This is what was announced in December 2017 after the then Chairman went to see Zeiss, Dr Currie was part of the board when this ASX announcement went out to the market and Dr Currie is the only one left, it would be good to hear from him on this.
CE is approved as this has been announced, though it wasn't clear to everyone and EU Sales were predicted to follow quickly by Zeiss in Europe.
If Zeiss told the Chairman and you have to assume normal governence, he would have consulted the board before releasing what is in this announcement to the ASX, then something has slowed down somewhere.
We know that it is not OIL slowing things down, so logic would suggest that it has to be Zeiss slowing down EU sales.
ASX Announcement OIL
Market Update 22 December 2017
Highlights:
- A minimum revenue of $1.95m from the sale of systems that will be delivered to Zeiss by June 2018
- CE approval anticipated well within the first quarter 2018 enabling a strong sales push into Europe
- FDA submission early 2018 with approval anticipated well before the end of the first half of 2018
Optiscan Imaging Limited (ASX:OIL) is pleased to provide this month’s market update following a recent visit by the Optiscan Chairman, Alan Hoffman, to the headquarters of Carl Zeiss Meditec (“CZM” in Oberkochen Germany. This update will therefore concentrate on the CZM project.
The key points of note are as follows:
CE Approval
- CZM anticipate CE approval will be following the approval of the sterility process of the sheath. This is anticipated to be well within the first quarter of 2018.
- Once CE mark is approved, the CZM Convivo systems can be sold in Europe.
- The CZM senior management are keen to strongly push European sales as soon as CE is approved.
- FDA Approval
- Following the sheath sterility regulatory approval, the complete system (incl sheath and fluorescein) will be submitted to the FDA for approval.
- The CZM USA regulatory team is, in parallel, preparing the FDA submission to minimize any delay. The submission will be made early in 2018 with approval anticipated to be secured well within the first half of 2018.
- CZM senior management are keen to push USA sales as soon as FDA is approved.
Future Deliveries
The revenue for Optiscan from next shipments is anticipated to be as follows:
- January 2018 AUD700k
- March 2018 AUD625k
- June 2018 AUD625k
*Note: The CZM contract provides for payment in EUR. The above revenue figures are based on expected AUD/EUR exchange rates
These figures are based on anticipated orders along with orders already received. There is upside potential in the first half of 2018 depending on the timing of CE and FDA approvals and the subsequent sales push as referred to above.
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