Episode Transcript
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Meg Sinclair (00:17):
Hi everyone.
And thank you for tuning in to,from the lab to launch podcast
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And if you're interested inbeing a guest on the show,
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(00:41):
Today, we're excited to welcomeJustin Zinenko, CEO and co
founder of SynerFuse.
Justin's background combinesfinance, theology, and a passion
for medical innovation.
Under his leadership, SynerFuseis pioneering a groundbreaking
approach to treating chronic lowback pain by integrating spinal
infusion with direct nervestimulation.
(01:02):
This innovative solution aimspostoperative opioids,
addressing a significant gap incurrent treatment options.
We'll delve into his journey,the challenges and successes of
centrifuge and his vision formedical, the future of medical
technology.
Please check out the show notesfor his full bio and links to
learn more.
Let's bring him in.
(01:22):
Welcome, Justin.
Justin Zenanko (01:24):
Thank you for
having me.
Happy to be here.
Meg Sinclair (01:27):
Great.
Can you tell us a little bitabout your journey from being a
CPA to co founding Centerfuseand what inspired your
transition into the med techindustry?
Justin Zenanko (01:37):
So I've always
had a passion for helping people
looking at problems and wantingto find solutions and you know
it was really interesting as Iwas going through college and
going through the whole thewhole journey of, you know, what
do you go for, for education orwhat do you study?
(01:58):
The one thing that I was alwaystold is, you know, business
accounting, you know, economics,you know, those are consistent
things in all businesses.
All businesses have accountingnumbers.
And I was given advice from alot of my dad's friends that
was, you know, you should gointo accounting and you can
figure out what business youwould like to be on.
(02:22):
So I became a CPA and I startedoff in a biotech company where I
left after 18 months to becomethe first CFO.
And that was a gene editingcompany called Reconbinetics.
And from there I really learnedabout how do you build
businesses?
How do you recruit doctors?
How do you actually go afterthose big problems?
(02:44):
And what I really found is thatI really.
Enjoy building things and, youknow, finding a solution that
people said couldn't be found orcouldn't be done.
And those solutions are whatreally drives innovation.
And, you know, you gotta, youknow, the bigger the problem,
(03:08):
the bigger the task.
Meg Sinclair (03:12):
That's
fascinating.
So CPA to right into med techthen.
Centerfuse has got a reallyinnovative approach to combining
spinal fusion with direct nervestimulation.
Can you elaborate on how thisidea came about and initial
challenges that you faced indeveloping this technology?
Justin Zenanko (03:29):
So the idea
really stemmed from a pain
doctor and a neuroscientist andmyself coming together and
really developing it.
you know, saying, well, there'sthere's already stimulation out
there.
There's already back fusion, butthe pain physician kept seeing
back fusions at patients whowere having pain and weren't
(03:51):
getting treated and frominjections.
And eventually they might go inbecause fusion begets fusion.
So they might go in for anotherspine fusion, but eventually
They get you know, diagnosed foras, uh, a stimulator.
And when we brought this to theneurosurgeons at the University
(04:12):
of Minnesota, Dr.
Michael Park, and then later,our former investigator, and now
our chief medical officer, Dr.
Lal, you know, as they thoughtabout it more and more, they go,
well, you know, fusion, you'refixing the back, But no one's
doing anything with the nerves.
And we try so hard to do anepidural approach, fish it up
(04:34):
the spine to get as close to thenerve as possible.
Why wouldn't we just combineeverything together?
And from my perspective, it was,well, why aren't we doing this?
And it came to a simple thing ofmoney and really no one ever
thought about it.
And there's no codes, there's noYou know, this is going back to
(04:57):
the way, you know, when you lookat how ideas get started and get
implemented and med devices goesall the way back to the Earl
Bakken days of Medtronic.
There's a problem and you go tosolve it.
And we were very fortunate tohave the University of Minnesota
in our backyard and havingneurosurgeons who believed in
(05:19):
fixing this problem.
Meg Sinclair (05:22):
And so with that,
Centerfuse is aiming to
eliminate the need for postsurgical opioids through this
integrated therapy.
Can you share some insights intoclinical results you've seen so
far and how patients haveresponded to that treatment?
Justin Zenanko (05:36):
Yeah, so early
data, uh, suggests that the
combined approach procedure, theCenterfuse procedure, is safe.
And based upon some news some,some, uh, recent media that came
out maybe a year ago that we hada couple, several patients who
(05:56):
were actually interviewed, youknow, on local news stations and
one patient, uh, was off of heropioids in less than a week and
was back to work in threemonths.
And you just don't see that infusion patients.
And based upon, you know, otherearly data that we're seeing,
we're, we're very encouraged andmotivated about what the future
(06:20):
holds for this approach because,you know, seeing these patients,
and we even had another patientwho, for example, could barely
walk, and now she's back toriding her motorcycle.
And it's like, you take someonethat looks disabled, and you're
like, well, she's disabled.
