Health: After seven months OncoSil has picked itself up off the canvas
Health & Biotech
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Seven months after it received a towering blow from the British Standards Institute (BSI) denying regulatory approval for its pancreatic cancer device, OncoSil (ASX:OSL) has recovered almost all the value it lost.
OncoSil informed shareholders on Friday morning that it had received a positive CE Mark status report from the BSI, and while it is some way from achieving full approval, the report is a step in the right direction.
OSL shares gained as much as 57 per cent on the news, to hit a high of 16.5c — their highest point since the BSI denied OncoSil’s original application in March.
The OncoSil product is a targeted radioactive phosphorous isotope implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound. The company has been seeking CE Mark approval since 2015, and told Stockhead a year ago that it believed it would secure the CE mark “in the coming months”, after it had submitted further data confirming its safety and efficacy.
But the BSI’s Clinical Oversight Committee determined earlier this year that “insufficient clinical benefit has been demonstrated to recommend approval”.
In July OncoSil submitted detailed responses to the BSI, including updated and new clinical data and testimonials from “leading, pre-eminent experts in medical oncology, radiation oncology and Hepato-Pancreato-Biliary surgery”.
It met with the BSI in early October and reported positive preliminary discussions, which sent shares moving upwards.
The CE Mark review now progresses to its final phase, assessing plans outlining how the OncoSil device would be rolled out by OncoSil into the European Market.
Daniel Kenny, OncoSil’s CEO, says his company will present its detailed plans in mid-November. “Receiving confirmation that OncoSil has closed out concerns raised earlier this year by BSI is very gratifying,” he said. Stockhead has reached out to Kenny for further comment.
Novita Healthcare (ASX:NHL) gets further good news. More good news if you hold shares in Novita, which has sextupled its share price in the past fortnight: another of its devices has gained clearance from the US FDA. Its TALi Train digital attention treatment program device has been approved for reimbursement.