
Apply HN: Infection Resistant Materials for Preventing Infections - jonwachob91
--- What we do<p>Using the properties of nanostructures we can create low-cost polymer nanotextured surfaces that are anti-microbial, prevent biofilm formation, reduce protein absorption, and increase blood biocompatibility, leading to increased patient outcomes through reducing healthcare associated infections.<p>1 in 20 patients that receive a central line catheter get an infection because of the catheter, about 7000,000&#x2F;year. 1 out of every 10 that get an infection will die, about 70,000&#x2F;year - these are stats from the CDC. We are nanotexturing the interior of a catheter to prevent platelet adhesion and thus clotting and the exterior of the catheter to prevent bacteria from getting close the catheter site.<p>- How?<p>Nanostuctured topography creates mechanical stress on settling bacteria. Nanoforce gradients caused by the surface variations induces stress gradients within the lateral plane of the surface membrane of a settling microorganism during initial contact. This stress gradient disturbs normal cell functions, forcing the microorganism to provide energy to adjust its contact area on each topographical feature to equalize the stresses. This expenditure of energy is thermodynamically unfavorable to the settler, inducing it to search for a different surface to attach to.<p>TLDR; microorganisms can&#x27;t find a surface to rest on.<p>In preliminary testing we found a reduction of platelet adhesion by 82.3% over the control and 84.9% over the positive control. Staph. E. observed an adhesion reduction of 68.6% over the control and 81.2% over the positive control. Staph. A. (also known as MRSA) had a reduction of 64.6% over the control and 83.7% over the positive control.  E. Coli had an 84.1% reduction over control and 97.5% over the positive control.
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jonwachob91
\- What's our Secret Sauce?

Not the technology... Nanostructure manufacturing has been around for decades
using lasers, heat, and/or pressure to texture a surface. My startup has
developed a new method for texturing a polymer surface without lasers, heat,
or pressure. We developed the process (accidentally) while working in a
material science lab at the University of Central Florida's Nanoscience
Technology Center. We are currently patent pending (no publish). Traditional
manufacturing processes often require a clean room and can cost over $300/sq
in. Our process doesn't require a clean room and costs about $1/sq ft.

\- Is our Secret Sauce repeatable and scalable?

We have textured hundreds of samples (by hand), and are working on designing
an automated process that can replicate our process and eliminate human error.

\- Funding to date?

After the accident that lead to the new process we applied to and have
received funding from the National Science Foundation to continue research. We
have applied to additional National Institute of Health and Center for Disease
Control grants, but they aren't suitable for building a startup. Yesterday we
submitted a grant worth $225K, but we won't even know if we get the grant
until September, not exactly a system that is good for funding startups. They
are great for alleviating costs for product R&D but that's about it.

\- What's our team look like?

Brandon - He's the inventor of the process and the omniphobicity expert. Dr. T
- Is our Science lead and material scientist. Myself - I play with data and do
the business side.

We started with the idea of a self-cleaning film for solar panels, while the
technology worked the finances didn't. Solar is an industry trying to drive
costs down, not add another $20 to the price of a panel. It shocked me, but
that was the general consensus from the industry (SunPower, SunTech, Solar
City, and many more).

Questions?

~~~
danieltillett
1\. Is there a limit on the material that can be used to make the pattern?

2\. With your catheter can you use the same plastic that is being currently
used so all you are changing is the surface structure?

~~~
jonwachob91
Thank you for the questions!

I can answer both your questions at once. We are limited to polymer materials.
HOWEVER, certain plastics have reactions that MAY have toxin issues. PVC
catheters were phased out because new materials were developed that have
better bio-compatibility. We can texture the PVC catheters and achieve similar
results as what we've already seen.

*Polyethelene is a common material for catheters, and while we can texture it the material forces us to add heat to the equation. Removing heat is a critical step that we removed cause it's time intensive. WORST case scenario, our method with heat is still cheaper and faster then current nanotexturing methods.

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Mz
I really like the idea, but I will caution you to not get overly confident
that this process will be a permanent solution. I know a little something
about infection control and biofilm. In a nutshell, when antibiotics were
discovered, they announced it was the end of disease. Fast forward a few
decades and the current reality is that we are dealing with scary super bugs
that are antibiotic resistant.

Infections are living organisms. Thus, keeping them at bay will always be an
ongoing battle. And battles evolve. As each side learns new tactics, old
tactics stop working.

