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ABIOMED Impella CP Gets Expanded FDA Approval, Stock Up

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Danvers, MA-based ABIOMED, Inc. , a leading medical product developer, announced the expanded U.S. FDA pre-market approval (PMA) for the usage of Impella CP heart pump. The heart pump is used for high-risk percutaneous coronary interventions (PCI) in patients with severe coronary artery disease and depressed left ventricular ejection fraction.

Meanwhile, shares of ABIOMED climbed almost 3.3%, to close at $116.65 following the news release.

A glimpse on the recent price movements of the stock reveals a stellar year-to-date return of 25.1%, way better than the Zacks categorized Medical Instrument sub-industry’s negative return of 1.9% and the S&P 500’s roughly 9.7%.

In fact, post the last reported quarter, the company’s shares gained 12.9%. We believe that the latest development will significantly enhance the company’s heart pumps portfolio, enabling it to tap opportunities in the niche market.

In this regard, ABIOMED has a long-term expected earnings growth rate of 26.67% and promises an earnings yield of 1.03%, comparing favorably with the industry average of -3.45%. Furthermore, a projected sales growth rate of 34.51% for the current year instills confidence amongst investors.

Coming back to the development, the PMA go-ahead is the second achievement for the company, after the approval of Impella CP, Impella 2.5, Impella 6.0 and Impella LC earlier this year. However, these approvals were for short-term use.

ABIOMED also gained the Japanese PMDA (Pharmaceuticals and Medical Devices Agency) approval for its Impella 2.5 and Impella 5.0 heart pumps in Japan, in September.

Management is highly optimistic about the regulatory progress as it provides Impella hemodynamic support (an exclusive feature of the device) to heart failure patients. Notably, there are approximately 121,000 high-risk patients in the U.S., suffering from chronic and inoperable heart disease, whose medical needs are unmet. The FDA go-ahead would boost ABIOMED’s capabilities to address them.

Our Take

We are highly upbeat about ABIOMED’s streak of new developments in the Impella platform. Of the notable ones, the introduction of Impella Quality (IQ) Assurance Program, to enhance the outcomes in ‘Protected PCI’ and cardiogenic shock patients deserves a mention.

Per a research report by the Mordor Intelligence, the U.S. holds the largest market share in the global cardiac assist devices market. Banking on such favorable trends, we expect ABIOMED to capture significant traction in the days to come.

On the flip side, the estimate revision trend for the stock has been dismal as four estimates moved down, with no upward revision in the last two months. Notably, the current year estimate for the stock dropped by a penny to $1.13 over the same time frame.

Zacks Rank & Key Picks

Currently, ABIOMED has a Zacks Rank #3 (Hold).

Better-ranked stocks in the broader medical sector include Addus HomeCare Corporation (ADUS - Free Report) , LHC Group, Inc. and HMS Holdings Corp. . Addus HomeCare and LHC Group sport a Zacks Rank #1 (Strong Buy), while HMS Holdings carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Addus HomeCare has a long-term expected earnings growth rate of approximately 15%. Notably, the stock represents an impressive one-year return of almost 41.9%.

LHC Group has a long-term expected earnings growth rate of 15%. The company has returned almost 16.8% in the last three months.

HMS Holdings has an expected earnings growth of almost 14.3%. The company posted a promising year-to-date return of almost 48.5%.

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