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OncoSil Medical achieves major milestone in CE Marking Pathway

Published: 19:00 27 Apr 2015 AEST

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OncoSil Medical (ASX:OSL) has been awarded ISO 13485:2012 and ISO 13485:2003 certification for the design, development and control of manufacture of radioactive implantable medical device in the area of oncology.

The Certification is a key requirement for CE Marking of Medical Devices in the European Union.

OncoSil now plans to secure CE Mark in both pancreatic and liver cancer indications in the September quarter, 2015.

Currently there are 280,000+ pancreatic cancer incidence each year world wide, with the global market for pancreatic drugs projected to exceed $1.2 billion by 2015.

The CE Mark would facilitate commercialisation of OncoSil™ for both indications in the EU, Australia, NZ and Canada.

OncoSil™ is an implantable device that emits radiation directly into a specific targeted tumour, and delivers radiation therapy locally for up to three months.

Daniel Kenny, CEO, commented: “ISO Certification is an important milestone on our commercialization pathway.

"Our goal is to provide a commercially available treatment option for pancreatic and liver cancer patients globally, and to explore use of our technology in other solid tumour indications in the future.

"Achievement of ISO certification reflects OncoSil Medical’s commitment to the highest level of quality management and to operational and production excellence.”


The importance of ISO 13485

By achieving ISO 13485 certification OncoSil Medical has met a key requirement for the CE Mark under the European Union Active Implantable Medical Devices Directive for its lead product candidate, the OncoSilTM localised radiation treatment for cancer.

The CE Mark is the mandatory designation required by regulators to sell OncoSil™ in the European Union, and as such is a key component of OncoSil™’s development pathway.


About ISO 13485


ISO 13485 is recognised globally as the best quality practice within the medical device industry.

Certification is a key requirement for CE marking high-risk medical devices in the European Union, and is accepted by most other major markets including the United States of America, Canada, Japan and Australia.

Certification demonstrates management’s commitment to quality management, and to the provision of safe and effective products that continually meet regulatory and customer expectations.


How OncoSil™ works

The OncoSil™ device is inserted directly into the centre of the tumour using well established technology.

Radiation therapy, such as that supplied by OncoSil™, is known to kill tumour cells.

OncoSil™ is classed by regulators as a class III medical device, not a drug.

In drug development human studies are typically undertaken as phase I, phase II and phase III studies.

In medical device development studies are undertaken as pilot and pivotal/registration studies.

Therefore medical devices typically require less clinical trial work for approval, less funding and have a faster time to approval when compared to drug development.


Analysis

The certification is a key requirement for CE Marking of Medical Devices in the European Union, and demonstrates that OncoSil has implemented a Quality Management System conforming to world-wide medical device standards.

The company now plans to secure CE Mark in both pancreatic and liver cancer indications in the September quarter, 2015.

The CE Mark would facilitate commercialisation of OncoSil™ for both indications in the EU, Australia, NZ and Canada.

Under the leadership of new CEO Daniel Kenny, OncoSil has conducted a detailed strategic clinical and regulatory review of the OncoSil device program.

As a result the company has determined to aggressively pursue a global registration program in both pancreatic and hepatocellular (primary liver cancer) cancer.

Kenny brings almost 30 years’ experience in the global pharmaceutical industry, including senior roles with Roche, Allergan and Baxter.

Entering the primary liver cancer market represents a significant market opportunity estimated to be worth $1.4 billion by 2019.

The estimated total market opportunity for OncoSil™ in pancreatic cancer exceeds $1 billion.

Upcoming catalysts
:

- Finalize design of Pivotal Study for Pancreatic cancer protocol by end of Q2 2015.
- Recruit 1st patient in Pivotal Study by end of Q3 2015.
- CE Mark approval by end Q3 2015.
- IDE approval by Q4 2015.

 

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