ABMD - ABIOMED, Inc.

ABIOMED, Inc.
Healthcare | Medical Appliances & Equipment | USA
ABIOMED, Inc. researches, develops, and sells medical devices in circulatory support and continuum of care in heart recovery to acute heart failure patients. The company offers Impella 2.5 catheter, a percutaneous micro heart pump with integrated motor and sensors for use in interventional cardiology; Impella CP that provides partial circulatory support using an extracorporeal bypass control unit; Impella 5.0 catheter and Impella LD, which are percutaneous micro heart pumps with integrated motors and sensors for use primarily in the heart surgery suite; and Impella RP, a percutaneous catheter-based axial flow pump. It also manufactures and sells AB5000 circulatory support system for temporary support of acute heart failure patients in profound shock, including patients suffering from cardiogenic shock after a heart attack, post-cardiotomy cardiogenic shock, or myocarditis. In addition, the company provides Symphony, a synchronized minimally invasive implantable cardiac assist device designed to treat chronic patients with moderate heart failure by improving patient hemodynamics. Further, it engages in the research, development, prototyping, and production of a percutaneous expandable catheter pump, which enhances blood circulation from the heart with an external drive shaft. The company sells its products through direct sales and clinical support personnel in the United States, Germany, France, Canada, Japan, and the United Kingdom. ABIOMED, Inc. was founded in 1981 and is headquartered in Danvers, Massachusetts.

 

Weekly chart, to see how strong this stock went from mid-4s to near-100 in 7 years. And to see a trend line support that it is currently sitting on.

Funny as it's gotten more expensive, it's also gotten more volume. Partly due to it moving onto bigger exchanges.

Daily chart with a Fib retracement. In addition to the weekly trend line support it's also sitting on the 0.618 Fib

Possibly at the bottom of a channel that goes to $136. But that's looking ahead, past a couple resistances.
Can put a stop as tight as $94.47 (market is shaky right now).

 

Continues to perform great, bounced right off the 50 ma yesterday. Reports next week.

 

Looking good. Beat EPS estimates 25%, revs +40% y/y, guided inline.

 

Looking for a pullback in ABMD

 

Another -8% selloff today


There's an FDA letter that went out to health care providers, warning of increased mortality in Abiomed's Impella heart device
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm630610.htm

Medical devices need to pass clinical trials before they are approved. The Impella did that with 44 out of 60 patients (73.3 percent) survived to 30 days post device explant. But in order to get approval, the FDA also wanted a post-approval study and this is where bad news is coming in. "Interim results from the most recent PAS report, which reflect device use in a broader patient population, indicate that only 4 out of the 23 enrolled PAS patients (17.4 percent) met the primary survival endpoint."

That's a very low survival rate they are seeing now. This device may be able to stay on the market, but it looks like it will have a more restricted population that will be approved for its use (the same restricted population as in the pre-clinical trials, at best). That is the bad news for the stock.

 

Let's do some speculation.

That FDA letter says "Sixteen (16) of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies".

1) Let's presume that all 16 of those PAS patients who did not meet the premarket trial enrollment criteria, failed to survive 30 days post device explant. It's a sensible guess, because then 4 out of 7 (57.1 percent) enrolled PAS patients who also met premarket trial enrollment criteria would have survived 30+ days. Note that this 57.1% figure is actually less than the 73.3% survival rate in the premarket trials, but the difference should be taken with a grain of salt because of the very small sample size (n=7).

This is background for #2, the big one:
2) I don't know how the 23 PAS patients got selected, if they are a representative sample of who is getting the Impella. But note that only 7 out of 23 patients in the PAS would have met the premarket trial enrollment criteria. This means that the viable population for the Impella may only be a measly 1/3 of everyone that they've been trying to put it into. And remember in #1, it is not crazy to presume that 16 out of 16 patients (100 percent) who do NOT meet the enrollment criteria failed to live 30 days.

ABMD is an expensive stock, currently P/S is over 60. And now they might have to restrict their Impella population to 1/3 of its former size.

 

Right on time...


Abiomed slumps on increased volume in early trade in apparent response to a pair of studies that showed its Impella heart pump is associated with higher mortality risk, bleeding and stroke in patients undergoing angioplasty to re-open clogged arteries. The data were presented at the American Heart Association Scientific Sessions in Philadelphia.

~45% of patients died during Impella-involved procedures compared to 34% of those whose blood flow was supported by an intra-aortic balloon. ~31% of patients with cardiogenic shock who were treated with Impella experienced major bleeding versus 16% who were treated with the balloon.

The use of the device added ~$15K to the average hospital tab according to the researchers.

Unsurprisingly, the company countered that repeated studies proved Impella's safety and efficacy. Data from a recent trial, for example, showed a 29% reduction in serious heart complications compared to the balloon.

Impella is used in ~1/3 of angioplasty procedures to provide blood flow support.