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

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

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.

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.

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