And granted, I don't know whoany of these people are until
you know, they get out of thetrial and they get to where the
(06:43):
media finds them, but, you know,you see a disabled person
becoming, you know, going on amotorcycle and getting their
lives back and doing the thingsthat they're used to doing, like
gardening, you know, the stuffthat we take for granted.
But for these people, they'regetting their lives back.
And that's what centerfuse isreally about is how do we
restore people and get them totheir lives back where they
(07:06):
don't have this chronic painthat overtakes their lives.
And they're having to takeopioids and, and go down this
terrible this terrible roadwhere, you know, everybody knows
somebody who has suffered fromthe, You know, the opioid
pandemic and and the crisis andhow can we actually make it, you
(07:27):
know, not happen.
And the key is you treat thenerves early and by treating the
nerves, you're actually you'retaking away and our aim is to
take away the need for opioidsaltogether.
Meg Sinclair (07:45):
That's amazing.
It'd be amazing to see thatapply to more pain method
treatments and really prevent,you know, and mitigate the need
for opioids altogether.
Justin Zenanko (07:55):
And that, and
that's why we're, you know, we,
we have to do, we did a, we dida small proof of concept study
on 15 patients at the Universityof Minnesota and then South Bend
Orthopedics.
Um, but now.
We are, we have to get ready to,you know, from this go through
the whole FDA process for classthree device and do a national
(08:17):
multi center trial and really toget the efficacy, you know,
statistical data points because,you know, what, what our primary
goal was, was to show safety,which we have the box checked,
but now it's.
You know, can we get theefficacy data in enough patients
(08:38):
where we can actually makeclaims?
And that's, that's the nextphase in our journey here.
Meg Sinclair (08:46):
So speaking of
that, because we provide a
quality management systemsoftware, we're always curious
to get an executive's feedback.
Take on quality and regulatorymanagement.
So we have to ask, how doesCenterfuse approach quality and
regulatory and its productdevelopment and its clinical
trials, especially, you know,with your next hurdle coming up?
Justin Zenanko (09:05):
Well, quality
and regulatory are really keys
to our success.
You know, it, it is a, it canbe, and I would say as for a lot
of companies, a blind spot,cause you don't know, you don't
know.
The way we mitigate that is bybringing the right partners in
from the product.
So everything is done anddocumented correctly, then
(09:27):
bringing in the right regulatorypeople, which we have currently,
and then it's making sure thatthe software that we are using,
everything gets done correctlyand, you know, you know, double
verified and all the stuff soyou can actually have
publications of your data.
So you're not missing things.
And, you know, that's been ajourney in itself because you
(09:51):
know, you missed some key pointsand you know, in your regulatory
that can be really detrimentalto the company and to advancing
therapies because, you know,dealing with the FDA or dealing,
you know, to some of the higheststandards and especially class
three devices, uh, very highstandards.
So we, we, we take a very youknow, a very thoughtful and
(10:16):
dedicated approach to it andmaking sure that you know, we're
trying to stay on top of it asmuch as possible.
Meg Sinclair (10:25):
Great.
Thanks for sharing your takethere on quality and regulatory
approaches.
Beyond the current applicationsof centerfuses technology for
chronic low back pain, are thereany other medical conditions or
areas you think you couldbenefit, that could benefit from
this integrated approach?
Justin Zenanko (10:42):
So we're, so
right now, our technology is
really focused on the firstapplication, which is back
fusions.
Bye.
Within our patent portfolio, wealso have laminectomies,
disectomies, anything where itinvolves a spine surgeon where
they're opening up the back tofix the bone on bone, bone on
(11:07):
nerve.
Our technology, uh, plays a rolein that.
And what we did is we startedwith the therapy of last resort,
which is spine fusion.
Because the outcomes are sopoor, from a pain perspective,
doesn't mean that they didn'tfix the mechanical issues, like
structure, the autonomy, or theanatomy, but it's really about
(11:28):
treating the nerves, and, youknow, wherever you have pain,
you know, you're dealing with anerve.
So, this can go to peripheralnerve stem.
There's a lot of otherapplications, but the one thing
that we as Centrifuge areprimarily focused on and where
we've, you know, we've raisedthe funds to deploy the
(11:50):
technology is focused on lowerchronic back pain and leg pain.
And.
You know, that's where, that'swhere we've started and that's
where we have to continue.
But the opportunities for us toaddress a lot of different pain
is going to be is going to bethere because we are building
(12:15):
one of the world's smalleststimulators.
And with that, and with thatdirect nerve approach, we're
seeing power levels that we'venever seen before, which means
you can reduce size, which meansless invasive.
And, you know, the idea is theless invasive, the faster you
can get through a surgery youknow, the better, uh, the
(12:37):
patient outcomes.
We think could be and obviouslywe have to prove that out my
disclaimer here, but the realityis, is that lower power and
direct access to the nerve, Ithink, is the future of where
we're going to see the spineindustry go, but also
(12:58):
stimulation in general,
Meg Sinclair (13:00):
and perhaps even
maybe the larger pain treatment
methodology too, with kind of anintegrated approach and, and
getting away from opiates andimagine too.
