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Stevanato Group Will Introduce Its Large-Volume Vertiva® 10mL On-Body Delivery System Platform for Injectable Therapies at CPHI Milan

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Stevanato Group (NYSE: STVN) has announced the expansion of its Vertiva® platform to include a 10mL option for on-body drug delivery. The platform offers a pre-filled and pre-loaded solution suitable for highly viscous biological drugs. Vertiva® features a single-use pod with a pre-filled cartridge and a reusable smart controller, allowing for versatile dosing profiles and easy home-based treatment.

The system's design simplifies treatment initiation and has shown positive results in a recent wearability study. It can record patient usage data and transfer it via Bluetooth to digital health applications. The platform's two-part system enhances sustainability by reducing electronic waste. Stevanato Group will collaborate with Thermo Fisher Scientific to bring Vertiva® 10mL to market, offering integrated capabilities from drug development to final packaging.

Stevanato Group (NYSE: STVN) ha annunciato l'espansione della sua piattaforma Vertiva® per includere un'opzione da 10 ml per la somministrazione di farmaci sul corpo. La piattaforma offre una soluzione pre-riempita e pre-caricata adatta a farmaci biologici altamente viscosi. Vertiva® presenta un pod monouso con una cartuccia pre-riempita e un controllore smart riutilizzabile, permettendo profili di dosaggio versatili e facile trattamento domiciliare.

Il design del sistema semplifica l'inizio del trattamento e ha mostrato risultati positivi in un recente studio sulla portabilità. Può registrare i dati di utilizzo del paziente e trasferirli via Bluetooth a applicazioni di salute digitale. Il sistema a due parti della piattaforma migliora la sostenibilità riducendo i rifiuti elettronici. Stevanato Group collaborerà con Thermo Fisher Scientific per portare il Vertiva® da 10 ml sul mercato, offrendo capacità integrate dallo sviluppo del farmaco alla confezione finale.

Stevanato Group (NYSE: STVN) ha anunciado la expansión de su plataforma Vertiva® para incluir una opción de 10 ml para la administración de medicamentos en el cuerpo. La plataforma ofrece una solución precargada y prellenada adecuada para medicamentos biológicos de alta viscosidad. Vertiva® cuenta con un pod desechable con un cartucho precargado y un controlador inteligente reutilizable, que permite perfiles de dosificación versátiles y un tratamiento domiciliario más fácil.

El diseño del sistema simplifica el inicio del tratamiento y ha mostrado resultados positivos en un reciente estudio de portabilidad. Puede grabar datos de uso del paciente y transferirlos a través de Bluetooth a aplicaciones de salud digital. El sistema de dos partes de la plataforma mejora la sostenibilidad al reducir los desechos electrónicos. Stevanato Group colaborará con Thermo Fisher Scientific para llevar al mercado el Vertiva® de 10 ml, ofreciendo capacidades integradas desde el desarrollo del medicamento hasta el empaquetado final.

Stevanato Group (NYSE: STVN)는 약물 전달용으로 바디에 장착할 수 있는 10mL 옵션을 포함하여 Vertiva® 플랫폼의 확장을 발표했습니다. 이 플랫폼은 고점도 생물학적 약물에 적합한 미리 채워진 및 미리 로드된 솔루션을 제공합니다. Vertiva®는 미리 채워진 카트리지가 포함된 일회용 포드재사용 가능한 스마트 컨트롤러를 특징으로 하여 다양한 용량 프로필과 쉬운 가정 치료를 가능하게 합니다.

시스템의 디자인은 치료 시작을 단순화하며 최근 착용성 연구에서 긍정적인 결과를 보여주었습니다. 이 시스템은 환자의 사용 데이터를 기록하고 이를 Bluetooth를 통해 디지털 건강 애플리케이션으로 전송할 수 있습니다. 또한 플랫폼의 2부 시스템은 전자 폐기물을 줄여 지속 가능성을 향상시킵니다. Stevanato Group은 Thermo Fisher Scientific와 협력하여 Vertiva® 10mL를 시장에 출시하고, 약물 개발에서 최종 포장까지 통합된 기능을 제공합니다.

Stevanato Group (NYSE: STVN) a annoncé l'extension de sa plateforme Vertiva® pour inclure une option de 10 ml pour l'administration de médicaments sur le corps. La plateforme offre une solution préremplie et préchargée adaptée aux médicaments biologiques très visqueux. Vertiva® se compose d'un pod jetable avec une cartouche préremplie et d'un contrôleur intelligent réutilisable, permettant des profils de dosage polyvalents et un traitement facile à domicile.

