OSL oncosil medical ltd

Commercial Revenues Now Likely · OncoSil Medical is a medical...

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    Commercial Revenues Now Likely


    · OncoSil Medical is a medical device company with a brachytherapy product (OncoSilTM) which we expect will shortly gain CE Mark approval for the treatment of pancreatic cancer.

    · A small clinical trial of the device in combination with chemotherapy indicated an extension in overall progression free survival versus the current standard of care in pancreatic cancer. The trial was not powered for statistical significance, however, the result was clinically significant and it is on this basis that the company applied for the  CE Mark in July 2015.  The company also applied for the CE Mark in Hepatocellular cancer.  The approval process is ongoing.  Subsequent requests for further information have delayed the approval beyond the company’s envisaged timetable. However, it remains confident that the CE Mark will be granted in both indications.

    · The company is pursuing a regulatory pathway in the US in pancreatic cancer only.  It has applied for an Investigational Device Exemption to allow it to conduct a clinical study. Details of the study are yet to be disclosed. We expect the primary endpoint will be localised progression free survival with a secondary endpoint of overall survival.

    · The company is led by CEO and MD Daniel Kenny, a highly experienced executive with significant international experience in medical device development, registration, marketing and sales.  He is supported by a highly experienced management team that are capable of driving the commercialisation process.  Following a recent capital raise the company has sufficient funds to commence the US trial and commercialisation within key markets in Europe.  
    Initiate With Buy Recommendation
    · OncoSil is now funded to drive commercialisation in Europe and commence a clinical study in the US.  Pending the awarding of the CE Mark, we expect first commercial revenues in CY2016. We initiate cover with a Buy rating and valuation of $0.30.
 
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Last
$1.16
Change
-0.075(6.10%)
Mkt cap ! $16.35M
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