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

Kiwi start-up Kitea Health has experienced a successful start to 2025. 

In the last three months, Kitea has secured a place in the FDA fast track programme and they’ve completed a world first - implanting one of their sensors into the brain of a child. 

The company has also revealed it's just shy of $7 million into a $10 million funding round.

Kitea Health co-founder Simon Malpas says their product went through 10 years of research before getting started.

"We're so pleased for Kitea to be in our clinical trials - and in Auckland City Hospital, treating Kiwis. It's just a fantastic position to be in." 

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Episode Transcript

Speaker 1 (00:06):
You're listening to the Sunday Session podcast with Francesca Rudkin
from News talksb Right now.

Speaker 2 (00:13):
Though, it's been a big start of the year for
Kiwi startup Kitia here Health, the digital health company has
created a world first censorship which wirelessly measures fluid on
the brain. In the last three months, Kitia has secured
a place in the FDA Fast Track Program. They've completed
a world first implanting one of their senses in the

(00:33):
brain of a child, and the company has opened up
to retail investors to raise capital. They're well on their
way to raising their funding target of ten million dollars.
Simon Malpass is the co founder of Kitia Health, and
he joins me now, good.

Speaker 3 (00:46):
Morning, Good morning, Simon.

Speaker 2 (00:50):
This is life saving technology. Talk me through why this
brain chip is so beneficial.

Speaker 3 (00:57):
Yeah, so, people who have this condition hydrocephalist great, big
tough word, but it means too much fluid around the
brain and it's do as they place this tube to
drain this excess fluid from the brain to the stomach.
And that's all great, but it has the worst failure
rate of any medical device. Fifty percent of these tubes,

(01:18):
these shunts will fail in the first two years, and
the symptoms of when it fails are simply headache, maybe
are feeling a bit unwell under the weather, and so
these poor people go after hospital repeatedly and it turns
out to be just a headache. So the problem is
there's no means to monitor the pressure within the brain,
and that's what we do for the very first time,

(01:39):
so these people can actually monitor their own brain pressure
at home and give guidance to themselves, their family and
physicians as to whether they're rarely got a life threatening
issue or it is just a headache.

Speaker 2 (01:51):
Oh, guidance and I imagine a huge amount of relief
as well.

Speaker 3 (01:55):
Simon Ah, Yes, yes, we've met lots of families around
the motive who so you know, it's it's like we
know a train crash is going to happen, but we
never know when. And so what we do is we
provide guidance for those families, reducing anxiety, but also reductions
in the healthcare system costs because we reduce the needless hospitalizations,

(02:19):
the MRIs and the cts as well. So it's a
lot of positive impacts across the board.

Speaker 2 (02:25):
Do you mind explaining to me sort of the size
of the chip and how it's implanted into the brain,
because it does sound a little bit scary, doesn't it.

Speaker 3 (02:33):
Yeah, I completely get it. It sounds very sci fi
and it is ten years of research in the University
of Auckland bio Engineering Institute before the company got started.
But it is based on semiconductor industry manufacturing about really
producing tiny, tiny glass microsensors that measure pressure. So it's

(02:55):
only point three of a gram and as such it
is the brain the world's smallest brain implant ever developed
at the moment, and we're so pleased to be in
our clinical trials in Auckland City Hospital treating treating kiwis.
So it's just a fantastic position to be in and

(03:16):
we just want to extend the trial next year around
the country and then around the world as well with
the FDA.

Speaker 2 (03:22):
So talk to us about how the human trials are going.
How many people currently have these chips at the moment.

Speaker 3 (03:28):
So we've finished all of the adults, they're all enrolled
and have have had surgery. We don't we should say
we only add five minutes extra surgery, so they're already
having a piece of neurosurgery to replace this tube that
I mentioned. It's not like a special thing, and that's
great from a surgical perspective. So ten adults are already

(03:50):
underway that most of them have finished the trial, and
then we've also just started the children and now done
some very young, very young children as well. So they
will continue throughout the next few months gathering and enrolling
more children as they come into meaning surgery for this condition.
And then that all gets wrapped up and reviewed independently,

(04:12):
and we expect to be able to continue the trial
rolling out around the country later next year.

Speaker 2 (04:18):
You've secured only one of sixty five places worldwide on
the FDA Fast Track approval program. How big is that
for a key company?

Speaker 3 (04:26):
Ah, yeah, it's We certainly are the first one to
do that. It's extreme. You know, you go from meeting
every three months with the FDA to meeting every couple
of weeks if you want to, and people think they're
the big bad wolf. Actually they're not. They're terribly helpful.
They want to see our technology and they've said this

(04:49):
is a game changer for our patient groups, So they
want to see us get through quicker. They want to
make sure obviously it's safe, but they really are trying
to help, so it is totally a game changer. The
other part is that it enables us to connect with
some of the insurers the payers call them the people
that we're paying for the technology, and make sure that

(05:10):
not only it gets regulatory approval, but someone will pay
for it as well.

Speaker 2 (05:15):
And will you have to do trials in the US?

Speaker 3 (05:18):
Yes, yes, we expect to start that and that's why
we're capital raising on Snowball at the moment. Yes, trials
do commence in the US next year with the FDA approval,
which we expect towards the end of the year. Yeah.
So the FDA does like you to have well wants
you to have US citizens enrolled in their trials, and
I understand that, but it's not a It will be

(05:39):
very similar to the New Zealand trials, looking at benefits,
health economics, a whole host of different things. But we
fully expect that we can be obtaining clearance into the
market to being able to sell in the US and
therefore the economic benefits coming back to the country for
really in the next couple of years.

Speaker 2 (05:59):
And as you said, that's all sort of coincides with
getting more investment on board and you've opened up to
read hell investors. What has the interest been like?

Speaker 3 (06:09):
Amazing, good, amazing, amazing. Yeah. I think medical technologies like
ours that are world first, and I think they do
resonate with New Zealanders. Also having an outcome, you know,
a health outcome and doing something good resonates as well.
So I'm just so stoked at having hundreds of New

(06:30):
Zealanders get behind us on Snowball. It has been amazing.
There's still work to be done, We're not there yet,
but we're quickly getting close to where we want to
be and then the trials will be able to go
forward with security.

Speaker 2 (06:45):
So this funding, sorry, was this to help you with
the work in the US and with the FDA, but
both to.

Speaker 3 (06:54):
Be able to secure running the New Zealand trial next year,
which is really about getting it out to New Zealanders.
We received fifteen million dollars of grant funding. Taxpayers dollars
in the universe came into us to develop the core technology.
We have a moral responsibility to get this out to
New Zealanders and we are very close to being able

(07:16):
to have this on market in New Zealand.

Speaker 2 (07:18):
That was my next question, How soon can we see
this technology in practice.

Speaker 3 (07:23):
No, that's right. Yeah. So the idea is we need
to do a follow what we call a pivotal trial
that shows the health economics to the health system that
it's not going to be cost a whole lot more.
That's really important. And then of course the US trial
we want to be able to fund as well. We
need to be able to do that.

Speaker 2 (07:43):
Oh, Simon, great news. Thank you so much for talking
to us this morning. Really appreciate it. That with Simon
Malpass who was one of the co founders of Kittya,
who have developed this world first this censorship which wirelessly
measures fluid on the brain. Simon was also shortlisted for
the Innovator of the Year at the Quibank New Zealander

(08:05):
of the Year Awards, which had just taken place. So
incredible work that they are doing.

Speaker 1 (08:11):
For more from the Sunday session with Francesca Rudkin, listen
live to News Talks at B from nine am Sunday,
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