Memphasys (ASX:MEM) progressing IVF separation device


by Rachael Jones

Memphasys Limited (ASX:MEM) Executive Chairman, Alison Coutts talks about progress with the company's human assisted reproductive device for the separation of sperm cells in IVF clinics.

Rachael Jones: Hello, I'm Rachael Jones for the Finance News Network. Joining me today from Memphasys(ASX:MEM) is Executive Chairman, Alison Coutts. Alison, welcome back to the network.

Alison Coutts: Hi, thanks very much.

Rachael Jones: Memphasys (ASX:MEM) is a medical device company specializing in bio-separation. How is progress?

Alison Coutts: It's going really well. We've developed a device called Felix and it's extremely good and we're not that far from launching in the market, say six, nine months. This is the device. It's got a disposable cartridge that is one off, you use it once. Quick and easy. Electric forces separate with size exclusion membranes and you press here, six minutes processing, three minute hydration, three minute the electrophoretic process. Really very, very simple, automated. It's just about ready to go.

Rachael Jones: And how did the Felix come about?

Alison Coutts: It's been a long time coming. Back in '08 before I ever joined the company they were live births with a predecessor prototype machine, which would have never seen the light of day in a proper clinic. But nevertheless there were a number of live births from people who really, really wanted the babies and they were having trouble with IVF. We took that device and re-engineered it such that we have a proper commercial thing now. And we've done it with Professor John Aitken, he's the co-inventor of the technology. He's at the University of Newcastle. And we've also got a clinical partner in Monash IVF, most particularly Professor Michelle Lane.

Rachael Jones: And what can you tell me about the Felix production?

Alison Coutts: There are two parts of the device. There's a cartridge, it's a one off, single use. This is where we're going to make the money. One cycle, one cartridge. Very easy. And then this is the console. We've got two different suppliers making these, getting a large number made already being sent out to key opinion leaders and they will test according to a particular protocols called Protocol A. They're all going to be testing according to that protocol. Some will do density gradient centrifuge, some will do swim-up. And they will have a look at how our Felix goes against their favourite process.

But simultaneously we're already now into engineering verification and validation of the device. This is something that all device manufacturers have to go through and it's a convoluted process to ensure that it all works according to how it's designed and it should be done by the middle of next year.

Rachael Jones: So let's talk more about 2020. What do you expect for progress?

Alison Coutts: It's going to be a big year. As I said, we're doing verification validation of the device. That's engineering development. The final side of it all. We're servicing the key opinion leaders. We're sending them out, we're seeding the market, and then putting a few more in and a few more in and making sure the key opinion leaders are well served and they're following the protocols and no particular problem there.

We're also doing regulatory approval submissions, so we're getting ready for a TGA submission. We're getting the final bit for getting a meeting with the TGA, which will be sometime hopefully early next year. That'll be followed up with a request for meeting with the FDA and we're also pursuing EU.

In conjunction, we just got an ARC linkage grant, which is a very prestigious grant. It's $550,000 for technologies or activities that are going to be important to the future of Australia. This is about manufacturing, very innovative manufacturing for next generation devices. And we hope that we'll be able to scale this up for doing the same for animals because we've got ideas of how we might do improved artificial insemination, cows, horses, pigs, et cetera. And besides that will be also useful to get a next generation product because you've always got to be looking at product improvements. So a bit of a busy year.

Rachael Jones: And let's talk about strategy now and share price performance. What can you tell me about that?

Alison Coutts: So the strategy is to just go like mad, to do a good job of getting this device out to the market, make sure that we service the key opinion leaders, answer any issues they might have. Get the regulatory side of things done for the high regulatory markets and just keep on pushing because there's actually nothing like this device. It's unique and we have a place in the sun. We've got to actually make the most of it.

Rachael Jones: Alison Coutts, thanks for the update.

Alison Coutts: Thank you very much.