Subject: FW: NASS follow-up
From: "Derrick Johns" <[email-masked]>
To: <[email-masked]>
Cc: <[email-masked]>
Date: Wed, 19 Nov 2014 09:00:35 -0700

NuVasive is likely the best company in Spine and they have ³plain PEEK²
implants - $800 million per year at risk to CleanFuzeŠ.and they know it.

From:  Frank Vizesi <[email-masked]>
Date:  Monday, November 17, 2014 at 7:09 PM
To:  Derrick Johns <[email-masked]>, Joe Crudden <[email-masked]>
Cc:  Augustus Denis <[email-masked]>
Subject:  RE: NASS follow-up

Very trueŠ yes the infections are usually from ³another surgeon on the other
side of town². But in all seriousness, I do agree that the stats speak for
themselves, and your timing couldn¹t be much better with all the changes to
Medicare that are coming.
 
Thanks again,

Frank Vizesi, PhD
Director, R&D, Biologics|NuVasive, Inc.|Speed of Innovation
direct.858-638-5561|fax.858-638-6561|mobile.858-699-1211|email.
[email-masked]
7475 Lusk Boulevard|San Diego|CA|92121

From: Derrick Johns [mailto:[email-masked]]
Sent: Monday, November 17, 2014 6:46 PM
To: Frank Vizesi; [email-masked]
Cc: Augustus Denis
Subject: Re: NASS follow-up

Thanks Frank,

We will certainly take these into consideration.  As we said a post-market
patient registry would likely be the best way to accomplish this given the p
value required to be statically significant for infection.  This would give
us the data to push large market shifts through the Kaisers and HCA¹s of the
world.   Even the FDA concurs with this methodology, and will grant an
antimicrobial claim and antibiofilm now.   We believe the osteoconductive
properties are significant enough on their own to convert or maintain
surgeons on an individual basis.   As you may have heard surgeons cite, ³I
don¹t have an infection problemŠ² which is odd given the statsŠ.  Hence, the
dual claim of antimicrobial (for C-Suite Contracting) and osteoconduction
(individual surgeons, as it is far better than ³plain PEEK² and gives you a
viable answer for Ti endplated PEEK competitors).

Rare is the technology that gives you a selling points in the C-Suite and
the OR with surgeons and risk managers.

You should see an email from Christina for clinical data soon.

Derrick W. Johns

CEO and Founder

www.difusiontech.com <http://www.difusiontech.com>

"All Truths are easy to understand once discovered,

             the point is to discover them²  - Galileo

(512) 863-7777 o

(512) 284-3338 c

 

From: Frank Vizesi <[email-masked]>
Date: Monday, November 17, 2014 at 6:27 PM
To: "[email-masked]" <[email-masked]>, Derrick Johns
<[email-masked]>
Cc: Augustus Denis <[email-masked]>
Subject: NASS follow-up

Derrick and Joe,

Great to meet you at NASS.  Thanks for taking the time out of your busy
schedules.
 
Looking forward to continuing discussions and further review of your data.
As a reminder, our biggest challenge is predicting the clinical
effectiveness and putting it into context with the available clinical
literature to determine the clinical opportunity.  As promised, I am
following up with a couple of relevant clinical papers.  One might consider
building the case for the clinical opportunity by stratifying the data in
these papers to focus on the higher risk categories (e.g. multi-level
cases), and those in which MIS techniques are not available.
 
With regards,
 
Frank Vizesi, PhD
Director, R&D, Biologics|NuVasive, Inc.|Speed of Innovation
direct.858-638-5561|fax.858-638-6561|mobile.858-699-1211|email.
[email-masked]
7475 Lusk Boulevard|San Diego|CA|92121