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FDA approval nearly doubles potential U.S. patients for Abiomed's heart pump

Awardee Story FDA approval nearly doubles potential U.S. patients for Abiomed's heart pump
Date: Apr 08, 2016
Author: W. Marc Bernsau
Source: bizjournal ( click here to go to the source)

Inknowvation Site Notes: 
 Founded in 1981 and located in MA, ABIOMED (NASDAQ: ABMD) was among the earliest SBIR awardees with their first award from NIH in 1983. With SBIR dollars still being used in 2014, the firm has continued to be SBIR involved over this 30 year period until recent success has taken them out of the relevant size range. With 41 Phase Is and 23 Phase IIs - often with only one or two projects underway at the same time and funding used primarily at critical turning points - the firm systematically used SBIR dollars from NIH and the Army to tackle the type of high-risk R&D that few other sources will support: a classic example of the the original intent of those who founded the Program.

Danvers-based medical device firm Abiomed says its Impella heart pump has been approved for use in about 100,000 or so patients in the U.S. every year who experience cardiac shock, nearly doubling the potential patients approved to use the device.

Abiomed (Nasdaq: ABMD) said after the close of markets Thursday that the Food and Drug Administration approved its Impella heart pumps, which are used during cardiovascular surgery, for patients who suffer cardiogenic shock, usually occuring after a heart attack or surgery. The device had been cleared for use in patients in the U.S. in 2011 as a "temporary surgical support," and in March 2015 it won additional FDA approval for use during an elective surgeries like angioplasty or stenting.
Michael R. Minogue, chairman, president and CEO of Abiomed, holds the Impella heart pump the company makes.

Michael R. Minogue, chairman, president and CEO of Abiomed, holds the Impella heart pump... more

The approval appears to have been largely anticipated by investors after a federal filing last month indicated that the company didn't think it would need to appear before an FDA advisory panel before approval. The company's shares were trading about flat on Friday at around $95 a share, up 37 percent from a year ago and giving the company a market value of $4 billion.

A company spokeswoman said the approval announced yesterday gives the company leeway to market the device to the majority of U.S. patients it could potentially help, around 220,000 per year. The device helps the heart pump blood, allowing the left ventricle to rest while a surgeon performs a procedure. According to the company, it's now been used in over 35,000 patients in the U.S., but up until now, the company has estimated that there are about 121,000 patients per year that could benefit from a procedure with Impella. The other 100,000 patients per year that experiences cardiogenic shock, according to American Heart Association statistics, includes patients with the most severe kind of heart attack (known as an ST-elevation myocardial infarction, or STEMI) and a slightly less severe form, called non-STEMI.

In February, CEO Mike Minogue said the company expects revenue for the 12 months that ended on March 31 to be $326 million, a 41 percent increase over its fiscal 2015. The company may provide updated guidance when it reports its full year 2016 financials, likely in early May.

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