EMAIL DETAILS
SUBJECT:
Re: FDA Meeting Report
PRI: NORMAL
FROM:
E
eschwerin@rosemontseneca.com
DATE:
2016-05-25 12:28:23
MSG_ID:
<8496910888138299047@unknownmsgid>
RECIPIENTS:
TO:
D
Derrick Johns
<derrick@difusiontech.com>
CC:
H
hbiden@rosemontseneca.com
CONTENT:
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PROCESSED
Thanks, Derrick. Congrats! Eric D. Schwerin eschwerin@rosemontseneca.com Sent from my iPhone On May 24, 2016, at 11:33 PM, Derrick Johns <derrick@difusiontech.com> wrote: Eric & Hunter, It took a few days for the hangover to wear off before I sent this out…Teijin 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 we’ll 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 million….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 Dad’s commencement speech online. It was an incredible speech and he didn’t look down one time, which led us to believe he had no teleprompter and was speaking from the heart. She said “he should be President..” - West Point SMART! Erynn Johns future West Point Cadet - Erynn Johns Goal - Texas States <http://www.nfhsnetwork.com/clips/uil/84770b8932/c42d03161d5d3567ee1302205de6bf76> - Goal 2 Header - Earned Corner <http://www.nfhsnetwork.com/clips/uil/84770b8932/d5dd0c8f539a826a8bc0381d31299f5b> Had to add those shes 6’1 and left footed with a 4.8 forty time and pretty awesome. Buba’s adoptive father Don Gemmell made her so I helped him with his son Buba. Derrick W. Johns CEO and Founder <1D44E4A7-AEC9-4D1E-A8ED-AAE1A3C8FDAD[14].png> www.difusiontech.com “Finally…A Medical Polymer Innovator” (512) 863-7777 o (512) 284-3338 c On May 24, 2016, at 2:08 PM, Derrick Johns <derrick@difusiontech.com> 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 “*Osteoconductive Claim*” 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 <1D44E4A7-AEC9-4D1E-A8ED-AAE1A3C8FDAD.png> www.difusiontech.com “Finally…A Medical Polymer Innovator” (512) 863-7777 o (512) 284-3338 c <USPatent#3.pdf> <1D44E4A7-AEC9-4D1E-A8ED-AAE1A3C8FDAD.png> <1D44E4A7-AEC9-4D1E-A8ED-AAE1A3C8FDAD[14].png
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