Latest / Best of Business / Simon Malpas: Kitea Health co-founder on the company winning spots on two FDA fast-track programmes

Transcript

Simon Malpas: Kitea Health co-founder on the company winning spots on two FDA fast-track programmes · Best of Business

• 0:09
  Speaker 1: You're listening to a podcast from News Talk SEDB. Follow
• 0:12
  Speaker 1: this and our wide range of podcasts now on iHeartRadio
• 0:17
  Speaker 1: right now.
• 0:17
  Speaker 2: Though. It's been a big start of the year for
• 0:19
  Speaker 2: Kiwi startup kitia here Health. The digital health company has
• 0:23
  Speaker 2: created a world first censorship which wirelessly measures fluid on
• 0:27
  Speaker 2: the brain. In the last three months, kitia has secured
• 0:31
  Speaker 2: a place in the FDA Fast Track Program, They've completed
• 0:35
  Speaker 2: a world first implanting one of their senses in the
• 0:37
  Speaker 2: brain of a child, and the company has opened up
• 0:40
  Speaker 2: to retail investors to raise capital. They're well on their
• 0:42
  Speaker 2: way to raising their funding target of ten million dollars.
• 0:46
  Speaker 2: Simon Malpass is the co founder of Kitia Health and
• 0:49
  Speaker 2: he joins me now, good morning, Goo, Good morning, Simon.
• 0:54
  Speaker 2: This is life saving technology. Talk me through why this
• 0:57
  Speaker 2: brain chip is so beneficial.
• 1:00
  Speaker 3: Yeah, so, people who have this conditioned hydrocephalist great, big
• 1:05
  Speaker 3: tough word, but it means too much fluid around the brain.
• 1:08
  Speaker 3: And it's what surgeons do is they place this tube
• 1:12
  Speaker 3: to drain this excess fluid from the brain to the stomach.
• 1:16
  Speaker 3: And that's all great, but it has the worst failure
• 1:19
  Speaker 3: rate of any medical device fifty percent of these tubes.
• 1:22
  Speaker 3: These shunts will fail in the first two years, and
• 1:25
  Speaker 3: the symptoms of when it fails are simply headache. Maybe
• 1:28
  Speaker 3: are feeling a bit unwell under the weather, and so
• 1:31
  Speaker 3: these poor people go after hospital repeatedly and it turns
• 1:34
  Speaker 3: out to be just a headache. So the problem is
• 1:37
  Speaker 3: there's no means to monitor the pressure within the brain,
• 1:40
  Speaker 3: and that's what we do for the very first time,
• 1:43
  Speaker 3: so these people can actually monitor their own brain pressure
• 1:46
  Speaker 3: at home and give guidance to themselves, their family and
• 1:49
  Speaker 3: physicians as to whether they're rarely got a life threatening
• 1:53
  Speaker 3: issue or it is just a headache.
• 1:55
  Speaker 2: Oh, guidance, and I imagine a huge amount of relief
• 1:58
  Speaker 2: as well.
• 1:59
  Speaker 3: Simon Ah, Yes, yes, we've met lots of families around
• 2:04
  Speaker 3: the motive who so you know, it's like we know
• 2:08
  Speaker 3: it train crash is going to happen, but we never
• 2:10
  Speaker 3: know when. And so what we do is we provide
• 2:13
  Speaker 3: guidance for those families, reducing anxiety, but also reductions in
• 2:18
  Speaker 3: the healthcare system costs because we reduce the needless hospitalizations,
• 2:23
  Speaker 3: the MRIs and the cts as well. So it's a
• 2:26
  Speaker 3: lot of positive impacts across the board.
• 2:29
  Speaker 2: Do you mind explaining to me sort of the size
• 2:33
  Speaker 2: of the chip and how it's implanted into the brain,
• 2:35
  Speaker 2: because it does sound a little bit scary, doesn't it.