So while new materials can play a role in that, I believe new processes will
play a bigger role. I will suggest that, as you develop your products, you do
so with an eye towards ease of use in terms of properly flushing them,
cleaning them etc. If you can make it easier and more convenient for people to
clean them, insert them in a manner that keeps them sterile and so on, this
will have more lasting value in the battle against infection than merely
upgrading the material.

But thank you for working on this vital area. I wish you nothing but good
luck.

~~~
jonwachob91
Hey, sorry for the late response, but I was fielding this question around the
lab to get thoughts.

The general consensus is that because we aren't relying on biology to prevent
the spread of infection but rather the physical chemistry the likely hood of
the bacteria evolving is significantly lower.

Our goal isn't to prevent all bacteria to sticking to all surfaces (forcing
them to evolve), but rather to control what areas they do stick to. We just
want the bacteria to hang out away for areas that can lead to infections. If
we coat a door handle in our polymer films, the bacteria will simply fall to
the floor, it is really unlikely for the bacteria to make it's way from the
floor to a nurses shoe to a patients vascular catheter, then the bacteria is
killed during the daily mopping of the floor, so I've done my job of herding
the bacteria until it can be killed.

~~~
Mz
Well, I think you have completely missed my point.

Whatever you do, let me suggest that you be incredibly careful to avoid
implying that use of this new and improved material means you can slack off on
other hygiene practices. If you market it as a means to not have to bother
with cleaning as regularly and that sort of thing, or even if you fail to
rebut this assumption that other people will almost certainly make (that they
can clean less because it is germ resistant -- which a lot of people think
means _germ proof_ ), you will be practically guaranteed to eventually grow a
superbug.

And I hope you take that seriously. I am not trying to shoot down your
product. I just know something about this stuff.

Best of luck.

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timv
How far would the YCF get you?

From you comments, it sounds like your immediate areas to look into are:

\- Options for getting FDA approval

\- Licensing vs self-Manufacturing

\- Determine whether catheters are the right launch product

\- Getting your ducks in a row so that you can do some sort of deal that gives
you enough money to execute on the above (that is, start an FDA trial, build
up a manufacturing capability, etc as needed)

Does $20k and 8 weeks get you to that point? Or are you planning to use the
YCF time to tackle a different set of problems?

Or, to phrase it differently: Why is YFC the right next step for you?

 _Note: I like what you guys are doing, and I really like that answers you 've
provided so far. I'm mostly just asking questions to help you flesh
out/present your ideas clearly._

~~~
jonwachob91
Our immediate area to look at is do we have a business or a license? And what
is the best product for us to invest in? A catheter may be the easiest, but
funding may be more readily available for heart valves or stents.

That being said, we'd like to spend at least half the money on additional
testing. Primarily how the structure size and pattern effect adhesion. Pillars
w/ points vs pillars with flat tops, or any other geometry? 600nm vs 60nm?
Whats the optimum gap spacing? And after all that how do the same tests we've
already performed compare?

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Cogito
What are people already doing in this space?

Specifically, are there any technologies out there or in development that aim
to reduce infection rates related to the use of medical devices?

What remediation processes are used to reduce infection rates, that are not
technology based? What is the cost for these, and how does that compare to the
cost of using your technology?

I really like the idea of improving outcomes by simply swapping out one piece
of equipment for a better piece (especially as you are not making the process
more complicated, it's a straight upgrade).

~~~
jonwachob91
Thank you for the questions!

Sharklet developed a micron sized pattern for use on catheters, and has
licensed the pattern to Cook Medical. But the transaction was completed a few
years ago (2013) and nothing has come to market. There is no clear evidence
why this is, but we do know they are using pressure stamping to texture the
catheters, a process that is still expensive and time intensive. Their patent
didn't cover manufacturing, just the texture pattern. Inaddition to our lower
cost manufacturing, we can texture at the nano-scale. Bacteria tends to be 1-3
micron's in size, any surface bigger then them and they can rest and attach.
Because Sharklet/Cook use a micron-scale pattern some bacteria can still
adhere, you still get a deep reduction in bacteria adhesion but it's not
better then what we can observe at the nano-scale.

