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Mercy Places First Commercial Eversense 365: The World’s First and Only 365-Day Continuous Glucose Monitor

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Senseonics Holdings, Inc. (NYSE American: SENS) and Mercy healthcare system have announced the first commercial use of Eversense 365, the world's only 365-day continuous glucose monitoring (CGM) system. This milestone marks the beginning of the commercial launch by Ascensia Diabetes Care for the FDA-approved Eversense 365, which offers patients with Type 1 and Type 2 diabetes a full year of accurate glucose monitoring with minimal interruptions.

Key features of Eversense 365 include:

  • One-year monitoring duration
  • No additional sensor replacements required
  • Only one calibration per week
  • Improved glycemic control and reduced diabetes management distress
  • Potential to lower overall healthcare costs

Mercy, serving 3 million patients annually, estimates that approximately 30,000 of its patients could benefit from this CGM system. The collaboration between Senseonics and Mercy aims to make this technology accessible to more patients across the U.S.

Senseonics Holdings, Inc. (NYSE American: SENS) e il sistema sanitario Mercy hanno annunciato il primo utilizzo commerciale di Eversense 365, l'unico sistema di monitoraggio continuo della glicemia (CGM) al mondo con una durata di 365 giorni. Questo traguardo segna l'inizio del lancio commerciale da parte di Ascensia Diabetes Care per l'Eversense 365 approvato dalla FDA, che offre ai pazienti con diabete di tipo 1 e tipo 2 un monitoraggio glicemico accurato per un anno con interruzioni minime.

Le caratteristiche chiave di Eversense 365 includono:

  • Durata del monitoraggio di un anno
  • Nessuna sostituzione del sensore necessaria
  • Solo una calibrazione alla settimana
  • Controllo glicemico migliorato e riduzione dello stress nella gestione del diabete
  • Potenziale riduzione dei costi complessivi della sanità

Mercy, che serve 3 milioni di pazienti all'anno, stima che circa 30.000 dei suoi pazienti potrebbero beneficiare di questo sistema CGM. La collaborazione tra Senseonics e Mercy mira a rendere questa tecnologia accessibile a più pazienti negli Stati Uniti.

Senseonics Holdings, Inc. (NYSE American: SENS) y el sistema de salud Mercy han anunciado el primer uso comercial de Eversense 365, el único sistema de monitorización continua de glucosa (CGM) del mundo que dura 365 días. Este hito marca el inicio del lanzamiento comercial por parte de Ascensia Diabetes Care del Eversense 365 aprobado por la FDA, que ofrece a los pacientes con diabetes tipo 1 y tipo 2 un monitoreo preciso de la glucosa durante un año con mínimas interrupciones.

Las características clave de Eversense 365 incluyen:

  • Duración del monitoreo de un año
  • No se requieren reemplazos de sensor adicionales
  • Solo una calibración por semana
  • Mejor control glucémico y reducción del estrés en la gestión de la diabetes
  • Potencial para reducir los costos generales de atención médica

Mercy, que atiende a 3 millones de pacientes al año, estima que aproximadamente 30,000 de sus pacientes podrían beneficiarse de este sistema CGM. La colaboración entre Senseonics y Mercy tiene como objetivo hacer que esta tecnología sea accesible para más pacientes en los EE. UU.

센소닉스 홀딩스(주)(NYSE American: SENS)와 머시 헬스케어 시스템은 Eversense 365의 상업적 사용을 최초로 발표했습니다, 세계 유일의 365일 지속 혈당 모니터링(CGM) 시스템입니다. 이 이정표는 FDA 승인 Eversense 365의 상업적 출시가 아센시아 당뇨병 관리에 의해 시작되었음을 의미하며, 이는 제1형 및 제2형 당뇨병 환자에게 최소한의 중단으로 정확한 혈당 모니터링을 제공합니다.

