Shares of ABIOMED, Inc. (NASDAQ:ABMD) fell 19.03% to trade close at $9.87 following the early termination of PROTECT-II study. The Stock traded in the range of $9.55 – $10.70 yesterday with 2.30 million of shares traded. The market capitalization of the company stands at $373.51 million and has 52 week trading range of $9.55-$10.70.
On Monday, ABMD disclosed the company’s PROTECT-II study comparing Impella to intra-aortic balloon pump (IABP) in high-risk percutaneous coronary intervention (PCI) was halted due to futility at the suggestion of the data safety monitoring board following an interim look (translation: based on accrued results the trial will not be able to show a significant difference in favor of Impella). The trial did not meet its primary endpoint of a reduction in major adverse events at 30 days when comparing Impella versus IABP.
ABMD believes the cause of the problem in the Impella arm was higher rates of adverse events in a subset of Impella patients who were also managed with atherectomy at the time of PCI. ABMD postulates that the more frequent use of atherectomy in Impella patients (2x the rate in IABP patients) led to higher rates of heart attack (MI) in these patients which was a component of the primary endpoint. ABMD believes some clinicians took advantage of the incremental cardiac support provided by Impella relative to IABP to perform more aggressive interventions, which ultimately led to the higher rates of MIs.
305 patients were analyzed for major adverse event (MAE) rates at 30 days in the interim look. Within the total population, the MAE rate in the Impella group was 38% while the MAE rate in the IABP group was 43%. Two hundred sixty seven patients out of the 305 total (88%) were managed without atherectomy.
Following the above report, an analyst at Jefferies & Company, Inc lowered its price target to $10 from $11 by maintain its rating at Hold. Piper Jaffray released a report yesterday following the termination of Protect II Study saying that “Looking beyond the negative headline, there are aspects of Protect II that are highly encouraging, but in the short term, the confusion could impact utilization.”
ABMD develops medical devices used to provide circulatory support. The products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping function of the heart.
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