📄 Extracted Text (863 words)
From: Jean Luc Brunel <
To: "[email protected]" <[email protected]>
Subject: Re: FDA Registration and validation
Date: Thu, 08 Nov 2012 21:22:20 +0000
At least I have a book from stefan Zweig. Wonders of life. I hope this is the right translation
From: Jean Luc Brunel
Sent: Thursday, November 08, 2012 04:00 PM
To: [email protected] <[email protected]>
Subject Fw: FDA Registration and validation
It might interest you
lust arrived in Riga without suitcase and rain rain. Lovely
From: Steven Victor MD [mallto
Sent: Thursday, November 08, 2012 03:54 PM
To:
Subject: FDA Registration and validation
Dear Shareholder, Investor and Friends
Today we received our FDA Establishment Registration Certificate and the FDA validated us under CFR 1271.10
Look at our press release and this is GREAT news for all of us
And I want to thank the team, lawyers, consultants and shareholders for all their support and hard work
IntelliCell BioSciences Announces FDA Listing For Human
Cells, Tissues, and Cellular Based Products
NEW YORK, November 8, 2012 -- IntelliCell BioSciences, Inc. ("Company") (SVFC) announced today that it has been
notified according to the FDA validation registration number 3009842420, that its new facility located at 460 Park
Avenue, New York, NY 10022 is now registered to recover, process, package, store, and label human cells and tissue
products (HCT/P's) such as the IntelliCell autologous stromal vascular fraction cellular product. In the registration
notification, FDA acknowledged that the IntelliCell process is to be covered under regulations for tissue products..
The HCT/P regulations are described in 21 CFR section 1271.10s
IntelliCell's Chairman and CEO, Dr. Steven Victor, stated "Our Company is very pleased to announce today that our
new cellular processing facility has now been registered to process an individual's own tissue for the purpose of
acquiring their stem and regenerative cells for use in regenerative medicine. The IntelliCell processing technology is
designed to allow physicians to treat their patients during a same day and same procedure basis much the same way
that bone marrow transplants and IVF treatments are performed today. This is a significant step for the Company as
it continues its mission to be a leading regenerative medicine company. We look forward to continuing to work with
FDA as we prepare a number of clinical studies for disease states with high unmet clinical needs."
Robert Sexauer, EVP of Clinical Development stated "We can now begin to move forward with our plans for in-
human clinical studies such as lower limb ischemia by applying to Institutional Review Boards (IRB's) with study
EFTA00633529
protocols and laboratory processes that will be compliant with the federal and state regulations. By operating under
regulations for 21 CFR 1271.10 regulations, similar to autologous tissue transplants, we may be able to prepare a
number of regenerative medicine projects and we look forward to working with FDA to meet any and all
requirements."
About IntelliCell BioSciences
IntelliCell BioSciences is a Regenerative Medicine company developing novel technologies that address the
regenerative, curative, and preventative conditions of disease states with high unmet clinical needs. The Company
has several patent pending applications including an industry unique method of obtaining autologous stromal
vascular fraction cells (SVF) from the vasculature surrounding adipose tissue containing adult stem cells and a robust
population of regenerative healing cells. The Company is also pioneering the development of autologous and
allogeneic cells from living and non-living tissue donors for research purposes. IntelliCell is planning a series of in-
human clinical studies with top tier universities for the treatment of osteoarthritis, multiple sclerosis, lower limb
ischemic wounds, and gum regeneration in the oral cavity as well as medical aesthetics. The Company has developed
a first in class cGTP cellular processing facility in New York City, purpose built and designed to be fully integrated
into its ambulatory surgery center.
Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements." Forward-looking
statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results,
performance or achievements, and may contain the words "estimate," "project," "intend," "forecast," "anticipate,"
"plan," "planning," "expect," "believe," "will likely," "will reach," "will change," "will soon," "should," "could," "would,"
"may," "can" or words or expressions of similar meaning. Such statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause the company's actual results and financial position to differ
materially from those included within the forward-looking statements. Forward-looking statements involve risks and
uncertainties, including those relating to the Company's ability to grow its business. Actual results may differ
materially from the results predicted and reported results should not be considered as an indication of future
performance. The potential risks and uncertainties include, among others, the Company's limited operating history,
the limited financial resources, domestic or global economic conditions, activities of competitors and the presence of
new or additional competition, and changes in Federal or State laws. More information about the potential factors
that could affect the Company's business and financial results is included in the Company's filings, available via the
United States Securities and Exchange Commission.
Contacts:
IntelliCell BioSciences, Inc.
Angela Metelitsa
Email Contact:
EFTA00633530
Steven Victor MD
IntelliCell BioSciences
Chairman/CEO
460 Park Avenue 17th Floor
New York, New York 10022
212-249-3050
Fax
Cell
EFTA00633531
ℹ️ Document Details
SHA-256
9a2236cf76ec117d66b63af86f3af6a7519485797a930660a38368f9db398739
Bates Number
EFTA00633529
Dataset
DataSet-9
Document Type
document
Pages
3
Comments 0