Subject: FW: FDA Meeting Report
From: "Derrick Johns" <[email-masked]>
To: <[email-masked]>
Cc: <[email-masked]>
Date: Tue, 24 May 2016 22:45:26 -0400

Eric & Hunter,

It took a few days for the hangover to wear off before I sent this
outŠTeijin Pharma, Genzyme and Zimmer already engaged on the same news.
The claim I reference below was surprise as we will be the first and only
medical polymer that can claim bone growth and antimicrobial properties.
Ibankers say We are starting at $150mm and we¹ll see where it goes.    We
want more at the table like Medtronic and J&J.  we have about 11 million
shares out so I think you two will be well looked after for the help with
China and further introductions.

John was amazing we got on very well and may do some work for a green card
program for investors who invest more than $1 millionŠ.for which he also got
a warrant retainer.:))

He has also been great in guiding us to John Carter whose Chief of Staff
Jonas Miller is currently working with John, so Buba has a good chance of
actually getting home and when he does ESPN is planning on doing a feel good
story.   You put all that in motion and did not need too.   I thank you for
that.

Hunter by the way my eldest daughter Erynn Is headed to West Point as a
soccer recruit (see below) - she cried when she watched your Dad¹s
commencement speech online.   It was an incredible speech and he didn¹t look
down one time, which led us to believe he had no teleprompter and was
speaking from the heart.  She said ³he should be President..² - West Point
SMART!

Erynn Johns future West Point Cadet
* Erynn Johns Goal - Texas States
<http://www.nfhsnetwork.com/clips/uil/84770b8932/c42d03161d5d3567ee1302205de
6bf76> 
* Goal 2 Header - Earned Corner
<http://www.nfhsnetwork.com/clips/uil/84770b8932/d5dd0c8f539a826a8bc0381d312
99f5b> 
Had to add those shes 6¹1 and left footed with a 4.8 forty time and pretty
awesome.  Buba¹s adoptive father Don Gemmell made her so I helped him with
his son Buba.

Derrick W. Johns
CEO and Founder
www.difusiontech.com

³FinallyŠA Medical Polymer Innovator²

(512) 863-7777 o
(512) 284-3338 c

 
On May 24, 2016, at 2:08 PM, Derrick Johns <[email-masked]> wrote:

> CONFIDENTIAL
> 
> Dear Shareholders,
> 
> On Friday May 21st at 1:30 pm we held our FDA Pre Submission Meeting face to
> face with our FDA review Panel in Maryland the following people were in
> attendance;
> 
> DiFUSION Technologies, Inc.
> 
> €Derrick W. Johns, CEO
> €Joe Crudden, Ph.D., Senior VP R&D
> €Sriram Sankar, M.S., R&D Director
> €Daniel George, M.D., Board Certified Orthopedic Surgeon
> €Lisa Ferrara, Ph.D., Biomechanical Consultant (via telephone)
> 
> 
> Hogan Lovells US LLP (Our Regulatory Counsel)
> 
> €John Smith, M.D., J.D., Partner
> http://www.hoganlovells.com/john-smith
> Megana Sankaran, M.P.H., Regulatory Affairs Specialist
> 
>     I am extremely happy to report the meeting went better than expected in
> that and we affirmed that ZFUZE is in fact a bona fide 510(k) pathway with FDA
> and that our rabbit data was substantial enough in conjunction with a sheep
> study to warrant an ³Osteoconductive Claim² which no other medical polymer in
> the world can presently claim.   This is exaclty what our recently issued IP
> covers(attached) and what the current spine market has been demanding.   We
> will be relaunching our current web site to reflect these events in the next
> several weeks and doing at major press release as well.
> 
>    Additionally, we will now commence our validation of production for the US
> Launch of ZFUZE and complete the final testing required for our ZFUZE 510(k)
> submission with Osteoconductive Claims.
> 
>   To be clear, this is the news our shareholders, management team and
> potential industry suitors have been waiting a very long time to hear.   Any
> future C series financing for DiFusion will be conducted at a vastly increased
> enterprise value, as the B Series round is NOW CLOSED.   Hence, those A series
> Investors who still hold A Series Warrants may want to exercise those warrants
> immediately as the expiration is imminent.   Please contact me directly if you
> wish to do so.  
> 
> ** We have also been allowed a second patent  for ZFUZE which is in the
> process of issuing.   I will circulate that in a week or so when it does
> issue.
> 
> Derrick W. Johns
> CEO and Founder
> www.difusiontech.com <http://www.difusiontech.com>
> 
> ³FinallyŠA Medical Polymer Innovator²
> 
> (512) 863-7777 o
> (512) 284-3338 c
> 
> 
> 
>  
> 
> 
> <USPatent#3.pdf>