Independent Study Reaffirms Penumbra Aspiration as Frontline Thrombectomy Approach for Acute Ischemi

 Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced the presentation of the results of the COMPASS Trial, an independent, prospective, multi-center randomized trial that showed the use of Penumbra’s aspiration system was non-inferior to stent retrievers for patients with acute ischemic stroke. The COMPASS Trial results were featured in the main event plenary session at the International Stroke Conference and add to the growing body of evidence demonstrating Penumbra’s aspiration system is an effective frontline thrombectomy approach for acute ischemic stroke as part of the ADAPT (A Direct Aspiration, First Pass Technique) approach.

"The COMPASS Trial met its primary objective, demonstrating that acute ischemic stroke patients treated with the ADAPT approach do not have inferior outcomes to those treated with a first-line stent retriever," stated J Mocco, M.D., M.S., vice chair of neurosurgery, director, Cerebrovascular Center, Icahn School of Medicine at Mount Sinai, New York. "An aspiration first approach to clot removal is now a proven approach for improving severe stroke patients’ outcomes."

The data showed that the ADAPT technique was non-inferior to stent retrievers for treatment of large vessel occlusions: 52 percent of patients treated with Penumbra’s aspiration system achieved the primary endpoint of modified Rankin Score (mRS) 0-2 at 90 days compared with 49 percent of patients treated with stent retrievers. Final revascularization rates were also similar for the two study arms: 92 percent of patients treated with ADAPT using Penumbra’s aspiration system achieved mTICI 2b-3 revascularization compared to 89 percent with stent retrievers (p=0.54). Moreover, the percentage of patients achieving TICI 3 was 38 percent for the ADAPT arm and 29 percent in the stent retriever arm (p=0.15). The trial also revealed a non-significant trend in revascularization speed that favored aspiration with a 10-minute numeric advantage in achieving reperfusion success (p=0.0194).

"The COMPASS Trial validates what we have believed for a long time: an aspiration first approach is very fast, effective and safe," stated Aquilla Turk, D.O., director of neurointerventional surgery section, Departments of Radiology and Neurosurgery, Medical University of South Carolina. "The preliminary results presented reinforce the metrics we experienced in single arm studies that drove us to do this trial."

Secondary safety endpoints presented, including embolization in new territory (ENT) and symptomatic intracranial hemorrhage (sICH), were not statistically different between the two arms.

"In my mind, these two approaches not only show equivalent revascularization and outcomes but also are complementary," said Adnan Siddiqui, M.D., Ph.D., professor of neurosurgery, Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, Buffalo, N.Y. "When used in conjunction, these approaches will open blood vessels and help improve the outcomes of the vast majority of patients with acute ischemic stroke."

The COMPASS Trial reaffirmed the results of two previous multi-center randomized controlled trials – Penumbra’s 3D Trial and the independent ASTER (Adapt versus StEnt Retriever) Trial – demonstrating improvements in procedure and technique while maintaining a strong safety profile and 90-day clinical outcomes for Penumbra’s aspiration system. COMPASS is the first of the three randomized trials to study the company’s latest reperfusion catheter, ACE™68 with the Penumbra System®.

"The COMPASS Trial, together with the PROMISE, ASTER, and 3D Trial results, provides overwhelming evidence that the ADAPT technique with the Penumbra System is a proven frontline approach," said Adam Elsesser, chairman, chief executive officer and president of Penumbra. "Notwithstanding this great data, Penumbra will continue to innovate and improve its Penumbra System; however, all of us in the stroke field now have an obligation to ensure all ischemic stroke patients have access to hospitals that offer mechanical thrombectomy for the best possible outcomes."

About COMPASS Trial

The COMPASS Trial: A Comparison of Direct Aspiration vs. Stent Retriever as a First Approach is an independent, prospective, randomized trial that compared mechanical thrombectomy with the ADAPT (A Direct Aspiration First Pass Technique) approach to stent retrievers in patients presenting with acute ischemic stroke (AIS) within six hours of symptom onset. The primary objective of the trial was to show that AIS patients, with appropriate image selection, treated with the ADAPT approach within 6 hours of symptom onset do not have inferior clinical outcomes to those treated with a first-line stent retriever with 90-day global disability assessed via the modified Rankin Scale score (mRS) analyzed using success criteria as mRS 0 to 2. The study enrolled 270 patients at 20 centers in the U.S., and was funded by the company through a research grant. (Clinicaltrials.gov Identifier: NCT02466893)

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 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 statement s. 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.