OncoSec Medical has had a busy July with clinical trials for various cancer treatment therapies, and the company finishes out the month by achieving the ISO 13485 certification for electroporation devices. The certification demonstrates an ability to provide medical devices and related services that meet customer and regulatory requirements.

Electroporation is a form of drug delivery that generates electrical pulses via an electrode placed in a solid tumor to enhance the ability of a chemotherapeutic. It works by opening up pores in human cells to allow easier and more efficient entrance of beneficial pharmaceutical products or genes.

The San Diego, Calif.-based biopharmaceutical company offers patients alternative treatments to existing therapies to treat cancerous tumors and cells. Companies that receive ISO 13485 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.

“Certification affirms our quality management system meets the highest standards and strengthens OncoSec's commitment to product quality and development,” said Punit Dhillon, CEO of OncoSec. “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.

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