Randomized Penumbra 3D Trial of Next Generation Stent Retriever Meets Primary Endpoints

BOSTON –
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.

Source: Penumbra, Inc.

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Merryman Communications
Betsy Merryman, 310-560-8176
[email protected]