NEW LATE BREAKING DATA DEMONSTRATE PENUMBRA'S COMPUTER ASSISTED VACUUM THROMBECTOMY TECHNOLOGY FOR PULMONARY EMBOLISM IMPROVED PATIENT OUTCOMES

Rhea-AI Summary

Penumbra's computer assisted vacuum thrombectomy (CAVT) is safe and effective at reducing right heart strain and improving clinical and functional outcomes for the treatment of pulmonary embolism. The latest STRIKE-PE data show low rates of major adverse events and major bleeding. Functional measures also improved, including patient-reported shortness of breath, functional ability measured by 6-minute walk distance, and return to pre-PE state. The data confirm the significant benefits of CAVT.

Positive

• Penumbra's CAVT is safe and effective at reducing right heart strain and improving clinical outcomes.
• Low rates of major adverse events and major bleeding were observed in the STRIKE-PE data.
• Functional measures, such as patient-reported shortness of breath and functional ability, significantly improved.
• Patients returned to their pre-PE state with no significant difference in NYHA classification.
• The data confirm the significant benefits of CAVT for the treatment of pulmonary embolism.

Negative

• None.

• Latest STRIKE-PE data show that computer assisted vacuum thrombectomy (CAVT) for the treatment of pulmonary embolism is safe and effective at reducing right heart strain; it also improved clinical and functional outcomes
• Penumbra's Indigo^® Aspiration with Lightning™ portfolio offers the only CAVT technologies currently available in the U.S.

ALAMEDA, Calif., Nov. 1, 2023 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced the latest STRIKE-PE data evaluating Penumbra's Indigo® Aspiration System with Lightning™. The results show Penumbra's computer assisted vacuum thrombectomy (CAVT) is safe and effective at reducing right heart strain. It also improved clinical outcomes, including heart rate and respiratory rate, and functional outcomes, including dyspnea, walking distance and New York Heart Association (NYHA) classification, when used to treat acute high and intermediate risk pulmonary embolism (PE). The data were presented at this week's Vascular Interventional Advances (VIVA) 2023 Conference.

"The latest STRIKE-PE data looking at the first 150 patients show that not only is Penumbra's Indigo System safe and effective for removing thrombus, but also confirm that the removal of the clot can have a significant, positive physiologic impact on patients," said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. "The latest STRIKE-PE data add to the growing body of evidence that demonstrates the significant benefits of CAVT, which is redefining the way physicians treat significant symptomatic pulmonary emboli."

Penumbra's CAVT is designed to allow physicians to remove large blood clots in the body safely, simply and with speed. The interim results of the prospective, muti-center study, which evaluated Penumbra's Lightning technology in 150 of 600 anticipated patients to be enrolled, include:

Safety & Performance:

• Low 48hr major adverse event rate of 2.7%
• Low 48hr major bleeding rate of 2.7%
• Significant reduction of right ventricle/left ventricle ratio by 25.7%

Functional Measures:

• Significantly improved patient reported shortness of breath (dyspnea) by discharge with increasing improvement by 90-days
• Functional ability, measured by 6-minute walk distance, significantly increased by 120 meters from discharge to 90-days
• Patients returned to pre-PE state with no significant difference in NYHA classification from before the event to 90-days

"The complexity of treating pulmonary embolisms appropriately cannot be overstated. They are often complicated to diagnose and, in many cases, if not treated quickly, can be life-threatening," said Ido Weinberg, M.D., who presented the data and is a vascular medicine physician at the Massachusetts General Hospital. "While surviving a pulmonary embolism is a victory, patients regaining their quality of life and ability to function without ongoing limitation is critical. The STRIKE-PE data set is very encouraging as it confirms the promise of CAVT to restore blood flow quickly, safely and effectively while also showing promising, prompt and lasting improvement in patient outcomes."

Additional STRIKE-PE data were previously presented at the recent TCT Annual Scientific Meeting, showing improved quality-of-life outcomes, including improved mobility and ability to provide self-care and a decrease in pain/discomfort from discharge to 90-day follow-up.

"The real-world data from STRIKE-PE allow us, for the first time, to continuously evaluate the impact of intermediate and high-risk PE treated with CAVT," said John Moriarty, M.D., principal investigator of the STRIKE-PE study and interventional radiologist at University of California, Los Angeles. "The latest results continue to show improved functional outcomes and quality of life, suggesting that CAVT should be considered as a valuable frontline treatment option."

In the U.S., an estimated 900,000 cases of symptomatic PE occur annually[i]. Incomplete physical recovery after PE has been documented as a common outcome as patients often report decreased quality of life and persistent shortness of breath. Pulmonary embolism can be life-threatening with 10-30 percent of individuals dying within one month of diagnosisⁱ.

"We believe that our CAVT technology will help transform care so PE patients can return home quickly with minimal impairments and minimal impact on their quality of life," said Adam Elsesser, president and chief executive officer of Penumbra, Inc. "The latest STRIKE-PE data confirm that the safety, speed and simplicity of our devices can have a lasting impact on patients and our focus on clinical evidence will continue to advance the patient care paradigm."

Penumbra is also conducting STORM-PE, a first-of-its kind randomized controlled trial comparing CAVT using Penumbra's Lightning Flash with anticoagulation versus anticoagulation alone, with the goal of showing the clinical benefits to patients who receive CAVT.

About Penumbra 
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra supports healthcare providers, hospitals and clinics in more than 100 countries. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn.

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 here.

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; 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, 2022 filed with the SEC on February 23, 2023. 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.

Contact
Jennifer Heth	Parinaz Farzin
Penumbra, Inc	Merryman Communications
jheth@penumbrainc.com	parinaz@merrymancommunications.com
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.

FAQ

What is the latest STRIKE-PE data evaluating?

The latest STRIKE-PE data evaluated Penumbra's Indigo® Aspiration System with Lightning™ for the treatment of pulmonary embolism.

What are the key findings of the STRIKE-PE data?

The key findings of the STRIKE-PE data include the safety and effectiveness of Penumbra's computer assisted vacuum thrombectomy (CAVT) in reducing right heart strain and improving clinical and functional outcomes for pulmonary embolism.

What were the safety and performance results of the STRIKE-PE data?

The STRIKE-PE data showed a low 48-hour major adverse event rate of 2.7% and a low 48-hour major bleeding rate of 2.7%.

What functional measures improved according to the STRIKE-PE data?

The STRIKE-PE data showed significant improvements in patient-reported shortness of breath (dyspnea) by discharge, functional ability measured by 6-minute walk distance, and return to pre-PE state with no significant difference in NYHA classification.

What is the goal of Penumbra's STORM-PE trial?

The goal of Penumbra's STORM-PE trial is to compare CAVT using Penumbra's Lightning Flash with anticoagulation versus anticoagulation alone and show the clinical benefits to patients who receive CAVT.