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Penumbra and Asahi Intecc Partner With Goal of Introducing Indigo™ System Including Lightning™ Intelligent Aspiration to Japan

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Penumbra, Inc. (NYSE: PEN) has announced a collaboration with Asahi Intecc Co. to introduce the Indigo™ Aspiration System in Japan after gaining regulatory approval. This advanced peripheral mechanical thrombectomy technology targets blood clot removal in arterial and venous systems, addressing conditions like acute limb ischemia and pulmonary embolism. The system features cutting-edge Lightning technology, designed to differentiate between clot and blood, minimizing blood loss during procedures. This partnership aims to enhance patient care and meet the increasing medical needs in Japan.

Positive
  • Collaboration with Asahi Intecc for introduction in Japan, expanding market reach.
  • Advanced technology designed to reduce blood loss and improve patient outcomes.
Negative
  • Dependence on regulatory approval for market entry in Japan.
  • Companies aim to introduce Penumbra’s most advanced peripheral mechanical thrombectomy technology to Japan upon regulatory approval
  • Lightning technology is designed for single session blood clot removal in peripheral arterial and venous systems, including for diseases such as acute limb ischemia, vein thrombosis and pulmonary embolism
  • First and only computer-aided mechanical aspiration technology that can differentiate between clot and blood, which is designed to minimize blood loss

ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, and Asahi Intecc Co., a leading Japanese medical device manufacturer, announced that they will collaborate to introduce Penumbra’s Indigo™ Aspiration System into the Japanese market upon regulatory approval.

Penumbra, Inc. and Asahi Intecc Co. will collaborate to introduce Penumbra’s Indigo™ Aspiration System into the Japanese market upon regulatory approval. Penumbra’s Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Penumbra’s newest generation offering combines hypotube-based Indigo Aspiration Catheters with Lightning Intelligent Aspiration, a unique computer-aided clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding complications. (Graphic: Business Wire)

Penumbra, Inc. and Asahi Intecc Co. will collaborate to introduce Penumbra’s Indigo™ Aspiration System into the Japanese market upon regulatory approval. Penumbra’s Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Penumbra’s newest generation offering combines hypotube-based Indigo Aspiration Catheters with Lightning Intelligent Aspiration, a unique computer-aided clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding complications. (Graphic: Business Wire)

“By bringing together our newest innovations with Asahi’s leadership and expertise in the Japanese medical device market, we can provide physicians in Japan with technology that has been proven highly effective, helping patients return home quickly and in good health,” said Adam Elsesser, president and chief executive officer of Penumbra. “This furthers our commitment to advance novel technologies to address unmet needs and improve patient care worldwide.”

Penumbra’s Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Penumbra’s newest generation offering combines hypotube-based Indigo Aspiration Catheters with Lightning Intelligent Aspiration, a unique computer-aided clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding complications.

“Our companies share a similar mission to help expand the available treatment options for serious conditions that impact an increasing number of people in Japan,” said Masahiko Miyata, president and chief executive officer of Asahi Intecc. “We believe that, together, we are able to provide physicians with the latest innovations that best meet their patients’ needs and help advance patient care.”

Penumbra’s neurovascular thrombectomy and neurovascular and peripheral embolization devices will continue to be distributed by its long-time trusted partner, Medico’s Hirata. This includes the latest RED™ reperfusion catheters, which are designed with optimized trackability and aspiration efficiency to help navigate the complex anatomy of the brain and deliver efficient aspiration for the removal of blood clots in a broad range of stroke patients.

About Penumbra

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra supports healthcare providers, hospitals and clinics in more than 100 countries. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn.

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. Risk information can be found here.

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: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; 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; potential adverse regulatory actions; and the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 22, 2022. 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.

Jennifer Heth

Penumbra, Inc

jheth@penumbrainc.com

510-995-9791

Joni Ramirez

Merryman Communications

joni@merrymancommunications.com

323.532.0746

Source: Penumbra, Inc.

FAQ

What is Penumbra's Indigo Aspiration System?

The Indigo Aspiration System is a medical device designed for the removal of blood clots from peripheral arterial and venous systems, particularly effective for conditions such as acute limb ischemia and pulmonary embolism.

How does Penumbra's technology minimize blood loss?

The Indigo Aspiration System uses Lightning technology, a computer-aided clot detection system that differentiates between clot and blood, designed to minimize blood loss during procedures.

When will Penumbra launch its Indigo Aspiration System in Japan?

Penumbra plans to launch the Indigo Aspiration System in Japan upon obtaining regulatory approval.

What conditions does Penumbra’s technology address?

The technology is designed to treat conditions like acute limb ischemia, vein thrombosis, and pulmonary embolism.

Penumbra, Inc.

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