Abiomed : Corporate Presentation

MICHAEL MINOGUE

CHAIRMAN, PRESIDENT, & CEO

CORPORATE PRESENTATION | JAN 12, 2022

FOR INVESTORS ONLY

LEGAL DISCLAIMERS

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This presentation contains forward-looking statements, including, without limitation, statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities, the Company's guidance for future financial performance and expected regulatory approvals. Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

U.S Food and Drug Administration Approvals, Clearances & Authorizations

• The Impella 2.5® and Impella CP® devices are U.S. FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.
• The Impella 2.5®, Impella CP®, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock, Tha and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
• Impella Left Ventricular (LV) Support Systems are also authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on V-A ECMO support or late cardiac decompensation from myocarditis while on V-V ECMO support. The authorized Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. The Impella LV Support Systems have been authorized for the above emergency use by FDA under an EUA and have been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• The Impella RP® is U.S. FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery.
• The Impella RP is also authorized for emergency use by healthcare providers (HCPs) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID‐19), including pulmonary embolism (PE). The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19. The Impella RP and Impella LV Support Systems have been authorized for the above emergency use by FDA under an EUA and have been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• The Abiomed Breethe OXY-1 System™ is cleared by the U.S. Food and Drug Administration (FDA) to provide extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to six (6) hours in duration.
• Under guidance issued by FDA, on April 6, 2020, the Abiomed Breethe OXY-1 System is now permitted to be used temporarily in the U.S. for ECMO therapy greater than six hours. Therefore, it now has a limited indication modification for use longer than six hours in an extracorporeal membrane oxygenation (ECMO) circuit to treat patients who are experiencing acute temporary respiratory or acute cardiopulmonary failure. This limited indication modification for ECMO therapy greater than six hours has not been cleared or approved by FDA and is in effect only for the duration of the public health emergency related to COVID-19 as declared by the U.S. Department of Health and Human Services (HHS).
• The Impella XR Sheath™ set is cleared by the U.S. FDA and is intended for use for the percutaneous introduction of the Impella 2.5 Catheter and ancillary devices.

In addition, there are other WARNINGS and PRECAUTIONS associated with Abiomed devices. Visit http://www.abiomed.com/important-safety-information to learn more.

Impella ECP™ and preCARDIA™ are investigational devices in FDA Early Feasibility Studies. The Impella BTR™ has FDA conditional investigational device approval for Early Feasibility Study. The Impella Pediatric™ is in development and is not approved for use or sale.

The ABIOMED logo, ABIOMED, Impella 2.5, Impella CP, Impella RP, Impella 5.0, Impella LD, Impella 5.5 SmartAssist Platform, and Recovering Hearts. Saving Lives are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries. Impella ECP, Impella BTR, Impella XR Sheath, Impella RP IJ, cVAD Study, Automated Impella Controller and preCARDIA are pending trademarks of Abiomed, Inc.

FOR INVESTORS ONLY

CHAVEZ ADAMS - PATIENT STORY

Impella CP®

with SmartAssist®

DR. NEUPANE

FOR INVESTORS ONLY

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MYOCARDITIS

		INFLAMMATION
		OF THE
HEALTHY	INFLAMED	HEART
MUSCLE
HEART	HEART

Click Here for Chavez Adams' Story

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THE ABIOMED MISSION

To recover heart muscle and save lives with percutaneous heart pump

and oxygenation technologies, enabling safer, more effective treatment

and minimally invasive therapies for high-risk, urgent and emergent patients.

FOR INVESTORS ONLY

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IMPELLA® HEART PUMPS: BREAKTHROUGH TECHNOLOGY

✓ 2008/2009: Impella 2.5®/5.0® - 510(k) Clearance

✓ Exclusive FDA US Approvals:

High-Risk PCI (2015)

AMI Cardiogenic Shock (2016)

Impella RP® for Right Heart Failure (2017)

Cardiomyopathy/Myocarditis Shock (2018)

Expanded High-Risk PCI; SmartAssist® (2018)

COVID Emergency Use Authorizations (EUA-2020)

✓ Medicare (6 DRGs) & Commercial Payers

✓ Approved in Europe and Japan

(CE Mark 2002; PMDA 2016)

✓ >$850M* R&D

(1,338 patents and 1,310 pending)

>210,000 patients treated world-wide;

13 Clinical Guidelines; ~1,200 publications

Statistics as of Dec 2021

FOR INVESTORS ONLY	*Since FY2005