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Sequel Med Tech and Senseonics Integrate Technologies to Create First Automated Insulin Delivery (AID) System with One-Year Continuous Glucose Monitor (CGM)

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Sequel Med Tech and Senseonics have partnered to create the first Automated Insulin Delivery (AID) System compatible with a one-year continuous glucose monitor. The integration combines Sequel's twiist™ AID System with Senseonics' Eversense® 365, the world's first and only one-year CGM system.

Key highlights:

  • Launch expected in Q3 2025
  • System offers enhanced diabetes management tools
  • twiist will be compatible with both Eversense 365 and Abbott's FreeStyle Libre 3 Plus sensor
  • Eversense 365 received FDA iCGM clearance in September 2024

The collaboration aims to provide greater flexibility and personalization for people with type 1 diabetes. This integration marks a significant advancement in diabetes care, combining Senseonics' long-duration CGM technology with Sequel's state-of-the-art insulin delivery system to potentially improve glucose control and increase convenience for users.

Sequel Med Tech e Senseonics hanno collaborato per creare il primo Sistema di Somministrazione Automatica di Insulina (AID) compatibile con un sensore di glucosio continuo della durata di un anno. L'integrazione unisce il sistema twiist™ AID di Sequel con Eversense® 365 di Senseonics, il primo e unico sistema CGM con durata annuale al mondo.

Punti salienti:

  • Lancio previsto nel terzo trimestre 2025
  • Il sistema offre strumenti avanzati per la gestione del diabete
  • twiist sarà compatibile sia con Eversense 365 che con il sensore FreeStyle Libre 3 Plus di Abbott
  • Eversense 365 ha ottenuto l'approvazione FDA iCGM a settembre 2024

Questa collaborazione mira a garantire maggiore flessibilità e personalizzazione per le persone con diabete di tipo 1. L'integrazione rappresenta un importante progresso nella cura del diabete, combinando la tecnologia CGM a lunga durata di Senseonics con il sistema di somministrazione insulina all’avanguardia di Sequel, con il potenziale di migliorare il controllo glicemico e aumentare la comodità per gli utenti.

Sequel Med Tech y Senseonics se han asociado para crear el primer Sistema de Administración Automática de Insulina (AID) compatible con un monitor continuo de glucosa de un año de duración. La integración combina el sistema twiist™ AID de Sequel con el Eversense® 365 de Senseonics, el primer y único sistema CGM de un año en el mundo.

Puntos clave:

  • Lanzamiento previsto para el tercer trimestre de 2025
  • El sistema ofrece herramientas mejoradas para el manejo de la diabetes
  • twiist será compatible tanto con Eversense 365 como con el sensor FreeStyle Libre 3 Plus de Abbott
  • Eversense 365 recibió la aprobación FDA iCGM en septiembre de 2024

La colaboración busca ofrecer mayor flexibilidad y personalización para personas con diabetes tipo 1. Esta integración representa un avance significativo en el cuidado de la diabetes, combinando la tecnología CGM de larga duración de Senseonics con el sistema de administración de insulina de última generación de Sequel, con el potencial de mejorar el control glucémico y aumentar la comodidad para los usuarios.

Sequel Med TechSenseonics가 1년 지속 연속 혈당 측정기와 호환되는 최초의 자동 인슐린 투여 시스템(AID)을 공동 개발했습니다. 이번 통합은 Sequel의 twiist™ AID 시스템과 Senseonics의 Eversense® 365를 결합한 것으로, 세계 최초이자 유일한 1년 지속 CGM 시스템입니다.

주요 내용:

  • 출시 예정일: 2025년 3분기
  • 시스템은 향상된 당뇨병 관리 도구 제공
  • twiist는 Eversense 365와 Abbott의 FreeStyle Libre 3 Plus 센서 모두와 호환 가능
  • Eversense 365는 2024년 9월 FDA iCGM 승인을 받음

이번 협력은 제1형 당뇨병 환자에게 더 큰 유연성과 개인맞춤형 관리를 제공하는 것을 목표로 합니다. 이 통합은 Senseonics의 장기 지속 CGM 기술과 Sequel의 최첨단 인슐린 투여 시스템을 결합하여 혈당 조절을 개선하고 사용자 편의성을 높이는 중요한 진전입니다.

Sequel Med Tech et Senseonics se sont associés pour créer le premier Système de Distribution Automatisée d’Insuline (AID) compatible avec un moniteur continu de glucose d’une durée d’un an. Cette intégration combine le système twiist™ AID de Sequel avec le Eversense® 365 de Senseonics, le premier et unique système CGM d’une durée d’un an au monde.

Points clés :

  • Lancement prévu au troisième trimestre 2025
  • Le système offre des outils améliorés pour la gestion du diabète
  • twiist sera compatible à la fois avec Eversense 365 et le capteur FreeStyle Libre 3 Plus d’Abbott
  • Eversense 365 a obtenu l’autorisation FDA iCGM en septembre 2024

Cette collaboration vise à offrir plus de flexibilité et de personnalisation aux personnes atteintes de diabète de type 1. Cette intégration marque une avancée majeure dans le soin du diabète, combinant la technologie CGM longue durée de Senseonics avec le système de distribution d’insuline de pointe de Sequel, afin d’améliorer potentiellement le contrôle glycémique et d’augmenter la commodité pour les utilisateurs.