Eversense 365의 주요 특징은 다음과 같습니다:

  • 1년 모니터링 기간
  • 추가 센서 교체 불필요
  • 주당 한 번의 보정만 필요
  • 혈당 조절 개선 및 당뇨 관리 스트레스 감소
  • 전체 의료 비용 절감 가능성

연간 300만 명의 환자를 담당하는 머시는 약 30,000명의 환자가 이 CGM 시스템의 혜택을 받을 수 있을 것으로 추정하고 있습니다. 센소닉스와 머시의 협력은 이 기술을 미국 내 더 많은 환자에게 제공하는 것을 목표로 하고 있습니다.

Senseonics Holdings, Inc. (NYSE American: SENS) et le système de santé Mercy ont annoncé le premier usage commercial de l'Eversense 365, le seul système de surveillance continue de la glycémie (CGM) au monde d'une durée de 365 jours. Ce jalon marque le début du lancement commercial par Ascensia Diabetes Care de l'Eversense 365 approuvé par la FDA, qui offre aux patients atteints de diabète de type 1 et de type 2 une surveillance précise de la glycémie pendant un an avec un minimum d'interruptions.

Les caractéristiques clés de l'Eversense 365 comprennent:

  • Durée de surveillance d'un an
  • Aucun remplacement de capteur supplémentaire requis
  • Une seule calibration par semaine
  • Contrôle glycémique amélioré et réduction du stress lié à la gestion du diabète
  • Potentiel de réduction des coûts globaux des soins de santé

Mercy, qui dessert 3 millions de patients par an, estime qu'environ 30 000 de ses patients pourraient bénéficier de ce système CGM. La collaboration entre Senseonics et Mercy vise à rendre cette technologie accessible à un plus grand nombre de patients aux États-Unis.

Die Senseonics Holdings, Inc. (NYSE American: SENS) und das Mercy-Gesundheitssystem haben die erste kommerzielle Nutzung von Eversense 365 angekündigt, dem weltweit einzigen kontinuierlichen Blutzuckerüberwachungssystem (CGM) mit einer Dauer von 365 Tagen. Dieser Meilenstein markiert den Beginn des kommerziellen Starts von Ascensia Diabetes Care für das FDA-zugelassene Eversense 365, das Patienten mit Typ-1- und Typ-2-Diabetes ein ganzes Jahr lang präzise Blutzuckerüberwachung mit minimalen Unterbrechungen bietet.

Zu den wichtigsten Funktionen von Eversense 365 gehören:

  • Einjährige Überwachungsdauer
  • Keine zusätzlichen Sensorauswechslungen erforderlich
  • Nur eine Kalibrierung pro Woche
  • Verbesserte glykämische Kontrolle und reduzierte Stress bei der Diabetesverwaltung
  • Potenzial zur Senkung der Gesamtkosten im Gesundheitswesen

Mercy, das jährlich 3 Millionen Patienten betreut, schätzt, dass ungefähr 30.000 ihrer Patienten von diesem CGM-System profitieren könnten. Die Zusammenarbeit zwischen Senseonics und Mercy zielt darauf ab, diese Technologie für mehr Patienten in den USA zugänglich zu machen.

Positive
  • First commercial use of Eversense 365, the world's only 365-day CGM system
  • FDA approval received for Eversense 365
  • Commercial launch underway through partnership with Ascensia Diabetes Care
  • Collaboration with Mercy healthcare system, serving 3 million patients annually
  • Potential market of approximately 30,000 Mercy patients for the CGM system
  • Improved patient experience with one-year monitoring and reduced calibrations
Negative
  • None.

Insights

The commercial launch of Eversense 365 marks a significant advancement in diabetes management technology. This 365-day continuous glucose monitoring (CGM) system addresses key limitations of traditional short-term CGMs, potentially improving patient adherence and outcomes.

Key advantages include:

  • Reduced sensor replacements (once per year vs. every 10-14 days)
  • Minimal calibration requirements (weekly vs. daily)
  • Potential for improved glycemic control and reduced diabetes-related distress

The collaboration with Mercy, a major healthcare system, could accelerate adoption and provide valuable real-world data. However, the long-term impact on Senseonics' market position and financials will depend on wider acceptance, reimbursement policies and competition from established CGM manufacturers.