Le design du système simplifie le début du traitement et a montré des résultats positifs dans une récente étude de portabilité. Il peut enregistrer les données d'utilisation des patients et les transférer via Bluetooth vers des applications de santé numérique. Le système en deux parties de la plateforme améliore la durabilité en réduisant les déchets électroniques. Stevanato Group collaborera avec Thermo Fisher Scientific pour commercialiser le Vertiva® 10 ml, offrant des capacités intégrées du développement du médicament à l'emballage final.

Stevanato Group (NYSE: STVN) hat die Erweiterung seiner Vertiva®-Plattform bekannt gegeben, um eine 10-mL-Option für die Arzneimittelverabreichung am Körper einzuschließen. Die Plattform bietet eine vorgeladene und vorgefüllte Lösung, die für hochviskose biologische Arzneimittel geeignet ist. Vertiva® verfügt über eine Einwegkapsel mit einer vorgefüllten Patrone und einem wiederverwendbaren intelligenten Controller, der vielseitige Dosierungsprofile und eine einfache Heimbehandlung ermöglicht.

Das Design des Systems vereinfacht den Beginn der Behandlung und hat in einer aktuellen Tragestudie positive Ergebnisse gezeigt. Es kann Patientennutzungsdaten aufzeichnen und diese über Bluetooth an digitale Gesundheitsanwendungen übertragen. Das Zwei-Teil-System der Plattform verbessert die Nachhaltigkeit, indem es den elektronischen Abfall reduziert. Stevanato Group wird mit Thermo Fisher Scientific zusammenarbeiten, um Vertiva® 10mL auf den Markt zu bringen, und integrierte Möglichkeiten vom Arzneimittelentwicklungsprozess bis zur endgültigen Verpackung zu bieten.

Positive
  • Expansion of Vertiva® platform to include 10mL option, increasing market potential
  • Versatile dosing capabilities suitable for a wide range of therapies
  • Positive results from wearability study, indicating patient acceptance
  • Smart controller with data recording and Bluetooth transfer capabilities
  • Sustainable two-part system design reducing electronic waste
  • Partnership with Thermo Fisher Scientific for integrated production capabilities
Negative
  • None.

Insights

The introduction of Stevanato Group's Vertiva® 10mL on-body delivery system represents a significant advancement in drug delivery technology. This platform offers several key benefits:

  • Versatility: Suitable for a wide range of therapies, including highly viscous biologics
  • Customizable dosing: Pre-programmable for various delivery profiles
  • User-friendly design: Pre-filled and pre-loaded for easy home use
  • Sustainability: Reusable controller reduces electronic waste
  • Patient comfort: Wearability study shows good acceptance and comfort

The expansion to 10mL capacity opens up possibilities for treating more conditions and accommodating larger dose volumes. This could potentially reduce the frequency of drug administration for some patients. The partnership with Thermo Fisher Scientific for fill-and-finish services also streamlines the path to market for pharmaceutical companies.

While this news is positive for Stevanato Group's product portfolio, its immediate impact on the company's financials may be until adoption rates and specific drug partnerships are established. Investors should monitor future announcements regarding pharmaceutical company partnerships and clinical trials using this platform.

The Vertiva® 10mL platform addresses several critical needs in the biopharmaceutical industry:

  • Large volume delivery: Essential for many biologics and new therapies
  • Flexibility: Adaptable to various drug viscosities and dosing regimens
  • Home administration: Aligns with the trend towards patient-centric care
  • Data connectivity: Enables patient monitoring and adherence tracking

This innovation could potentially accelerate the development of new therapies by providing a ready-made delivery solution for drugs in development. The platform's versatility may be particularly attractive for companies working on biologics, which often require larger volumes and have complex delivery needs.

From an investment perspective, this product line extension could strengthen Stevanato Group's position in the drug delivery market. However, the real value will depend on adoption by pharmaceutical companies and successful integration into drug development pipelines. Investors should look for future announcements of partnerships or licensing agreements as indicators of the platform's market potential.

The platform provides a versatile pre-filled and pre-loaded on-body solution, suitable for highly viscous biological drugs

PIOMBINO DESE, Italy--(BUSINESS WIRE)-- Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology and life sciences industries, announced today the expansion of its Vertiva® platform, which will include a 10mL option to be presented at CPHI Milan in October. The Vertiva® easy-to-use platform can be pre-programmed to accommodate different motor driven dosing profiles, from micro-precision basal delivery to full-content bolus injections. This flexibility makes the platform ideal for administering a wide range of small molecule and biologic therapies, enabling treatment for conditions such as cardiovascular and metabolic disorders, oncology, immunology, and pain management.