Sequel Med Tech und Senseonics haben sich zusammengeschlossen, um das erste Automatisierte Insulinabgabesystem (AID) zu entwickeln, das mit einem kontinuierlichen Glukosemonitor mit einjähriger Laufzeit kompatibel ist. Die Integration kombiniert das twiist™ AID System von Sequel mit dem Eversense® 365 von Senseonics, dem weltweit ersten und einzigen CGM-System mit einjähriger Tragedauer.

Wichtige Highlights:

  • Markteinführung voraussichtlich im dritten Quartal 2025
  • Das System bietet verbesserte Werkzeuge zur Diabetesverwaltung
  • twiist wird sowohl mit Eversense 365 als auch mit dem FreeStyle Libre 3 Plus Sensor von Abbott kompatibel sein
  • Eversense 365 erhielt im September 2024 die FDA iCGM-Zulassung

Die Zusammenarbeit zielt darauf ab, Menschen mit Typ-1-Diabetes mehr Flexibilität und Personalisierung zu bieten. Diese Integration stellt einen bedeutenden Fortschritt in der Diabetesversorgung dar, indem Senseonics’ langlebige CGM-Technologie mit Sequel’s hochmodernem Insulinabgabesystem kombiniert wird, um die Blutzuckerkontrolle zu verbessern und den Komfort für die Anwender zu erhöhen.

Positive
  • First-mover advantage: twiist becomes the first AID system compatible with one-year CGM system
  • Strategic partnership expands market reach by offering compatibility with two major CGM partners (Senseonics Eversense 365 and Abbott's FreeStyle Libre 3 Plus)
  • Near-term catalyst: Product launch expected in Q3 2025
  • FDA clearance already secured for Eversense 365 as an iCGM system (September 2024)
  • Integration creates unique product offering combining long-term CGM with automated insulin delivery
Negative
  • No financial terms or revenue projections disclosed for the partnership
  • Integration development still in progress with uncertain timeline risks
  • Competitive market with established players in diabetes management technology

Insights

Senseonics gains strategic advantage as its one-year CGM integrates with automated insulin delivery, filling critical product gap.

The partnership between Sequel Med Tech and Senseonics (NYSE American: SENS) represents a significant technological advancement in diabetes management. By integrating Sequel's twiist Automated Insulin Delivery (AID) System with Senseonics' Eversense 365 continuous glucose monitor, the companies are addressing a key functionality gap for Senseonics' product portfolio.

The Eversense 365 already holds a unique position as the world's only one-year implantable CGM, but its utility has been limited by lack of compatibility with automated insulin delivery systems. This integration creates a comprehensive diabetes management solution combining the convenience of long-term glucose monitoring with automated insulin delivery technology.

From a competitive standpoint, this partnership strengthens Senseonics' market position by aligning with the industry trend toward connected diabetes care ecosystems. The September 2024 FDA clearance of Eversense 365 as an integrated continuous glucose monitoring (iCGM) system was a necessary regulatory milestone enabling this partnership.

With a Q3 2025 launch timeframe, the companies have established a clear commercialization pathway. For diabetic patients, the integration means fewer sensor changes (once yearly) while maintaining the benefits of automated insulin delivery, potentially improving treatment adherence and quality of life.

twiist™ expands compatibility offerings to become the first AID system compatible with Senseonics Eversense® 365 one-year CGM system

twiist with Eversense 365 launch expected in Q3

MANCHESTER, N.H. and GERMANTOWN, Md., April 29, 2025 (GLOBE NEWSWIRE) -- Sequel Med Tech, LLC, a company developing state-of-the-art insulin delivery technologies, and Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable CGM systems for people with diabetes, today announced their commercial development agreement to integrate Sequel’s twiist Automated Insulin Delivery (AID) System powered by Tidepool with Senseonics’ Eversense 365 CGM. Through this collaboration, the twiist™ Automated Insulin Delivery (AID) System will become the first AID system compatible with the Senseonics Eversense 365, the world’s first and only one-year CGM system, offering people with type 1 diabetes a new level of flexibility and personalization in their diabetes management.

The agreement between Sequel and Senseonics will provide individuals with type 1 diabetes the option of a one-year CGM system that integrates with the twiist AID System. The integrated system aims to enhance diabetes management by offering people with diabetes more tools to manage care, which may lead to improved glucose control, increased convenience, and provide greater flexibility.

“Sequel is committed to investing in innovations that empower people with diabetes with options in how they manage their diabetes,” said Sequel CEO and Co-Founder Alan Lotvin, M.D. “By partnering with Senseonics, a company pioneering long-duration CGM, we aim to deliver the flexibility people want to personalize their diabetes management on their terms.”

