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August 13, 2012
To the Shareholders of Intellieell Bioscienccs, Inc.:
It has been over a year since we completed our reverse merger with Media Exchange
Group, Inc. There have been a number of exciting events that have taken place, and I
would like to share and summarize some of them for you.
First, we are now quoted on the OTCQB under the symbol SVFC. Secondly, we have
opened our flagship location, which consists of a new, state-of-the-art medical, surgical
and tissue processing facility located at 460 Park Avenue in New York City. This new
facility houses not only our corporate headquarters but also the Regen Medical practice
(which is managed by the Company), 4 physician offices, 2 AAAA surgical suites and a
cGTP tissue processing laboratory. This facility will also be staffed by several physicians
of varying disciplines, including, a part time internist, sports medicine orthopedists, as well
as a pain management doctor. Our tissue processing cGTP lab just underwent an
independent FDA audit by our outside consultants and is fully compliant with all Food and
Drug Administration ("FDA") standards.
We have added two new members to our staff, Ms. Sarah Young, our Quality Assurance
Director, and Mr. Robert Sexauer, our EVP of Clinical Research. These skilled
professionals have brought many years of experience with them to the Company which has
allowed us to build on the foundation of what we believe will be our future success —
having the necessary quality assurance in place for our proposed programs and tissue
processing laboratory, and coordinating clinical research projects and protocols with
academic institutions and medical centers.
We have also been fortunate to put together what we think is one of the best advisory
boards of any company in our field, consisting of both medical and other professionals that
possess insight and significant experience in the emerging market for regenerative
medicine, as well as the potential areas of application of our proprietary, patent pending
process technology.
FDA Update
Since receiving the warning letter from the FDA on March 13, 2012 (the "Warning
Letter"), we have worked continuously and closely with our outside consultants, as well
as our FDA regulatory counsel, to address all the issues set forth in the Warning Letter.
On May 23, 2012, we met with the FDA to present an overview of our technology and
our new cGTP facility. Management and our outside consultants believe the meeting was
positive and we will continue to work with the FDA to make the Company fully compliant
with all FDA rules and regulations. We are confident that we will be able to meet FDA
requirements under section 361 of the Public Health Act and/or 21 CFR 1271.15, continue
to treat patients and, mostly importantly, have a FDA compliant cGTP tissue processing
lab.
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In addition, we are very excited to report that the first study of cells generated by our
patent pending proprietary process has commenced at the University of Florida, and we
hope to have results that we can publish shortly. We continue to engage in discussions for
other studies with additional academic institutions and medical centers.
Significant Developments
• We have registered our common stock pursuant to Section 12(g) of the Securities
Exchange Act of 1934 and our periodic filings with the SEC are current and up to
date (our amended Annual Report on Form 10-K for the fiscal year ended
December 31, 2011 was filed on April 23, 2011 and our most recent Quarterly
Report on Form 10-Q for the quarterly period ended March 31, 2012 was filed on
May 21, 2012).
• In addition, we have signed licenses with partners covering the territories of
Canada, Australia and New Zealand, and Thailand, from which we have received
investments and/or licensing revenue totaling approximately $1.2 Million to date.
The lab in Sydney Australia has treated over 30 patients so far and growing.
• Our technology has been featured in a MI page article in New York Daily News
that was written by Sean Brennan and published on February 19, 2012 - Manhattan
basketball's Torgrim Sommerfeldt turned to stem cell treatment to get him back on
court. (http://www.nydailynews.com/sports/college/manhattan-basketball-torgrim-
sommerfeldt-tumed-stem-cell-treatment-back-court-art icle-1.1025227).
• In addition, we were invited to demonstrate our stromal vascular fraction
technology at the Baseball Injuries Symposium at the Andrews Sports Medicine
Institute in Birmingham, Alabama, held and sponsored by USA Baseball in
February 2012.
• We recently filed a provisional patent, titled "ISOLATION OF STROMAL
VASCULAR FRACTION FROM NON-LIVING ADIPOSE TISSUE USING
ULTRASONIC CAVITATION" that we believe could expand the field of cellular
therapy, and specifically, research in adipose stromal vascular fraction (SVF).
Our Business Model
During the fiscal year ended December 31, 2012 and beyond, we believe we will have up
to four different sources of revenues. The first source of revenue is our new flagship
center where we currently manage the Regen Medical, PC practice and the ambulatory
operating rooms and will be operating our tissue processing laboratory. We will also be
seeking to acquire other ambulatory surgical centers (ASC) in other major cities and add
our cGTP cellular processing labs. Our goal is to have these centers provide topline
revenue as well as bottom line profits, and, with our tissue processing labs we believe we
will increase both.
Additional sources of revenue are currently anticipated to include revenue tiom the
following:
• International licenses for the use of our patent pending proprietary process.
• The collection, processing and storage of autologous cells for future use.
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• The licensing of our technology indications that we are not focused on in
collaboration with other partners in the regenerative medicine field.
In addition, the patent we recently filed for our discovery for processing SVF from non-
living tissue may yield an additional source of revenue from the sale of SVF to
researchers.
Since we have become a publicly traded reporting company, we have taken the foundation
upon which this business is being built, our core proprietary patent pending technology,
and made great strides thanks to your help and continued support. We believe that we
now on the road to developing an exciting regenerative medicine business that will help
people in the figure from other invasive medical procedures. I am proud of the
organization of physicians, business people and scientists that have joined the Company to
be a part of this exciting new technology in medicine and thank all of them for their
continued support.
I am proud of the organization of physicians, business people and scientists that have
joined Intellicell Biosciences to be a part of this exciting new technology in medicine, and
thankful for all of your support. You have my commitment and the commitment of every
employee here that we will keep working hard to create increasing shareholder value. We
have come a long way together and I want you all to know how much we value each and
every one of you. As a shareholder, I hope that you arc pleased and excited with the
progress that the Company has made to date, and I look forward to sharing the
Company's future and anticipated medical, scientific and financial events that we expect
will add to the growth of our Company.
We appreciate the support you have shown to the Company over the last year and look
forward to your continued support as we work to grow and develop our business with the
goal of providing value to you as shareholders of the Company.
Sincerely,
Steven Victor MD
Chairman/CEO
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ℹ️ Document Details
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66b8718a08d4e0debc3091501face0d76f1d4bea893192fb15b83d5d87ad0e99
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EFTA02700799
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