Senseonics Announces CE Mark Approval for Eversense® XL CGM System
Senseonics Holdings, Inc. (NYSE-MKT-SENS) today announced it has received CE Mark approval for the Eversense® XL Continuous Glucose Monitoring (CGM) System. The Eversense XL System includes an extended life implanted glucose sensor lasting up to 180 days, a removable discreet smart transmitter, and a mobile app for display of real-time glucose readings. The Eversense XL System provides the world’s longest-lasting sensor, compared to the frequent weekly sensor insertions required by other CGM systems.
"We are pleased to announce the CE Mark approval of the Eversense XL System, representing another significant milestone for Senseonics. When we introduced the Eversense System last year, we were providing the longest-wear sensor with up to 90-day wear for people with diabetes. Now with the new Eversense XL System’s even longer sensor duration, patients can extend a single sensor wear over 3 seasons – inserting a new sensor in the Fall which will continue through the Winter to be replaced in Spring,” said Tim Goodnow, CEO and President of Senseonics. “As we continue to advance our product portfolio with extended long-term sensor capabilities, we are offering added convenience to support patients’ continuous glucose management. We are excited to bring this product to market in Europe in the fourth quarter of 2017.”
CE Mark indicates that the product design conforms to the requirements of the Active Implantable Medical Device Directive (AIMDD 90/385/EEC). Eversense XL is indicated for continually measuring interstitial fluid glucose levels in adults and to be used as an adjunctive device to complement information obtained from standard home blood glucose meters.
“We are all aware of the advantages of continuous glucose monitoring seen now in many studies, including improvements in glycemic control, quality of life and reduction in hypoglycemia,” said Dr. Pratik Choudhary, Senior Lecturer and Consultant in Diabetes at King’s College London. “The benefits have been linked with long-term usage, which for many requires changing sensors every week. Eversense now offers a unique option for people who want to use CGM long term, with a long-lasting sensor that has demonstrated accuracy.”
Eversense XL - advanced CGM technology with best in class sensor wear time for people with diabetes #ExtendedLifeCGM #EversenseCGM #AdvancedCGMTechnology
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics' CGM systems, Eversense and Eversense XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about the continued advancement of Senseonics’ product portfolio, the commercialization of Eversense XL in Europe and other statements containing the words “expect,” “intend,” “may,” “will,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the underwritten public offering on the anticipated terms or at all, uncertainties inherent in the expanded commercial launch of Eversense and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2016, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.
Senseonics Holdings, Inc.
R. Don Elsey, 301-556-1602
Chief Financial Officer
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
OTEZLA® (Apremilast) Phase III Data Showed Significant Improvements in Patients with Active Behçet’s Disease with Oral Ulcers18.2.2018 00:00 | Tiedote
Celgene Corporation (NASDAQ:CELG) today announced that data from the phase III RELIEF™ clinical trial of OTEZLA® (apremilast) in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4). Behçet’s Disease is a rare, chronic, multi-system inflammatory syndrome. Oral ulcers, the most common manifestation of Behçet’s Disease, can be disabling and have a substantial effect on quality of life. This study primarily evaluated the effect of apremilast on recurring oral ulcers in patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication. “Reducing oral ulcers, which are painful and can negatively im
CT-P13 (biosimilar infliximab) is comparable to reference infliximab and adalimumab in highly anticipated real-world study17.2.2018 11:00 | Tiedote
Twelve-month data from the Personalised Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO). The results indicate that the clinical effectiveness, safety and immunogenicity of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.1 The UK-wide, three-year prospective observational study investigated primary non-response (PNR), loss of response (LOR) and adverse drug reactions (ADR) to infliximab (reference infliximab and CT-P13) and adalimumab in 1610 CD patients. The data show comparable efficacy between CT-P13, reference infliximab and adalimumab in relation to PNR, LOR and ADR rates. In addition, at week 54, the remission rate was 39.7%, 39.0% and 32.7% for reference infliximab, CT-P13 and adalimumab treated patients, respectively.1 The PANTS study investigates
