Latest Data Demonstrates Penumbra System and RED® Reperfusion Catheters Effective for Broad Stroke Care

Rhea-AI Summary

Penumbra, Inc. (NYSE: PEN) announced promising results from its initial INSIGHT Registry data, revealing that its RED^® reperfusion catheters achieved a first-pass revascularization rate of 68.9% in acute ischemic stroke patients. Additionally, findings from the COMPLETE study indicate that the Penumbra System effectively treats patients with tandem lesions and those in the late treatment window, with successful revascularization rates of 89% for tandem lesions and 83.2% for late window patients. These data were presented at the 2022 WFITN conference in Kyoto, Japan.

Positive

• First-pass revascularization rate of 68.9% for RED catheters.
• COMPLETE study shows 89% success in revascularization for tandem lesions.
• 83.2% revascularization success in late window patients.

Negative

• None.

• Initial INSIGHT Registry data demonstrated RED^® reperfusion catheters were highly effective in removing all clot types with an impressive 68.9% mTICI > 2b-3 overall first pass effect rate
• COMPLETE study sub-analyses of tandem lesions and late window showed aspiration thrombectomy with Penumbra System^® restored blood flow and resulted in improved 90-day functional outcomes

ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced initial INSIGHT Registry data showing Penumbra’s RED^® reperfusion catheters were successful in removing all clot types. Additionally, results of sub-analyses of the COMPLETE study showed use of the Penumbra System is effective for acute ischemic stroke (AIS) patients with tandem lesions, as well as patients who are considered in the late window of treatment. The results were presented at the 2022 World Federation of Interventional and Therapeutic Neuroradiology (WFITN) in Kyoto, Japan.

Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced initial INSIGHT Registry data showing Penumbra’s RED® reperfusion catheters were successful in removing all clot types. Additionally, results of sub-analyses of the COMPLETE study showed use of the Penumbra System is effective for acute ischemic stroke (AIS) patients with tandem lesions, as well as patients who are considered in the late window of treatment. The results were presented at the 2022 World Federation of Interventional and Therapeutic Neuroradiology (WFITN) in Kyoto, Japan. (Photo: Penumbra, Inc.)

“The initial data from our INSIGHT Registry is very promising. With such a high first pass rate, Penumbra’s RED catheters can restore blood flow much quicker, which we know can lead to improved outcomes for patients,” said Sandra Lesenfants, president of interventional at Penumbra, Inc. “Penumbra’s focus has always been to help as many people as we can, and this data demonstrates that our latest technology is indeed making a positive impact.”

The initial INSIGHT Registry data evaluating Penumbra’s latest RED reperfusion catheters in 161 AIS patients showed 68.9% had successful first-pass revascularization (mTICI≥2b-3), and 97.0% had successful revascularization after final angiogram through site reported findings. Final mTICI≥2b-3 scores were reported in 98.1% of patients with firm-red clots and in 100% of patients with other clot types. The INSIGHT Registry is a multicenter post-market evaluation.

“Mechanical aspiration thrombectomy is becoming an increasingly important option for physicians treating acute ischemic stroke, especially patients with more complicated cases,” said Osama Zaidat, M.D., the National Principal Investigator of the COMPLETE study. “Oftentimes, patients that presented late or have tandem lesions (15% of MT cases) are difficult to treat. However, the data showed the Penumbra System delivered good functional outcomes and low 90-day mortality rates for these patients, which compared favorably to other options.”

COMPLETE is a global, prospective, multicenter post-market study assessing the performance of the company’s Penumbra System. The Core Lab adjudicated findings include:

• Patients with anterior circulation tandem lesions with stenosis greater than 50% treated with Penumbra System resulted in successful revascularization: 89% of patients achieved mTICI 2b-3 and nearly 64% of patients achieved 90-day mRS 0-2.
• Late window patients achieved successful revascularization with the use of the Penumbra System in 83.2% of cases, with a 90-day good functional outcome rate of 55.4%. Additionally, there were no device related adverse events observed.

“The presented data confirms that Penumbra’s aspiration thrombectomy innovations are highly effective. Our drive to advance novel technologies allows us to provide physicians with the broadest portfolio of proven solutions for stroke management,” continued Lesenfants.

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 http://www.penumbrainc.com/healthcare-professionals. 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: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; 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, including our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 22, 2022. 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.

Source: Penumbra, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220825005260/en/

Jennifer Heth

Penumbra, Inc

jheth@penumbrainc.com

510-995-9791

Joni Ramirez

Merryman Communications

joni@merrymancommunications.com

323.532.0746

Source: Penumbra, Inc.

FAQ

What were the results of the initial INSIGHT Registry for Penumbra (PEN)?

The INSIGHT Registry data showed a 68.9% first-pass revascularization rate using Penumbra's RED^® reperfusion catheters.

How effective is the Penumbra System for treating tandem lesions?

In the COMPLETE study, the Penumbra System achieved a successful revascularization rate of 89% for patients with anterior circulation tandem lesions.

What does the COMPLETE study reveal about late window treatment efficacy?

The COMPLETE study showed the Penumbra System's effectiveness with a successful revascularization rate of 83.2% in late window patients.

Where were the results of the study presented?

The results were presented at the 2022 World Federation of Interventional and Therapeutic Neuroradiology conference in Kyoto, Japan.