Company Announcements

ALAMEDA, Calif. , June 5, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN) announced the U.S. Food and Drug Administration (FDA) clearance and launch of the Ruby^® XL System, the longest, largest and softest coil on the marketⁱ. The Ruby XL System is designed to help physicians achieve more efficient embolization, potentially reducing radiation exposure, and optimizing outcomes — especially in large vessel and high-flow embolizationⁱⁱ.

"We've engineered Ruby XL to deliver more volume per coil than any other coil on the market, which may result in cost savings," said Shruthi Narayan, President of Interventional Business at Penumbra, Inc. "Ruby XL embodies Penumbra's commitment to innovation, delivering mechanical occlusion through more volume without sacrificing softness or deliverability."

The Ruby XL System introduces three unique technologies — Ruby XL, POD^® XL, and Packing Coil XL — all of which can be delivered through a 0.035"+ diagnostic catheter. They have a primary diameter of .030" and are designed for procedural efficiency. These coils offer more volume (up to 40mm in size) and are available in extended lengths up to 70 cm.

• Engineered with a 3D complex shape, Ruby XL coil is designed to frame aneurysms in a variety of clinical applications.
• POD XL features a hybrid, multistage design and is engineered with three-in-one coil occlusion technology — an anchoring segment, a framing segment, and a dense filling segment. Designed for high flow vessels, POD XL offers smooth delivery and targeted vessel control.
• Packing Coil XL features an innovative liquid metal wave shape technology, which is designed to adjust dynamically to the size of any vessel (up to 70 cm length).

Penumbra's Ruby portfolio of peripheral embolization products, now with Ruby XL System, provides physicians with one of the most expansive embolization offerings, enabling physicians to have the latest coil technologies and most extensive options for every case. For more information, please visit www.penumbrainc.com/products/ruby-xl.

About Penumbra
Penumbra, Inc., the world's leading thrombectomy company, is focused on developing the most innovative technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT™), centers on removing blood clots from head-to-toe with speed, safety and simplicity. By pioneering these innovations, we support healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life. For more information, visit www.penumbrainc.com and connect on Instagram, LinkedIn and X.

Important Safety Information
Additional information about Penumbra's products can be located on Penumbra's website at https://www.penumbrainc.com/providers. Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Please visit www.peninc.info/risk for the complete IFU Summary Statements.

The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.

Forward-Looking Statements

Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory or other assets; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission ("SEC"), including our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 18, 2025. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.

 

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SOURCE Penumbra, Inc.