Avanti Communications HYLAS 4 Satellite Arrives in French Guiana16.2.2018 21:26 | Tiedote
Avanti Communications Group plc (“Avanti”), a leading provider of satellite data communications services in Europe, the Middle East and Africa (“EMEA”), announces its HYLAS 4 satellite has arrived safely in French Guiana ahead of its March 2018 launch. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180216005586/en/ Avanti Communications HYLAS 4 Satellite Arrives in French Guiana (Photo: Business Wire) The spacecraft, built by Orbital ATK was packed and shipped at their Satellite Manufacturing Facility in Dulles, Virginia, United States and flown to French Guiana, where it was unloaded and will be taken to the Arianespace launch facilities in Kourou. HYLAS 4 uses the latest High Throughput Satellite technology, doubling Avanti's Ka-band capacity across EMEA. The latest addition to Avanti's HYLAS fleet will provide: Backhaul services for mobile network operators Wholesale broadband for ISPs Connectivity for governments (civil a
General Cable Corporation Stockholders Approve Acquisition By Prysmian Group16.2.2018 20:05 | Tiedote
General Cable Corporation (NYSE: BGC) today announced the voting results from the Company’s special meeting of stockholders held this morning. Stockholders of General Cable approved the Company’s previously announced acquisition by Prysmian Group (BIT: PRY) for $30.00 per share in cash. A total of 38,140,754 shares, representing approximately 75.34% of the total number of shares of common stock outstanding and approximately 99% of the total votes cast, were voted in favor of the merger. Subject to regulatory approvals and other customary closing conditions, the transaction is expected to close by the third quarter of 2018. About General Cable General Cable (NYSE:BGC), with headquarters in Highland Heights, Kentucky, is a global leader in the development, design, manufacture, marketing and distribution of aluminum, copper and fiber optic wire and cable products for the energy, communications, automotive, industrial, construction and specialty segments. General Cable is one of the larges
Systemic Sclerosis World Congress:Inspirational Patient Stories Reveal the Challenging Realities of Living with Devastating Rare Disease16.2.2018 12:03 | Tiedote
Boehringer Ingelheim today unveils a new phase of 'More Than Scleroderma: The Inside Story', and launches the new patient website www.morethanscleroderma.com. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180216005188/en/ Anna, 36, living with scleroderma (Photo: Business Wire) The global initiative highlights the importance of understanding the ‘inside story’ of each individual living with scleroderma, also known as systemic sclerosis. To coincide with the Systemic Sclerosis World Congress in Bordeaux, 15-17 February 2018, new and truly inspiring patient stories are revealed, reflecting the real-life, diverse and very moving journeys of people living with scleroderma across the world. The campaign will also be launched in the U.S. The new website www.morethanscleroderma.com features a powerful collection of photographs and video stories of people living with scleroderma across the world, revealing the life-changing impact o
Philip Morris International Recognized as a Global Top Employer for the Second Year in a Row16.2.2018 11:00 | Tiedote
Philip Morris International Inc. (PMI) (NYSE/Euronext Paris: PM) today is recognized for the second year in a row as a Global Top Employer. This year’s certification from the Top Employer Institute is awarded to PMI teams in 44 countries, a testament to the company’s consistency and excellence in offering an enriching and dynamic work environment, and exceptional development opportunities for employees across the globe. PMI has been recognized by the Top Employer Institute for six consecutive years. This year, PMI was awarded with five regional certifications in Europe, the Middle East, Africa and, for the first time, in North America and Latin America. Additionally, Indonesia was the first PMI affiliate to be certified in Asia. “It is a proud moment for all of us at PMI,” said Charles Bendotti, PMI Senior Vice President, People and Culture. “Our success as a company relies on the men and women who come to work every day with a passion to achieve, and a willingness to learn, grow, and
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme