ABIOMED, Inc. provides medical devices that provide circulatory support and oxygenation. The company develops, manufactures and markets proprietary products that are designed to enable the heart to rest and recover by improving blood flow and/or performing the pumping function of the heart and provide sufficient oxygenation to those in respiratory failure. The company’s products are used in the cardiac catheterization lab, or cath lab, by interventional cardiologists and in the heart surgery sui...
ABIOMED, Inc. provides medical devices that provide circulatory support and oxygenation. The company develops, manufactures and markets proprietary products that are designed to enable the heart to rest and recover by improving blood flow and/or performing the pumping function of the heart and provide sufficient oxygenation to those in respiratory failure. The company’s products are used in the cardiac catheterization lab, or cath lab, by interventional cardiologists and in the heart surgery suite by cardiac surgeons for patients who are in need of hemodynamic support prophylactically or emergently before, during or after angioplasty or heart surgery procedures.
The company’s strategic focus and the driver of its revenue growth is the market penetration of its family of Impella heart pumps. The company’s Impella device portfolio, which includes the Impella 2.5, Impella CP, Impella 5.0, Impella LD, Impella 5.5 and Impella RP devices, has supported thousands of patients worldwide. The company expects that most of its product and service revenue in the near future will be from its Impella devices. The company’s Impella 2.5, Impella CP, Impella 5.0, Impella LD, Impella 5.5 and Impella RP devices has the U.S. Food and Drug Administration, or FDA, and CE Mark approvals, which allow it to market these devices in the U.S. and European Union, respectively. The company expects to continue to make additional pre-market approval, or PMA, supplement submissions for its Impella portfolio of devices for additional indications. The company’s Impella 2.5, Impella CP, Impella 5.0 and Impella 5.5 devices have regulatory approval from the Pharmaceuticals and Medical Devices Agency in Japan, or PMDA. In October 2020, the company also received a 510(k) clearance for the Abiomed Breethe OXY-1 System (the Breethe OXY-1 System) from the FDA for an all-in-one, compact cardiopulmonary bypass system.
Existing Products
The company’s strategic focus and the primary driver of its revenue growth is the market penetration of its family of Impella heart pumps. The Impella device portfolio, which includes the Impella 2.5, Impella CP, Impella 5.0, Impella LD, Impella 5.5 and Impella RP devices, has supported thousands of patients worldwide.
As it continues to innovate its product portfolio, the company expects to continue to transition its sales focus to newer generations of Impella devices over time. In the catheterization lab, the company expects to continue shifting sales focus from the Impella 2.5 device to the Impella CP device and in the surgical suite, from the Impella 5.0 device to the Impella 5.5 device. Accordingly, the company expects that a greater concentration of its product revenues will be from Impella CP and Impella 5.5 devices in the future. Below is a summary of the company’s existing products and the countries where they have received regulatory approval. The company expects to continue to make additional regulatory submissions for its products for additional indications and in additional countries.
Impella 2.5
The Impella 2.5 device is a percutaneous heart pump with an integrated motor and sensors. The technology is designed primarily for use by interventional cardiologists to support patients in the cath lab who may require assistance to maintain circulation. The Impella 2.5 heart pump can be quickly inserted via the femoral artery to reach the left ventricle of the heart, where it is directly deployed to draw blood out of the ventricle and deliver it to the circulatory system. This function is intended to reduce ventricular work and provide blood flow to vital organs. The Impella 2.5 heart pump is introduced with normal interventional cardiology procedures and can pump up to 2.5 liters of blood per minute.
The company’s Impella 2.5 device has received the U.S. Food and Drug Administration (FDA) and the Pharmaceuticals and Medical Devices Agency in Japan (PMDA) approvals, which allows it to market it in the U.S. and Japan, respectively. The technology is also approved for use in multiple other countries.
Impella CP
The Impella CP device provides blood flow of up to 4.3 liters of blood per minute and is primarily used by either interventional cardiologists to support patients in the cath lab or by cardiac surgeons in the heart surgery suite.
The company’s Impella CP device has received FDA, CE Mark, PMDA approvals, which allows it to market it in the U.S., European Union and Japan, respectively. The technology is also approved for use in multiple other countries.
Impella 5.0 and Impella LD
The Impella 5.0 and Impella LD devices are percutaneous heart pumps with integrated motors and sensors for use primarily in the heart surgery suite. These devices are designed to support patients who require higher levels of circulatory support as compared to the Impella 2.5 and Impella CP devices.
The company’s Impella 5.0 and Impella LD devices have received FDA, CE Mark, PMDA approvals, which allow it to market them in the U.S., European Union and Japan, respectively. The technology is also approved for use in multiple other countries.
Impella 5.5
The Impella 5.5 device is designed to be a percutaneous heart pump with integrated motors and sensors. The Impella 5.5 device delivers peak flows of greater than six liters per minute. The Impella 5.5 device has a motor housing that is thinner and 45% shorter than the Impella 5.0 device and it improves ease of pump insertion through the vasculature.
In September 2019, the Impella 5.5 device received PMA approval from the FDA for safety and efficacy in the therapy of cardiogenic shock for up to 14 days in the U.S. The Impella 5.5 device was introduced in the U.S. through a controlled rollout at hospitals with established heart recovery protocols beginning in fiscal year 2020. In April 2018, the Impella 5.5 device received CE Mark approval in Europe and was introduced in Europe through a controlled rollout, similar to the U.S. In November 2021, the Impella 5.5 device received PMDA approval and the company began a controlled rollout in Japan, similar to the U.S. and Europe.
Impella RP
The Impella RP device is a percutaneous catheter-based axial flow pump that is designed to allow for greater than four liters of blood flow per minute and is intended to provide the flow and pressure needed to compensate for right side heart failure. The company’s Impella RP device has received FDA and CE Mark approval, which allows it to market this technology in the U.S. and European Union. The Impella RP device is the first percutaneous heart pump designed for right heart support to receive FDA approval. The Impella RP device is approved to provide support of the right heart during times of acute failure for certain patients who have received a left ventricle assist device or have suffered heart failure due to acute myocardial infarction (AMI), a failed heart transplant, or following open heart surgery. Additionally, the company has adapted the design of the Impella RP device to be implanted through the internal jugular vein in the neck, this approach is the preferred method for heart surgeons as it allows for patient ambulation. The company anticipates making a regulatory submission for this technology in fiscal year 2023.
Impella SmartAssist
The Impella SmartAssist platform includes optical sensor technology for improved pump positioning and the use of algorithms that enable improved native heart assessment during the weaning process. The Impella SmartAssist platform is available for the company’s Impella CP, Impella 5.5 and Impella RP heart pumps. The Impella SmartAssist platform received FDA, CE Mark and PMDA approvals, which allows it to market it in the U.S., European Union and Japan, respectively. The technology is also approved for use in multiple other countries.
Impella Connect
Impella Connect is a cloud-based technology that enables secure, remote viewing of the Automated Impella Controller, or AIC, for physicians and hospital staff. The company began a controlled rollout of Impella Connect at certain hospital sites during fiscal year 2020 and has transitioned most of its customers to this technology. The company continues to introduce this technology to hospitals outside the U.S.
Abiomed Breethe OXY-1 System
The Breethe OXY-1 System is a portable external respiratory assistance device that the company acquired as part of its acquisition of Breethe, Inc (Breethe), in April 2020 in connections with its efforts to expand its product portfolio to support the needs of patients, such as those suffering from cardiogenic shock or respiratory failure, whose lungs can no longer provide sufficient oxygenation. The Breethe OXY-1 System takes venous blood from the patient, removes carbon dioxide and adds oxygen much like a human lung, and returns the oxygenated blood safely back to the patient. In October 2020, the Breethe OXY-1 System received 510(k) clearance from the FDA for an all-in-one, compact cardiopulmonary bypass system. The company has conducted a controlled launch of the Breethe OXY-1 System at a limited number of hospitals in the U.S. and has seen positive results regarding survival, blood compatibility, durability of the Pump Lung Unit (PLU), hemodynamic flow rates and ease of patient ambulation. Based on its early patient study, the company has identified areas of improvement around the electronics of the console and implemented a voluntary recall at the seven hospitals where the Breethe OXY-1 Systems were placed. The console upgrades may require a 510(k) clearance from the FDA. The company expects to resume commercialization of the Breethe OXY-1 System under a controlled rollout in the second half of fiscal year 2023.
Product Pipeline
Impella ECP
The Impella ECP device is designed for blood flow of greater than three and a half liters per minute. It is intended to be delivered on a standard sized (9 French) catheter and will include an expandable inflow in the left ventricle. The Impella ECP device has achieved initial FDA safety milestones, including completion of the first stage in its FDA early feasibility study (EFS). The prospective, multi-center, non-randomized EFS is designed to allow the company, study investigators, and the FDA to make qualitative assessments about the safety and feasibility of the use of the Impella ECP device in high-risk percutaneous coronary intervention (PCI) patients. In fiscal year 2021, the company received approval from the FDA to expand the EFS for the Impella ECP device and it continues to enroll patients in this study. In August 2021, the company received Breakthrough Device designation by the FDA for the Impella ECP device, which is provided pursuant to the FDA’s Breakthrough Device Program, a program intended to help patients receive more timely access to certain medical technologies by providing a speedier development, assessment and review process for such technologies. The protocol of a single arm pivotal high-risk PCI study for the Impella ECP device, as part of an investigational device exemption (IDE) has been approved by the FDA. The company has supported over 25 patients in its early feasibility study and began patient enrollment under a pivotal-like protocol in March 2022. The company expects to transition to a pivotal trial in fiscal year 2023. The Impella ECP device is still in development and has not been approved for commercial use or sale.
Impella XR Sheath
The Impella XR Sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with certain Impella heart pumps. It inserts at 10 French and the flexible, nitinol braids momentarily expand during insertion, then recoil, simplifying access for complex interventions. The Impella XR Sheath is intended to produce less trauma at the arterial access site compared to large bore sheaths. In December 2020, the company received 510(k) clearance from the FDA for the Impella XR Sheath for the Impella 2.5 device. The Impella XR Sheath for the company’s Impella CP device is still in development and has not been cleared for commercial use or sale.
Impella BTR
The Impella BTR device is designed to be a percutaneous, weanable, smart heart pump with integrated motors and sensors. The Impella BTR device is designed to allow for greater than six liters of blood flow per minute, provide up to one year of hemodynamic support and include a wearable driver designed for hospital discharge. The Impella BTR device is expected to and intended to allow for heart recovery or heart remodeling with adjunctive therapies for class III and class IV heart-failure patients. In December 2021, the company received conditional approval for an IDE early feasibility study for the Impella BTR device and it enrolled its first patient in April 2022. The Impella BTR device is still in development and has not been approved for commercial use or sale.
precardiac
The preCARDIA system is a minimally invasive, catheter-mounted superior vena cava therapy system designed to rapidly treat acutely decompensated heart failure (ADHF) related volume overload by effectively reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function. The preCARDIA system allows for straightforward placement in the ICU by physicians and hemodynamic monitoring by medical staff. Prior to the acquisition of preCARDIA, the preCARDIA system received Breakthrough Device Designation by the FDA. In January 2022, the company announced results of the first-in-human early feasibility study of the preCARDIA system. The multicenter, prospective, single-arm VENUS-HF early feasibility study examined 30 patients with ADHF who were assigned preCARDIA therapy for 12 or 24 hours. The primary endpoint was a composite of major adverse events through 30 days. The results support additional study of the preCARDIA system. In the third quarter of fiscal year 2022, the FDA authorized the preCARDIA early feasibility study to be expanded by 30 additional patients. The preCARDIA system is still in development and has not been approved for commercial use or sale.
Research and Development
The company expended $163.4 million on research and development for the year ended March 31, 2022.
Sales, Clinical Support, Marketing and Field Service
The company’s clinical support personnel consist primarily of registered nurses and other personnel with considerable experience in either the surgery suite or the cath lab, and they play a critical role in training and educating physicians in the use of its products. The company has significantly increased the number of its direct sales and clinical support personnel in the U.S, Germany and Japan.
Intellectual Property
A substantial portion of the company’s intellectual property rights relating to the Impella devices and other products under development, such as the Impella ECP, Impella XR Sheath and Impella BTR devices, are in the form of trade secrets and patents. The company owns or has rights to numerous U.S. and foreign patents. Patents filed both in the U.S. and Europe generally have a life of 20 years from the filing date. The company’s U.S. and foreign patents have expiration dates ranging from 2022 to 2040 and beyond as it continues to innovate and file for new patent applications.
