexcom (DXCM.O), opens new tab beat first-quarter sales estimates helped by strong demand for its continuous glucose monitors (CGMs) used by patients with diabetes. Shares of the company rose 3.26% to $72.55 in after market trading. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Increasing diabetes care awareness, wider insurance coverage, and preference for devices that do not need finger pricks have benefited CGM devices such as Dexcom's Stelo and G7. The San Diego, California-based company reiterated its annual revenue forecast of $4.60 billion. Analysts on average expect 2025 revenue of $4.61 billion, according to data compiled by LSEG. It expects annual gross profit margin of about 62%, compared to between 64% and 65% expected previously. This is due to incremental costs related to short-term supply factors, which were previously announced, as the company rebuilds its finished goods inventory to ideal levels, Dexcom said. Last year, Dexcom's shares were hit after the company slashed its annual revenue forecast, citing a restructuring of its sales team, fewer customers and lower revenue. The device maker is pinning its hopes on Stelo, which was launched for adults aged 18 and older who do not use insulin, making it the first CGM available for over-the-counter sales. Earlier this month, the FDA cleared Dexcom's updated G7 15-day CGM. Dexcom's first-quarter revenue increased 12% to $1.04 billion, beating analysts' estimates of $1.02 billion. On an adjusted basis, the company earned a profit of 32 cents per share, compared to estimates of 33 cents per share.
India Today
25-04-2025
- Health
- India Today
Axiom-4 astronauts to test diabetes glucose monitor aboard Space Station
To enhance monitoring of glucose level, and diabetes in space, Axiom-4 astronauts will test Continuous Glucose Monitors (CGMs) during their mission aboard the International Space astronauts will launch on ISS aboard a SpaceX Dragon spacecraft piloted by Indian astronaut Shubhanshu Shukla in May 2025. The new CGMs have become the standard for glucose monitoring in individuals with diabetes on Earth and Burjeel Holdings, which develops the instrument now wants to test its efficiency in space so that they can be used on long-duration space The Suite Ride initiative involves flying and operating a suite of medical capabilities to further advancements in diabetes monitoring and treatment. Axiom Space's multi-tiered approach aims to eventually demonstrate that astronauts with insulin-dependent diabetes (IDDM) can be safely monitored, treated, and participate in off-planet Space has partnered with @BurjeelHoldings to test a suite of tools and technologies needed to support astronauts with insulin-dependent diabetes, enabling them to live and work in space. Learn more about the Suite Ride research that will be conducted during #Ax4: Axiom Space (@Axiom_Space) April 24, 2025Axiom Space said that comprehensive preflight, inflight, and post-flight protocols will employ various testing methods to validate these technologies. The Ax-4 mission also plans to look at insulin exposure in microgravity to assess the potency and stability of the drug product upon its return to technologies and advances that could result from this project could also improve our ability to provide remote care for patients with diabetes and other health conditions on Earth," Dr. Mike Harrison, chief medical officer at Axiom Space test is aimed at creating pathway for astronauts with IDDM to fly to space."The successful demonstration of glucose monitoring on subjects without diabetes will next open the door to flying astronauts with non-insulin-dependent Type 2 diabetes, looking to prove that people with diabetes can one day thrive in the unique environment of space," Axiom Space said in a In
Gulf News
24-04-2025
- Health
- Gulf News
UAE-led diabetes study to launch into space aboard Elon Musk's SpaceX Dragon on Ax-4 Mission
Abu Dhabi: In a historic collaboration that could redefine both space medicine and diabetes care, a UAE study led by Abu Dhabi-headquartered Burjeel Holdings is set to blast off to the International Space Station (ISS) aboard Axiom Mission 4 (Ax-4), launching on a SpaceX Dragon spacecraft in May. The mission marks a groundbreaking attempt to explore how astronauts with diabetes might one day participate in long-duration space missions—a group historically excluded due to health risks associated with insulin-dependent diabetes. 