“This collaboration with Sequel marks a significant step forward in transforming diabetes care,” said Tim Goodnow, PhD, President and CEO of Senseonics. “People with diabetes who choose the convenience and ease of our one-year CGM sensor have been waiting for a compatible AID system to enhance their diabetes management. The synergy of Eversense and twiist will provide people with diabetes our most recent innovations in advanced pump, algorithm, and sensor technologies to simplify diabetes management, providing users with an AID solution that unlocks the full experience of our year-long CGM technology.”

Sequel remains committed to advancing diabetes technology and expanding partnerships to give people with diabetes more choice and flexibility in how they manage their diabetes. People living with type 1 diabetes who choose to use twiist will have the flexibility to select from two compatible CGM partners, the Senseonics Eversense 365 and Abbott’s FreeStyle Libre 3 Plus sensor, to best suit their individual needs for managing diabetes.

In September 2024, Eversense 365 received FDA clearance as an integrated continuous glucose monitoring (iCGM) system for people with diabetes, paving the way for its use within an automated insulin delivery (AID) system. United by a shared commitment to simplifying diabetes management and improving quality of life, Senseonics and Sequel have begun work to integrate Senseonics’ newest generation one-year sensor, Eversense 365, with twiist, Sequel’s state-of-the-art AID system. This expanded CGM compatibility between Eversense and twiist will mark a significant advancement—offering greater personalization, more choice, and the potential for improved outcomes for people living with diabetes. The integration is expected to be available in the third quarter of this year.

About twiist

The twiist AID System is the first insulin delivery system that directly measures the volume of insulin delivered with every micro-dose. Cleared for people ages six and up with type 1 diabetes, the twiist AID System offers the capability and flexibility to address each person’s individual dosing needs. The twiist Loop algorithm, based on the diabetes community-driven Tidepool Loop, allows the system to automatically adjust basal insulin delivery based on real-time sensor readings and predicted glucose levels. For more information about twiist, set to be commercially available in Q2 2025, please visit www.twiist.com.

About Sequel Med Tech

Headquartered in Manchester, N.H., Sequel Med Tech, LLC is developing the next generation of transformative drug-delivery advancements. Sequel’s approach is to look at disease management holistically to advance systems that make living with disease simpler and easier for all. Its FDA-cleared innovation, the twiist® Automated Insulin Delivery (AID) system, integrates novel technologies to reimagine insulin delivery and sets a new standard for drug delivery. Co-founded by visionary Dean Kamen, serial entrepreneur Pablo Legorreta, seasoned medical device executive Bill Doyle and healthcare visionary Alan Lotvin, MD. Sequel is bringing the latest developments in science and technology to help drive more accessible drug delivery. For more information, visit sequelmedtech.com and twiist.com.

About Eversense

Eversense 365 is developed by Senseonics and brought to patients by Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE: 6523). As the only implantable CGM available, it offers patients a truly differentiated CGM experience, providing One Year of exceptionally accurate monitoring with minimal interruptions. It benefits endocrinologists and care teams by offering their patients confidence in decision-making, long-term peace of mind and enhanced quality of life with just one CGM. The unique approach also allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

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 13 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 www.eversensediabetes.com/safety-info/.

A media kit for Eversense 365, including images, logos and further information, can be accessed at www.ascensia.com/media/eversense365-media-kit/

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 system Eversense® 365 includes 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.

Forward Looking Statements

Any statements in this press release about the expectations regarding potential impact on people with diabetes’ and providers’ experience, benefits and outcomes, statements regarding the results, success and timeline for completion of the integration, 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 new product launch and ongoing commercialization of Eversense 365, uncertainties inherent in the coordination with third parties and new partners, uncertainties inherent in the development of new technologies, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in prescriber and patient decisions and responses to new technology or initiatives, 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, 2023 and subsequent quarterly reports on Form 10-Q filed 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.

Sequel Media Contact
Greta Gustafson
Highwire PR
sequel.med.tech@highwirepr.com

Senseonics Investor Contact
Jeremy Feffer
LifeSci Advisors
investors@senseonics.com


FAQ

When will Senseonics (SENS) launch the integrated twiist AID system with Eversense 365 CGM?

According to the press release, the integrated system launch is expected in Q3 2025, following Eversense 365's FDA iCGM clearance in September 2024.

What makes Senseonics Eversense 365 unique in the diabetes CGM market?

Eversense 365 is the world's first and only one-year continuous glucose monitoring (CGM) system, offering significantly longer monitoring duration compared to other CGM systems.

Which CGM systems are compatible with Sequel's twiist Automated Insulin Delivery System?

The twiist AID System is compatible with two CGM partners: Senseonics Eversense 365 and Abbott's FreeStyle Libre 3 Plus sensor.

How will the Sequel-Senseonics partnership benefit Type 1 diabetes patients?

The partnership offers enhanced diabetes management through integrated one-year CGM monitoring with automated insulin delivery, potentially improving glucose control, convenience, and flexibility for patients.

What regulatory approval has Senseonics (SENS) received for the Eversense 365 system?

Eversense 365 received FDA clearance as an integrated continuous glucose monitoring (iCGM) system in September 2024, enabling its use in automated insulin delivery systems.
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