Aspiration First Approach with Penumbra System Demonstrates Favorable Outcomes for Acute Ischemic Stroke

January 25, 2018

Results of the PROMISE Study Presented at International Stroke Conference

LOS ANGELES--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced results of the company-sponsored PROMISE Study, demonstrating real-world safety and efficacy of the Penumbra System with ACE™68 and ACE™64 Reperfusion Catheters as frontline treatment in patients with acute ischemic stroke using the ADAPT (A Direct Aspiration First Pass Technique) approach. The results were presented last night at the International Stroke Conference (ISC 2018) in Los Angeles.

“ADAPT as a frontline approach demonstrated excellent results – both in revascularization rates and clinical outcomes,” said Peter Schramm, M.D., from the department of Neuroradiology, Universitatsklinikum Schleswig-Holstein, Lubeck, Germany. “In addition, the low mortality rate and strong safety profile indicate that stroke revascularization with aspiration is safer and more effective with ACE68 and ACE64 than ever before.”

The PROMISE Study was a prospective, single-arm multi-center study that enrolled 204 patients across 20 European centers. Core-lab adjudicated mTICI 2b-3 revascularization was attained in 93.1 percent of patients, with 39.2 percent of patients attaining mTICI 3 revascularization. Clinical independence, measured by modified Rankin Score (mRS) 0-2, was achieved in 61 percent of patients at 90 days. Key secondary safety related endpoints also demonstrated excellent results: All-cause mortality at 90 days was 7.5 percent, symptomatic intracranial hemorrhage (sICH) at 24 hours was 2.9 percent and embolization in new territories (ENT) was 1.5 percent. Median procedure time, as measured as groin puncture to mTICI 2b-3 revascularization, was 31 min [20.0 – 53.0].

“We thank the PROMISE investigators for this important contribution to the growing body of global evidence supporting ADAPT as a frontline approach for patients with acute ischemic stroke,” said Adam Elsesser, chairman, chief executive officer and president of Penumbra. “The PROMISE study affirms our belief that the Penumbra System with ACE68 offers a rapid, safe and cost-effective approach for ischemic stroke revascularization.”

Results of an additional study evaluating Penumbra’s aspiration thrombectomy system for ischemic stroke revascularization using the ADAPT approach, the COMPASS Trial (A Comparison of Direct Aspiration vs. Stent Retriever as a First Approach), will be presented later today in the main event plenary session at the International Stroke Conference from 11-11:12 a.m. PT.

About PROMISE Study

PROMISE was a company-sponsored, prospective, single-arm, multi-center observational study that aimed to observe the real-life safety and effectiveness of the Penumbra System with ACE68 and ACE64 Reperfusion Catheters in patients with acute ischemic stroke from large vessel occlusion, treated with the ADAPT technique as a frontline approach. The study enrolled 204 patients across 20 European centers. The primary endpoints were revascularization rates as measured by mTICI 2b-3 adjudicated by independent Core Laboratory and clinical independence at 90 days, as measured by modified Rankin Score (mRS) 0-2. (ClinicalTrials.gov Identifier: NCT02678169)

About Penumbra System

The Penumbra System® is a fully integrated system designed specifically for mechanical thrombectomy by aspiration that first received 510(k) clearance by the U.S. Food & Drug Administration in December 2007. The Penumbra System enables physicians to use aspiration, which acts like a minimally invasive “vacuum” inside the artery to remove stroke-causing blood clots from the brain safely and effectively. It is intended for use in the revascularization of patients with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion. The latest generation of the Penumbra System features the ACE™ Reperfusion Catheters, Hi-Flow Aspiration Tubing, the 3D Revascularization Device™ and Pump MAX™ aspiration pump and accessories. Launched in 2016, the ACE68 Reperfusion Catheter offers outstanding trackability and enables even greater aspiration power for clot removal through its large .068” lumen. Launched in 2017, the 3D Revascularization Device is a next generation stroke device, designed and optimized for aspiration with ACE Reperfusion Catheters.

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.

About Penumbra

Penumbra, Inc., headquartered in Alameda, Calif., is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra, the Penumbra P logo, Penumbra System, ACE, 3D Revascularization Device and MAX are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com.

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; and potential adverse regulatory actions. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2016. 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.

Source: Penumbra, Inc.

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