'This research is truly exciting as it opens the door for astronauts with diabetes and other chronic conditions to participate in future human spaceflight missions, paving the way for many who were previously medically disqualified,' said veteran astronaut and Ax-4 Commander Peggy Whitson. The study dubbed 'Suite Ride' aims to evaluate diabetes monitoring and management technologies under microgravity conditions aboard the ISS. Joining Whitson on this international mission are Pilot Shubhanshu Shukla (India), Mission Specialist Sławosz Uznański-Wiśniewski (Poland/ESA), and Tibor Kapu (Hungary). The crew will spend up to 14 days conducting advanced research and technology demonstrations in space, with Suite Ride emerging as one of the most medically consequential experiments of the mission. Medical milestone in microgravity The research will test blood glucose monitoring technologies, including glucometer readings and the calibration of continuous glucose monitors (CGMs), as well as explore insulin stability in space. Data will be transmitted in real-time to medical teams on the ground, enabling comprehensive post-mission analysis. 'Studying glucose metabolism in space provides critical insights into insulin sensitivity, metabolic adaptation, and remote monitoring—advancing both astronaut health and diabetes care on Earth. At Burjeel Holdings, we are committed to transforming these findings into innovative treatments for our patients,' said Dr Mohammad Fityan, Chief Medical Officer at Burjeel Medical City and Clinical Lead of the study. Real-world benefits The technology and protocols used in space could eventually enable remote monitoring and care for individuals in extreme Earth environments, from oil rigs to arctic expeditions, and even patients managing chronic conditions at home. The stakes are high. According to the International Diabetes Federation, diabetes will affect approximately 783 million people by 2045, a 46% increase from current figures. In the MENA region alone, cases are projected to surge by 87%. One of the important aspects of the experiment will be testing the performance of CGMs—now standard in diabetes care—within a space environment. The goal is to verify their accuracy in microgravity and confirm whether commercially available insulin pens remain effective in space, as demonstrated in a recent precursor test aboard Galactic 07. Studying biological processes in microgravity offers unique opportunities to understand diseases in ways that are impossible to replicate on Earth. The absence of gravity alters cellular behavior, enabling deeper insights into conditions such as Alzheimer's, Parkinson's, and cancer. Previous research in space has already contributed to significant insights in protein crystallization and cellular aging, which are advancing the development of new treatments. 'The research we will conduct during Ax-4 is an important step in providing significant benefits for patients in the UAE and the wider MENA region. As we push the boundaries of space exploration, this research will empower Burjeel to expand on their remote healthcare practices and technologies,' Whitson emphasised. UAE vision for scientific leadership Dr Shamsheer Vayalil, Founder and Chairman of Burjeel Holdings, underscored the significance of this collaboration, stating, 'Burjeel Holdings is proud to collaborate on this groundbreaking study aboard Ax-4, which marks a milestone in medical research and diabetes management. The findings from this study have the potential to not only benefit future astronauts but also translate into meaningful advancements in patient care here on the ground. We wish the mission and its crew great success and look forward to the impact this research will have on shaping the future of healthcare.' Commander Whitson also commended the UAE's role in enabling scientific progress. 'The UAE's commitment to advancing space science and healthcare provides a unique platform for young scientists and healthcare professionals to make significant contributions,' she said. 'To the aspiring astronauts and researchers in the UAE—your curiosity and dedication are the driving forces behind the future of exploration and innovation.' From the stars to the streets 'Our collaboration with Axiom Space on diabetes management in microgravity highlights our commitment to enhancing remote healthcare capabilities. For us, space is a proving ground, as this diabetes research aims to provide invaluable data that will directly benefit underserved communities and difficult-to-reach areas across the globe, especially in MENA. By leveraging the advancements in monitoring and treatment technologies, we are poised to revolutionize healthcare delivery, ensuring that individuals in remote locations receive the quality care they deserve,' added Dr Fityan.
