Monday, 30 July 2012

OncoSec Medical gets ISO 13485 certification for electroporation devices

OncoSec Medical (OTC:ONCS) has received International Organization for Standards 13485 certification for the design and distribution of its electroporation devices.

The San Diego, California-based biopharmaceutical company offers patients alternative treatments to existing therapies to treat cancerous tumours and cells. 

Companies who get ISO 13485 certification must demonstrate an ability to provide medical devices and related services that meet customer and regulatory requirements.

OncoSec's review was conducted by SGS, an inspection, verification and certification company helping companies to become more efficient.

“The ISO certification is a significant accomplishment and an important milestone for OncoSec,” OncoSec's chief executive Punit Dhillon said in a statement.

“Certification affirms our quality management system meets the highest standards and strengthens OncoSec's commitment to product quality and development. 

“With this certification in place, OncoSec is now one major step closer to obtaining the CE (European Conformity) Marking necessary for commercialization in Europe.”

OncoSec’s electroporation device, the OncoSec Medical System, is now being used in three on-going clinical trials to treat metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.

The device has also been used in Europe in Phase IV clinical trials to treat head and neck cancer and cutaneous and subcutaneous skin cancers.

OncoSec’s electroOncology therapies address an unmet medical need and are a less invasive and less expensive therapy able to minimize the harsh effects caused by chemotherapy and immunotherapy treatments.

Its electroporation delivery system applies short electric pulses to cells, which open the pores and cell membranes and allow efficient and safe delivery of immunotherapy or chemotherapy agents to treat a range of solid tumour cancers.

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