Abiomed (NSDQ:ABMD) today pushed up the timeline for pre-market approval of its flagship Impella heart pump, saying it now expects the FDA to convene an advisory panel and decided on the PMA by March 2015, 2 months ahead of schedule.
In December 2012, the FDA’s Circulatory Devices Advisory panel recommended against shifting non-roller-type cardiopulmonary bypass blood pumps to a lower-risk category for temporary ventricular support, forcing Abiomed to seek a PMA nod for the Impella device. The pump had been allowed on the U.S. market via the FDA’s less-stringent 510(k) clearance protocol.
"We are reducing the timeline range for a panel and PMA approval by 2 months for a projected approval by March 2015, based on progress and interaction with the FDA," Abiomed spokeswoman Aimee Genzler told MassDevice.com this morning via email.
The news came as Abiomed announced its fiscal 1st-quarter results, posting losses of -$1.7 million, or -4¢ per share, on sales of $48.8 million for the 3 months ended June 30, for a roughly even bottom line on sales growth of 14.4% compared with Q1 2014. Analysts on Wall Street were expecting earnings of 2¢ per share on sales of $49.6 million.
"Abiomed delivered revenue growth of 14% and patient growth of 16%. We have now grown top-line revenue double digits for 19 straight quarters year over year," chairman, president & CEO Michael Minogue said in prepared remarks. "This first quarter is really marked by our significant progress on execution of our strategic plans for regulatory approvals and intellectual property advantage."
Abiomed reinforced its sales outlook for fiscal 2015, saying it still expects revenues of $205 million to $212 million. But the Danvers, Mass.-based company lowered its outlook on operating margins, mostly due to the acquisition of German heart pump maker ECP, to 1% to 4% from prior guidance of 5% to 7%.
Genzler said the company was able to respond "rather quickly" to a U.S. Health & Human Services Dept. probe of Abiomed’s reimbursement of expenses and remuneration to healthcare providers during July 2012 to December 2012.
"We have been able to compile and produce all of the responsive documents rather quickly for them and have been engaged with the HHS investigators," Genzler wrote.