OncoSec Receives CE Mark for Its Electroporation Device CE Certification Enables Commercialization of OncoSec Medical System (OMS) Electroporation Device in European Economic Area
SAN DIEGO, Oct. 17, 2012 /PRNewswire/ -- 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."
About OncoSec Medical Inc.
OncoSec Medical Incorporated is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers. ImmunoPulse and NeoPulse therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec's core technology is based upon its proprietary use of an electroporation platform to dramatically enhance the delivery and uptake of a locally delivered DNA-based immunocytokine (ImmunoPulse) or chemotherapeutic agent (NeoPulse). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec's clinical programs include three Phase II clinical trials for ImmunoPulse targeting lethal skin cancers. More information is available at http://www.oncosec.com/. Additional information may also be found at OncoSec's Facebook, Twitter, and LinkedIn sites.
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec's filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SOURCE OncoSec Medical Incorporated