OncoSec Medical (OTC:ONCS) won CE Mark approval in the European Union for its gene- and drug-delivery platform, the OncoSec Medical System.
The OMS product is an electroporation device, which targets a tumor with short electrical pulses that opens pores and allows anti-cancer agents to more effectively destroy the cells.
"The approval marks an essential regulatory milestone on the road to commercialization and further approval of the OncoSec Medical System," president & CEO Punit Dhillon said in prepared remarks. "The CE Mark shows that OncoSec has the capability to manufacture and develop a device that meets commercial regulatory requirements."
The San Diego-based device maker last month announced progress on its Phase II metastatic melanoma clinical trial, which won access to a 4th enrolling site at the University of Washington, which joins the University of California at San Francisco, John Wayne Cancer Institute and Lakeland Cancer Center, according to a press release.