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.
review was conducted by SGS, an inspection, verification and
certification company helping companies to become more efficient.
ISO certification is a significant accomplishment and an important
milestone for OncoSec,” OncoSec's chief executive Punit Dhillon said in a
“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
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
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
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.