The CDC, and hospitals, are primarily turning to better processes. Ensuring
that central line catheters are routinely cleaned, no clots are forming,
little things like that. Try and identify any clots early to give maximum time
to get a new catheter. Conduct additional testing to look for infections and
treat as early as possible. Those are all things that hospitals can easily do
and have been doing quiet well, it's just not enough. Catheters are incredibly
price sensitive, they are treated like a commodity and no one wants to pay any
extra then they have too. Adding and additional few pennies to the overall
cost would have hurt us a few years ago. But the Affordable Care Act is our
friend, ANY infection that a patient can connect to a hospital (whether it's
the hospitals fault or not) has to be treated and paid for by the hospital.
All of a sudden a few extra pennies now can save a hospital tens of thousands
later. Our financial story won't depend on an out-price cost comparison, but a
reduction of later hospital expenses (not sure the correct finance term for
that).

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chadnickbok
This sounds _awesome_

You mentioned that your process doesn't require a clean room. What are the
regulations around getting a catheter "approved" for human use? Do you need to
run some expensive trials or is this something that you can scoot around?

ie. If I wanted to use your catheters tomorrow, other than a repeatable
manufacturing process whats stopping me from ordering a few thousand and
putting them to use?

~~~
jonwachob91
We know that it does need FDA approval and trials. What we are hoping is that
we can file what is known as a 510(k). A 510(k) is a process where we tell the
FDA "Hey look at these guys, we are doing pretty much the same thing" and we
can skip most of the hard and expensive part. We don't know yet if we can file
a 510(k) or if we need to go through the whole process.

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giarc
I work in infection control and conduct CLABSI and SSI surveillance daily.
Have you tested your application method on implants?

~~~
jonwachob91
I'm assuming you mean stents and artificial heart valve type implants. The
short answer is no, however we have identified those implants and want to
research applications on them when we have the resources to do so.

If you mean something else can you clarify?

Thank you for the question!

~~~
giarc
Prosthetic joints and ortho hardware (pins, rods, screws).

~~~
jonwachob91
We haven't explored an application for ortho hardware and I don't know that
much about the space. But I'll certainly go out and learn more, and when I say
me I mean I'll ask a guy who has been helping us who has his masters
(w/thesis) in Orthopedic Biomedical Engineering. Hell maybe he can even us
that as his topic for his Ph.D :D

~~~
giarc
It's a huge area. In 2011 there were nearly 1 million total joint replacement
procedures in the US alone (that doesn't include many other type of procedures
involving hardware)[1]. Rates of infection are around 1-2% depending on the
joint. Many infections can be treated with antibiotics, but many need the
joint replaced. Replacement means another procedure that carry risks and
costs. Therefore, prevention of these infections is key. Most of these
infections occur as a result of biofilm formation on the surface of the
artificial joint. Seeding of these biofilms occurs either through break in
sterile practice during the operative procedure or from a BSI or some other
systemic infection. Either way, surface improvements could drop the SSI rate,
and therefore drop associated costs.

1 -
[http://orthoinfo.aaos.org/topic.cfm?topic=a00233](http://orthoinfo.aaos.org/topic.cfm?topic=a00233)

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asakurasol
Probably my favorite so far. What is the business model and how do you get
your first customer?

~~~
jonwachob91
Thank you for the vote of confidence :)

The first customer is our easy part. We've already signed up Florida Hospital,
the nations largest hospital (3,282 beds at one campus) to agree to be our
clinical trial partner when we are ready. Obviously that's a ways away, but
they are on board. IF the trials are successful they'll be our first customer.

The business model is something we don't know about yet. Using the YC
Fellowship money we want to go out and further understand where we fit in; can
we license, do we need to do this ourselves, what is the most profitable
business model, what is the lost cost to market model, etc. We haven't been on
this for very long, it was over a year that we spent trying to figure out were
we fit into the solar market (with no funding) before we learned it's not a
good market just because a $20 price increase per panel. It was 2 months ago
that we pivoted to infection resistant materials and wanted to find out if the
science worked. Well it does and now we feel comfortable committing real cash
into understanding our model.

~~~
giarc
My humble opinion, this is a license play. You don't want to get into
manufacturing catheter's. Leave that to Bard et al and let them implement your
process.

~~~
jonwachob91
You may be correct, but playing this out. GE isn't in the catheter business,
maybe they are willing to commit cash for an acquisition so that they can get
into the catheter business. With a powerful strategic partner manufacturing
may be the way to go.

But that's one of the things we need to learn - are there any big players not
in the market that want in and will commit real money to do it?