Justin Zenanko (13:12):
Yeah, I mean,
there's 600, 000 patients per
year that are gettingbackfusions.
Wow.
And then if you look atlaminectomy and disectomy,
you're probably at another halfa million to 600, 000 patients.
So right there you got about,you got well over a million
patients per year that are Are
Meg Sinclair (13:31):
they being
prescribed opioids?
Justin Zenanko (13:33):
Yes.
And, and if we want to really goafter this issue, this crisis,
it's going to take the communityand take everybody coming
together to really address thatissue because this is a crisis
that needs to be dealt withfirsthand and it takes all of us
to make that a reality and itstarts first with patients, then
(13:59):
the doctors, and then it's thebroader community and that is
that's something that, you know,you know, we, we, we want to get
serious in this country abouthealth.
Let's, let's take the surgeriesof last resort and let's make
them better, not worse.
Let's make them better.
And the sad thing is thattechnologies have been around
(14:22):
for a long time that could dothis.
However, it was never attemptedbefore, which is mind boggling
to me because for me, there's aproblem.
Why don't we have a solution?
Oh, it comes down to money.
Well, we're the richest countryin the world.
And we're not trying to tacklethese big crises, these big
(14:44):
problems because of money, youknow, let's get serious about
it.
Meg Sinclair (14:50):
I think we need
more CPAs and med tech, perhaps
to help drive this innovation,Justin.
That's what that's what itsounds like we need.
You had mentioned raisingcapital.
It's a competitive market outthere, especially as the costs
of borrowing are increasing.
is relatively high these days.
What advice would you give otherfounders who are looking to
raise funds to solve their ownbig problems?
Justin Zenanko (15:14):
So the advice
that I can give is that you
first, first, it needs to makesense to you as the founder, as
the leader of what you're doing.
Is it fair from a pricingperspective?
Meaning is, am I willing to payfor it?
And then I think you have tolead by example, which is you
(15:36):
have to put your own money in.
And, you know, I've beenfortunate enough being a CPA
entrepreneur that I was able tolead every round with my own
dollars into the company and toset forth that example because
I'm not selling anything thatI'm, I'm not buying myself.
(15:58):
And if you're not willing to putyour money where your mouth is,
there's really, you know, if, ifyou, if you succumb to the VCs
and the private equity.
which most of the founders thatI know and CEOs do, then you're,
you kind of become, you know,um, you're subjected to what
(16:23):
they think your value is.
And that's how in my Myexperience and from seeing other
people, that's how you lose yourcompanies and you lose this
vision.
And you know, there's going tobe challenges that come across
and it's always going to takeyou more money than what you
planned.
And if you have the wrongpartner, in a VC or private
(16:45):
equity and not to demonize thembecause I'm sure there's some
private equity and VCs thatlisten to this show that I'm
sure are great people, but Iwould just say you have to find
those investors and people thatbelieve in what you're doing and
want to join you on the ride andunderstand that, hey, not
(17:05):
everything's going to go welland things are going to take
longer and to.
and to ride with you.
And that's how you, that's howyou build companies is you have
the right backers, the rightpeople that will support you
through the ups and the downs.
And I mean, we, we came out witha clinical trial during COVID.
And, you know, talk abouthospitals getting shutting down,
(17:27):
you got a clinical trial, howare we going to get through
this?
And, and we've been veryfortunate to have a very strong
network of investors andshareholders that believe in
what we're doing.
And they recognize the greaterneed of solving these bigger
problems.
Meg Sinclair (17:46):
That's great
advice for our future investors
and entrepreneurs out there.
Our last question is more of afun one.
We like to ask each of ourguests.
If we ran into Justin at abookstore or at your local
library, in what section wouldwe find you?
Justin Zenanko (18:02):
Oh, that, that's
a hard one.
You know, the theologybackground of my Masters of
Divinity, I would say, you know,the religious section, but, But
the reality is, is I lovetechnology and new things, so
innovation, if there's even asection like that, but, you
know, at the end of the day Ilove learning about new things
(18:25):
and applying new things.
And, you know, as I keep goingthrough life, there's always new
things that I learned that Inever thought I would learn.
And.
And you never know, you mighteven go past the poetry section
or something and something mightcatch your eye there too.
Meg Sinclair (18:44):
There you go.
Always wandering thebookshelves, I guess.
Lovely.
It was lovely to meet you today,Justin, and chat with you.
Where can people go to followalong about your journey and
connect with you?
Justin Zenanko (18:57):
So, they can
find us on www.
SynerFuse.
com.
And there we have our, you know,our website, we have our team,
we have our therapy we evenhave, uh, links to the news the
news that made with thesepatients.
(19:18):
And we're also on LinkedIn.
Meg Sinclair (19:21):
Great.
Well, we'll post those in theshow notes.
Thanks so much for joining ustoday, Justin.
It was great having you.
Justin Zenanko (19:26):
Yeah.
Thank you.
I appreciate it.
And thank you very much.