• 2:37
  Speaker 3: Yeah, I completely get it. It sounds very sci fi
• 2:41
  Speaker 3: and it is ten years of research in the University
• 2:44
  Speaker 3: of Auckland bio Engineering Institute before the company got started.
• 2:49
  Speaker 3: But it is based on semiconductor industry manufacturing about really
• 2:54
  Speaker 3: producing tiny, tiny glass microsensors that measure pressure. So it's
• 2:59
  Speaker 3: only point three of a gram and as such it
• 3:02
  Speaker 3: is the brain the world's smallest brain implant ever developed
• 3:06
  Speaker 3: at the moment, and we're so please to be in
• 3:11
  Speaker 3: our clinical trials in Auckland City Hospital treating treating kiwis.
• 3:16
  Speaker 3: So it's just a fantastic position to be in and
• 3:20
  Speaker 3: we just want to extend the trial next year around
• 3:23
  Speaker 3: the country and then around the world as well with
• 3:25
  Speaker 3: the FDA.
• 3:26
  Speaker 2: So talk to us about how the human trials are going.
• 3:29
  Speaker 2: How many people currently have these chips at the moment.
• 3:32
  Speaker 3: So we've finished all of the adults, they're all enrolled
• 3:37
  Speaker 3: and have have had surgery. They we don't we should
• 3:40
  Speaker 3: say we only add five minutes extra surgery, so they're
• 3:43
  Speaker 3: already having a piece of neurosurgery to replace this tube
• 3:47
  Speaker 3: that I mentioned. It's not like a special thing, and
• 3:49
  Speaker 3: that's great from a surgical perspective. So ten adults are
• 3:53
  Speaker 3: already underway that most of them have finished the trial,
• 3:57
  Speaker 3: and then we've also just started the children and now
• 4:00
  Speaker 3: done some very young, very young children as well. So
• 4:03
  Speaker 3: they will continue throughout the next few months gathering and
• 4:07
  Speaker 3: enrolling more children as they come into meaning surgery for
• 4:11
  Speaker 3: this condition. And then that all gets wrapped up and
• 4:15
  Speaker 3: reviewed independently, and we expect to be able to continue
• 4:19
  Speaker 3: the trial rolling out around the country later next year.
• 4:22
  Speaker 2: You've secured only one of sixty five places worldwide on
• 4:26
  Speaker 2: the FDA Fast Track approval program. How big is that
• 4:28
  Speaker 2: for a keewy company.
• 4:30
  Speaker 3: Ah, yeah, it's We certainly are the first one to
• 4:33
  Speaker 3: do that. It's extreme. You go from meeting every three
• 4:40
  Speaker 3: months with the FDA to meeting every couple of weeks
• 4:43
  Speaker 3: if you want to, and people think they're the big
• 4:47
  Speaker 3: bad wolf. Actually they're not. They're terribly helpful. They want
• 4:50
  Speaker 3: to see our technology and they've said this is a
• 4:53
  Speaker 3: game changer for our patient groups, So they want to
• 4:56
  Speaker 3: see us get through quicker. They want to make sure
• 4:59
  Speaker 3: obviously it's safe, but they really are trying to help,
• 5:02
  Speaker 3: so it is totally a game changer. The other part
• 5:05
  Speaker 3: is that it enables us to connect with some and
• 5:08
  Speaker 3: ensures the payers as we call them, the people that
• 5:11
  Speaker 3: we're paying for the technology and make sure that not
• 5:14
  Speaker 3: only it gets regulatory approval, but someone will pay for
• 5:17
  Speaker 3: it as well.
• 5:19
  Speaker 2: And will you have to do trials in the US?
• 5:22
  Speaker 3: Yes, yes, we expect to start that and that's why
• 5:24
  Speaker 3: we're capital raising on Snowball at the moment. Yes, trials
• 5:27
  Speaker 3: do commence in the US next year with the FDA approval,
• 5:32
  Speaker 3: which we expect towards the end of the year. Yeah.
