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FDA approves Eversense 365 as year-long diabetes monitor

Published 09/17/2024, 07:18 PM
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GERMANTOWN, Md. & PARSIPPANY, N.J. - Senseonics Holdings (NYSE:SENS), Inc. (NYSE American: SENS), in partnership with Ascensia Diabetes Care, has announced the U.S. Food and Drug Administration (FDA) clearance of Eversense® 365, a continuous glucose monitoring (CGM) system for adults with diabetes. This marks the introduction of the world's first year-long CGM system, designed to minimize the frequency of sensor replacements and provide consistent, long-term glucose monitoring.


The Eversense 365 system, which is fully implantable, offers a significant innovation in diabetes care, extending the life of the CGM sensor to 365 days. This contrasts with the 10-14 day lifespan of existing short-term CGM sensors, potentially reducing the inconvenience and disruptions associated with frequent sensor changes.


According to Tim Goodnow, President and CEO of Senseonics, the Eversense 365 system was developed to enhance the quality of life for individuals managing diabetes by offering a more dependable and less intrusive monitoring option. The system aims to help users maintain optimal glucose levels and improve their overall diabetes management.


Brian Hansen, President of CGM at Ascensia Diabetes Care, emphasized the importance of technology that reduces the burden of diabetes management. The Eversense 365 system allows users to focus more on their daily lives rather than the limitations of short-term CGMs. Ascensia, a subsidiary of PHC Holdings Corporation (TSE 6523), anticipates launching Eversense 365 in the U.S. early in the fourth quarter of 2024.


The Eversense 365 CGM system also integrates with compatible medical devices, including insulin pumps, as part of automated insulin delivery (AID) systems. The integration is expected to address common limitations of AID systems, and discussions with various pump manufacturers are progressing.


The Eversense 365 CGM system's features include a single yearly insertion, high accuracy, and the convenience of a removable transmitter without the need to waste a sensor. It also offers on-body vibration alerts for discreet monitoring.


This announcement is based on a press release statement, and for more information about the Eversense 365 system, interested healthcare providers can visit the Ascensia Diabetes Care website. The system is a prescription device and patients are advised to consult with their healthcare providers for more details.

InvestingPro Insights


As Senseonics Holdings, Inc. (NYSE American: SENS) teams up with Ascensia Diabetes Care to revolutionize diabetes management with Eversense® 365, the world's first year-long continuous glucose monitoring (CGM) system, the financial metrics of the company provide a mixed picture. With a market capitalization of approximately $972.66 million, Senseonics is positioning itself as a notable player in the Healthcare Equipment & Supplies industry, according to InvestingPro Tips. This aligns with the company's innovative strides in the CGM market.


InvestingPro Data indicates that Senseonics has a negative P/E ratio of -11.37, reflecting its current lack of profitability over the last twelve months. Despite this, the company's valuation implies a strong free cash flow yield, suggesting potential for future financial health and investor returns. Additionally, the firm's price-to-book ratio stands at 0.92, which could indicate that the stock is potentially undervalued relative to its assets.


InvestingPro Tips also highlight that Senseonics is trading at a high EBIT valuation multiple, which may be a point of consideration for investors looking at the company's earnings relative to its market valuation. For those interested in a deep dive into Senseonics' financials and additional insights, InvestingPro offers numerous tips, with a total of 5 additional tips listed on the platform to help investors make informed decisions.


The introduction of Eversense 365 is a significant milestone for Senseonics and the broader diabetes care market, and understanding the company's financial health is crucial for stakeholders. For a comprehensive analysis of Senseonics' financial outlook and strategic positioning within the industry, visit https://www.investing.com/pro/SENS.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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