Independent Study Reaffirms Penumbra Aspiration as Frontline Thrombectomy Approach for Acute Ischemic Stroke

LOS ANGELES –
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.

Source: Penumbra, Inc.

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