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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 the Eversense 365 CGM system, the world's only continuous glucose monitor providing one year of accurate monitoring with minimal interruptions. This milestone marks the beginning of the commercial launch managed by Ascensia Diabetes Care.

Eversense 365, recently approved by the FDA, offers patients with Type 1 and Type 2 diabetes aged 18 and older a differentiated CGM experience, requiring only one sensor replacement per year and one calibration per week. Mercy, serving 3 million patients annually, estimates that about 30,000 of its patients could benefit from this technology.

The long-term monitoring solution aims to improve glycemic control, reduce diabetes-related distress, and lower overall healthcare costs. Senseonics and Mercy expect this breakthrough to enhance the quality of care while reducing costs for providers and payers.

Senseonics Holdings, Inc. (NYSE American: SENS) e il sistema sanitario Mercy hanno annunciato il primo utilizzo commerciale del system Eversense 365 CGM, l'unico monitor per la glicemia continuo al mondo che offre un anno di monitoraggio accurato con interruzioni minime. Questo traguardo segna l'inizio del lancio commerciale gestito da Ascensia Diabetes Care.

Eversense 365, recentemente approvato dalla FDA, offre ai pazienti con diabete di Tipo 1 e Tipo 2, di età pari o superiore a 18 anni, un'esperienza CGM differenziata, richiedendo solo un cambio di sensore all'anno e una calibrazione a settimana. Mercy, che serve 3 milioni di pazienti all'anno, stima che circa 30.000 dei suoi pazienti potrebbero beneficiare di questa tecnologia.

La soluzione di monitoraggio a lungo termine mira a migliorare il controllo glicemico, ridurre lo stress legato al diabete e abbattere i costi complessivi della sanità. Senseonics e Mercy si aspettano che questa innovazione migliori la qualità dell'assistenza riducendo al contempo i costi per i fornitori e i pagatori.

Senseonics Holdings, Inc. (NYSE American: SENS) y el sistema de salud Mercy han anunciado el primer uso comercial del sistema Eversense 365 CGM, el único monitor continuo de glucosa en el mundo que proporciona un año de monitoreo preciso con interrupciones mínimas. Este hito marca el comienzo del lanzamiento comercial gestionado por Ascensia Diabetes Care.

Eversense 365, recientemente aprobado por la FDA, ofrece a los pacientes con diabetes tipo 1 y tipo 2 de 18 años o más una experiencia CGM diferenciada, que requiere solo un reemplazo de sensor al año y una calibración por semana. Mercy, que atiende a 3 millones de pacientes anualmente, estima que alrededor de 30,000 de sus pacientes podrían beneficiarse de esta tecnología.

La solución de monitoreo a largo plazo tiene como objetivo mejorar el control glucémico, reducir la angustia relacionada con la diabetes y disminuir los costos generales de atención médica. Senseonics y Mercy esperan que este avance mejore la calidad de la atención al mismo tiempo que reduce los costos para los proveedores y pagadores.

센소닉스 홀딩스, Inc. (NYSE American: SENS)와 머시 헬스케어 시스템이 세계 유일의 1년 간의 정확한 모니터링과 최소한의 중단을 제공하는 Eversense 365 CGM 시스템의 상용화를 처음으로 발표했습니다. 이 획기적인 성과는 아센시아 당뇨병 관리에 의해 관리되는 상업적 출시의 시작을 의미합니다.

최근 FDA의 승인을 받은 Eversense 365는 18세 이상의 1형 및 2형 당뇨병 환자에게 차별화된 CGM 경험을 제공하며, 매년 하나의 센서 교체와 매주 하나의 교정만을 요구합니다. 머시는 매년 300만 명의 환자를 치료하며, 약 30,000명의 환자가 이 기술의 혜택을 받을 수 있다고 추산하고 있습니다.

이 장기 모니터링 솔루션은 혈당 조절 개선, 당뇨병 관련 스트레스 감소 및 전체 의료 비용 절감을 목표로 합니다. 센소닉스와 머시는 이 혁신이 환자와 지불자 모두에게 비용을 줄이면서 치료의 질을 향상시킬 것으로 기대하고 있습니다.

Senseonics Holdings, Inc. (NYSE American: SENS) et le système de santé Mercy ont annoncé le premier usage commercial du système Eversense 365 CGM, le seul moniteur de glucose continu au monde offrant un an de surveillance précise avec des interruptions minimales. Ce jalon marque le début du lancement commercial géré par Ascensia Diabetes Care.

Eversense 365, récemment approuvé par la FDA, offre aux patients atteints de diabète de type 1 et de type 2 âgés de 18 ans et plus une expérience CGM différenciée, nécessitant un seul remplacement de capteur par an et une calibration par semaine. Mercy, qui s'occupe de 3 millions de patients par an, estime qu'environ 30 000 de ses patients pourraient bénéficier de cette technologie.

