CE Certification Enables Commercialization of OncoSec Medical System (OMS) Electroporation Device in European Economic Area
SAN DIEGO – October 17, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse drug-based chemotherapy to treat solid tumor cancers, announced it has received authorization to CE mark its proprietary gene and drug delivery platform, the OncoSec Medical System (OMS) electroporation device, for use in the European Economic Area (EEA). SGS Group, an industry-leading inspection, verification, testing and certification company, supervised the assessment and certification process.
A CE mark verifies the OMS electroporation device has met all applicable directives of the European Commission (EC) and subsequently the laws and regulations of the European Union (EU) member states and therefore can be commercialized within the 30-nation EEA and Switzerland. The electroporation device applies short electric impulses to a tumor, causing pores to open in the membrane of cancer cells, significantly increasing the uptake of anti-cancer agents into these cells. The granting of this CE mark involved a comprehensive audit of the company’s quality system as well as thorough evaluation and testing of the OMS electroporation device to assure it performs safely and as designed. The CE mark affirms OncoSec’s commitment to product quality and development, and augments the notified body certification to the International Organization for Standardization’s (ISO) 13485 standard for the “design, development, manufacture, and distribution of electroporation devices,” which the company received in July.
Punit Dhillon, President and CEO of OncoSec, commented,
“The approval marks an essential regulatory milestone on the road to commercialization and further approval of the OncoSec Medical System. The CE mark shows that OncoSec has the capability to manufacture and develop a device that meets commercial regulatory requirements.”