The Eversense 365 system presents a compelling value proposition for healthcare systems and payers. Key economic considerations include:

  • Potential reduction in overall healthcare costs through improved glycemic control and fewer diabetes-related complications
  • Decreased frequency of sensor replacements, potentially lowering supply costs and clinical staff time
  • Improved patient adherence, which could lead to better long-term health outcomes

With Mercy estimating that 30,000 of their patients could benefit from CGM systems, this represents a significant market opportunity. However, the initial cost of the system and potential reimbursement challenges may impact adoption rates. Long-term cost-effectiveness studies will be important for wider acceptance among healthcare providers and insurers.

Senseonics’ Eversense 365 is approved in the US as an integrated continuous glucose monitoring (iCGM) system for people with Type 1 and Type 2 diabetes aged 18 and older

Commercial launch by Ascensia Diabetes Care underway with a new campaign to highlight the unique benefits of having just one CGM for one full year

GERMANTOWN, Md. and ST. LOUIS, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American: SENS) (“Senseonics” or the “Company”), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, and Mercy, a leading healthcare system, today announced that the first commercial patient received the next-generation Eversense® 365 CGM system. This milestone, part of the company’s previously announced collaboration with Mercy, marks the world’s first commercial use of Eversense 365, the only CGM to provide one-year of accurate monitoring with minimal interruptions.

This patient and those who follow, along with their doctors, will be able to monitor glucose levels and trends for a full year, with no requirement for additional sensor replacements and only one calibration per week. Eversense 365 offers patients a truly differentiated CGM experience, enabling confident decisions, long-term peace of mind and enhanced quality of life with just one CGM. It also helps people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs that are indicated to last just 10-14 days. Senseonics and Mercy expect this significant breakthrough in diabetes technology and management to improve glycemic control for patients, reduce distress associated with managing diabetes and lower overall healthcare costs for providers and payers.

“Without the technology, patients deal with constant finger pricks to test their glucose or have sensors that need to be replaced every few days,” said Dr. Jeff Ciaramita, Mercy’s president of specialty service lines. “This is a pivotal moment for people with diabetes because this groundbreaking technology allows patients a more convenient and reliable way to manage their condition for an entire year with a single sensor. As Mercy strives to make care easy for our patients, what better way than to be the first in the world to offer Eversense 365?”

Eversense 365 was approved by the U.S. Food and Drug Administration last month. The commercial launch, which has now begun, is being managed by Senseonics global commercial partner, Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). Mercy serves 3 million patients annually and expects that approximately 30,000 of Mercy’s patients could benefit from a CGM system.

“We are thrilled to see the successful first commercial insertion of the Eversense 365 CGM system at Mercy,” said Francine Kaufman, M.D. Senseonics’ chief medical officer. “Eversense 365 addresses many of the challenges that patients experience with traditional, short-term CGMs and we are excited to see the real-world benefit it can have as it is rolled out to patients across the U.S. We expect that health systems across the country will recognize the benefits that Mercy has embraced and can adopt Eversense 365 towards enhancing the quality of care while reducing the cost of care. Our goal is to make this life-changing technology accessible to as many patients as possible through collaborations with forward-thinking health care leaders such as Mercy.”

“This long-term monitoring solution empowers patients with real-time data and enables our clinicians to deliver proactive, personalized care, ultimately leading to better health and quality of life for those we serve,” Dr. Ciaramita said. “By adopting Eversense 365, we're enhancing our commitment to value-based care‒driving to improve patient outcomes while reducing overall health care costs.”

To learn more about Eversense 365 and for additional information about when the system will be available, go to www.eversensecgm.com. Physicians, nurse practitioners and physician assistants who are interested in offering the Eversense CGM System can sign up at https://provider.eversensecgm.com/contact-us/. Alternatively, contact 1-844-SENSE4U (1-844-736-7348) to learn more about the first and only long-term implantable CGM system.

About Senseonics

Senseonics Holdings, Inc. ("Senseonics") is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems Eversense® 365 and Eversense® E3 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.

About Eversense

The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/.

About Ascensia Diabetes Care

Ascensia Diabetes Care is a global company focused entirely on helping people with diabetes. Our mission is to empower those living with diabetes through innovative solutions that simplify and improve their lives.

