Pulse Biosciences (NSDQ:PLSE) said yesterday that the FDA asked for more data on the 510(k) application for its CellFX dermatology device and reported higher-than-expected first-quarter losses, sending its share price down.
Hayward, Calif.-based Pulse is seeking an indication for treating general benign lesions including sebaceous hyperplasia and seborrheic keratosis. The company said it received a letter yesterday afternoon from the federal watchdog agency seeking more data on CellFX and questioning the predicate device cited in the 510(k) application. That sets the timeline for getting CellFX on the U.S. market – a crucial concern for a pre-revenue company – back as much as six months, president & CEO Darrin Uecker told investors and analysts during a conference call yesterday to discuss first-quarter results.
The FDA grants 180 days for additional 510(k) information requests, Uecker said, noting that Pulse had expected to win clearance during the third quarter.
“My early read on the letter from FDA is that it’s likely that it would take us a good amount of that time, if not that total time, to put a response together,” Uecker said during the call. “I think that our timeline now is pushed out based on, again, our early read of this information and how long that is, it’s difficult to handicap, but again, I would say that at least out toward the end of the year.”
Pulse is still evaluating the FDA letter and could shift to seeking de novo clearance, which doesn’t require naming a predicate device.
“Based on the letter, I think either process is going to require us to submit additional data to the FDA. And so I think it’s just a matter of us going through and reviewing the letter in detail, having discussions with the FDA, collaborative discussions where we understand the trade-offs between the time lines and the data that we would need for each process. And then I think we’ll make a decision based on all that information on what we think the best path is for Pulse Biosciences,” Uecker said on the call. “But I think in each case, we’re going to have to provide additional data.”
Uecker said Pulse is not planning to seek CE Mark approval in the European Union until after it wins access to the market here.
First-quarter losses grew 16.3% to -$10.1 million, or -49¢ per share, a full nickel ahead of the -44¢ expectation on Wall Street.
PLSE shares closed down -5.2% at $16.02 apiece yesterday and were off another -7.1% at $14.89 each today in pre-market trading.