La solution de surveillance à long terme vise à améliorer le contrôle glycémique, à réduire le stress lié au diabète et à abaisser les coûts globaux des soins de santé. Senseonics et Mercy s'attendent à ce que cette avancée améliore la qualité des soins tout en réduisant les coûts pour les prestataires et les payeurs.

Senseonics Holdings, Inc. (NYSE American: SENS) und das Mercy Gesundheitsystem haben die erste kommerzielle Nutzung des Eversense 365 CGM Systems angekündigt, des weltweit einzigen kontinuierlichen Glukosemonitors, der ein Jahr lang präzises Monitoring mit minimalen Unterbrechungen bietet. Dieser Meilenstein markiert den Beginn des kommerziellen Starts, der von Ascensia Diabetes Care geleitet wird.

Eversense 365, das kürzlich von der FDA genehmigt wurde, bietet Patienten mit Typ-1- und Typ-2-Diabetes ab 18 Jahren ein differenziertes CGM-Erlebnis, das nur einen Sensorwechsel pro Jahr und eine Kalibrierung pro Woche erfordert. Mercy, das jährlich 3 Millionen Patienten betreut, schätzt, dass etwa 30.000 seiner Patienten von dieser Technologie profitieren könnten.

Die langfristige Monitoring-Lösung zielt darauf ab, die glykämische Kontrolle zu verbessern, diabetesbedingten Stress zu reduzieren und die Gesamtkosten im Gesundheitswesen zu senken. Senseonics und Mercy erwarten, dass dieser Durchbruch die Qualität der Versorgung verbessert und gleichzeitig die Kosten für Anbieter und Kostenübernehmer senkt.

Positive
  • First commercial use of Eversense 365, the only CGM providing one year of continuous monitoring
  • FDA approval received for Eversense 365
  • Commercial launch underway through partnership with Ascensia Diabetes Care
  • Potential market of 30,000 patients at Mercy healthcare system alone
  • Aims to improve glycemic control and reduce healthcare costs
Negative
  • None.

Insights

The commercial launch of Eversense 365, the world's first 365-day continuous glucose monitor (CGM), is a significant advancement in diabetes management. This FDA-approved device addresses key limitations of traditional CGMs, offering year-long monitoring with just one sensor insertion and weekly calibration. The collaboration between Senseonics and Mercy Health System for the first commercial placement is strategically important.

Key benefits include:

  • Reduced sensor replacements (annually vs. every 10-14 days)
  • Potential for improved glycemic control and reduced diabetes-related distress
  • Cost-efficiency for healthcare systems and payers

With 30,000 potential beneficiaries in Mercy's patient population alone, the market potential is substantial. However, adoption rates, reimbursement policies and long-term clinical outcomes will be important factors to monitor. This launch could significantly impact Senseonics' market position in the competitive CGM space, potentially driving revenue growth if widely adopted.

The commercial launch of Eversense 365 represents a potential game-changer for Senseonics (NYSE American: SENS). With a current market cap of $181.56 million, this product could significantly boost the company's financial outlook. Key financial implications include:

  • Expanded market opportunity in the growing CGM sector
  • Potential for increased recurring revenue from annual sensor placements
  • Improved competitive positioning against larger players like Dexcom and Abbott

However, investors should consider:

  • Initial adoption rates and reimbursement coverage will be critical
  • The company's ability to scale production and distribution
  • Potential impact on gross margins due to the longer-lasting sensor

While the news is positive, SENS remains a small-cap stock with significant execution risks. The partnership with Ascensia Diabetes Care for commercialization is important for successful market penetration. Investors should closely monitor quarterly reports for adoption metrics and revenue growth trends.

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 /PRNewswire/ -- 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 is a pivotal moment for people with diabetes..."

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 gylcemic 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.

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SOURCE Mercy

FAQ

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

The Eversense 365 CGM system is the world's first and only continuous glucose monitor that lasts for a full year (365 days) with a single sensor, providing accurate monitoring with minimal interruptions for people with diabetes.

When was the Eversense 365 CGM system approved by the FDA?

The Eversense 365 CGM system was approved by the U.S. Food and Drug Administration in September 2024, as mentioned in the press release.

Who is eligible to use the Eversense 365 CGM system?

The Eversense 365 CGM system is approved in the US for people with Type 1 and Type 2 diabetes aged 18 and older.

How often does the Eversense 365 CGM system need to be calibrated?

The Eversense 365 CGM system requires only one calibration per week, which is less frequent than traditional short-term CGMs.

What are the potential benefits of the Eversense 365 CGM system for SENS stock?

The commercial launch of Eversense 365 could potentially benefit SENS stock by expanding market reach, improving patient care, and reducing healthcare costs, which may lead to increased adoption and revenue for Senseonics Holdings, Inc.

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