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January 7, 2008, 4:00 am PST

PRESS RELEASE

Penumbra, Inc. Announces 510(k) Clearance Of The Penumbra System™ For Use In The
Revascularization Of Patients With Acute Ischemic Stroke.

Device To Be Available For Immediate Commercialization; Clinical Data From 125 Patient
Pivotal Trial To Be Released At The ASA International Stroke Conference In New Orleans On
February 22, 2008.

SAN LEANDRO, CA – (BUSINESS WIRE) – January 7, 2008

Penumbra, Inc. today announced the 510(k) clearance by the US Food and Drug Administration
of the Penumbra System, which is indicated for use in the revascularization of patients with acute
ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of
symptom onset. Penumbra will commence the immediate commercialization of the device in the
United States.

“We were very impressed with the performance and efficacy of the Penumbra System during the
clinical trial, and are excited to now have access to this important tool to treat acute ischemic
stroke patients in our daily practice. This system of tools is an important advance that may
transform the acute treatment of this devastating disease,” said Michael Madison, MD, Director
of Interventional Neuroradiology, St. Paul Radiology in St. Paul, Minnesota.

“Acute ischemic stroke is a major public health issue and its treatment often requires a variety of
therapeutic approaches. We welcome the addition of the Penumbra System to the therapeutic
options available to the neuro interventionalist, and look forward to seeing it in clinical practice,”
said Mary E. (Lee) Jensen, M.D. Professor of Radiology and Neurosurgery at the University of
Virginia Health System in Charlottesville, Virginia, and President of the Society of
NeuroInterventional Surgery.

Clinical results from the pivotal trial of the Penumbra System have been accepted for
presentation at the 2008 ASA International Stroke Conference in New Orleans. The abstract was
accepted under the Late Breaking Science category and will be presented by Dr. Cameron
McDougall, Chief of Endovascular Neurosurgery at Barrow Neurological Institute, on Friday,
February 22 in Plenary Session III. Based upon the American Stroke Association’s requirements,
the clinical data is embargoed from public disclosure prior to presentation at the International
Stroke Conference.

“Physicians treating patients with acute ischemic stroke often have limited treatment options to
offer, particularly for patients presenting beyond the three-hour time window for intravenous
thrombolysis. The availability of a new endovascular device system that may allow safe
revascularization of occluded vessels and restoration of brain blood flow in acute ischemic stroke
for up to 8 hours after symptom onset is a promising development. We look forward to
additional data addressing the effect of revascularization on clinical outcome,” said Pierre Fayad,
MD the Reynolds Centennial Professor and Chairman of the Department of Neurological
Sciences at the University of Nebraska Medical Center in Omaha, Nebraska, and Chair-elect of
the Stroke and Vascular Neurology section of the American Academy of Neurology.

The Penumbra System is a package of tools used by neuro interventional specialists to remove
occlusions from the large vessels of the brain that are causing an acute ischemic stroke. It works
on the proximal surface of the occlusion, optimizing safety and eliminating the need for
navigation beyond the occlusion. The Penumbra System is comprised of an aspiration platform
containing multiple devices that are size-matched to the specific neurovascular anatomy allowing
clots to be gently aspirated out of intracranial vessels.

In the pivotal trial, in addition to the multiple aspiration devices, the system included a clot-
grabbing device that was designed to be used if the aspiration devices were not successful. Based
upon the results of the trial with the aspiration devices, and due to the small number of cases in
which the clot-grabbing device was necessary, Penumbra, in consultation with the FDA, decided
to exclude the clot-grabbing device from its final submission.

The Penumbra System is CE Marked and has been commercially available in Europe since June,
2007.

ABOUT PENUMBRA

Penumbra, Inc. (www.penumbrainc.com) is a medical device company committed to delivering


clinically beneficial products that help patients suffering from stroke and neurovascular disease.
Penumbra’s global headquarters is located in the east San Francisco Bay city of San Leandro,
California with sales operations in the United States and Europe.

CONTACT: Penumbra, Inc.


Media Relations:
Darlene Clemente, 510-618-3200

SOURCE: Penumbra, Inc.

Copyright Business Wire 2008

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