I'd rather not lose money because we didn't do that work now. At the same
time, what is a Cook Medical and a Bard looking for in a license? Where do we
need to be at, what tests do they want data for? Are they looking to invest in
the catheter space?

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phillc73
I've just spent almost three weeks in hospital.

I went in for routine elective surgery and a two night stay. I ended up in for
around three weeks after post-operation infection. Fortunately, it wasn't MRSA
and easily controlled with antibiotics (some of which I had a bad reaction
to.... good times). At home now, but still having the dressings changed on
open wounds.

This idea gets a big up vote from me. Reducing the risk of infection could
have had a massive positive impact on my life over the last month.

~~~
jonwachob91
Did the hospital tell you what the source of the infection was?

~~~
phillc73
No, and I'm not sure they knew.

Basically, I had the operation, spent two nights in hospital and came home for
two nights. The second night at home I had severe headache, elevated
temperature, swelling around one of the wounds, redness and heat. Basically,
the fun of an infection.

Back to hospital, they cut me open, cleaned me up, put me on IV antibiotics
and kept me in for another two weeks.

I suppose the infection could have been something I picked up at home or could
have been some instrument not properly sterilised. The surgeon said they have
about one in 10,000 who get an infection after the type of operation I had. If
it was poor sterilisation in the workflow somewhere, I could hope your startup
might have been able to have reduced the risk there.

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buss
This sounds very promising to me, but I know almost nothing about this field.

How does the cost of one of your textured catheters compare to the cost of an
existing catheter? Would the additional savings in antibiotics and deaths
negate that cost?

Do you have an estimate of how many fewer infections would result from using
your textured catheter? (I don't know if infections only happen if you cross
some threshold on the number of bacteria.)

Do you have anything you can share with actual numbers and analysis? Has an
outside lab reproduced your findings?

~~~
jonwachob91
1\. Ours does cost a few pennies more, which is a big deal for catheters. ANY
increase is hurtful. HOWEVER the Affordable Healthcare Act works in our favor.
Any infection that a patient develops and can connect to the hospital,
regardless if it's the hospital's fault or not, has to be paid for by the
hospital. This treatment can often cost tens of thousands of dollars. It's
better to spend a few extra pennies now and avoid spending tens of thousands
later.

2\. Really god question that we aren't sure about yet. As we learn more we
expect to be able to answer this.

3\.
[https://www.dropbox.com/s/dqnl3d7dalj08yo/Preliminary%20Data...](https://www.dropbox.com/s/dqnl3d7dalj08yo/Preliminary%20Data.docx?dl=0)
<\- a quick 1.5 pager about how we did the testing. Remember these were
preliminary tests. An outside lab has not tested to replicate our results, we
are a little early for that, but we are actively looking for university
research labs that we can do sponsored research through to help with a lot of
the testing.

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d--b
This sounds pretty great. The question I would have is whether the nano
texture may or may not damage the inside of the body. Will it tear the tissue
it's going through in a different manner than a non textured material. This
could make the insertion harder and the healing process longer.

~~~
jonwachob91
It shouldn't. The nanotexture pattern we used on the preliminary testing was
super-hydrophobic, the texture pattern we are going begin testing in a few
weeks _should_ be ultra-hydrophobic. These high phobicity rates mean they are
slick and minimize friction. Tissue should slide across the nanostructures
with minimal friction and no damage.

------
ph0rque
Can you use the same technique to produce mold-resistant plastic for showers
and baths?

~~~
jonwachob91
YES!

But the grout has us a little confused. Ya know, because it's not plastic and
what not. We could make a film to place on top of your grout, but we aren't
sure about that yet. We are afraid that when we nanotexture the floor of a
shower (or apply a polymer film on top of the tile) that the surface will
become a hazard to someone trying to take a shower*.

I'd also like to see this on my toilet seat, so I can be lazy and not lift the
seat up (lol). We did do contact angel testing and imaging of urine on the
structures but left it out of our analysis since it didn't apply to catheters.
The contact angel's were GREAT, and the images looked good, but again we
didn't do a real analysis of the results.

EDIT: included the comment about nanotexturing the floor of a shower.

~~~
ph0rque
_We are afraid that when we nanotexture the floor of a shower (or apply a
polymer film on top of the tile) that the surface will become a hazard to
someone trying to take a shower_

You mean because it's slippery? If so, don't worry about it. My shower floor
(plastic, not tile) has ~millimeter-sized bumps that make it not slippery at
all.