An image of a person wearing the large-volume (10mL) version of Stevanato Group's Vertiva® on-body delivery system. (Photo: Business Wire)

An image of a person wearing the large-volume (10mL) version of Stevanato Group's Vertiva® on-body delivery system. (Photo: Business Wire)

The Vertiva® platform features a unique design with a single-use pod containing a pre-filled, pre-loaded cartridge, paired with a reusable, smart controller that communicates with a patented and magnetically coupled drive mechanism. The pod, securely interlocked with the controller, contains a pre-filled glass cartridge available in formats ranging from 3mL up to 10mL and is assembled at the factory for immediate use. This simplifies home-based treatment initiation, offering patients a safe and comfortable experience. A recent wearability study underscored this sentiment and revealed that Vertiva® 10mL is generally well-accepted by patients who found it comfortable to wear. The device proved to securely adhere to the body without restricting movement, allowing patients to go about their daily activities easily.

The smart controller provides the option to record patient usage data, which can be transferred via Bluetooth to digital health applications. Additionally, the two-part system allows for easy separation of the reusable controller from the disposable pod after treatment, significantly reducing the environmental impact of electronic components and enhancing the device's overall sustainability.

“We are excited to announce that the Vertiva® platform represents a significant breakthrough for the biopharma industry,” said Michele Monico, Vice President, Business Line DDS at Stevanato Group. “By combining sustainable and modular design with versatile delivery capabilities, the move to larger volume capacity extends treatment options for a wider range of therapies, enabling biopharma companies to faster and lower cost stability and clinical evaluations. This advancement will redefine how we approach patient at-home and on-body treatment, paving the way for more adaptable and patient-centered solutions.”

Stevanato Group will leverage its integrated capabilities and its existing partnership with Thermo Fisher Scientific to bring Vertiva® 10mL to market. Along with the proprietary device platform, Stevanato Group will offer its pre-sterilized EZ-fill® cartridges as drug containment solutions and assembly equipment, while Thermo Fisher will provide fill-and-finish and final assembly services. The unparalleled combination of capabilities from two established industry providers will support pharma companies from drug development through to the final packaged product, reducing risks and accelerating time-to-market.

Demonstrations of Vertiva® 10mL will be available at CPHI in Milan (Oct 8-10) at Stevanato Group’s booth, 20C1. To learn more about Vertiva® visit stevanatogroup.com.

Forward-Looking Statements

This press release may include forward-looking statements. The words "will", “can”, "accelerating", and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the investments the Company expects to receive, the expansion of manufacturing capacity, the Company’s plans regarding its presence in the U.S. market or other markets, business strategies, the Company’s capacity to meet future market demands and support preparedness for future public health emergencies, and results of operations. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. In particular, the Company may determine not to conduct a registered initial public offering in the time frame that it currently expects or at all, due to a number of potential important factors, including conditions in the U.S. capital markets, negative global economic conditions, potential negative developments in the Company’s business, or unfavorable or regulatory developments. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements.

About Stevanato Group

Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. To learn more, visit: www.stevanatogroup.com.

Media Stevanato Group

Stevanato Group: media@stevanatogroup.com

Cassie Gonzalez: stevanatoUS@teamlewis.com



Investor Relations Stevanato Group

Lisa Miles: lisa.miles@stevanatogroup.com

Source: Stevanato Group

FAQ

What is the new product Stevanato Group (STVN) is introducing at CPHI Milan?

Stevanato Group is introducing the large-volume Vertiva® 10mL on-body delivery system platform for injectable therapies at CPHI Milan in October.

What are the key features of Stevanato Group's (STVN) Vertiva® platform?

The Vertiva® platform features a single-use pod with a pre-filled cartridge, a reusable smart controller, versatile dosing profiles, easy home-based treatment initiation, and the ability to record and transfer patient usage data via Bluetooth.

How does the Vertiva® 10mL system by Stevanato Group (STVN) contribute to sustainability?

The Vertiva® 10mL system's two-part design allows for easy separation of the reusable controller from the disposable pod after treatment, significantly reducing the environmental impact of electronic components and enhancing overall sustainability.

What partnership has Stevanato Group (STVN) formed to bring Vertiva® 10mL to market?

Stevanato Group has partnered with Thermo Fisher Scientific to bring Vertiva® 10mL to market, combining Stevanato's device platform and drug containment solutions with Thermo Fisher's fill-and-finish and final assembly services.

Stevanato Group S.p.A.

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