Penumbra, Inc. Announces Completion of Enrollment for Landmark STORM-PE Randomized Controlled Trial
- Trial completed enrollment ahead of schedule, demonstrating strong clinical interest and execution
- Partnership with prestigious PERT Consortium enhances trial credibility
- Large addressable market with 900,000 annual PE cases in the U.S.
- Lightning Flash technology features advanced dual clot detection algorithms and innovative MaxID hypotube design
- Results of the trial are still pending and success is not guaranteed
- Current PE mortality rates of 10-30% highlight treatment challenges
- Competition from existing anticoagulation treatments which are well-established
Insights
Penumbra's STORM-PE trial completion positions them to potentially establish new standard of care in the lucrative PE treatment market.
Penumbra's completion of enrollment in the STORM-PE randomized controlled trial represents a significant clinical milestone that was achieved ahead of schedule. This trial evaluates their proprietary Computer Assisted Vacuum Thrombectomy (CAVT) technology with the Lightning Flash device against standard anticoagulation therapy for pulmonary embolism (PE).
The market implications are substantial. PE affects approximately 900,000 patients annually in the US alone, with 10-30% mortality within one month of diagnosis. This represents a large, underserved market with substantial growth potential for Penumbra's thrombectomy solutions.
The trial's partnership with The PERT Consortium adds credibility and could accelerate clinical adoption if results are positive. What makes this particularly valuable is that it will provide Level 1 clinical evidence in a therapeutic area where treatment guidelines for intermediate-high risk patients remain poorly defined.
From a competitive standpoint, Penumbra describes their Lightning Flash portfolio as "the most advanced mechanical thrombectomy system on the market" for venous and pulmonary thrombus. The technology's dual clot detection algorithms and MaxID hypotube design could differentiate it from competing devices if clinical outcomes support these engineering advantages.
For investors, this milestone reduces timeline uncertainty and execution risk in the company's clinical development program. If positive, STORM-PE results could significantly expand Penumbra's addressable market and solidify their position as "the world's leading thrombectomy company," potentially translating to accelerated revenue growth in this therapeutic category.
STORM-PE is a first-of-its-kind clinical trial comparing computer assisted vacuum thrombectomy (CAVT™) using Penumbra's Lightning Flash™ with anticoagulation versus anticoagulation alone in the treatment of acute intermediate-high risk pulmonary embolism
"This is an important milestone that underscores Penumbra's commitment to transforming care for patients with pulmonary embolism," said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. "The trial successfully randomized patients well ahead of schedule thanks to the dedication of our clinical partners and the tireless efforts of our internal teams."
Conducted in partnership with The PERT Consortium®, a multi-disciplinary group dedicated to improving the care of patients with PE, the trial aims to provide high-quality evidence on the role of CAVT in improving right heart function and clinical outcomes in this critically ill patient population.
"Pulmonary embolism remains a leading cause of cardiovascular morbidity and mortality, yet treatment strategies for intermediate-high risk patients are not well defined." said Rachel Rosovsky, MD, MPH, co-global principal investigator of STORM-PE and hematologist at the Massachusetts General Hospital. "The results of this trial will provide level 1 clinical evidence aimed at informing treatment guidelines and patient care."
In the
"We are pleased to announce that STORM-PE has successfully completed enrollment," said Robert Lookstein, MD, MHCDL co-global principal investigator and professor of radiology and surgery at the Icahn School of Medicine at Mount Sinai. "We congratulate all the sites and the investigators for their dedication and commitment to answering the critical clinical question of whether endovascular therapy with CAVT is superior to medical therapy for acute intermediate-high risk pulmonary embolism."
Penumbra's Lightning Flash portfolio is the most advanced mechanical thrombectomy system on the market to address venous and pulmonary thrombus. It features Penumbra's Lightning CAVT technology with the latest dual clot detection algorithms, using both pressure and flow-based processes to detect blood clot and blood flow. The Lightning Flash catheter is made with MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip design. They are designed to help remove blood clots with speed, safety and simplicity, allowing physicians to better navigate the body's complex anatomy and deliver high power aspiration for clot removal.
For more information about the STORM-PE trial (NCT05684796), please visit www.penumbrainc.com/storm-pe-trial.
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. Its 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, Penumbra supports 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. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. Risk information can be found at http://www.peninc.info/risk.
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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Jennifer Heth | Parinaz Farzin |
Penumbra, Inc. | Merryman Communications |
510-995-9791 | 310.600.6746 |
i "Learn about Pulmonary Embolism," American Lung Association. Accessed on Oct. 26, 2023. https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism |
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SOURCE Penumbra, Inc.
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