Pulse Biosciences seeks FDA 510(k) for PulseTx system

Pulse Biosciences (NSDQ:PLSE) said today that it submitted a 510(k) application to the FDA for its PulseTx nano-pulse stimulation system.

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.

“The PulseTx 510(k) submission is an important step in our mission to improve healthcare by delivering this unique technology to physicians and their patients,” president & CEO Darrin Uecker said in prepared remarks. “This is our 1st 510(k) submission, and the 1st step in our strategy to pursue a general indication for soft tissue ablation followed by submissions for specific indications in the future. We look forward to working with FDA on this important first step.”

PLSE shares were trading at $21.00 apiece in afternoon trading activity today, up 1.8%.

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

The former execs bought a total of 819,673 shares of the company’s common stock at $6.10 apiece and an additional equal amount from existing shareholders, according to a regulatory filing. Dr Zanganeh will join Pulse’s board of directors as part of the placement.

Net proceeds from the placement will support working capital and general corporate purposes.

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