OncoSil talks CE Mark progress and growth plans


by Anna Napoli

Transcription of Finance News Network Interview with OncoSil Medical Limited (ASX:OSL) CEO, Daniel Kenny
Carolyn Herbert: OncoSil Medical Limited (ASX:OSL) is an Australian medical device company, developing an implanted radioactive medical treatment for inoperable pancreatic and liver cancers. I’m Carolyn Herbert and joining me at the CEO Sessions in Sydney is the company’s CEO, Daniel Kenny. Daniel, welcome to FNN.
Daniel Kenny: Thank you very much.
Carolyn Herbert: Could you start by giving us an introduction to Oncosil Medical?
Daniel Kenny: OncoSil Medical is an ASX listed company formed in early 2013. The story of OncoSil goes back almost 15 years to the original device development, by PSIMedica Group and pSivida Medical.
Carolyn Herbert: Can you tell us more about how the OncoSil treatment actually works?
Daniel Kenny: The OncoSil device is actually an implantable class III radioactive device, its implanted directly into a solid tumour. We’ve demonstrated it in pancreatic and primary liver cancer. And we deliver a very high, relatively high radiation dose, which essentially kills the tumour from within. And what’s key about this is it’s delivering something like 50 to 100 times the daily dose that’s possible, by external beam therapy. So the data shows that this device can significantly damage tumours and cause significant tumour reduction and stabilisation, which is exactly what the patient and the oncologist want.
Carolyn Herbert: What sort of advantages does the OncoSil treatment offer compared to say, other treatments like chemotherapy?
Daniel Kenny: Great question Carolyn. I think the key thing to remind everyone is that OncoSil is meant to be used, in conjunction with standard of care chemotherapy. OncoSil will be positioned as first line abdomen therapy, and so patients would be on two infusions for example of chemotherapy, before starting the brachytherapy with Oncosil. So we’re basically trying to drive a synergy between the OncoSil therapy internally implanted radiation device and chemotherapy, to give the best possible outcome for the patient.
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 17th 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.
Carolyn Herbert: Finally Daniel, where would you like to see the company 12 month’s from now?
Daniel Kenny: In 12 months I would be delighted to come back and share with you what we’ve achieved in 2016. But I think the highlights would be first of all, on the back of a CE mark approval, would be to take this device globally and sell the product in Europe, and in other geographies. To drive that clinical adoption, I think the key thing when I talk to oncologists and liver surgeons and others involved in the treating of pancreatic and liver cancer, is this device is very exciting. They want to use it, so we want to drive that clinical adoption.
We’d also like to share with the market subsequently, what we’re doing with our clinical development program. We’re going to generate more data to drive that adoption, to drive sales, but also to report back on how we’re doing with the FDA.
Carolyn Herbert: Daniel Kenny thanks for the update on OncoSil Medical.
Daniel Kenny: Thank you.