Health: Oncosil stays hopeful with regulators, shares move higher
Health & Biotech
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Cancer treatment company Oncosil Medical (ASX:OSL) has had a rough trot on the regulatory front so far this year.
But the company is staying optimistic that its lead product — an insertion device used to treat pancreatic cancer — will still get the go ahead.
OSL said today that it had a productive meeting with UK regulators on October 3, where it addressed previous concerns raised.
Oncosil shareholders a well-versed in the difficulties associated with regulatory approval. The company’s share’s dropped off a cliff back in March when British Standards Institute (BSI) declined its application for a CE Mark designation.
While still well off their 12-month high above 20 cents, shares in the company rose by more than 10 per cent this morning to 7.3 cents.
This morning’s update included regulatory developments on both sides of the Atlantic.
The aim of the company’s UK presentation was to address the previous concerns raised by the BSI in March, when it deemed the Oncosil device offered “insufficient clinical benefit”.
OSL said it was assisted in its latest presentation by a number of “international experts in medical oncology, radiation oncology and hepato-pancreato-biliary surgery”, as well as a team of regulatory specialists.
Oncosil said it was encouraged by the meeting, and the company will now submit an updated Clinical Evaluation Report (CER) for the device, which includes the results from a more recent study.
Oncosil said a formal assessment report from British Authorities for its CE Mark application should be provided “in the coming weeks”.
Over in the US, the company is also working towards approval from the Food & Drug Administration (FDA).
Oncosil said it applied for and had been granted approval for a Humanitarian Use Designation (HUD), which lays the groundwork for its next application — a Humanitarian Device Exemption (HDE).
The company said it expects to submit the HDE application — which will include data from its most recent study results — in the coming months.
Medical imaging company IMEXHS Limited (ASX:IME) said its signed up its first Australian customer — a mobile radiology company called CMU Holdings based on the NSW central coast. The agreement spans a period of 10 years, although monthly payments from CMU are “not expected to be material to the revenues” of IME, the company said. Shares in IME were up nine per cent at 4.8 cents.
And medical device company Oventus Medical (ASX:OVN), which is commercialising a treatment for sleep apnea and snoring, said it has established its first distribution networks in the US and Canada after receiving regulatory clearance in September. First revenues from the North American market are expected to be received before the end of the year.