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OncoSil talks CE Mark progress and growth plans November 23, 2015 01:50 PM

Transcription of Finance News Network Interview with OncoSil Medical Limited (ASX:OSL) CEO, Daniel Kenny


Carolyn Herbert: OncoSil has recently undergone a review for its CE mark, which would enable you to sell the product in Europe. Where’s the company at with that?

Daniel Kenny: It’s exciting times for OncoSil Medical. We filed our CE mark dossier on July 17^th and we’ve been working with the notified bodies since then. We were scheduled and granted a fast track revue in early October. We had a four-day revue meeting with the notified body, with the regulatory authorities at our facility in the UK. That went well, the face-to-face sessions were concluded and we’re now in the final phases of this lengthy and complex process. And we’re confident of getting the CE mark by the end of November, perhaps early December. And the final phase is basically two eternal expert revues, and we’re currently working with those external experts on answering their final questions.

Carolyn Herbert: Is FDA Approval something the company is going to be seeking?

Daniel Kenny: We’re actively and aggressively pursuing the FDA Approval. We’ve been in dialogue with the FDA for much of this year and we plan to file an FDA IDE submission, before the end of the year.

Carolyn Herbert: Now to your FY2015 results. What were some of the highlights?

Daniel Kenny: As you know, we’re not trading; we’re not selling our product as of yet, we hope to move into commercialisation in 2016. So the highlights this year are essentially the ISO Certification, the ISO 13485 Certification for our device earlier this year, which is an essential requirement for a CE mark. We’ve also expanded our team. I think we’ve got a first rate executive management team to drive forward in the final phases of regulatory approval. And I think the two highlights have been clearly the CE mark and how well that has gone in our discussions and liaison with the notified body. And of course, I think one more highlight yet to come is the FDA IDE submission.