Pulse Biosciences pulls, plans to refile FDA 510(k) clearance bid for PulseTx nanostim

Pulse Biosciences (NSDQ:PLSE) said today it withdrew its FDA 510(k) application for its PulseTX nano-pulse stimulation platform, but said it has plans to resubmit the application “in the coming months.”

The Burlingame, Calif.-based company’s PulseTx system uses short-duration electrical pulses directed at solid tumors to induce immunogenic cell death. The cell death process exposes the tumor cell antigens to the immune system, which triggers an adaptive immune response, according to Pulse.

Pulse Biosciences said that it pulled the application after failing to deliver requested additional information to the federal watchdog befoer Sept. 10. The company said it is “committed to generating the requested data and analysis” and that it will submit its application again shortly.

“Over the past several months, we have been engaged in very productive and positive conversations with the FDA staff, and we remain confident in our ability to obtain a 510(k) clearance for the PulseTx system and more broadly for nano-pulse stimulation,” prez & CEO Darrin Uecker said in a prepared statement.

The company originally submitted the 510(k) application for the device in March.

In February, ex-Pharmacyclics CEO Robert Duggan and COO Maky Zanganeh purchased a 17% stake in Pulse Biosciences.

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