• 5:35
  Speaker 3: So the FDA does like you to have well wants
• 5:37
  Speaker 3: you to have US citizens enrolled in their trials, and
• 5:40
  Speaker 3: I understand that, but it's not a It will be
• 5:43
  Speaker 3: very similar to the New Zealand trials, looking at benefits,
• 5:46
  Speaker 3: health economics, a whole host of different things. But we
• 5:50
  Speaker 3: fully expect that we can be obtaining clearance into the
• 5:55
  Speaker 3: market to being able to sell in the US and
• 5:56
  Speaker 3: therefore the economic benefits coming back to the country for
• 6:01
  Speaker 3: really in the next couple of years.
• 6:03
  Speaker 2: And as you said, that's all sort of coincides with
• 6:06
  Speaker 2: getting more investment on board, and you've opened up two
• 6:10
  Speaker 2: retail investors. What has the interest.
• 6:11
  Speaker 3: Been like amazing, good, amazing, amazing. Yeah. I think medical
• 6:19
  Speaker 3: technologies like ours that are world first, and I think
• 6:22
  Speaker 3: they do resonate with New Zealanders. Also having an outcome,
• 6:27
  Speaker 3: you know, a health outcome and doing something good resonates
• 6:30
  Speaker 3: as well. So I'm just so stoked at having hundreds
• 6:34
  Speaker 3: of New Zealanders get behind us on snowball. It has
• 6:38
  Speaker 3: been amazing. There's still work to be done, We're not
• 6:41
  Speaker 3: there yet, but we're quickly getting close to where we
• 6:45
  Speaker 3: want to be and then the trials will be able
• 6:47
  Speaker 3: to go forward with security.
• 6:49
  Speaker 2: So this this funding, sorry, was this to help you
• 6:53
  Speaker 2: with the work in the US and with the FDA.
• 6:57
  Speaker 3: But both to be able to secure running the New
• 7:00
  Speaker 3: Zealand trial next year, which is really about getting it
• 7:03
  Speaker 3: out to New Zealanders. We received fifteen million dollars of
• 7:07
  Speaker 3: grant funding, taxpayers dollars in the university came into us
• 7:11
  Speaker 3: to develop the core technology. We have a moral responsibility
• 7:15
  Speaker 3: to get this out to New Zealanders and we are
• 7:18
  Speaker 3: very close to being able to have this on market
• 7:21
  Speaker 3: in New Zealand.
• 7:22
  Speaker 2: That was my next question. How soon can we see
• 7:26
  Speaker 2: this technology in practice?
• 7:27
  Speaker 3: No, that's right. Yeah. So the idea is we need
• 7:31
  Speaker 3: to do a follow what we call a pivotal trial
• 7:33
  Speaker 3: that shows the health economics to the health system that
• 7:37
  Speaker 3: it's not going to be cost a whole lot more.
• 7:40
  Speaker 3: That's really important. And then of course the US trial
• 7:44
  Speaker 3: we want to be able to fund as well. We
• 7:46
  Speaker 3: need to be able to do that.
• 7:47
  Speaker 2: Oh, Simon, great news. Thank you so much for talking
• 7:50
  Speaker 2: to us this morning. Really appreciate it. That with Simon
• 7:53
  Speaker 2: Malpass who was one of the co founders of Kittya
• 7:57
  Speaker 2: who have developed this world first this censorship which wirelessly
• 8:03
  Speaker 2: measures fluid on the brain. Simon was also shortlisted for
• 8:07
  Speaker 2: the Innovator of the Year the Kiwibank New Zealander of
• 8:09
  Speaker 2: the Year Awards, which have just taken place. So incredible
• 8:13
  Speaker 2: work that they are doing.
• 8:14
  Speaker 1: For more from News Talks at b listen live on
• 8:17
  Speaker 1: air or online, and keep our shows with you wherever
• 8:20
  Speaker 1: you go with our podcasts on iHeartRadio.