Trademarks
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella 5.5, Impella Connect, and SmartAssist are registered trademarks of the company and are registered in the U.S. and certain foreign countries. Impella ECP, Impella XR Sheath, Impella BTR, CVAD STUDY, STEMI DTU, Automated Impella Controller, Abiomed Breethe OXY-1 System and preCARDIA are pending trademarks of the company.
Seasonality
The company’s quarterly revenues are influenced by many factors, including new product introductions, acquisitions, regulatory approvals, patient and physician holiday schedules, and other factors. Revenues in the first half of the company’s most recent fiscal year represented 49% of total fiscal year revenues for fiscal year 2022. The company’s revenues in the first half of its fiscal years (year ended March 31, 2022) have historically generally represented a lower percentage of total annual revenues than revenues in the second half of the fiscal year due to the seasonality of the U.S., European and Japanese markets, where summer vacation schedules normally result in fewer medical procedures for its products.
Competition
There are a number of companies, including Cardiovascular Systems Inc.; Abbott Laboratories; Medtronic; Edwards Lifesciences; Boston Scientific; LivaNova; Terumo Heart; Teleflex; Getinge (Maquet Cardiovascular); and several early-stage companies that are developing medical devices that provide circulatory support and oxygenation, including implantable left ventricular assist devices, miniaturized rotary ventricular assist devices and cardiopulmonary bypass devices that directly and indirectly compete with the company’s products.
Government Regulation and Other Matters
The company’s products and facilities are subject to regulation by numerous government agencies, including but not limited to the FDA, European Union Member States competent authorities, and the Japanese Pharmaceuticals and Medical Devices Agency, to confirm compliance with the various laws and regulations governing the development, testing, manufacturing, labeling, marketing, and distribution of its products. The company must also comply with Medical Device Reporting, or MDR requirements, which require it to report to the FDA any incident in any of its products that may have caused or contributed to a death or serious injury, including medical intervention to prevent a death or serious injury, or in which any of its products malfunctioned and if such malfunction were to recur, would be likely to cause or contribute to a death or serious injury.
The company is subject to routine inspection by the FDA for compliance with the Quality System Regulation (QSR) and Medical Device Reporting (MDR) requirements, as well as other applicable regulations. The company is subject to additional laws and regulations that govern its business operations, products, and technologies, including federal, state, and foreign anti-kickback laws and regulations, which generally prohibit payments to anyone, including physicians, as an inducement to purchase or recommend a product; the Stark law, which prohibits physicians from referring Medicare or Medicaid patients to a provider that bills these programs for the provision of certain designated health services if the physician (or a member of the physician's immediate family) has a financial relationship with that provider; federal, state and foreign laws and regulations that protect the confidentiality of certain personal information, including patient health information, and restrict the use and disclosure of such information, in particular, the Health Insurance Portability and Accountability Act in the U.S., and the European Union’s General Data Protection Regulation (GDPR); the Physician Payments Sunshine Act, which requires public disclosure of the financial relationships of. healthcare professionals and teaching hospitals in the U.S. with applicable manufacturers, including medical device, pharmaceutical, and biologics companies; the False Claims Act, which prohibits the submission of false or otherwise improper claims for payment to the United States government, including federally funded health care program, and health care fraud statutes that prohibit false statements and improper claims to any third-party payor; and the United States Foreign Corrupt Practices Act (FCPA), which can be used to prosecute United States companies for arrangements with foreign government officials or other parties, or for not keeping accurate financial records or maintaining adequate internal controls to prevent and detect arrangements with foreign government officials or other parties. The company is subject to the U.S. Foreign Corrupt Practices Act and other anticorruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing its operations.
In Europe, the company’s products are subject to extensive regulatory requirements. The company’s Impella CP, Impella 5.0, Impella LD, Impella 5.5, Impella RP, and Impella AIC are all approved under CE Mark and are available for sale in the European Union and other markets that recognize CE Mark approval.
History
ABIOMED, Inc. was founded in 1981. The company was incorporated in 1987.
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