We are home to the world-renowned CONTOUR® portfolio of blood glucose monitoring systems and the exclusive global distribution partner for the Eversense® Continuous Glucose Monitoring Systems from Senseonics. These products combine advanced technology with user-friendly functionality to help people with diabetes manage their condition and make a positive difference to their lives. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity.

Ascensia is a member of PHC Group and was established in 2016 through the acquisition of Bayer Diabetes Care by PHC Holdings Corporation. Ascensia products are sold in more than 100 countries. Ascensia has around 1,400 employees and operations in 29 countries.

For further information, please visit the Ascensia Diabetes Care website at: http://www.ascensia.com

About PHC Holdings Corporation

PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Ascensia Diabetes Care Holdings AG, Epredia Holdings Ltd., LSI Medience Corporation, Mediford Corporation, and Wemex. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group’s consolidated net sales in FY2023 were JPY 353.9 billion with global distribution of products and services in more than 125 countries.
www.phchd.com

©2024 Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

About Mercy

Mercy, one of the 20 largest U.S. health systems and named the top large system in the U.S. for excellent patient experience by NRC Health, serves millions annually with nationally recognized care and one of the nation’s largest and highest performing Accountable Care Organizations in quality and cost. Mercy is a highly integrated, multi-state health care system including more than 50 acute care and specialty (heart, children’s, orthopedic and rehab) hospitals, convenient and urgent care locations, imaging centers and pharmacies. Mercy has over 900 physician practice locations and outpatient facilities, more than 4,500 physicians and advanced practitioners and 50,000 co-workers serving patients and families across Arkansas, Kansas, Missouri and Oklahoma. Mercy also has clinics, outpatient services and outreach ministries in Arkansas, Louisiana, Mississippi and Texas. In fiscal year 2023 alone, Mercy provided more than half a billion dollars of free care and other community benefits, including traditional charity care and unreimbursed Medicaid.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements regarding plans and timing for the commercial launch of the 356-day system, statements regarding the attributes experienced by people with diabetes and differentiating the system from short-term CGM, and statements regarding the experience, potential results and decisions of health care systems, and other statements containing the words "believe," “expect,” “intend,” “may,” “projects,” “will,” “planned,” 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: uncertainties inherent in the execution of the independent business unit of Ascensia Diabetes Care, the Company’s commercialization partner for Eversense, and other commercial initiatives, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration and roll-out of new technology and solutions, uncertainties inherent in finalizing integration and commercial terms and coordinations with health systems and other new collaboration partners and third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense product, uncertainties relating to the current economic environment and such other factors as are set forth in the risk factors detailed in Senseonics' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 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 Investor Contact

Jeremy Feffer
LifeSci Advisors
investors@senseonics.com

Ascensia Communications Contact

Lorraine Chandler
Head of Corporate Communications
Lorraine.chandler@ascensia.com

Mercy Communications Contact

Bethany Pope
314-251-4472
Mercy Media Relations
Bethany.Pope@Mercy.net


FAQ

What is the Eversense 365 CGM system and how long does it last?

Eversense 365 is the world's first and only 365-day continuous glucose monitoring (CGM) system for people with Type 1 and Type 2 diabetes. It provides accurate glucose monitoring for a full year with minimal interruptions.

When was Eversense 365 approved by the FDA?

Eversense 365 was approved by the U.S. Food and Drug Administration in September 2024, as mentioned in the press release dated October 10, 2024.

Who is managing the commercial launch of Eversense 365?

The commercial launch of Eversense 365 is being managed by Ascensia Diabetes Care, Senseonics' global commercial partner and a subsidiary of PHC Holdings

How many patients could potentially benefit from Eversense 365 at Mercy?

Mercy estimates that approximately 30,000 of its patients could benefit from the Eversense 365 CGM system.

What are the key advantages of Eversense 365 over traditional CGMs?

Eversense 365 offers one full year of monitoring with no additional sensor replacements, only one calibration per week, and aims to improve glycemic control, reduce diabetes management distress, and lower overall healthcare costs compared to traditional short-term CGMs.

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