Independent Study Supports Use of Penumbra Aspiration as Frontline Thrombectomy Therapy for Acute Ischemic Stroke

HOUSTON –
Penumbra,
Inc. (NYSE: PEN), a global interventional therapies company, today
announced the presentation of the results of the ASTER Trial, the first
independent, prospective, randomized trial comparing the use of
Penumbra’s aspiration system to stent retriever, in the opening plenary
session at the International Stroke Conference in Houston, Texas. The
ASTER Trial provides additional evidence of Penumbra’s aspiration system
as an effective frontline thrombectomy approach for acute ischemic
stroke as part of the ADAPT (A Direct
Aspiration, First Pass
Technique) technique.

“The ASTER study provides evidence that starting with Penumbra
aspiration first as part of the ADAPT technique is similar to the stent
retriever technique,” said Michel Piotin, MD, principal investigator and
interventional neuroradiologist at Rothschild Fondation Hospital in
Paris. “The ADAPT technique offers the possibility to easily add a stent
retriever following Penumbra aspiration if needed, leading to time
savings.”

The data showed that the ADAPT technique compared favorably: 85.4
percent of patients treated with Penumbra’s aspiration system achieved
the primary endpoint of TICI 2b/3 at the end of the procedure compared
with 83.1 percent of patients treated with stent retrievers (p=0.53).
Moreover, 63.0 percent of patients treated with Penumbra’s aspiration
system achieved the secondary endpoint of TICI 2b/3 after frontline
treatment compared to 67.7 percent with stent retrievers (p=0.33).

“The ASTER Trial shows no significant difference in revascularization
rate and safety using either thrombectomy technique – Penumbra
aspiration and stent retrievers – for acute ischemic stroke patients
with large vessel occlusions,” said Bertrand Lapergue, MD, PhD, Division
of Neurology, Stroke Center, Foch Hospital, University Versailles
Saint-Quentin en Yvelines (France) and scientific coordinator for the
study. “The broad eligibility criteria achieved in the ASTER Trial make
the results generalizable to the majority of stroke patients with large
vessel occlusions.”

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

“The ASTER Trial builds on the results of the 3D Trial, providing
additional evidence supporting the use of Penumbra System direct
aspiration devices as a first-line treatment for acute ischemic stroke
patients,” said Adam Elsesser, chairman, chief executive officer and
president of Penumbra. “The ADAPT technique with the Penumbra System as
a frontline approach together with complementary adjunctive devices when
needed offers a cost-effective solution for treating stroke patients,
which is critical as patient access to mechanical thrombectomy is
further expanded.”

About ASTER Trial

The ASTER (Adapt versus StEnt
Retriever) Trial is a prospective,
randomized controlled study that compared the safety and efficacy of the
Penumbra aspiration system used frontline as part of the ADAPT technique
versus stent retrievers. The primary endpoint was end of procedure
revascularization (TICI 2b/3). The study enrolled 381 patients at eight
centers in France over 12 months beginning in October 2015. Penumbra
provided an institutional grant to support the ASTER Trial.

About 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. 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. The Penumbra System is the only FDA cleared integrated
aspiration system for the revascularization of ischemic stroke patients.

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, the Penumbra logo, ACE, and Pump MAX are trademarks
of Penumbra, Inc. Other trademarks are the property of their respective
owners.

Forward-Looking Statements

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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]