Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) has been scheduled for a Conformité Européenne (CE) Mark Fast Track review for OncoSil™.
OncoSil™ is a localised radiation treatment for cancer, and is the company's lead product candidate.
There is also potential use for OncoSil™ in other solid tumours outside of pancreatic cancer.
A CE Mark is the mandatory regulatory designation required to commercially market and sell OncoSil™ in the European Union, and would be a company-making milestone.
Once received, this will open up a potentially sales pipeline allowing OncoSil to target the top five European markets of the UK, Germany, France, Italy and Spain.
In addition to these markets, OncoSil under the CE Mark licensing will also be able to target Australia, New Zealand, Singapore and Canada.
The company can then file for licensure in those countries.
The estimated world-wide market opportunity for OncoSil™ in pancreatic cancer exceeds US$1 billion.
Daniel Kenny, CEO for OncoSil, brings previous experience delivering the CE Mark process for other companies when he was based in Europe.
Kenny told Proactive Investors, "On two previous occasions I have worked through the CE Mark process for medical devices, and am very familiar with the process.
"And I am pleased to say that OncoSil is progressing in a way that I would have hoped for."
Kenny added, "Once you are in a fast-track review you would expect the full administrative process to take four to six weeks.
"Following the four days there is still an administrative review period to accept the recommendation to issue the CE Mark, then actually issue the certification.
"The review was initially forecast for September, but considering the long term opportunity of OncoSil™ and the fact we are now moving towards certification, the delay was disappointing but not material."
OncoSil's submission to U.S. FDA for Investigational Device Exemption (IDE) for OncoSil™ remains on schedule to be granted later in 2015.
CE Mark details
The Fast Track review will assess OncoSil Medical’s design dossier and make a recommendation in respect of the CE Mark for OncoSil™.
The review will take place in the UK commencing October 6th 2015, and will be conducted over four days.
Upon completion of this review the Notified Body will make a determination to either recommend the granting of CE Mark certification for OncoSil™, or ask OncoSil to provide additional information in order to obtain certification.
Kenny added, "We are now on schedule for our final review.
"We filed the CE Mark to the Notified Body in July, and now they have scheduled the final review.
"This process will take to around the end of October, so therefore we are getting very close to getting regulated and approved.
"Following approval, the next step is going to market."
Kenny brings almost 30 years’ experience in the global pharmaceutical industry, including senior roles with Roche, Allergan and Baxter.
Pathway to market
Post CE Mark certification, OncoSil will then be able to provide what are currently confidential details of its go-to-market strategy for each target market, region and country.
This would include market share targets and potential forecasts on revenue streams.
How OncoSil™ works
OncoSil™ is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.
The device is inserted directly into the centre of the tumour using well established technology.
OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.
Buyers and users of OncoSil™
The devices would be purchased by governments, national health services, or individual hospitals.
The next step is that the surgeons involved need to be trained and certified to use OncoSil's device.
Every physician or surgeon involved in using the device would have to be certified or trained by OncoSil, which would be part of its license requirements.
OncoSil would therefore require clinical adoption from both medical and radiation oncologists, along with GI surgeons and liver surgeons to cover the two indications.
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