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FW: FDA Meeting Report
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FROM:
D
derrick@difusiontech.com
DATE:
2016-05-25 02:45:26
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<D36A8961.7A091%derrick@difusiontech.com>
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E
eschwerin@rosemontseneca.com
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H
hbiden@rosemontseneca.com
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Eric & Hunter, It took a few days for the hangover to wear off before I sent this outTeijin 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 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 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 ³FinallyA Medical Polymer Innovator² (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 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 > <1D44E4A7-AEC9-4D1E-A8ED-AAE1A3C8FDAD.png> > www.difusiontech.com <http://www.difusiontech.com> > > ³FinallyA Medical Polymer Innovator² > > (512) 863-7777 o > (512) 284-3338 c > > > > > > > <USPatent#3.pdf> > <1D44E4A7-AEC9-4D1E-A8ED-AAE1A3C8FDAD.png>
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FDA Meeting Report
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