Public Release: 

Randomized penumbra 3D trial of next generation stent retriever meets primary endpoints

Data also highlight frontline effectiveness of aspiration using Penumbra System for stroke revascularization

Merryman Communications

BOSTON, Mass. - July 27, 2016 - Penumbra, Inc. (NYSE: PEN), a global interventional therapies company, today announced that the Penumbra 3D Trial successfully met the primary trial endpoints, demonstrating non-inferiority in both safety and efficacy of the company's next-generation stent retriever, Penumbra 3D Revascularization Device, when used with Penumbra System aspiration devices compared to Penumbra System aspiration devices alone. The data were presented in the Late Breaking Abstract Presentations session today at the Society of NeuroInterventional Surgery (SNIS) 13th Annual Meeting in Boston, Massachusetts.

Results showed non-inferior revascularization rates according to the FDA-defined primary effectiveness measure of TICI 2-3 in the Penumbra 3D Revascularization Device with Penumbra System aspiration devices arm (3D+aspiration device arm) compared to the Penumbra System aspiration devices only arm (aspiration device-only arm) (88.5 percent vs. 85.9 percent). In addition, the more strictly defined revascularization measure, TICI 2b/3, showed non-inferiority between the 3D+aspiration device arm and the aspiration device-only arm (83.9 percent vs 74.1 percent). The primary safety endpoints - device-related serious adverse events (SAEs) and procedure-related SAEs - were not statistically different between the two arms (p=1.0 and p=0.4920, respectively).

"The results of the Penumbra 3D Trial speak positively on the use of Penumbra's 3D Revascularization Device in combination with the Penumbra System aspiration devices, as well as on the use of Penumbra System aspiration devices alone," said Donald Frei, MD, lead investigator of the study and director, NeuroInterventional Surgery at Radiology Imaging Associates/Swedish Medical Center in Englewood, Colorado. "The data also suggest that the revascularization rate in the Penumbra 3D plus aspiration device arm and the aspiration device-only arm - 83.9 and 74.1 percent, respectively - compare favorably to the 71 percent revascularization rate published in the HERMES meta-analysis of five major randomized controlled trials in acute ischemic stroke."

Patients in both arms experienced similar rates of return to functional independence (mRS ? 2 at 90 days): 41.6 percent in the 3D+aspiration device arm and 48.8 percent in the aspiration device-only arm (p=0.4260). These clinical outcomes were obtained without the benefit of selecting patients using imaging techniques designed to detect viable brain tissue.

"The trial results are encouraging for our Penumbra 3D Revascularization Device, and we are focused on continuing our plan to pursue regulatory submission by the end of this year," said Adam Elsesser, chairman and chief executive officer of Penumbra. "Furthermore, the broader implications of the data support frontline use of the Penumbra System direct aspiration devices in the revascularization of stroke patients."

###

About the Penumbra 3D Trial

The Penumbra 3D Trial was a prospective, randomized controlled non-inferiority study that compared the safety and efficacy of the Penumbra 3D Revascularization Device, used in conjunction with Penumbra System aspiration devices, to that of Penumbra System aspiration devices alone for the endovascular treatment of acute ischemic stroke patients with a large vessel occlusion. The primary study endpoints included core lab-adjudicated angiographic revascularization and safety. A total of 198 patients were randomized at 25 U.S. centers. The Penumbra 3D Revascularization Device is approved for investigational use only in the United States.

About the Penumbra System

The Penumbra System consists of large diameter, highly flexible, and reliably trackable reperfusion catheters that utilize the full aspiration power of the Penumbra Pump MAX™ through its Hi-Flow Aspiration Tubing. This integrated, proprietary system removes stroke-causing occlusions safely and effectively. The next generation Penumbra 3D Revascularization Device is designed to be used with the Penumbra System's family of reperfusion catheters. It features innovative three-dimensional chambers within the lumen to enable secure clot engagement while minimizing contact with the vessel wall. The majority of Penumbra System aspiration devices used in the 3D Trial included 4MAX™, 5MAX™ and 5MAXACE™ reperfusion catheters and separators.

About Penumbra

Penumbra, Inc., headquartered in Alameda, California, is a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices. The company has a broad portfolio of products that address challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra and the Penumbra logo are trademarks of Penumbra, Inc.

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, 2015. 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.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.